{ "snapshot": "2026-08-23", "reviewed": "2026-09-18", "fiscalYears": [ 2020, 2021, 2022, 2023, 2024, 2025 ], "unit": "Sum of FDA published citation frequencies across all Bioresearch Monitoring sheets; not clinical-investigator inspections, unique sites, trials or participants", "sourceRows": 479, "totalFrequency": 1715, "byReference": { "21 CFR 312.60": 522, "21 CFR 312.62(b)": 271, "21 CFR 312.64(b)": 71, "21 CFR 312.62(a)": 63, "21 CFR 312.66": 52, "21 CFR 312.50": 43, "21 CFR 56.115(a)(2)": 40, "21 CFR 50.20": 28, "21 CFR 50.27(a)": 27, "21 CFR 56.108(a)(1)": 24, "21 CFR 58.81(a)": 20, "21 CFR 58.35(b)(5)": 19, "21 CFR 56.115(a)(5)": 17, "21 CFR 56.108(c)": 15, "21 CFR 58.63(a)": 15, "21 CFR 312.62(c)": 14, "21 CFR 312.20(a)": 14, "21 CFR 58.33(b)": 13, "21 CFR 58.33(f)": 13, "21 CFR 58.130(a)": 12, "21 CFR 58.35(b)(1)": 12, "21 CFR 58.35(b)(6)": 10, "21 CFR 58.185(a)(9)": 10, "21 CFR 312.56(c)": 10, "21 CFR 50.25(a)(1)": 9, "21 CFR 312.56(b)": 9, "21 CFR 58.81(b)": 9, "21 CFR 56.106(e)": 9, "21 CFR 312.57(a)": 8, "21 CFR 58.190(a)": 8, "21 CFR 56.108(b)(2)": 8, "21 CFR 58.130(c)": 8, "21 CFR 58.31(f)": 8, "21 CFR 58.33(a)": 8, "21 CFR 58.35(a)": 8, "21 CFR 58.33(c)": 7, "21 CFR 50.25(c)": 7, "21 CFR 56.115(b)": 7, "21 CFR 56.115(a)(6)": 6, "21 CFR 58.107": 6, "21 CFR 56.110(c)": 6, "21 CFR 50.25(a)(2)": 6, "21 CFR 50.25(a)(5)": 6, "21 CFR 56.109(f)": 5, "21 CFR 58.90(g)": 5, "21 CFR 56.115(a)(3)": 5, "21 CFR 50.27(b)(2)": 5, "21 CFR 50.25(a)(4)": 5, "21 CFR 312.53(c)(1)": 5, "21 CFR 312.56(a)": 5, "21 CFR 58.83": 5, "21 CFR 58.35(b)(3)": 5, "21 CFR 56.107(e)": 4, "21 CFR 58.29(a)": 4, "21 CFR 58.185(a)(12)": 4, "21 CFR 56.108(b)(1)": 4, "21 CFR 50.55(f)": 4, "21 CFR 50.55(e)(2)": 4, "21 CFR 50.25(a)(6)": 4, "21 CFR 50.25(a)(8)": 4, "21 CFR 58.29(b)": 4, "21 CFR 56.108(b)(3)": 4, "21 CFR 58.35(b)(7)": 3, "21 CFR 58.51": 3, "21 CFR 58.63(c)": 3, "21 CFR 56.110(b)(2)": 3, "21 CFR 312.59": 3, "21 CFR 312.64(d)": 3, "21 CFR 312.57(c)": 3, "21 CFR 56.110(b)": 3, "21 CFR 58.120(b)": 3, "21 CFR 58.185(a)(10)": 3, "21 CFR 58.190(b)": 3, "21 CFR 58.33": 3, "21 CFR 312.20(b)": 3, "21 CFR 58.113(a)(1)": 3, "21 CFR 58.185(c)": 3, "21 CFR 58.130(e)": 3, "21 CFR 312.53(b)": 3, "21 CFR 50.25(a)(7)": 2, "21 CFR 58.10": 2, "21 CFR 58.61": 2, "21 CFR 58.90(b)": 2, "21 CFR 58.185(a)(13)": 2, "21 CFR 56.109(b)": 2, "21 CFR 56.115(a)(4)": 2, "21 CFR 56.115(a)(1)": 2, "21 CFR 56.109(a)": 2, "21 CFR 58.31(e)": 2, "21 CFR 58.185(a)(11)": 2, "21 CFR 58.195(b)": 2, "21 CFR 56.103(a)": 2, "21 CFR 312.6(a)": 2, "21 CFR 58.31(g)": 2, "21 CFR 58.105(c)": 2, "21 CFR 58.185(a)(4)": 2, "21 CFR 56.107(d)": 2, "21 CFR 56.110(b)(1)": 2, "21 CFR 56.109(e)": 2, "21 CFR 58.185(a)": 2, "21 CFR 58.190(c)": 2, "21 CFR 56.113": 2, "21 CFR 58.105(d)": 2, "21 CFR 312.55(a)": 2, "21 CFR 312.68": 2, "21 CFR 58.90(f)": 2, "21 CFR 58.120(a)(4)": 2, "21 CFR 58.185(a)(7)": 2, "21 CFR 58.41": 2, "21 CFR 58.31(c)": 1, "21 CFR 58.120(a)": 1, "21 CFR 56.107(a)": 1, "21 CFR 56.111(c)": 1, "21 CFR 312.58(a)": 1, "21 CFR 56.107(f)": 1, "21 CFR 58.45": 1, "21 CFR 58.81(c)": 1, "21 CFR 58.90(h)": 1, "21 CFR 58.120(a)(9)": 1, "21 CFR 58.190(d)": 1, "21 CFR 312.52(a)": 1, "21 CFR 56.106(c)": 1, "21 CFR 58.29(c)": 1, "21 CFR 58.35(b)(4)": 1, "21 CFR 58.185(a)(14)": 1, "21 CFR 56.104(c)": 1, "21 CFR 50.52": 1, "21 CFR 312.69": 1, "21 CFR 58.31(b)": 1, "21 CFR 58.49": 1, "21 CFR 56.108(a)(4)": 1, "21 CFR 56.108(a)(3)": 1, "21 CFR 56.108(a)(2)": 1, "21 CFR 50.25(b)(1)": 1, "21 CFR 312.53(c)(2)": 1, "21 CFR 312.57(d)": 1, "21 CFR 312.57(b)": 1, "21 CFR 312.55(b)": 1, "21 CFR 312.7(b)": 1, "21 CFR 56.106(b)(2)": 1, "21 CFR 56.106(b)(3)": 1, "21 CFR 58.31(d)": 1, "21 CFR 58.90(a)": 1, "21 CFR 58.120(a)(6)": 1, "21 CFR 58.120(a)(7)": 1, "21 CFR 58.120(a)(8)": 1, "21 CFR 58.120(a)(11)": 1, "21 CFR 58.185(a)(5)": 1, "21 CFR 58.185(a)(6)": 1, "21 CFR 56.107(c)": 1 }, "byYear": { "2020": { "rows": 79, "frequencyTotal": 221, "all31260": 58, "protocol7560": 54, "caseHistory31262b": 30, "irbMinutes56115a2": 7, "sponsor31257AllSubsections": 4 }, "2021": { "rows": 63, "frequencyTotal": 249, "all31260": 90, "protocol7560": 84, "caseHistory31262b": 48, "irbMinutes56115a2": 1, "sponsor31257AllSubsections": 1 }, "2022": { "rows": 87, "frequencyTotal": 298, "all31260": 77, "protocol7560": 70, "caseHistory31262b": 36, "irbMinutes56115a2": 13, "sponsor31257AllSubsections": 0 }, "2023": { "rows": 78, "frequencyTotal": 301, "all31260": 104, "protocol7560": 94, "caseHistory31262b": 49, "irbMinutes56115a2": 7, "sponsor31257AllSubsections": 2 }, "2024": { "rows": 81, "frequencyTotal": 312, "all31260": 104, "protocol7560": 99, "caseHistory31262b": 56, "irbMinutes56115a2": 9, "sponsor31257AllSubsections": 5 }, "2025": { "rows": 91, "frequencyTotal": 334, "all31260": 89, "protocol7560": 80, "caseHistory31262b": 52, "irbMinutes56115a2": 3, "sponsor31257AllSubsections": 1 } }, "31260Rows": [ { "year": 2020, "citeId": "7560", "description": "FD-1572, protocol compliance", "frequency": 54 }, { "year": 2020, "citeId": "7562", "description": "Informed consent", "frequency": 4 }, { "year": 2021, "citeId": "7560", "description": "FD-1572, protocol compliance", "frequency": 84 }, { "year": 2021, "citeId": "7562", "description": "Informed consent", "frequency": 6 }, { "year": 2022, "citeId": "7560", "description": "FD-1572, protocol compliance", "frequency": 70 }, { "year": 2022, "citeId": "7562", "description": "Informed consent", "frequency": 7 }, { "year": 2023, "citeId": "7560", "description": "FD-1572, protocol compliance", "frequency": 94 }, { "year": 2023, "citeId": "7562", "description": "Informed consent", "frequency": 10 }, { "year": 2024, "citeId": "7560", "description": "FD-1572, protocol compliance", "frequency": 99 }, { "year": 2024, "citeId": "7562", "description": "Informed consent", "frequency": 5 }, { "year": 2025, "citeId": "7560", "description": "FD-1572, protocol compliance", "frequency": 80 }, { "year": 2025, "citeId": "7562", "description": "Informed consent", "frequency": 9 } ], "recordsSliceDefinition": [ "21 CFR 312.62(b)", "21 CFR 56.115(a)(2)" ], "recordsSliceTotal": 311, "sponsor31257AllSubsections": 13, "inputSha256": "524ff91283c6ef87d0484417e817dd22da7d7de4f203c08dbb21148aeeb94d5c", "limitations": [ "Program-wide frequency aggregate; selection of inspections and published observations is not a representative sampling frame.", "Same inspection can contribute multiple citations; public frequency sheets do not identify site/participant outcomes.", "312.60 includes protocol and consent citation IDs.", "Exact 312.57 matching would miss subsections.", "Records slice is explicitly narrow, not all documentation findings or central TMF findings." ], "hypotheticalModels": { "workload": { "preliminaryMinutes": 10, "laterBundleMinutes": 40, "passShares": [ 0.4, 0.6, 0.8 ], "expectedMinutes": [ 26, 34, 42 ], "limitations": "Planning assumptions; excludes travel, waiting, repeats and medical review. Activities must follow approved protocol and consent requirements." }, "labRatio": { "result": 72, "referenceLimits": [ 50, 45 ], "ratios": [ 1.44, 1.6 ], "threshold": 1.5, "meaning": "Hypothetical analyte and protocol; no clinical recommendation." }, "screeningFlow": { "episodesStarted": 100, "randomized": 30, "ineligible": 40, "withdrawn": 10, "unresolved": 20, "determinedEligibility": 70, "ineligibleShareOfStarted": 40, "ineligibleShareOfDetermined": 57.1 } }, "selectedFrequencyRows": [ { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7560", "reference_number": "21 CFR 312.60", "short_description": "FD-1572, protocol compliance", "long_description": "An investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan]. Specifically, ***", "frequency": "54", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7530", "reference_number": "21 CFR 312.62(b)", "short_description": "Case history records- inadequate or inadequate", "long_description": "Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data pertinent to the investigation] [informed consent]. Specifically, ***", "frequency": "30", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7526", "reference_number": "21 CFR 312.62(a)", "short_description": "Accountability records", "long_description": "Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects]. Specifically, ***", "frequency": "11", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7318", "reference_number": "21 CFR 56.115(a)(2)", "short_description": "Minutes of IRB meetings", "long_description": "Minutes of IRB meetings have not been [prepared] [maintained] in sufficient detail to show [attendance at the meetings] [actions taken by the IRB] [the vote on actions, including the number of members voting for, against and abstaining] [the basis for requiring changes in or disapproving research] [a written summary of the discussion of controverted issues and their resolution]. Specifically, ***", "frequency": "7", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7520", "reference_number": "21 CFR 312.64(b)", "short_description": "Safety reports", "long_description": "Failure to report [promptly] to the sponsor adverse effects that may reasonably be regarded as caused by, or probably caused by, an investigational drug. Specifically, ***", "frequency": "6", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3932", "reference_number": "21 CFR 58.35(b)(6)", "short_description": "QAU: review final study report", "long_description": "The quality assurance unit failed to review the final study report to assure that such report accurately described the methods and standard operating procedures, and that the reported results accurately reflected the raw data of the study. Specifically, ***", "frequency": "4", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7281", "reference_number": "21 CFR 56.108(a)(1)", "short_description": "Initial and continuing reviews", "long_description": "The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, ***", "frequency": "4", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7334", "reference_number": "21 CFR 56.115(a)(5)", "short_description": "List of members", "long_description": "A list of IRB members has not been [prepared] [maintained], identifying members by [name] [earned degrees] [representative capacity] [indications of experience sufficient to describe each member's chief anticipated contribution to IRB deliberations] [any employment or other relationship between each member and the institution]. Specifically, ***", "frequency": "4", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7482", "reference_number": "21 CFR 312.50", "short_description": "General responsibilities of sponsors", "long_description": "Failure to [select qualified investigators] [provide investigators with the information needed to conduct the study properly] [ensure proper monitoring of the study] [ensure the study is conducted in accordance with the protocol and/or investigational plan] [ensure that FDA and all investigators are promptly informed of significant new adverse effects or risks]. Specifically, ***", "frequency": "4", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7498", "reference_number": "21 CFR 312.66", "short_description": "Unanticipated problems", "long_description": "Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others. Specifically, ***", "frequency": "4", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7562", "reference_number": "21 CFR 312.60", "short_description": "Informed consent", "long_description": "Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to [drug administration] [conducting study-related tests]. Specifically, ***", "frequency": "4", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7290", "reference_number": "21 CFR 56.108(c)", "short_description": "Members present for review", "long_description": "For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. Specifically, ***", "frequency": "3", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7335", "reference_number": "21 CFR 56.115(a)(6)", "short_description": "Written procedures per 56.108(a) and (b)", "long_description": "Documentation has not been [prepared] [maintained] of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b). Specifically, ***", "frequency": "3", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7459", "reference_number": "21 CFR 312.57(a)", "short_description": "Records of receipt, shipment, disposition", "long_description": "Lack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an investigational drug. Specifically, ***", "frequency": "3", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7480", "reference_number": "21 CFR 312.50", "short_description": "Ensuring compliance with plan and protocol", "long_description": "Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND. Specifically, ***", "frequency": "3", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3920", "reference_number": "21 CFR 58.33(c)", "short_description": "Study director: unforeseen circumstances", "long_description": "The study director failed to assure that unforeseen circumstances that might affect the quality and integrity of the nonclinical laboratory study were noted when they occurred and corrective action was taken and documented. Specifically, ***", "frequency": "2", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3931", "reference_number": "21 CFR 58.35(b)(5)", "short_description": "QAU: authorize deviations from protocols or SOPs", "long_description": "The quality assurance unit failed to determine whether any deviations from approved protocols or standard operating procedures had been made with proper authorization and documentation. Specifically, ***", "frequency": "2", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3957", "reference_number": "21 CFR 58.81(a)", "short_description": "SOPs: laboratory methods", "long_description": "The testing facility does not have written standard operating procedures setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. Specifically, ***", "frequency": "2", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3989", "reference_number": "21 CFR 58.107", "short_description": "Test article: handling", "long_description": "Procedures have not been established for the handling of the test and control articles to ensure that [there is proper storage] [distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage] [proper identification is maintained throughout the distribution process] [the receipt and distribution of each batch is documented including the date and quantity of each batch distributed or returned]. Specifically, ***", "frequency": "2", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4007", "reference_number": "21 CFR 58.130(a)", "short_description": "Conduct: in accordance with protocol", "long_description": "Not all nonclinical laboratory studies were conducted in \naccordance with the protocol. Specifically, ***", "frequency": "2", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4035", "reference_number": "21 CFR 58.190(a)", "short_description": "Archives: data, documentation, specimens", "long_description": "Not all [raw data] [documentation] [protocols] [final reports] [specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids)] generated as a result of a nonclinical laboratory study were retained. Specifically, ***", "frequency": "2", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7227", "reference_number": "21 CFR 50.27(a)", "short_description": "Consent form not approved/signed/dated", "long_description": "Informed consent was not properly documented in that the written informed consent used in the study [was not approved by the IRB] [was not signed by the subject or the subject's legally authorized representative at the time of consent ] [was not dated by the subject or the subject's legally authorized representative at the time of consent]. Specifically, ***", "frequency": "2", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7278", "reference_number": "21 CFR 56.107(e)", "short_description": "Conflict of interest", "long_description": "The IRB allowed a member to participate in the IRB's [initial] [continuing review] of a project in which the member had a conflicting interest. Specifically, ***", "frequency": "2", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7293", "reference_number": "21 CFR 56.109(f)", "short_description": "Continuing review", "long_description": "The IRB does not conduct continuing review of research at intervals [appropriate to the degree of risk] [of not less than once per year]. Specifically, ***", "frequency": "2", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7392", "reference_number": "21 CFR 50.25(a)(7)", "short_description": "Whom to contact", "long_description": "The informed consent document lacked an explanation of whom to contact [for answers to pertinent questions about the research and research subjects' rights] [in the event of a research-related injury to the subject]. Specifically, ***", "frequency": "2", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7517", "reference_number": "21 CFR 312.66", "short_description": "Initial and continuing review", "long_description": "Failure to assure that an IRB [complying with applicable regulatory requirements] was responsible for the initial and continuing review and approval of a clinical study. Specifically, ***", "frequency": "2", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7531", "reference_number": "21 CFR 312.62(c)", "short_description": "Record retention", "long_description": "Investigational records were not retained for a period of two years following [approval of a drug's marketing application] [discontinuance of the investigation and notification of FDA]. Specifically, ***", "frequency": "2", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7666", "reference_number": "21 CFR 50.20", "short_description": "Understandable language", "long_description": "The general requirements for informed consent were not met in that the information given was not in language understandable to the subject or the subject's representative. Specifically, ***", "frequency": "2", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3900", "reference_number": "21 CFR 58.10", "short_description": "Notifying contractor of GLP status", "long_description": "Not all consulting laboratories, contractors, or grantees were notified that the study must be conducted in compliance with FDA GLP regulations. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3902", "reference_number": "21 CFR 58.29(a)", "short_description": "Personnel: education, training, experience", "long_description": "Not all individuals engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study have education, training, and experience, or combination thereof, to enable that individual to perform assigned functions. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3911", "reference_number": "21 CFR 58.31(c)", "short_description": "Management: assure there is a QAU", "long_description": "Testing facility management failed to assure that there was a quality assurance unit in conformance with FDA GLP regulations. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3919", "reference_number": "21 CFR 58.33(b)", "short_description": "Study director: all data recorded and verified", "long_description": "The study director failed to assure that all experimental data, including observations of unanticipated responses of the test system, were accurately recorded and verified. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3923", "reference_number": "21 CFR 58.33(f)", "short_description": "Study director: transfer of data to archives", "long_description": "The study director failed to assure that all raw data, documentation, protocols, specimens, and final reports were transferred to the archives during or at the close of the study. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3926", "reference_number": "21 CFR 58.35(b)(1)", "short_description": "QAU: maintain a master schedule", "long_description": "The quality assurance unit failed to maintain a copy of a master schedule sheet that contained all required elements for all nonclinical laboratory studies conducted by the testing facility. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3933", "reference_number": "21 CFR 58.35(b)(7)", "short_description": "QAU: signed statement in final report", "long_description": "The quality assurance unit failed to prepare and sign a statement to be included with the final study report which specified the dates inspections were made and findings reported to management and to the study director. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3951", "reference_number": "21 CFR 58.51", "short_description": "Facility: archives", "long_description": "Space is not provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3952", "reference_number": "21 CFR 58.61", "short_description": "Equipment: appropriate design and adequate capacity", "long_description": "Not all [equipment used in the generation, measurement, or assessment of data] [equipment used for facility environmental control] is of appropriate design and adequate capacity to function according to the protocol and is suitably located for operation, inspection, cleaning, and maintenance. