China's September 2026 Guideline on Computerized Systems and Electronic Data in Drug Trials: What Changed From the Draft and What a Study Build Must Configure

TL;DR

Takeaway: Notice 2026 No. 44 took effect on publication on 22 September 2026. [1] [2] Configure the issued autofill test, the word 流程, and the named systems in scope. [3] Against the November 2025 draft, three rows changed