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3953", "reference_number": "21 CFR 58.63(a)", "short_description": "Equipment: inspection, cleaning and maintenance", "long_description": "Not all equipment is adequately inspected, cleaned, and maintained. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3956", "reference_number": "21 CFR 58.63(c)", "short_description": "Equipment: maintenance records", "long_description": "Adequate written records are not maintained of all equipment inspection, maintenance, testing, calibrating and/or standardizing operations. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3958", "reference_number": "21 CFR 58.81(a)", "short_description": "SOPs: authorization and documentation of deviations", "long_description": "Not all deviations from standard operating procedures in a study were authorized by the study director and documented in the raw data. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3966", "reference_number": "21 CFR 58.90(b)", "short_description": "Animal care: new animal isolation", "long_description": "Not all newly received animals from outside sources were isolated and their health status evaluated in accordance with acceptable veterinary medical practice. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3977", "reference_number": "21 CFR 58.90(g)", "short_description": "Animal care: analysis of feed and water", "long_description": "Not all animal feed and water were analyzed periodically to ensure that expected contaminants were not present at levels above those specified in the protocol. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3993", "reference_number": "21 CFR 58.120(a)", "short_description": "Protocol: approved", "long_description": "Not all studies had an approved written protocol that clearly indicated the objectives and all methods for the conduct of the study. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4025", "reference_number": "21 CFR 58.185(a)(9)", "short_description": "Final report: circumstances affecting data qual., integrity", "long_description": "The final study report did not include a description of all circumstances that may have affected the quality or integrity of the data. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4028", "reference_number": "21 CFR 58.185(a)(12)", "short_description": "Final report: reports of individual scientists", "long_description": "The final study report did not include the signed and dated reports of each of the individual scientists or other professionals involved in the study. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4029", "reference_number": "21 CFR 58.185(a)(13)", "short_description": "Final report: storage locations", "long_description": "The final study report did not include the locations where all [specimens] [raw data] [the final report] are to be stored. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7209", "reference_number": "21 CFR 50.25(a)(1)", "short_description": "Procedures, identification of those which were experimental", "long_description": "The informed consent document did not contain [a description of the procedures to be followed] [identification of any procedures which were experimental]. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7231", "reference_number": "21 CFR 50.20", "short_description": "Consent not obtained, exceptions do not apply", "long_description": "Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7274", "reference_number": "21 CFR 56.107(a)", "short_description": "At least five members with varying backgrounds", "long_description": "The IRB is not composed of at least five members [with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution]. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7286", "reference_number": "21 CFR 56.108(b)(1)", "short_description": "Prompt reporting of unanticipated problems", "long_description": "The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any unanticipated problems involving risks to human subjects or others. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7297", "reference_number": "21 CFR 56.109(b)", "short_description": "Information given to subjects", "long_description": "The IRB does not require that information given to subjects as part of informed consent contain all necessary elements of informed consent. Specifically, ***:", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7305", "reference_number": "21 CFR 56.110(b)(2)", "short_description": "Minor changes", "long_description": "The IRB used an expedited review procedure to review supposedly minor changes to previously-approved research, but the changes were not minor in nature. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7316", "reference_number": "21 CFR 56.115(a)(4)", "short_description": "Copies of IRB/CI correspondence", "long_description": "Copies have not been maintained of all correspondence between the IRB and the investigators. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7317", "reference_number": "21 CFR 56.115(a)(1)", "short_description": "Copies of all research proposals and related documents", "long_description": "Copies have not been [prepared] [maintained] of all [research proposals reviewed] [scientific evaluations, if any, accompanying research proposals] [approved sample consent documents] [progress reports submitted by investigators] [reports of injuries to subjects]. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7319", "reference_number": "21 CFR 56.115(a)(3)", "short_description": "Records of continuing review", "long_description": "Records have not been [prepared] [maintained] of all continuing review activities. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7321", "reference_number": "21 CFR 56.110(c)", "short_description": "Method to keep members advised", "long_description": "The IRB uses an expedited review procedure, but [has not adopted] [is not following] a method for keeping members advised of research proposals which have been approved under the procedure. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7342", "reference_number": "21 CFR 56.108(b)(2)", "short_description": "Prompt reporting of noncompliance", "long_description": "The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7363", "reference_number": "21 CFR 50.55(f)", "short_description": "Documentation of permission by parents or guardian", "long_description": "Permission by parents or guardians for the participation of children as subjects in a clinical investigation was not documented in accordance with and to the extent required by 21 CFR 50.27. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7367", "reference_number": "21 CFR 50.55(e)(2)", "short_description": "Two parents' permission: studies under Parts 50.53 - 50.54", "long_description": "For a clinical investigation involving children, conducted under [21 CFR 50.53] [21 CFR 50.54], the investigator did not always obtain the permission of both parents where feasible. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7370", "reference_number": "21 CFR 56.111(c)", "short_description": "Children as subjects", "long_description": "The IRB approved the conduct of research involving children as subjects, but did not determine that the research was in compliance with 21 CFR 50 Subpart D. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7378", "reference_number": "21 CFR 50.27(a)", "short_description": "Copy of consent form not provided", "long_description": "A copy of the written consent form which had been approved by the IRB and signed and dated by the subject or the subject's legally authorized representative, was not provided to the subject or the subject's legally authorized representative at the time of consent. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7381", "reference_number": "21 CFR 50.27(b)(2)", "short_description": "Short form: Summary copy not signed/given", "long_description": "In a situation where a short form written consent document was prepared, a copy of the summary of what was to be said to the subject or the subject's legally authorized representative [was not signed by the witness] [was not signed by the person actually obtaining the consent] [was not given to the subject or the subject's legally authorized representative (in addition to a copy of the short form)]. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7388", "reference_number": "21 CFR 50.25(a)(2)", "short_description": "Reasonably foreseeable risks or discomforts", "long_description": "The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7390", "reference_number": "21 CFR 50.25(a)(4)", "short_description": "Alternate procedures, courses of treatment", "long_description": "There was [no] [an incomplete] disclosure in the informed consent document of appropriate alternate procedures or courses of treatment, if any, that might be advantageous to the subject. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7406", "reference_number": "21 CFR 56.109(a)", "short_description": "Scope of reviews", "long_description": "The IRB does not review all research activities covered by the regulations. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7411", "reference_number": "21 CFR 312.53(c)(1)", "short_description": "Investigator statement (FDA 1572)", "long_description": "Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7453", "reference_number": "21 CFR 312.56(b)", "short_description": "Investigator non-compliance", "long_description": "An investigator who did not comply with [the signed agreement] [the general investigational plan] [applicable regulatory requirements] was not [promptly brought into compliance] [terminated]. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7461", "reference_number": "21 CFR 312.58(a)", "short_description": "FDA access to sponsor records", "long_description": "Failure to permit FDA to [have access to] [review] [copy] records or reports related to a clinical investigation. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7479", "reference_number": "21 CFR 312.56(a)", "short_description": "Monitoring investigations", "long_description": "Failure to monitor the progress of an investigation conducted under your IND. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring+A13", "cite_id": "7488", "reference_number": "21 CFR 312.59", "short_description": "Records of unused drug disposition", "long_description": "Failure to maintain [adequate] written records of the disposition of an investigational drug in accordance with 21 CFR Part 312.57. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7518", "reference_number": "21 CFR 312.64(d)", "short_description": "Financial info", "long_description": "Information necessary for submission of required financial [certification] [disclosure] statements to FDA was not provided to the sponsor. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7552", "reference_number": "21 CFR 312.66", "short_description": "Changes in research", "long_description": "Not all changes in research activity were approved by an Institutional Review Board prior to implementation. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7557", "reference_number": "21 CFR 312.56(b)", "short_description": "Notification of FDA of termination of investigator", "long_description": "Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7558", "reference_number": "21 CFR 312.57(c)", "short_description": "Record retention requirement", "long_description": "Records and reports were not retained for two years after [marketing application approval] [discontinuance of the investigation and notification of FDA]. Specifically***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7638", "reference_number": "21 CFR 312.20(a)", "short_description": "Failure to submit an IND", "long_description": "The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug. Specifically,***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7654", "reference_number": "21 CFR 56.110(b)", "short_description": "Research not eligible for expedited review", "long_description": "The IRB used an expedited review procedure for research which did not appear in an FDA list of categories eligible for expedited review, and which had not previously been approved by the IRB [within one year]. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7659", "reference_number": "21 CFR 50.25(a)(6)", "short_description": "Compensation, medical treatment in event of injury", "long_description": "For research involving more than minimal risk, the informed consent document lacked an explanation as to whether any [compensation] [medical treatments] were available if injury occurred, and, if so, [of what they consisted] [where further information might be obtained]. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7664", "reference_number": "21 CFR 50.20", "short_description": "Circumstances of obtaining consent", "long_description": "The general requirements for informed consent were not met in that [you] [the investigator] did not seek consent under circumstances that [provided the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate] [minimized the possibility of coercion or undue influence]. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2020, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7665", "reference_number": "21 CFR 50.20", "short_description": "Exculpatory language, waiving of rights", "long_description": "The general requirements for informed consent were not met in that the consent form contained exculpatory language [through which the subject or the subject's representative was made to waive or appear to waive some of the subject's legal rights] [that released or appeared to release the investigator, sponsor, the institution, or its agents from liability for negligence]. Specifically, ***", "frequency": "1", "column_7": "" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7560", "reference_number": "21 CFR 312.60", "short_description": "FD-1572, protocol compliance", "long_description": "An investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan]. Specifically, ***", "frequency": "84" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7530", "reference_number": "21 CFR 312.62(b)", "short_description": "Case history records- inadequate or inadequate", "long_description": "Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data pertinent to the investigation] [informed consent]. Specifically, ***", "frequency": "48" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7526", "reference_number": "21 CFR 312.62(a)", "short_description": "Accountability records", "long_description": "Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects]. Specifically, ***", "frequency": "12" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7520", "reference_number": "21 CFR 312.64(b)", "short_description": "Safety reports", "long_description": "Failure to report [promptly] to the sponsor adverse effects that may reasonably be regarded as caused by, or probably caused by, an investigational drug. Specifically, ***", "frequency": "9" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7227", "reference_number": "21 CFR 50.27(a)", "short_description": "Consent form not approved/signed/dated", "long_description": "Informed consent was not properly documented in that the written informed consent used in the study [was not approved by the IRB] [was not signed by the subject or the subject's legally authorized representative at the time of consent ] [was not dated by the subject or the subject's legally authorized representative at the time of consent]. Specifically, ***", "frequency": "7" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7517", "reference_number": "21 CFR 312.66", "short_description": "Initial and continuing review", "long_description": "Failure to assure that an IRB [complying with applicable regulatory requirements] was responsible for the initial and continuing review and approval of a clinical study. Specifically, ***", "frequency": "6" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7562", "reference_number": "21 CFR 312.60", "short_description": "Informed consent", "long_description": "Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to [drug administration] [conducting study-related tests]. Specifically, ***", "frequency": "6" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7638", "reference_number": "21 CFR 312.20(a)", "short_description": "Failure to submit an IND", "long_description": "The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug. Specifically,***", "frequency": "5" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4007", "reference_number": "21 CFR 58.130(a)", "short_description": "Conduct: in accordance with protocol", "long_description": "Not all nonclinical laboratory studies were conducted in \naccordance with the protocol. Specifically, ***", "frequency": "4" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7231", "reference_number": "21 CFR 50.20", "short_description": "Consent not obtained, exceptions do not apply", "long_description": "Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7482", "reference_number": "21 CFR 312.50", "short_description": "General responsibilities of sponsors", "long_description": "Failure to [select qualified investigators] [provide investigators with the information needed to conduct the study properly] [ensure proper monitoring of the study] [ensure the study is conducted in accordance with the protocol and/or investigational plan] [ensure that FDA and all investigators are promptly informed of significant new adverse effects or risks]. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3957", "reference_number": "21 CFR 58.81(a)", "short_description": "SOPs: laboratory methods", "long_description": "The testing facility does not have written standard operating procedures setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4006", "reference_number": "21 CFR 58.120(b)", "short_description": "Protocol: approval of changes", "long_description": "Not all changes in, or revisions of, an approved protocol and the reasons therefore were documented, signed by the study director, dated, and maintained with the protocol. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4009", "reference_number": "21 CFR 58.130(c)", "short_description": "Conduct: identification of test specimens", "long_description": "Not all specimens were identified by test system, study, nature, and date of collection. This information was not located on the specimen container or did not accompany the specimen in a manner that precluded error in the recording and storage of data. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4025", "reference_number": "21 CFR 58.185(a)(9)", "short_description": "Final report: circumstances affecting data qual., integrity", "long_description": "The final study report did not include a description of all circumstances that may have affected the quality or integrity of the data. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7209", "reference_number": "21 CFR 50.25(a)(1)", "short_description": "Procedures, identification of those which were experimental", "long_description": "The informed consent document did not contain [a description of the procedures to be followed] [identification of any procedures which were experimental]. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7378", "reference_number": "21 CFR 50.27(a)", "short_description": "Copy of consent form not provided", "long_description": "A copy of the written consent form which had been approved by the IRB and signed and dated by the subject or the subject's legally authorized representative, was not provided to the subject or the subject's legally authorized representative at the time of consent. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7388", "reference_number": "21 CFR 50.25(a)(2)", "short_description": "Reasonably foreseeable risks or discomforts", "long_description": "The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7498", "reference_number": "21 CFR 312.66", "short_description": "Unanticipated problems", "long_description": "Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7518", "reference_number": "21 CFR 312.64(d)", "short_description": "Financial info", "long_description": "Information necessary for submission of required financial [certification] [disclosure] statements to FDA was not provided to the sponsor. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7695", "reference_number": "21 CFR 50.25(c)", "short_description": "ClincialTrials.gov statement", "long_description": "The informed consent document does not include the [complete] required statement: \"A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.\" Specifically, ***", "frequency": "2" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3902", "reference_number": "21 CFR 58.29(a)", "short_description": "Personnel: education, training, experience", "long_description": "Not all individuals engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study have education, training, and experience, or combination thereof, to enable that individual to perform assigned functions. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3913", "reference_number": "21 CFR 58.31(e)", "short_description": "Management: availability of resources", "long_description": "Testing facility management failed to assure that all personnel, resources, facilities, equipment, materials, and methodologies were available as scheduled. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3914", "reference_number": "21 CFR 58.31(f)", "short_description": "Management: personnel understand their functions", "long_description": "Testing facility management failed to assure that all personnel clearly understood the functions they were to perform. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3918", "reference_number": "21 CFR 58.33(a)", "short_description": "Study director: follow study protocol", "long_description": "The study director failed to assure that the protocol, including any change, was approved and was followed. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3919", "reference_number": "21 CFR 58.33(b)", "short_description": "Study director: all data recorded and verified", "long_description": "The study director failed to assure that all experimental data, including observations of unanticipated responses of the test system, were accurately recorded and verified. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3920", "reference_number": "21 CFR 58.33(c)", "short_description": "Study director: unforeseen circumstances", "long_description": "The study director failed to assure that unforeseen circumstances that might affect the quality and integrity of the nonclinical laboratory study were noted when they occurred and corrective action was taken and documented. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3923", "reference_number": "21 CFR 58.33(f)", "short_description": "Study director: transfer of data to archives", "long_description": "The study director failed to assure that all raw data, documentation, protocols, specimens, and final reports were transferred to the archives during or at the close of the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3924", "reference_number": "21 CFR 58.35(a)", "short_description": "QAU: monitor facilities, etc.", "long_description": "The quality assurance unit did not monitor each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls were in conformance with FDA GLP regulations. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3926", "reference_number": "21 CFR 58.35(b)(1)", "short_description": "QAU: maintain a master schedule", "long_description": "The quality assurance unit failed to maintain a copy of a master schedule sheet that contained all required elements for all nonclinical laboratory studies conducted by the testing facility. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3931", "reference_number": "21 CFR 58.35(b)(5)", "short_description": "QAU: authorize deviations from protocols or SOPs", "long_description": "The quality assurance unit failed to determine whether any deviations from approved protocols or standard operating procedures had been made with proper authorization and documentation. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3932", "reference_number": "21 CFR 58.35(b)(6)", "short_description": "QAU: review final study report", "long_description": "The quality assurance unit failed to review the final study report to assure that such report accurately described the methods and standard operating procedures, and that the reported results accurately reflected the raw data of the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3951", "reference_number": "21 CFR 58.51", "short_description": "Facility: archives", "long_description": "Space is not provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3952", "reference_number": "21 CFR 58.61", "short_description": "Equipment: appropriate design and adequate capacity", "long_description": "Not all [equipment used in the generation, measurement, or assessment of data] [equipment used for facility environmental control] is of appropriate design and adequate capacity to function according to the protocol and is suitably located for operation, inspection, cleaning, and maintenance. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3953", "reference_number": "21 CFR 58.63(a)", "short_description": "Equipment: inspection, cleaning and maintenance", "long_description": "Not all equipment is adequately inspected, cleaned, and maintained. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3954", "reference_number": "21 CFR 58.63(a)", "short_description": "Equipment: calibration", "long_description": "Not all equipment used for the generation, measurement, or assessment of data is adequately tested, calibrated and/or standardized. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3964", "reference_number": "21 CFR 58.83", "short_description": "Reagents: outdated", "long_description": "Deteriorated or outdated reagents and solutions were used. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3989", "reference_number": "21 CFR 58.107", "short_description": "Test article: handling", "long_description": "Procedures have not been established for the handling of the test and control articles to ensure that [there is proper storage] [distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage] [proper identification is maintained throughout the distribution process] [the receipt and distribution of each batch is documented including the date and quantity of each batch distributed or returned]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4026", "reference_number": "21 CFR 58.185(a)(10)", "short_description": "Final report: names of those involved", "long_description": "The final study report did not include [the name of the study director] [the names of other scientists or professionals] [the names of all supervisory personnel] involved in the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4027", "reference_number": "21 CFR 58.185(a)(11)", "short_description": "Final report: operations on data, analysis of data", "long_description": "The final study report did not include [a description of the transformations, calculations, or operations performed on the data] [a summary and analysis of the data] [a statement of the conclusions drawn from the analysis]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4028", "reference_number": "21 CFR 58.185(a)(12)", "short_description": "Final report: reports of individual scientists", "long_description": "The final study report did not include the signed and dated reports of each of the individual scientists or other professionals involved in the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4029", "reference_number": "21 CFR 58.185(a)(13)", "short_description": "Final report: storage locations", "long_description": "The final study report did not include the locations where all [specimens] [raw data] [the final report] are to be stored. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4037", "reference_number": "21 CFR 58.190(b)", "short_description": "Archives: conditions of storage", "long_description": "Conditions of storage failed to minimize deterioration of the [documents] [specimens] in accordance with the requirements for the time period of their retention and the nature of the [documents] [specimens]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4042", "reference_number": "21 CFR 58.195(b)", "short_description": "Archives: retention for appropriate time", "long_description": "Not all required documentation records, raw data, and specimens pertaining to a nonclinical laboratory study were retained in the archives for the appropriate time. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7270", "reference_number": "21 CFR 56.103(a)", "short_description": "IRB review requirement", "long_description": "A clinical investigation requiring prior submission to the FDA was initiated without [IRB review] [IRB approval] [being subject to continuing IRB review]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7279", "reference_number": "21 CFR 56.107(f)", "short_description": "Invited individual allowed to vote with IRB", "long_description": "The IRB invited an individual with competence in a special area to assist in the review of complex issues which required expertise beyond or in addition to that available on the IRB; however, the IRB allowed the individual to vote with the IRB. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7290", "reference_number": "21 CFR 56.108(c)", "short_description": "Members present for review", "long_description": "For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7318", "reference_number": "21 CFR 56.115(a)(2)", "short_description": "Minutes of IRB meetings", "long_description": "Minutes of IRB meetings have not been [prepared] [maintained] in sufficient detail to show [attendance at the meetings] [actions taken by the IRB] [the vote on actions, including the number of members voting for, against and abstaining] [the basis for requiring changes in or disapproving research] [a written summary of the discussion of controverted issues and their resolution]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7319", "reference_number": "21 CFR 56.115(a)(3)", "short_description": "Records of continuing review", "long_description": "Records have not been [prepared] [maintained] of all continuing review activities. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7334", "reference_number": "21 CFR 56.115(a)(5)", "short_description": "List of members", "long_description": "A list of IRB members has not been [prepared] [maintained], identifying members by [name] [earned degrees] [representative capacity] [indications of experience sufficient to describe each member's chief anticipated contribution to IRB deliberations] [any employment or other relationship between each member and the institution]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7335", "reference_number": "21 CFR 56.115(a)(6)", "short_description": "Written procedures per 56.108(a) and (b)", "long_description": "Documentation has not been [prepared] [maintained] of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b). Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7342", "reference_number": "21 CFR 56.108(b)(2)", "short_description": "Prompt reporting of noncompliance", "long_description": "The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7387", "reference_number": "21 CFR 50.25(a)(1)", "short_description": "Statement of research, purpose, duration of participation", "long_description": "The informed consent document did not contain [a statement that the study involved research] [an explanation of the purposes of the research, and the expected duration of the subject's participation]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7391", "reference_number": "21 CFR 50.25(a)(5)", "short_description": "Confidentiality, FDA inspection of records", "long_description": "There was no statement in the informed consent document that [described the extent, if any, to which confidentiality of records identifying the subject would be maintained] [noted the possibility that the Food and Drug Administration might inspect the records]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7393", "reference_number": "21 CFR 50.25(a)(8)", "short_description": "Participation; refusal and discontinuance", "long_description": "The informed consent document did not contain a statement that [participation was voluntary] [refusal to participate would involve no penalty or loss of benefits to which the subject was otherwise entitled] [the subject might discontinue participation at any time without penalty or loss of benefits to which the subject was otherwise entitled]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7411", "reference_number": "21 CFR 312.53(c)(1)", "short_description": "Investigator statement (FDA 1572)", "long_description": "Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7453", "reference_number": "21 CFR 312.56(b)", "short_description": "Investigator non-compliance", "long_description": "An investigator who did not comply with [the signed agreement] [the general investigational plan] [applicable regulatory requirements] was not [promptly brought into compliance] [terminated]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7459", "reference_number": "21 CFR 312.57(a)", "short_description": "Records of receipt, shipment, disposition", "long_description": "Lack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an investigational drug. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7487", "reference_number": "21 CFR 312.59", "short_description": "Unused drug disposition (sponsor)", "long_description": "Failure to assure the return or other disposition of all unused supplies of an investigational drug from each individual investigator whose participation in the investigation was discontinued or terminated. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7527", "reference_number": "21 CFR 312.62(a)", "short_description": "Unused drug disposition (investigator)", "long_description": "Unused supplies of an investigational drug were not [returned to the sponsor] [disposed of in accordance with sponsor instructions]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7531", "reference_number": "21 CFR 312.62(c)", "short_description": "Record retention", "long_description": "Investigational records were not retained for a period of two years following [approval of a drug's marketing application] [discontinuance of the investigation and notification of FDA]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7632", "reference_number": "21 CFR 312.6(a)", "short_description": "Required label statement", "long_description": "The immediate package of the investigational new drug does not bear a label with the statement \"Caution: New Drug- Limited by Federal (or United States) law to investigational use", "frequency": "1" }, { "fiscal_year": 2021, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7656", "reference_number": "21 CFR 56.108(c)", "short_description": "Approval from a majority of members present", "long_description": "For other than expedited reviews, research approved by the IRB does not always receive the approval of a majority of those IRB members present. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7560", "reference_number": "21 CFR 312.60", "short_description": "FD-1572, protocol compliance", "long_description": "An investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan]. Specifically, ***", "frequency": "70" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7530", "reference_number": "21 CFR 312.62(b)", "short_description": "Case history records- inadequate or inadequate", "long_description": "Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data pertinent to the investigation] [informed consent]. Specifically, ***", "frequency": "36" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7318", "reference_number": "21 CFR 56.115(a)(2)", "short_description": "Minutes of IRB meetings", "long_description": "Minutes of IRB meetings have not been [prepared] [maintained] in sufficient detail to show [attendance at the meetings] [actions taken by the IRB] [the vote on actions, including the number of members voting for, against and abstaining] [the basis for requiring changes in or disapproving research] [a written summary of the discussion of controverted issues and their resolution]. Specifically, ***", "frequency": "13" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7526", "reference_number": "21 CFR 312.62(a)", "short_description": "Accountability records", "long_description": "Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects]. Specifically, ***", "frequency": "13" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7281", "reference_number": "21 CFR 56.108(a)(1)", "short_description": "Initial and continuing reviews", "long_description": "The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, ***", "frequency": "7" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7520", "reference_number": "21 CFR 312.64(b)", "short_description": "Safety reports", "long_description": "Failure to report [promptly] to the sponsor adverse effects that may reasonably be regarded as caused by, or probably caused by, an investigational drug. Specifically, ***", "frequency": "7" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7562", "reference_number": "21 CFR 312.60", "short_description": "Informed consent", "long_description": "Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to [drug administration] [conducting study-related tests]. Specifically, ***", "frequency": "7" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3931", "reference_number": "21 CFR 58.35(b)(5)", "short_description": "QAU: authorize deviations from protocols or SOPs", "long_description": "The quality assurance unit failed to determine whether any deviations from approved protocols or standard operating procedures had been made without proper authorization and documentation. Specifically, ***", "frequency": "5" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3954", "reference_number": "21 CFR 58.63(a)", "short_description": "Equipment: calibration", "long_description": "Not all equipment used for the generation, measurement, or assessment of data is adequately tested, calibrated and/or standardized. Specifically, ***", "frequency": "5" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3957", "reference_number": "21 CFR 58.81(a)", "short_description": "SOPs: laboratory methods", "long_description": "The testing facility does not have written standard operating procedures setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. Specifically, ***", "frequency": "5" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7498", "reference_number": "21 CFR 312.66", "short_description": "Unanticipated problems", "long_description": "Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others. Specifically, ***", "frequency": "5" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3960", "reference_number": "21 CFR 58.81(b)", "short_description": "SOPs: required", "long_description": "Standard operating procedures have not been established for [animal room preparation] [animal care] [receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles] [test system observations] [laboratory tests] [handling of animals found moribund or dead during study] [necropsy of animals or postmortem examination of animals] [collection and identification of specimens] [histopathology] [data handling, storage, and retrieval] [maintenance and calibration of equipment] [transfer, proper placement, and identification of animals]. Specifically, ***", "frequency": "4" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7227", "reference_number": "21 CFR 50.27(a)", "short_description": "Consent form not approved/signed/dated", "long_description": "Informed consent was not properly documented in that the written informed consent used in the study [was not approved by the IRB] [was not signed by the subject or the subject's legally authorized representative at the time of consent ] [was not dated by the subject or the subject's legally authorized representative at the time of consent]. Specifically, ***", "frequency": "4" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7337", "reference_number": "21 CFR 56.115(b)", "short_description": "Retention of records", "long_description": "Records required by 21 CFR 56 have not been maintained for three years following completion of the research. Specifically, ***", "frequency": "4" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3903", "reference_number": "21 CFR 58.29(b)", "short_description": "Personnel: summary of training, job description", "long_description": "The testing facility failed to maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3914", "reference_number": "21 CFR 58.31(f)", "short_description": "Management: personnel understand their functions", "long_description": "Testing facility management failed to assure that all personnel clearly understood the functions they were to perform. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3919", "reference_number": "21 CFR 58.33(b)", "short_description": "Study director: all data recorded and verified", "long_description": "The study director failed to assure that all experimental data, including observations of unanticipated responses of the test system, were accurately recorded and verified. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3920", "reference_number": "21 CFR 58.33(c)", "short_description": "Study director: unforeseen circumstances", "long_description": "The study director failed to assure that unforeseen circumstances that might affect the quality and integrity of the nonclinical laboratory study were noted when they occurred and corrective action was taken and documented. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3924", "reference_number": "21 CFR 58.35(a)", "short_description": "QAU: monitor facilities, etc.", "long_description": "The quality assurance unit did not monitor each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls were in conformance with FDA GLP regulations. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4025", "reference_number": "21 CFR 58.185(a)(9)", "short_description": "Final report: circumstances affecting data qual., integrity", "long_description": "The final study report did not include a description of all circumstances that may have affected the quality or integrity of the data. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7290", "reference_number": "21 CFR 56.108(c)", "short_description": "Members present for review", "long_description": "For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7334", "reference_number": "21 CFR 56.115(a)(5)", "short_description": "List of members", "long_description": "A list of IRB members has not been [prepared] [maintained], identifying members by [name] [earned degrees] [representative capacity] [indications of experience sufficient to describe each member's chief anticipated contribution to IRB deliberations] [any employment or other relationship between each member and the institution]. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7638", "reference_number": "21 CFR 312.20(a)", "short_description": "Failure to submit an IND", "long_description": "The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug. Specifically,***", "frequency": "3" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7664", "reference_number": "21 CFR 50.20", "short_description": "Circumstances of obtaining consent", "long_description": "The general requirements for informed consent were not met in that [you] [the investigator] did not seek consent under circumstances that [provided the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate] [minimized the possibility of coercion or undue influence]. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7693", "reference_number": "21 CFR 56.106(e)", "short_description": "Changes re: review new products or discontinue reviewing", "long_description": "The IRB did not report its decision [to review new types of FDA-regulated products] [to discontinue reviewing clinical investigations regulated by FDA] within 30 days of the change. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3917", "reference_number": "21 CFR 58.33", "short_description": "study director: overall study responsibility", "long_description": "The study director did not have overall responsibility for the technical conduct of the study as well as for the interpretation, analysis, documentation and reporting of results, and does not represent the single point of study control. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3918", "reference_number": "21 CFR 58.33(a)", "short_description": "Study director: follow study protocol", "long_description": "The study director failed to assure that the protocol, including any change, was approved and was followed. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3923", "reference_number": "21 CFR 58.33(f)", "short_description": "Study director: transfer of data to archives", "long_description": "The study director failed to assure that all raw data, documentation, protocols, specimens, and final reports were transferred to the archives during or at the close of the study. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3926", "reference_number": "21 CFR 58.35(b)(1)", "short_description": "QAU: maintain a master schedule", "long_description": "The quality assurance unit failed to maintain a copy of a master schedule sheet that contained all required elements for all nonclinical laboratory studies conducted by the testing facility. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3963", "reference_number": "21 CFR 58.83", "short_description": "Reagents: labeling", "long_description": "Not all reagents and solutions in the laboratory areas are labeled to indicate identity, titer or concentration, storage requirements, and expiration date. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4007", "reference_number": "21 CFR 58.130(a)", "short_description": "Conduct: in accordance with protocol", "long_description": "Not all nonclinical laboratory studies were conducted in \naccordance with the protocol. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4009", "reference_number": "21 CFR 58.130(c)", "short_description": "Conduct: identification of test specimens", "long_description": "Not all specimens were identified by test system, study, nature, and date of collection. This information was not located on the specimen container or did not accompany the specimen in a manner that precluded error in the recording and storage of data. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7209", "reference_number": "21 CFR 50.25(a)(1)", "short_description": "Procedures, identification of those which were experimental", "long_description": "The informed consent document did not contain [a description of the procedures to be followed] [identification of any procedures which were experimental]. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7319", "reference_number": "21 CFR 56.115(a)(3)", "short_description": "Records of continuing review", "long_description": "Records have not been [prepared] [maintained] of all continuing review activities. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7321", "reference_number": "21 CFR 56.110(c)", "short_description": "Method to keep members advised", "long_description": "The IRB uses an expedited review procedure, but [has not adopted] [is not following] a method for keeping members advised of research proposals which have been approved under the procedure. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7479", "reference_number": "21 CFR 312.56(a)", "short_description": "Monitoring investigations", "long_description": "Failure to monitor the progress of an investigation conducted under your IND. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7482", "reference_number": "21 CFR 312.50", "short_description": "General responsibilities of sponsors", "long_description": "Failure to [select qualified investigators] [provide investigators with the information needed to conduct the study properly] [ensure proper monitoring of the study] [ensure the study is conducted in accordance with the protocol and/or investigational plan] [ensure that FDA and all investigators are promptly informed of significant new adverse effects or risks]. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7517", "reference_number": "21 CFR 312.66", "short_description": "Initial and continuing review", "long_description": "Failure to assure that an IRB [complying with applicable regulatory requirements] was responsible for the initial and continuing review and approval of a clinical study. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7531", "reference_number": "21 CFR 312.62(c)", "short_description": "Record retention", "long_description": "Investigational records were not retained for a period of two years following [approval of a drug's marketing application] [discontinuance of the investigation and notification of FDA]. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7552", "reference_number": "21 CFR 312.66", "short_description": "Changes in research", "long_description": "Not all changes in research activity were approved by an Institutional Review Board prior to implementation. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7639", "reference_number": "21 CFR 312.20(b)", "short_description": "Starting a study before IND is in effect", "long_description": "The sponsor began a clinical investigation subject to IND requirements before an IND was in effect. Specifically,***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7692", "reference_number": "21 CFR 56.106(e)", "short_description": "Changes in contact or chairperson information", "long_description": "The IRB did not revise its registration information with respect to changes in [the contact person] [the chairperson] within 90 days of the change. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7695", "reference_number": "21 CFR 50.25(c)", "short_description": "ClincialTrials.gov statement", "long_description": "The informed consent document does not include the [complete] required statement: \"A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.\" Specifically, ***", "frequency": "2" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3900", "reference_number": "21 CFR 58.10", "short_description": "Notifying contractor of GLP status", "long_description": "Not all consulting laboratories, contractors, or grantees were notified that the study must be conducted in compliance with FDA GLP regulations. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3913", "reference_number": "21 CFR 58.31(e)", "short_description": "Management: availability of resources", "long_description": "Testing facility management failed to assure that all personnel, resources, facilities, equipment, materials, and methodologies were available as scheduled. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3915", "reference_number": "21 CFR 58.31(g)", "short_description": "Management: QAU findings to study director", "long_description": "Testing facility management failed to assure that any deviations from FDA GLP regulations reported by the quality assurance unit were communicated to the study director and corrective actions were taken and documented. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3925", "reference_number": "21 CFR 58.35(a)", "short_description": "QAU: separate and independent", "long_description": "The quality assurance unit, for any given study, was not entirely separate from and independent of the personnel engaged in the direction and conduct of that study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3928", "reference_number": "21 CFR 58.35(b)(3)", "short_description": "QAU: inspect study at adequate intervals", "long_description": "The quality assurance unit failed to inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3932", "reference_number": "21 CFR 58.35(b)(6)", "short_description": "QAU: review final study report", "long_description": "The quality assurance unit failed to review the final study report to assure that such report accurately described the methods and standard operating procedures, and that the reported results accurately reflected the raw data of the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3945", "reference_number": "21 CFR 58.45", "short_description": "Facility: perishable supplies", "long_description": "The testing facility does not provide appropriate storage areas for preservation of perishable supplies. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3956", "reference_number": "21 CFR 58.63(c)", "short_description": "Equipment: maintenance records", "long_description": "Adequate written records are not maintained of all equipment inspection, maintenance, testing, calibrating and/or standardizing operations. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3958", "reference_number": "21 CFR 58.81(a)", "short_description": "SOPs: authorization and documentation of deviations", "long_description": "Not all deviations from standard operating procedures in a study were authorized by the study director and documented in the raw data. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3959", "reference_number": "21 CFR 58.81(a)", "short_description": "SOPs: authorized changes", "long_description": "Not all significant changes in established standard operating procedures were properly authorized in writing by management. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3961", "reference_number": "21 CFR 58.81(c)", "short_description": "SOPs: availability", "long_description": "Not all laboratory areas have immediately available laboratory manuals and standard operating procedures relative to the laboratory procedures being performed. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3964", "reference_number": "21 CFR 58.83", "short_description": "Reagents: outdated", "long_description": "Deteriorated or outdated reagents and solutions were used. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3966", "reference_number": "21 CFR 58.90(b)", "short_description": "Animal care: new animal isolation", "long_description": "Not all newly received animals from outside sources were isolated and their health status evaluated in accordance with acceptable veterinary medical practice. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3977", "reference_number": "21 CFR 58.90(g)", "short_description": "Animal care: analysis of feed and water", "long_description": "Not all animal feed and water were analyzed periodically to ensure that expected contaminants were not present at levels above those specified in the protocol. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3979", "reference_number": "21 CFR 58.90(h)", "short_description": "Animal care: bedding interference", "long_description": "Bedding used in animal cages or pens interfered with the purpose or conduct of the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3987", "reference_number": "21 CFR 58.105(c)", "short_description": "Test article: assignment of storage containers", "long_description": "Not all storage containers were assigned to a particular test article for the duration of the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3989", "reference_number": "21 CFR 58.107", "short_description": "Test article: handling", "long_description": "Procedures have not been established for the handling of the test and control articles to ensure that [there is proper storage] [distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage] [proper identification is maintained throughout the distribution process] [the receipt and distribution of each batch is documented including the date and quantity of each batch distributed or returned]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3990", "reference_number": "21 CFR 58.113(a)(1)", "short_description": "Mixtures: uniformity and concentration", "long_description": "Not all test or control articles mixed with a carrier were tested by appropriate analytical methods to determine [the uniformity of the mixture] [periodically, the concentration of the test or control article in the mixture]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4002", "reference_number": "21 CFR 58.120(a)(9)", "short_description": "Protocol: tests, analyses, and measurements", "long_description": "Not all protocols contained the type and frequency of tests, analyses, and measurements to be made. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4020", "reference_number": "21 CFR 58.185(a)(4)", "short_description": "Final report: data on test and control articles", "long_description": "The final study report did not include the test and control articles identified by name, chemical abstracts number or code number, strength, purity, and composition or other appropriate characteristics. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4028", "reference_number": "21 CFR 58.185(a)(12)", "short_description": "Final report: reports of individual scientists", "long_description": "The final study report did not include the signed and dated reports of each of the individual scientists or other professionals involved in the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4035", "reference_number": "21 CFR 58.190(a)", "short_description": "Archives: data, documentation, specimens", "long_description": "Not all [raw data] [documentation] [protocols] [final reports] [specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids)] generated as a result of a nonclinical laboratory study were retained. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4036", "reference_number": "21 CFR 58.190(b)", "short_description": "Archives: orderly storage, expedient retrieval", "long_description": "Archives failed to provide for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4040", "reference_number": "21 CFR 58.190(d)", "short_description": "Archives: unauthorized personnel", "long_description": "Unauthorized personnel entered the archives. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4042", "reference_number": "21 CFR 58.195(b)", "short_description": "Archives: retention for appropriate time", "long_description": "Not all required documentation records, raw data, and specimens pertaining to a nonclinical laboratory study were retained in the archives for the appropriate time. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7231", "reference_number": "21 CFR 50.20", "short_description": "Consent not obtained, exceptions do not apply", "long_description": "Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7270", "reference_number": "21 CFR 56.103(a)", "short_description": "IRB review requirement", "long_description": "A clinical investigation requiring prior submission to the FDA was initiated without [IRB review] [IRB approval] [being subject to continuing IRB review]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7277", "reference_number": "21 CFR 56.107(d)", "short_description": "One non-affiliate member", "long_description": "The IRB does not include at least one member who is not otherwise affiliated with the institution, and who is not part of the immediate family of a person who is affiliated with the institution. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7304", "reference_number": "21 CFR 56.110(b)(1)", "short_description": "No more than minimal risk", "long_description": "The IRB used an expedited review procedure for research appearing in an FDA list of categories eligible for expedited review, but the reviewer did not find the research involved no more than minimal risk to the subjects. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7316", "reference_number": "21 CFR 56.115(a)(4)", "short_description": "Copies of IRB/CI correspondence", "long_description": "Copies have not been maintained of all correspondence between the IRB and the investigators. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7335", "reference_number": "21 CFR 56.115(a)(6)", "short_description": "Written procedures per 56.108(a) and (b)", "long_description": "Documentation has not been [prepared] [maintained] of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b). Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7342", "reference_number": "21 CFR 56.108(b)(2)", "short_description": "Prompt reporting of noncompliance", "long_description": "The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7343", "reference_number": "21 CFR 56.108(b)(3)", "short_description": "Reporting of suspension/termination", "long_description": "The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any suspension or termination of IRB approval . Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7372", "reference_number": "21 CFR 56.115(b)", "short_description": "Access to records", "long_description": "Records required to be maintained under 21 CFR 56 were not accessible for [inspection] [copying] by authorized representatives of the FDA. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7388", "reference_number": "21 CFR 50.25(a)(2)", "short_description": "Reasonably foreseeable risks or discomforts", "long_description": "The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7393", "reference_number": "21 CFR 50.25(a)(8)", "short_description": "Participation; refusal and discontinuance", "long_description": "The informed consent document did not contain a statement that [participation was voluntary] [refusal to participate would involve no penalty or loss of benefits to which the subject was otherwise entitled] [the subject might discontinue participation at any time without penalty or loss of benefits to which the subject was otherwise entitled]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7411", "reference_number": "21 CFR 312.53(c)(1)", "short_description": "Investigator statement (FDA 1572)", "long_description": "Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7452", "reference_number": "21 CFR 312.56(c)", "short_description": "IND safety report", "long_description": "Failure to provide [FDA] [all participating investigators] with [a] [an adequate] written IND safety report. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7480", "reference_number": "21 CFR 312.50", "short_description": "Ensuring compliance with plan and protocol", "long_description": "Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7488", "reference_number": "21 CFR 312.59", "short_description": "Records of unused drug disposition", "long_description": "Failure to maintain [adequate] written records of the disposition of an investigational drug in accordance with 21 CFR Part 312.57. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7507", "reference_number": "21 CFR 312.52(a)", "short_description": "Transfer of obligations", "long_description": "Transfer of obligations to a contract research organization [was not described in writing] [did not describe each of the obligations assumed by the contract research organization, where not all obligations were assumed]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7629", "reference_number": "21 CFR 312.56(c)", "short_description": "Annual report", "long_description": "Failure to submit to FDA [within 60 days of the anniversary date that the IND went into effect] an annual report of the investigation. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7666", "reference_number": "21 CFR 50.20", "short_description": "Understandable language", "long_description": "The general requirements for informed consent were not met in that the information given was not in language understandable to the subject or the subject's representative. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2022, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7690", "reference_number": "21 CFR 56.106(c)", "short_description": "Renewal every 3 years", "long_description": "The IRB failed to renew its registration every 3 years. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7560", "reference_number": "21 CFR 312.60", "short_description": "FD-1572, protocol compliance", "long_description": "An investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan]. Specifically, ***", "frequency": "94" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7530", "reference_number": "21 CFR 312.62(b)", "short_description": "Case history records- inadequate or inadequate", "long_description": "Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data pertinent to the investigation] [informed consent]. Specifically, ***", "frequency": "49" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7562", "reference_number": "21 CFR 312.60", "short_description": "Informed consent", "long_description": "Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to [drug administration] [conducting study-related tests]. Specifically, ***", "frequency": "10" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7482", "reference_number": "21 CFR 312.50", "short_description": "General responsibilities of sponsors", "long_description": "Failure to [select qualified investigators] [provide investigators with the information needed to conduct the study properly] [ensure proper monitoring of the study] [ensure the study is conducted in accordance with the protocol and/or investigational plan] [ensure that FDA and all investigators are promptly informed of significant new adverse effects or risks]. Specifically, ***", "frequency": "9" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7526", "reference_number": "21 CFR 312.62(a)", "short_description": "Accountability records", "long_description": "Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects]. Specifically, ***", "frequency": "9" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "22728", "reference_number": "21 CFR 312.64(b)", "short_description": "Safety Reports - Non-Serious Events", "long_description": "Failure to report non-serious adverse events to the sponsor in accordance with the study protocol timetable for reporting. \n Specifically, ***", "frequency": "8" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7318", "reference_number": "21 CFR 56.115(a)(2)", "short_description": "Minutes of IRB meetings", "long_description": "Minutes of IRB meetings have not been [prepared] [maintained] in sufficient detail to show [attendance at the meetings] [actions taken by the IRB] [the vote on actions, including the number of members voting for, against and abstaining] [the basis for requiring changes in or disapproving research] [a written summary of the discussion of controverted issues and their resolution]. Specifically, ***", "frequency": "7" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "22727", "reference_number": "21 CFR 312.64(b)", "short_description": "Safety Reports - Serious Events", "long_description": "Failure to report serious adverse events [promptly] to the sponsor. Specifically, ***", "frequency": "7" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7290", "reference_number": "21 CFR 56.108(c)", "short_description": "Members present for review", "long_description": "For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. Specifically, ***", "frequency": "4" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7498", "reference_number": "21 CFR 312.66", "short_description": "Unanticipated problems", "long_description": "Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others. Specifically, ***", "frequency": "4" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7552", "reference_number": "21 CFR 312.66", "short_description": "Changes in research", "long_description": "Not all changes in research activity were approved by an Institutional Review Board prior to implementation. Specifically, ***", "frequency": "4" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7664", "reference_number": "21 CFR 50.20", "short_description": "Circumstances of obtaining consent", "long_description": "The general requirements for informed consent were not met in that [you] [the investigator] did not seek consent under circumstances that [provided the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate] [minimized the possibility of coercion or undue influence]. Specifically, ***", "frequency": "4" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3918", "reference_number": "21 CFR 58.33(a)", "short_description": "Study director: follow study protocol", "long_description": "The study director failed to assure that the protocol, including any change, was approved and was followed. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3931", "reference_number": "21 CFR 58.35(b)(5)", "short_description": "QAU: authorize deviations from protocols or SOPs", "long_description": "The quality assurance unit failed to determine whether any deviations from approved protocols or standard operating procedures had been made without proper authorization and documentation. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7342", "reference_number": "21 CFR 56.108(b)(2)", "short_description": "Prompt reporting of noncompliance", "long_description": "The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7517", "reference_number": "21 CFR 312.66", "short_description": "Initial and continuing review", "long_description": "Failure to assure that an IRB [complying with applicable regulatory requirements] was responsible for the initial and continuing review and approval of a clinical study. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7629", "reference_number": "21 CFR 312.56(c)", "short_description": "Annual report", "long_description": "Failure to submit to FDA [within 60 days of the anniversary date that the IND went into effect] an annual report of the investigation. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3926", "reference_number": "21 CFR 58.35(b)(1)", "short_description": "QAU: maintain a master schedule", "long_description": "The quality assurance unit failed to maintain a copy of a master schedule sheet that contained all required elements for all nonclinical laboratory studies conducted by the testing facility. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4032", "reference_number": "21 CFR 58.185(c)", "short_description": "Final report: corrections or additions", "long_description": "Not all corrections or additions to a final report were in the form of an amendment by the study director. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4035", "reference_number": "21 CFR 58.190(a)", "short_description": "Archives: data, documentation, specimens", "long_description": "Not all [raw data] [documentation] [protocols] [final reports] [specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids)] generated as a result of a nonclinical laboratory study were retained. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7227", "reference_number": "21 CFR 50.27(a)", "short_description": "Consent form not approved/signed/dated", "long_description": "Informed consent was not properly documented in that the written informed consent used in the study [was not approved by the IRB] [was not signed by the subject or the subject's legally authorized representative at the time of consent ] [was not dated by the subject or the subject's legally authorized representative at the time of consent]. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7231", "reference_number": "21 CFR 50.20", "short_description": "Consent not obtained, exceptions do not apply", "long_description": "Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7281", "reference_number": "21 CFR 56.108(a)(1)", "short_description": "Initial and continuing reviews", "long_description": "The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7286", "reference_number": "21 CFR 56.108(b)(1)", "short_description": "Prompt reporting of unanticipated problems", "long_description": "The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any unanticipated problems involving risks to human subjects or others. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7293", "reference_number": "21 CFR 56.109(f)", "short_description": "Continuing review", "long_description": "The IRB does not conduct continuing review of research at intervals [appropriate to the degree of risk] [of not less than once per year]. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7305", "reference_number": "21 CFR 56.110(b)(2)", "short_description": "Minor changes", "long_description": "The IRB used an expedited review procedure to review supposedly minor changes to previously-approved research, but the changes were not minor in nature. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7320", "reference_number": "21 CFR 56.109(e)", "short_description": "IRB approvals/disapprovals - general", "long_description": "The IRB has not promptly notified in writing [the investigator] [the institution] when the IRB has [approved] [disapproved] [required modifications to secure IRB approval of] proposed research activity. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7334", "reference_number": "21 CFR 56.115(a)(5)", "short_description": "List of members", "long_description": "A list of IRB members has not been [prepared] [maintained], identifying members by [name] [earned degrees] [representative capacity] [indications of experience sufficient to describe each member's chief anticipated contribution to IRB deliberations] [any employment or other relationship between each member and the institution]. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7378", "reference_number": "21 CFR 50.27(a)", "short_description": "Copy of consent form not provided", "long_description": "A copy of the written consent form which had been approved by the IRB and signed and dated by the subject or the subject's legally authorized representative, was not provided to the subject or the subject's legally authorized representative at the time of consent. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7390", "reference_number": "21 CFR 50.25(a)(4)", "short_description": "Alternate procedures, courses of treatment", "long_description": "There was [no] [an incomplete] disclosure in the informed consent document of appropriate alternate procedures or courses of treatment, if any, that might be advantageous to the subject. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7391", "reference_number": "21 CFR 50.25(a)(5)", "short_description": "Confidentiality, FDA inspection of records", "long_description": "There was no statement in the informed consent document that [described the extent, if any, to which confidentiality of records identifying the subject would be maintained] [noted the possibility that the Food and Drug Administration might inspect the records]. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7638", "reference_number": "21 CFR 312.20(a)", "short_description": "Failure to submit an IND", "long_description": "The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug. Specifically,***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7666", "reference_number": "21 CFR 50.20", "short_description": "Understandable language", "long_description": "The general requirements for informed consent were not met in that the information given was not in language understandable to the subject or the subject's representative. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3902", "reference_number": "21 CFR 58.29(a)", "short_description": "Personnel: education, training, experience", "long_description": "Not all individuals engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study have education, training, and experience, or combination thereof, to enable that individual to perform assigned functions. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3903", "reference_number": "21 CFR 58.29(b)", "short_description": "Personnel: summary of training, job description", "long_description": "The testing facility failed to maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3904", "reference_number": "21 CFR 58.29(c)", "short_description": "Personnel: sufficient number", "long_description": "The testing facility did not have a sufficient number of personnel for the timely and proper conduct of the study according to the protocol. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3914", "reference_number": "21 CFR 58.31(f)", "short_description": "Management: personnel understand their functions", "long_description": "Testing facility management failed to assure that all personnel clearly understood the functions they were to perform. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3915", "reference_number": "21 CFR 58.31(g)", "short_description": "Management: QAU findings to study director", "long_description": "Testing facility management failed to assure that any deviations from FDA GLP regulations reported by the quality assurance unit were communicated to the study director and corrective actions were taken and documented. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3919", "reference_number": "21 CFR 58.33(b)", "short_description": "Study director: all data recorded and verified", "long_description": "The study director failed to assure that all experimental data, including observations of unanticipated responses of the test system, were accurately recorded and verified. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3920", "reference_number": "21 CFR 58.33(c)", "short_description": "Study director: unforeseen circumstances", "long_description": "The study director failed to assure that unforeseen circumstances that might affect the quality and integrity of the nonclinical laboratory study were noted when they occurred and corrective action was taken and documented. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3923", "reference_number": "21 CFR 58.33(f)", "short_description": "Study director: transfer of data to archives", "long_description": "The study director failed to assure that all raw data, documentation, protocols, specimens, and final reports were transferred to the archives during or at the close of the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3924", "reference_number": "21 CFR 58.35(a)", "short_description": "QAU: monitor facilities, etc.", "long_description": "The quality assurance unit did not monitor each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls were in conformance with FDA GLP regulations. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3925", "reference_number": "21 CFR 58.35(a)", "short_description": "QAU: separate and independent", "long_description": "The quality assurance unit, for any given study, was not entirely separate from and independent of the personnel engaged in the direction and conduct of that study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3930", "reference_number": "21 CFR 58.35(b)(4)", "short_description": "QAU: submit periodic status reports", "long_description": "The quality assurance unit failed to periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3932", "reference_number": "21 CFR 58.35(b)(6)", "short_description": "QAU: review final study report", "long_description": "The quality assurance unit failed to review the final study report to assure that such report accurately described the methods and standard operating procedures, and that the reported results accurately reflected the raw data of the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3933", "reference_number": "21 CFR 58.35(b)(7)", "short_description": "QAU: signed statement in final report", "long_description": "The quality assurance unit failed to prepare and sign a statement to be included with the final study report which specified the dates inspections were made and findings reported to management and to the study director. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3954", "reference_number": "21 CFR 58.63(a)", "short_description": "Equipment: calibration", "long_description": "Not all equipment used for the generation, measurement, or assessment of data is adequately tested, calibrated and/or standardized. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3956", "reference_number": "21 CFR 58.63(c)", "short_description": "Equipment: maintenance records", "long_description": "Adequate written records are not maintained of all equipment inspection, maintenance, testing, calibrating and/or standardizing operations. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3957", "reference_number": "21 CFR 58.81(a)", "short_description": "SOPs: laboratory methods", "long_description": "The testing facility does not have written standard operating procedures setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3960", "reference_number": "21 CFR 58.81(b)", "short_description": "SOPs: required", "long_description": "Standard operating procedures have not been established for [animal room preparation] [animal care] [receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles] [test system observations] [laboratory tests] [handling of animals found moribund or dead during study] [necropsy of animals or postmortem examination of animals] [collection and identification of specimens] [histopathology] [data handling, storage, and retrieval] [maintenance and calibration of equipment] [transfer, proper placement, and identification of animals]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3977", "reference_number": "21 CFR 58.90(g)", "short_description": "Animal care: analysis of feed and water", "long_description": "Not all animal feed and water were analyzed periodically to ensure that expected contaminants were not present at levels above those specified in the protocol. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4011", "reference_number": "21 CFR 58.130(e)", "short_description": "Conduct: recording in ink", "long_description": "Data generated without the use of an automated data collection system were not recorded directly, promptly, and legibly in ink. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4016", "reference_number": "21 CFR 58.185(a)", "short_description": "Final report: non-existent", "long_description": "A final report was not prepared for each nonclinical laboratory study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4027", "reference_number": "21 CFR 58.185(a)(11)", "short_description": "Final report: operations on data, analysis of data", "long_description": "The final study report did not include [a description of the transformations, calculations, or operations performed on the data] [a summary and analysis of the data] [a statement of the conclusions drawn from the analysis]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4030", "reference_number": "21 CFR 58.185(a)(14)", "short_description": "Final report: statement by QAU", "long_description": "The final study report did not include the statement prepared and signed by the quality assurance unit as required by FDA Good Laboratory Practice regulations. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4039", "reference_number": "21 CFR 58.190(c)", "short_description": "Archives: individual responsible", "long_description": "An individual was not identified as responsible for the archives. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7278", "reference_number": "21 CFR 56.107(e)", "short_description": "Conflict of interest", "long_description": "The IRB allowed a member to participate in the IRB's [initial] [continuing review] of a project in which the member had a conflicting interest. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7304", "reference_number": "21 CFR 56.110(b)(1)", "short_description": "No more than minimal risk", "long_description": "The IRB used an expedited review procedure for research appearing in an FDA list of categories eligible for expedited review, but the reviewer did not find the research involved no more than minimal risk to the subjects. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7319", "reference_number": "21 CFR 56.115(a)(3)", "short_description": "Records of continuing review", "long_description": "Records have not been [prepared] [maintained] of all continuing review activities. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7333", "reference_number": "21 CFR 56.104(c)", "short_description": "Emergency use and IRB approval", "long_description": "A clinical investigator did not report to the IRB [, within five days of use,] the emergency use of a test article for which the IRB had not reviewed the research proposal. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7343", "reference_number": "21 CFR 56.108(b)(3)", "short_description": "Reporting of suspension/termination", "long_description": "The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any suspension or termination of IRB approval . Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7353", "reference_number": "21 CFR 50.52", "short_description": "Factors required for approval", "long_description": "The IRB approved a clinical investigation in which more than minimal risk to children was presented by 1) an intervention or procedure that held out the prospect of direct benefit for the individual subjects, and/or 2) by a monitoring procedure which was likely to contribute to the individual subjects' well-being. However, the IRB did not [find] [document] that [the risk was justified by the anticipated benefit to the subjects] [the relation of the anticipated benefit to the risk was at least as favorable to the subjects as that presented by available alternative approaches] [adequate provisions had been made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in 21 CFR 50.55]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7367", "reference_number": "21 CFR 50.55(e)(2)", "short_description": "Two parents' permission: studies under Parts 50.53 - 50.54", "long_description": "For a clinical investigation involving children, conducted under [21 CFR 50.53] [21 CFR 50.54], the investigator did not always obtain the permission of both parents where feasible. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7380", "reference_number": "21 CFR 50.27(b)(2)", "short_description": "Short form: IRB approval of oral presentation", "long_description": "The IRB did not approve a written summary of what was to be said to the subject or the subject's legally authorized representative, in a situation where a short form written consent document was prepared. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7387", "reference_number": "21 CFR 50.25(a)(1)", "short_description": "Statement of research, purpose, duration of participation", "long_description": "The informed consent document did not contain [a statement that the study involved research] [an explanation of the purposes of the research, and the expected duration of the subject's participation]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7409", "reference_number": "21 CFR 312.53(b)", "short_description": "Shipment to unauthorized persons", "long_description": "Shipment of an investigational new drug to someone not an investigator participating in the investigation. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7411", "reference_number": "21 CFR 312.53(c)(1)", "short_description": "Investigator statement (FDA 1572)", "long_description": "Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7453", "reference_number": "21 CFR 312.56(b)", "short_description": "Investigator non-compliance", "long_description": "An investigator who did not comply with [the signed agreement] [the general investigational plan] [applicable regulatory requirements] was not [promptly brought into compliance] [terminated]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7459", "reference_number": "21 CFR 312.57(a)", "short_description": "Records of receipt, shipment, disposition", "long_description": "Lack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an investigational drug. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7480", "reference_number": "21 CFR 312.50", "short_description": "Ensuring compliance with plan and protocol", "long_description": "Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7531", "reference_number": "21 CFR 312.62(c)", "short_description": "Record retention", "long_description": "Investigational records were not retained for a period of two years following [approval of a drug's marketing application] [discontinuance of the investigation and notification of FDA]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7533", "reference_number": "21 CFR 312.69", "short_description": "Controlled substances (investigator)", "long_description": "Inadequate precautions to prevent theft or diversion with respect to [storage of] [access to] an investigational drug which is a controlled substance. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7557", "reference_number": "21 CFR 312.56(b)", "short_description": "Notification of FDA of termination of investigator", "long_description": "Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7558", "reference_number": "21 CFR 312.57(c)", "short_description": "Record retention requirement", "long_description": "Records and reports were not retained for two years after [marketing application approval] [discontinuance of the investigation and notification of FDA]. Specifically***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7639", "reference_number": "21 CFR 312.20(b)", "short_description": "Starting a study before IND is in effect", "long_description": "The sponsor began a clinical investigation subject to IND requirements before an IND was in effect. Specifically,***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7651", "reference_number": "21 CFR 56.113", "short_description": "Statement of reasons", "long_description": "The IRB's [suspension] [termination of approval] for research did not include a statement of the reasons for the IRB's action. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7652", "reference_number": "21 CFR 56.113", "short_description": "Reporting", "long_description": "The IRB's [suspension] [termination of approval] for research was not reported [promptly] to [the investigator] [appropriate institutional officials] [the Food and Drug Administration]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2023, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7695", "reference_number": "21 CFR 50.25(c)", "short_description": "ClincialTrials.gov statement", "long_description": "The informed consent document does not include the [complete] required statement: \"A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.\" Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7560", "reference_number": "21 CFR 312.60", "short_description": "FD-1572, protocol compliance", "long_description": "An investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan]. Specifically, ***", "frequency": "99" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7530", "reference_number": "21 CFR 312.62(b)", "short_description": "Case history records- inadequate or inadequate", "long_description": "Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data pertinent to the investigation] [informed consent]. Specifically, ***", "frequency": "56" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7482", "reference_number": "21 CFR 312.50", "short_description": "General responsibilities of sponsors", "long_description": "Failure to [select qualified investigators] [provide investigators with the information needed to conduct the study properly] [ensure proper monitoring of the study] [ensure the study is conducted in accordance with the protocol and/or investigational plan] [ensure that FDA and all investigators are promptly informed of significant new adverse effects or risks]. Specifically, ***", "frequency": "10" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7318", "reference_number": "21 CFR 56.115(a)(2)", "short_description": "Minutes of IRB meetings", "long_description": "Minutes of IRB meetings have not been [prepared] [maintained] in sufficient detail to show [attendance at the meetings] [actions taken by the IRB] [the vote on actions, including the number of members voting for, against and abstaining] [the basis for requiring changes in or disapproving research] [a written summary of the discussion of controverted issues and their resolution]. Specifically, ***", "frequency": "9" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "22727", "reference_number": "21 CFR 312.64(b)", "short_description": "Safety Reports - Serious Events", "long_description": "Failure to report serious adverse events [promptly] to the sponsor. Specifically, ***", "frequency": "9" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7281", "reference_number": "21 CFR 56.108(a)(1)", "short_description": "Initial and continuing reviews", "long_description": "The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, ***", "frequency": "8" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7526", "reference_number": "21 CFR 312.62(a)", "short_description": "Accountability records", "long_description": "Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects]. Specifically, ***", "frequency": "6" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7562", "reference_number": "21 CFR 312.60", "short_description": "Informed consent", "long_description": "Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to [drug administration] [conducting study-related tests]. Specifically, ***", "frequency": "5" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "22728", "reference_number": "21 CFR 312.64(b)", "short_description": "Safety Reports - Non-Serious Events", "long_description": "Failure to report non-serious adverse events to the sponsor in accordance with the study protocol timetable for reporting. \n Specifically, ***", "frequency": "5" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3957", "reference_number": "21 CFR 58.81(a)", "short_description": "SOPs: laboratory methods", "long_description": "The testing facility does not have written standard operating procedures setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. Specifically, ***", "frequency": "4" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7227", "reference_number": "21 CFR 50.27(a)", "short_description": "Consent form not approved/signed/dated", "long_description": "Informed consent was not properly documented in that the written informed consent used in the study [was not approved by the IRB] [was not signed by the subject or the subject's legally authorized representative at the time of consent ] [was not dated by the subject or the subject's legally authorized representative at the time of consent]. Specifically, ***", "frequency": "4" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3931", "reference_number": "21 CFR 58.35(b)(5)", "short_description": "QAU: authorize deviations from protocols or SOPs", "long_description": "The quality assurance unit failed to determine whether any deviations from approved protocols or standard operating procedures had been made without proper authorization and documentation. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7334", "reference_number": "21 CFR 56.115(a)(5)", "short_description": "List of members", "long_description": "A list of IRB members has not been [prepared] [maintained], identifying members by [name] [earned degrees] [representative capacity] [indications of experience sufficient to describe each member's chief anticipated contribution to IRB deliberations] [any employment or other relationship between each member and the institution]. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7363", "reference_number": "21 CFR 50.55(f)", "short_description": "Documentation of permission by parents or guardian", "long_description": "Permission by parents or guardians for the participation of children as subjects in a clinical investigation was not documented in accordance with and to the extent required by 21 CFR 50.27. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7459", "reference_number": "21 CFR 312.57(a)", "short_description": "Records of receipt, shipment, disposition", "long_description": "Lack of [adequate] records covering [receipt] [shipment to investigators] [disposition] of an investigational drug. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7498", "reference_number": "21 CFR 312.66", "short_description": "Unanticipated problems", "long_description": "Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7517", "reference_number": "21 CFR 312.66", "short_description": "Initial and continuing review", "long_description": "Failure to assure that an IRB [complying with applicable regulatory requirements] was responsible for the initial and continuing review and approval of a clinical study. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7531", "reference_number": "21 CFR 312.62(c)", "short_description": "Record retention", "long_description": "Investigational records were not retained for a period of two years following [approval of a drug's marketing application] [discontinuance of the investigation and notification of FDA]. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3953", "reference_number": "21 CFR 58.63(a)", "short_description": "Equipment: inspection, cleaning and maintenance", "long_description": "Not all equipment is adequately inspected, cleaned, and maintained. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7231", "reference_number": "21 CFR 50.20", "short_description": "Consent not obtained, exceptions do not apply", "long_description": "Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7321", "reference_number": "21 CFR 56.110(c)", "short_description": "Method to keep members advised", "long_description": "The IRB uses an expedited review procedure, but [has not adopted] [is not following] a method for keeping members advised of research proposals which have been approved under the procedure. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7342", "reference_number": "21 CFR 56.108(b)(2)", "short_description": "Prompt reporting of noncompliance", "long_description": "The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any instance of serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7343", "reference_number": "21 CFR 56.108(b)(3)", "short_description": "Reporting of suspension/termination", "long_description": "The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any suspension or termination of IRB approval . Specifically, ***", "frequency": "2" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7367", "reference_number": "21 CFR 50.55(e)(2)", "short_description": "Two parents' permission: studies under Parts 50.53 - 50.54", "long_description": "For a clinical investigation involving children, conducted under [21 CFR 50.53] [21 CFR 50.54], the investigator did not always obtain the permission of both parents where feasible. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7371", "reference_number": "21 CFR 56.108(a)(1)", "short_description": "Reporting findings and actions to investigator/institution", "long_description": "The IRB [has no] [did not follow its] written procedure for reporting its [findings] [actions] to the [investigator] [institution]. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7409", "reference_number": "21 CFR 312.53(b)", "short_description": "Shipment to unauthorized persons", "long_description": "Shipment of an investigational new drug to someone not an investigator participating in the investigation. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7453", "reference_number": "21 CFR 312.56(b)", "short_description": "Investigator non-compliance", "long_description": "An investigator who did not comply with [the signed agreement] [the general investigational plan] [applicable regulatory requirements] was not [promptly brought into compliance] [terminated]. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7480", "reference_number": "21 CFR 312.50", "short_description": "Ensuring compliance with plan and protocol", "long_description": "Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7629", "reference_number": "21 CFR 312.56(c)", "short_description": "Annual report", "long_description": "Failure to submit to FDA [within 60 days of the anniversary date that the IND went into effect] an annual report of the investigation. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7659", "reference_number": "21 CFR 50.25(a)(6)", "short_description": "Compensation, medical treatment in event of injury", "long_description": "For research involving more than minimal risk, the informed consent document lacked an explanation as to whether any [compensation] [medical treatments] were available if injury occurred, and, if so, [of what they consisted] [where further information might be obtained]. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7692", "reference_number": "21 CFR 56.106(e)", "short_description": "Changes in contact or chairperson information", "long_description": "The IRB did not revise its registration information with respect to changes in [the contact person] [the chairperson] within 90 days of the change. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3910", "reference_number": "21 CFR 58.31(b)", "short_description": "Management: replacing the study director", "long_description": "Testing facility management failed to promptly replace the study director as necessary during the conduct of a study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3919", "reference_number": "21 CFR 58.33(b)", "short_description": "Study director: all data recorded and verified", "long_description": "The study director failed to assure that all experimental data, including observations of unanticipated responses of the test system, were accurately recorded and verified. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3923", "reference_number": "21 CFR 58.33(f)", "short_description": "Study director: transfer of data to archives", "long_description": "The study director failed to assure that all raw data, documentation, protocols, specimens, and final reports were transferred to the archives during or at the close of the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3926", "reference_number": "21 CFR 58.35(b)(1)", "short_description": "QAU: maintain a master schedule", "long_description": "The quality assurance unit failed to maintain a copy of a master schedule sheet that contained all required elements for all nonclinical laboratory studies conducted by the testing facility. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3928", "reference_number": "21 CFR 58.35(b)(3)", "short_description": "QAU: inspect study at adequate intervals", "long_description": "The quality assurance unit failed to inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3929", "reference_number": "21 CFR 58.35(b)(3)", "short_description": "QAU: problems affecting study integrity", "long_description": "The quality assurance unit failed to immediately bring to the attention of the study director and management any problems found during the course of an inspection which are likely to affect study integrity. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3950", "reference_number": "21 CFR 58.49", "short_description": "Facility: laboratory operation space", "long_description": "Separate laboratory space is not provided, as needed, for the performance of the routine and specialized procedures required by nonclinical laboratory studies. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3951", "reference_number": "21 CFR 58.51", "short_description": "Facility: archives", "long_description": "Space is not provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3954", "reference_number": "21 CFR 58.63(a)", "short_description": "Equipment: calibration", "long_description": "Not all equipment used for the generation, measurement, or assessment of data is adequately tested, calibrated and/or standardized. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3958", "reference_number": "21 CFR 58.81(a)", "short_description": "SOPs: authorization and documentation of deviations", "long_description": "Not all deviations from standard operating procedures in a study were authorized by the study director and documented in the raw data. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3988", "reference_number": "21 CFR 58.105(d)", "short_description": "Test article: reserve sample retention", "long_description": "Not all reserve samples from each batch of test and control articles for studies of more than 4 weeks' duration were retained for the required period of time. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3989", "reference_number": "21 CFR 58.107", "short_description": "Test article: handling", "long_description": "Procedures have not been established for the handling of the test and control articles to ensure that [there is proper storage] [distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage] [proper identification is maintained throughout the distribution process] [the receipt and distribution of each batch is documented including the date and quantity of each batch distributed or returned]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4006", "reference_number": "21 CFR 58.120(b)", "short_description": "Protocol: approval of changes", "long_description": "Not all changes in, or revisions of, an approved protocol and the reasons therefore were documented, signed by the study director, dated, and maintained with the protocol. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4009", "reference_number": "21 CFR 58.130(c)", "short_description": "Conduct: identification of test specimens", "long_description": "Not all specimens were identified by test system, study, nature, and date of collection. This information was not located on the specimen container or did not accompany the specimen in a manner that precluded error in the recording and storage of data. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4011", "reference_number": "21 CFR 58.130(e)", "short_description": "Conduct: recording in ink", "long_description": "Data generated without the use of an automated data collection system were not recorded directly, promptly, and legibly in ink. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4025", "reference_number": "21 CFR 58.185(a)(9)", "short_description": "Final report: circumstances affecting data qual., integrity", "long_description": "The final study report did not include a description of all circumstances that may have affected the quality or integrity of the data. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4026", "reference_number": "21 CFR 58.185(a)(10)", "short_description": "Final report: names of those involved", "long_description": "The final study report did not include [the name of the study director] [the names of other scientists or professionals] [the names of all supervisory personnel] involved in the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4039", "reference_number": "21 CFR 58.190(c)", "short_description": "Archives: individual responsible", "long_description": "An individual was not identified as responsible for the archives. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7277", "reference_number": "21 CFR 56.107(d)", "short_description": "One non-affiliate member", "long_description": "The IRB does not include at least one member who is not otherwise affiliated with the institution, and who is not part of the immediate family of a person who is affiliated with the institution. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7278", "reference_number": "21 CFR 56.107(e)", "short_description": "Conflict of interest", "long_description": "The IRB allowed a member to participate in the IRB's [initial] [continuing review] of a project in which the member had a conflicting interest. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7286", "reference_number": "21 CFR 56.108(b)(1)", "short_description": "Prompt reporting of unanticipated problems", "long_description": "The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any unanticipated problems involving risks to human subjects or others. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7290", "reference_number": "21 CFR 56.108(c)", "short_description": "Members present for review", "long_description": "For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7293", "reference_number": "21 CFR 56.109(f)", "short_description": "Continuing review", "long_description": "The IRB does not conduct continuing review of research at intervals [appropriate to the degree of risk] [of not less than once per year]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7298", "reference_number": "21 CFR 56.109(a)", "short_description": "Authority of the IRB", "long_description": "The IRB does not have the authority to [approve] [require modifications in] [disapprove] all research activities covered by the regulations. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7335", "reference_number": "21 CFR 56.115(a)(6)", "short_description": "Written procedures per 56.108(a) and (b)", "long_description": "Documentation has not been [prepared] [maintained] of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b). Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7337", "reference_number": "21 CFR 56.115(b)", "short_description": "Retention of records", "long_description": "Records required by 21 CFR 56 have not been maintained for three years following completion of the research. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7339", "reference_number": "21 CFR 56.108(a)(4)", "short_description": "Changes in approved research", "long_description": "The IRB [has no] [did not follow its] written procedure for ensuring that changes in approved research, during the periods for which IRB approval had already been given, would not be initiated without IRB review and approval (except where necessary to eliminate apparent immediate hazards to the human subjects). Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7340", "reference_number": "21 CFR 56.108(a)(3)", "short_description": "Prompt reporting of changes", "long_description": "The IRB [has no] [did not follow its] written procedure for ensuring prompt reporting to the IRB of changes in research activity. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7368", "reference_number": "21 CFR 56.108(a)(2)", "short_description": "More frequent reviews, verification of no changes", "long_description": "The IRB [has no] [did not follow its] written procedure for determining which projects [require review more often than annually] [need verification from sources other than the investigator that no material changes have occurred since previous IRB review] . Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7384", "reference_number": "21 CFR 50.25(b)(1)", "short_description": "Statement of risks", "long_description": "The informed consent document did not contain a statement that the test article or procedure might involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7388", "reference_number": "21 CFR 50.25(a)(2)", "short_description": "Reasonably foreseeable risks or discomforts", "long_description": "The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7390", "reference_number": "21 CFR 50.25(a)(4)", "short_description": "Alternate procedures, courses of treatment", "long_description": "There was [no] [an incomplete] disclosure in the informed consent document of appropriate alternate procedures or courses of treatment, if any, that might be advantageous to the subject. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7411", "reference_number": "21 CFR 312.53(c)(1)", "short_description": "Investigator statement (FDA 1572)", "long_description": "Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7428", "reference_number": "21 CFR 312.53(c)(2)", "short_description": "Investigator CV or other statement of qualifications", "long_description": "Failure to obtain a curriculum vitae or other statement of the qualifications of the investigator, before permitting an investigator to participate in an investigation. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7452", "reference_number": "21 CFR 312.56(c)", "short_description": "IND safety report", "long_description": "Failure to provide [FDA] [all participating investigators] with [a] [an adequate] written IND safety report. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7456", "reference_number": "21 CFR 312.57(d)", "short_description": "Bioequivalence samples", "long_description": "Samples of the [test article] [reference standard] used in a [bioavailability] [bioequivalence] study were not [retained] [released to FDA upon request as required by 21 CFR Part 320.38]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7458", "reference_number": "21 CFR 312.57(b)", "short_description": "Records of Financial Interests", "long_description": "Failure to maintain [complete] [accurate] records of disclosable financial interests paid to clinical investigators by the sponsor. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7483", "reference_number": "21 CFR 312.55(b)", "short_description": "New observations, adverse effects and risks", "long_description": "Not all participating investigators were [promptly] informed of new observations discovered by or reported to the sponsor [with respect to adverse effects and safe use]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7505", "reference_number": "21 CFR 312.55(a)", "short_description": "Investigator brochure", "long_description": "Failure to provide to an investigator, prior to the start of an investigation, a brochure containing all of the information required by 21 CFR 312.23(a)(5). Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7534", "reference_number": "21 CFR 312.68", "short_description": "FDA access to clinical investigator records", "long_description": "Failure to permit an authorized officer or employee of FDA to [have access to] [copy] [verify] records or reports. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7552", "reference_number": "21 CFR 312.66", "short_description": "Changes in research", "long_description": "Not all changes in research activity were approved by an Institutional Review Board prior to implementation. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7557", "reference_number": "21 CFR 312.56(b)", "short_description": "Notification of FDA of termination of investigator", "long_description": "Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7635", "reference_number": "21 CFR 312.7(b)", "short_description": "Commercial distribution of an investigational drug", "long_description": "The investigational new drug was [commercially distributed] [test marketed]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7638", "reference_number": "21 CFR 312.20(a)", "short_description": "Failure to submit an IND", "long_description": "The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug. Specifically,***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7654", "reference_number": "21 CFR 56.110(b)", "short_description": "Research not eligible for expedited review", "long_description": "The IRB used an expedited review procedure for research which did not appear in an FDA list of categories eligible for expedited review, and which had not previously been approved by the IRB [within one year]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7656", "reference_number": "21 CFR 56.108(c)", "short_description": "Approval from a majority of members present", "long_description": "For other than expedited reviews, research approved by the IRB does not always receive the approval of a majority of those IRB members present. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7664", "reference_number": "21 CFR 50.20", "short_description": "Circumstances of obtaining consent", "long_description": "The general requirements for informed consent were not met in that [you] [the investigator] did not seek consent under circumstances that [provided the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate] [minimized the possibility of coercion or undue influence]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7666", "reference_number": "21 CFR 50.20", "short_description": "Understandable language", "long_description": "The general requirements for informed consent were not met in that the information given was not in language understandable to the subject or the subject's representative. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7683", "reference_number": "21 CFR 56.106(b)(2)", "short_description": "IRB registration information", "long_description": "Registration information does not include the IRB [name] [mailing address] [street address different from the mailing address] [phone number] [facsimilie number] [electronic mail address]. Specifically, **", "frequency": "1" }, { "fiscal_year": 2024, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7686", "reference_number": "21 CFR 56.106(b)(3)", "short_description": "Number of active protocols", "long_description": "The IRB registration does not state the approximate number of active protocols involving FDA-regulated products reviewed. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7560", "reference_number": "21 CFR 312.60", "short_description": "FD-1572, protocol compliance", "long_description": "An investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan]. Specifically, ***", "frequency": "80" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7530", "reference_number": "21 CFR 312.62(b)", "short_description": "Case history records- inadequate or inadequate", "long_description": "Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data pertinent to the investigation] [informed consent]. Specifically, ***", "frequency": "52" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "22727", "reference_number": "21 CFR 312.64(b)", "short_description": "Safety Reports - Serious Events", "long_description": "Failure to report serious adverse events [promptly] to the sponsor. Specifically, ***", "frequency": "12" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7526", "reference_number": "21 CFR 312.62(a)", "short_description": "Accountability records", "long_description": "Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects]. Specifically, ***", "frequency": "11" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7562", "reference_number": "21 CFR 312.60", "short_description": "Informed consent", "long_description": "Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to [drug administration] [conducting study-related tests]. Specifically, ***", "frequency": "9" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "22728", "reference_number": "21 CFR 312.64(b)", "short_description": "Safety Reports - Non-Serious Events", "long_description": "Failure to report non-serious adverse events to the sponsor in accordance with the study protocol timetable for reporting. \n Specifically, ***", "frequency": "8" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3923", "reference_number": "21 CFR 58.33(f)", "short_description": "Study director: transfer of data to archives", "long_description": "The study director failed to assure that all raw data, documentation, protocols, specimens, and final reports were transferred to the archives during or at the close of the study. Specifically, ***", "frequency": "7" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3919", "reference_number": "21 CFR 58.33(b)", "short_description": "Study director: all data recorded and verified", "long_description": "The study director failed to assure that all experimental data, including observations of unanticipated responses of the test system, were accurately recorded and verified. Specifically, ***", "frequency": "6" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7482", "reference_number": "21 CFR 312.50", "short_description": "General responsibilities of sponsors", "long_description": "Failure to [select qualified investigators] [provide investigators with the information needed to conduct the study properly] [ensure proper monitoring of the study] [ensure the study is conducted in accordance with the protocol and/or investigational plan] [ensure that FDA and all investigators are promptly informed of significant new adverse effects or risks]. Specifically, ***", "frequency": "6" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7552", "reference_number": "21 CFR 312.66", "short_description": "Changes in research", "long_description": "Not all changes in research activity were approved by an Institutional Review Board prior to implementation. Specifically, ***", "frequency": "6" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3926", "reference_number": "21 CFR 58.35(b)(1)", "short_description": "QAU: maintain a master schedule", "long_description": "The quality assurance unit failed to maintain a copy of a master schedule sheet that contained all required elements for all nonclinical laboratory studies conducted by the testing facility. Specifically, ***", "frequency": "5" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3931", "reference_number": "21 CFR 58.35(b)(5)", "short_description": "QAU: authorize deviations from protocols or SOPs", "long_description": "The quality assurance unit failed to determine whether any deviations from approved protocols or standard operating procedures had been made without proper authorization and documentation. Specifically, ***", "frequency": "5" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7531", "reference_number": "21 CFR 312.62(c)", "short_description": "Record retention", "long_description": "Investigational records were not retained for a period of two years following [approval of a drug's marketing application] [discontinuance of the investigation and notification of FDA]. Specifically, ***", "frequency": "5" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3960", "reference_number": "21 CFR 58.81(b)", "short_description": "SOPs: required", "long_description": "Standard operating procedures have not been established for [animal room preparation] [animal care] [receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles] [test system observations] [laboratory tests] [handling of animals found moribund or dead during study] [necropsy of animals or postmortem examination of animals] [collection and identification of specimens] [histopathology] [data handling, storage, and retrieval] [maintenance and calibration of equipment] [transfer, proper placement, and identification of animals]. Specifically, ***", "frequency": "4" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4007", "reference_number": "21 CFR 58.130(a)", "short_description": "Conduct: in accordance with protocol", "long_description": "Not all nonclinical laboratory studies were conducted in \naccordance with the protocol. Specifically, ***", "frequency": "4" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7334", "reference_number": "21 CFR 56.115(a)(5)", "short_description": "List of members", "long_description": "A list of IRB members has not been [prepared] [maintained], identifying members by [name] [earned degrees] [representative capacity] [indications of experience sufficient to describe each member's chief anticipated contribution to IRB deliberations] [any employment or other relationship between each member and the institution]. Specifically, ***", "frequency": "4" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3914", "reference_number": "21 CFR 58.31(f)", "short_description": "Management: personnel understand their functions", "long_description": "Testing facility management failed to assure that all personnel clearly understood the functions they were to perform. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3932", "reference_number": "21 CFR 58.35(b)(6)", "short_description": "QAU: review final study report", "long_description": "The quality assurance unit failed to review the final study report to assure that such report accurately described the methods and standard operating procedures, and that the reported results accurately reflected the raw data of the study. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3953", "reference_number": "21 CFR 58.63(a)", "short_description": "Equipment: inspection, cleaning and maintenance", "long_description": "Not all equipment is adequately inspected, cleaned, and maintained. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4009", "reference_number": "21 CFR 58.130(c)", "short_description": "Conduct: identification of test specimens", "long_description": "Not all specimens were identified by test system, study, nature, and date of collection. This information was not located on the specimen container or did not accompany the specimen in a manner that precluded error in the recording and storage of data. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4025", "reference_number": "21 CFR 58.185(a)(9)", "short_description": "Final report: circumstances affecting data qual., integrity", "long_description": "The final study report did not include a description of all circumstances that may have affected the quality or integrity of the data. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4035", "reference_number": "21 CFR 58.190(a)", "short_description": "Archives: data, documentation, specimens", "long_description": "Not all [raw data] [documentation] [protocols] [final reports] [specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids)] generated as a result of a nonclinical laboratory study were retained. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7227", "reference_number": "21 CFR 50.27(a)", "short_description": "Consent form not approved/signed/dated", "long_description": "Informed consent was not properly documented in that the written informed consent used in the study [was not approved by the IRB] [was not signed by the subject or the subject's legally authorized representative at the time of consent ] [was not dated by the subject or the subject's legally authorized representative at the time of consent]. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7318", "reference_number": "21 CFR 56.115(a)(2)", "short_description": "Minutes of IRB meetings", "long_description": "Minutes of IRB meetings have not been [prepared] [maintained] in sufficient detail to show [attendance at the meetings] [actions taken by the IRB] [the vote on actions, including the number of members voting for, against and abstaining] [the basis for requiring changes in or disapproving research] [a written summary of the discussion of controverted issues and their resolution]. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7391", "reference_number": "21 CFR 50.25(a)(5)", "short_description": "Confidentiality, FDA inspection of records", "long_description": "There was no statement in the informed consent document that [described the extent, if any, to which confidentiality of records identifying the subject would be maintained] [noted the possibility that the Food and Drug Administration might inspect the records]. Specifically, ***", "frequency": "3" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3918", "reference_number": "21 CFR 58.33(a)", "short_description": "Study director: follow study protocol", "long_description": "The study director failed to assure that the protocol, including any change, was approved and was followed. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3928", "reference_number": "21 CFR 58.35(b)(3)", "short_description": "QAU: inspect study at adequate intervals", "long_description": "The quality assurance unit failed to inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3976", "reference_number": "21 CFR 58.90(f)", "short_description": "Animal care: cage and equipment cleaning", "long_description": "Not all animal cages, racks and accessory equipment were cleaned and sanitized at appropriate intervals. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3977", "reference_number": "21 CFR 58.90(g)", "short_description": "Animal care: analysis of feed and water", "long_description": "Not all animal feed and water were analyzed periodically to ensure that expected contaminants were not present at levels above those specified in the protocol. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3990", "reference_number": "21 CFR 58.113(a)(1)", "short_description": "Mixtures: uniformity and concentration", "long_description": "Not all test or control articles mixed with a carrier were tested by appropriate analytical methods to determine [the uniformity of the mixture] [periodically, the concentration of the test or control article in the mixture]. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3997", "reference_number": "21 CFR 58.120(a)(4)", "short_description": "Protocol: test system description", "long_description": "Not all protocols contained the number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4023", "reference_number": "21 CFR 58.185(a)(7)", "short_description": "Final report: description of test system", "long_description": "The final study report did not include a description of the test system used and, where applicable, the number of animals used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7230", "reference_number": "21 CFR 50.27(b)(2)", "short_description": "Short form: Oral presentation/signing", "long_description": "A short form informed consent document [did not state that the required elements of informed consent had been presented orally to the subject or the subject's legally authorized representative] [was not signed by the subject or the subject's legally authorized representative] [was not signed by the witness]. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7393", "reference_number": "21 CFR 50.25(a)(8)", "short_description": "Participation; refusal and discontinuance", "long_description": "The informed consent document did not contain a statement that [participation was voluntary] [refusal to participate would involve no penalty or loss of benefits to which the subject was otherwise entitled] [the subject might discontinue participation at any time without penalty or loss of benefits to which the subject was otherwise entitled]. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7479", "reference_number": "21 CFR 312.56(a)", "short_description": "Monitoring investigations", "long_description": "Failure to monitor the progress of an investigation conducted under your IND. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7480", "reference_number": "21 CFR 312.50", "short_description": "Ensuring compliance with plan and protocol", "long_description": "Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7498", "reference_number": "21 CFR 312.66", "short_description": "Unanticipated problems", "long_description": "Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7517", "reference_number": "21 CFR 312.66", "short_description": "Initial and continuing review", "long_description": "Failure to assure that an IRB [complying with applicable regulatory requirements] was responsible for the initial and continuing review and approval of a clinical study. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7629", "reference_number": "21 CFR 312.56(c)", "short_description": "Annual report", "long_description": "Failure to submit to FDA [within 60 days of the anniversary date that the IND went into effect] an annual report of the investigation. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7638", "reference_number": "21 CFR 312.20(a)", "short_description": "Failure to submit an IND", "long_description": "The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug. Specifically,***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7692", "reference_number": "21 CFR 56.106(e)", "short_description": "Changes in contact or chairperson information", "long_description": "The IRB did not revise its registration information with respect to changes in [the contact person] [the chairperson] within 90 days of the change. Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7695", "reference_number": "21 CFR 50.25(c)", "short_description": "ClincialTrials.gov statement", "long_description": "The informed consent document does not include the [complete] required statement: \"A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.\" Specifically, ***", "frequency": "2" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3902", "reference_number": "21 CFR 58.29(a)", "short_description": "Personnel: education, training, experience", "long_description": "Not all individuals engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study have education, training, and experience, or combination thereof, to enable that individual to perform assigned functions. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3912", "reference_number": "21 CFR 58.31(d)", "short_description": "Management: testing of test and control articles", "long_description": "Testing facility management failed to assure that all test and control articles or mixtures had been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3917", "reference_number": "21 CFR 58.33", "short_description": "study director: overall study responsibility", "long_description": "The study director did not have overall responsibility for the technical conduct of the study as well as for the interpretation, analysis, documentation and reporting of results, and does not represent the single point of study control. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3924", "reference_number": "21 CFR 58.35(a)", "short_description": "QAU: monitor facilities, etc.", "long_description": "The quality assurance unit did not monitor each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls were in conformance with FDA GLP regulations. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3933", "reference_number": "21 CFR 58.35(b)(7)", "short_description": "QAU: signed statement in final report", "long_description": "The quality assurance unit failed to prepare and sign a statement to be included with the final study report which specified the dates inspections were made and findings reported to management and to the study director. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3936", "reference_number": "21 CFR 58.41", "short_description": "Facility: suitable size and construction", "long_description": "The testing facility is not of suitable size and construction to facilitate the proper conduct of nonclinical laboratory studies. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3937", "reference_number": "21 CFR 58.41", "short_description": "Facility: separation of function or activity", "long_description": "The testing facility is not designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3957", "reference_number": "21 CFR 58.81(a)", "short_description": "SOPs: laboratory methods", "long_description": "The testing facility does not have written standard operating procedures setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3959", "reference_number": "21 CFR 58.81(a)", "short_description": "SOPs: authorized changes", "long_description": "Not all significant changes in established standard operating procedures were properly authorized in writing by management. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3963", "reference_number": "21 CFR 58.83", "short_description": "Reagents: labeling", "long_description": "Not all reagents and solutions in the laboratory areas are labeled to indicate identity, titer or concentration, storage requirements, and expiration date. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3965", "reference_number": "21 CFR 58.90(a)", "short_description": "Animal care: SOPs", "long_description": "Standard operating procedures for the housing, feeding, handling, and care of animals did not exist. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3986", "reference_number": "21 CFR 58.105(c)", "short_description": "Test article: storage container labeling", "long_description": "Not all storage containers for a test or control article were labeled by name, chemical abstract number or code number, batch number, expiration date, if any, and, where appropriate, storage conditions necessary to maintain the identity, strength, purity, and composition of the test or control article. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3988", "reference_number": "21 CFR 58.105(d)", "short_description": "Test article: reserve sample retention", "long_description": "Not all reserve samples from each batch of test and control articles for studies of more than 4 weeks' duration were retained for the required period of time. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3989", "reference_number": "21 CFR 58.107", "short_description": "Test article: handling", "long_description": "Procedures have not been established for the handling of the test and control articles to ensure that [there is proper storage] [distribution is made in a manner designed to preclude the possibility of contamination, deterioration, or damage] [proper identification is maintained throughout the distribution process] [the receipt and distribution of each batch is documented including the date and quantity of each batch distributed or returned]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "3999", "reference_number": "21 CFR 58.120(a)(6)", "short_description": "Protocol: experimental design", "long_description": "Not all protocols contained a description of the experimental design, including the methods for the control of bias. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4000", "reference_number": "21 CFR 58.120(a)(7)", "short_description": "Protocol: diet description", "long_description": "Not all protocols contained a description and/or identification of the diet used in the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4001", "reference_number": "21 CFR 58.120(a)(8)", "short_description": "Protocol: dosage", "long_description": "Not all protocols contained each dosage level of the test or control article to be administered and the method and frequency of administration. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4004", "reference_number": "21 CFR 58.120(a)(11)", "short_description": "Protocol: date and signature", "long_description": "Not all protocols contained the date of approval of the protocol by the sponsor and the dated signature of the study director. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4011", "reference_number": "21 CFR 58.130(e)", "short_description": "Conduct: recording in ink", "long_description": "Data generated without the use of an automated data collection system were not recorded directly, promptly, and legibly in ink. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4016", "reference_number": "21 CFR 58.185(a)", "short_description": "Final report: non-existent", "long_description": "A final report was not prepared for each nonclinical laboratory study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4020", "reference_number": "21 CFR 58.185(a)(4)", "short_description": "Final report: data on test and control articles", "long_description": "The final study report did not include the test and control articles identified by name, chemical abstracts number or code number, strength, purity, and composition or other appropriate characteristics. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4021", "reference_number": "21 CFR 58.185(a)(5)", "short_description": "Final report: stability of test and control articles", "long_description": "The final study report did not include the stability of the test and control articles under the conditions of administration. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4022", "reference_number": "21 CFR 58.185(a)(6)", "short_description": "Final report: description of methods", "long_description": "The final study report did not include a description of the methods used. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4026", "reference_number": "21 CFR 58.185(a)(10)", "short_description": "Final report: names of those involved", "long_description": "The final study report did not include [the name of the study director] [the names of other scientists or professionals] [the names of all supervisory personnel] involved in the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4028", "reference_number": "21 CFR 58.185(a)(12)", "short_description": "Final report: reports of individual scientists", "long_description": "The final study report did not include the signed and dated reports of each of the individual scientists or other professionals involved in the study. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4032", "reference_number": "21 CFR 58.185(c)", "short_description": "Final report: corrections or additions", "long_description": "Not all corrections or additions to a final report were in the form of an amendment by the study director. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "4037", "reference_number": "21 CFR 58.190(b)", "short_description": "Archives: conditions of storage", "long_description": "Conditions of storage failed to minimize deterioration of the [documents] [specimens] in accordance with the requirements for the time period of their retention and the nature of the [documents] [specimens]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7209", "reference_number": "21 CFR 50.25(a)(1)", "short_description": "Procedures, identification of those which were experimental", "long_description": "The informed consent document did not contain [a description of the procedures to be followed] [identification of any procedures which were experimental]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7231", "reference_number": "21 CFR 50.20", "short_description": "Consent not obtained, exceptions do not apply", "long_description": "Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7276", "reference_number": "21 CFR 56.107(c)", "short_description": "One scientific and one non-scientific member", "long_description": "The IRB does not include [at least one member whose primary concerns are in the scientific area] [at least one member whose primary concerns are in nonscientific areas]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7281", "reference_number": "21 CFR 56.108(a)(1)", "short_description": "Initial and continuing reviews", "long_description": "The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7290", "reference_number": "21 CFR 56.108(c)", "short_description": "Members present for review", "long_description": "For other than expedited reviews, the IRB does not always review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7297", "reference_number": "21 CFR 56.109(b)", "short_description": "Information given to subjects", "long_description": "The IRB does not require that information given to subjects as part of informed consent contain all necessary elements of informed consent. Specifically, ***:", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7317", "reference_number": "21 CFR 56.115(a)(1)", "short_description": "Copies of all research proposals and related documents", "long_description": "Copies have not been [prepared] [maintained] of all [research proposals reviewed] [scientific evaluations, if any, accompanying research proposals] [approved sample consent documents] [progress reports submitted by investigators] [reports of injuries to subjects]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7321", "reference_number": "21 CFR 56.110(c)", "short_description": "Method to keep members advised", "long_description": "The IRB uses an expedited review procedure, but [has not adopted] [is not following] a method for keeping members advised of research proposals which have been approved under the procedure. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7337", "reference_number": "21 CFR 56.115(b)", "short_description": "Retention of records", "long_description": "Records required by 21 CFR 56 have not been maintained for three years following completion of the research. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7380", "reference_number": "21 CFR 50.27(b)(2)", "short_description": "Short form: IRB approval of oral presentation", "long_description": "The IRB did not approve a written summary of what was to be said to the subject or the subject's legally authorized representative, in a situation where a short form written consent document was prepared. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7387", "reference_number": "21 CFR 50.25(a)(1)", "short_description": "Statement of research, purpose, duration of participation", "long_description": "The informed consent document did not contain [a statement that the study involved research] [an explanation of the purposes of the research, and the expected duration of the subject's participation]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7388", "reference_number": "21 CFR 50.25(a)(2)", "short_description": "Reasonably foreseeable risks or discomforts", "long_description": "The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7390", "reference_number": "21 CFR 50.25(a)(4)", "short_description": "Alternate procedures, courses of treatment", "long_description": "There was [no] [an incomplete] disclosure in the informed consent document of appropriate alternate procedures or courses of treatment, if any, that might be advantageous to the subject. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7505", "reference_number": "21 CFR 312.55(a)", "short_description": "Investigator brochure", "long_description": "Failure to provide to an investigator, prior to the start of an investigation, a brochure containing all of the information required by 21 CFR 312.23(a)(5). Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7534", "reference_number": "21 CFR 312.68", "short_description": "FDA access to clinical investigator records", "long_description": "Failure to permit an authorized officer or employee of FDA to [have access to] [copy] [verify] records or reports. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7557", "reference_number": "21 CFR 312.56(b)", "short_description": "Notification of FDA of termination of investigator", "long_description": "Failure to notify FDA of the ending, for cause, of an investigator's participation in an investigation. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7558", "reference_number": "21 CFR 312.57(c)", "short_description": "Record retention requirement", "long_description": "Records and reports were not retained for two years after [marketing application approval] [discontinuance of the investigation and notification of FDA]. Specifically***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7632", "reference_number": "21 CFR 312.6(a)", "short_description": "Required label statement", "long_description": "The immediate package of the investigational new drug does not bear a label with the statement \"Caution: New Drug- Limited by Federal (or United States) law to investigational use", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7654", "reference_number": "21 CFR 56.110(b)", "short_description": "Research not eligible for expedited review", "long_description": "The IRB used an expedited review procedure for research which did not appear in an FDA list of categories eligible for expedited review, and which had not previously been approved by the IRB [within one year]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7659", "reference_number": "21 CFR 50.25(a)(6)", "short_description": "Compensation, medical treatment in event of injury", "long_description": "For research involving more than minimal risk, the informed consent document lacked an explanation as to whether any [compensation] [medical treatments] were available if injury occurred, and, if so, [of what they consisted] [where further information might be obtained]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7664", "reference_number": "21 CFR 50.20", "short_description": "Circumstances of obtaining consent", "long_description": "The general requirements for informed consent were not met in that [you] [the investigator] did not seek consent under circumstances that [provided the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate] [minimized the possibility of coercion or undue influence]. Specifically, ***", "frequency": "1" }, { "fiscal_year": 2025, "program_area": "Bioresearch Monitoring", "citation_program_area": "Bioresearch Monitoring", "cite_id": "7666", "reference_number": "21 CFR 50.20", "short_description": "Understandable language", "long_description": "The general requirements for informed consent were not met in that the information given was not in language understandable to the subject or the subject's representative. Specifically, ***", "frequency": "1" } ] }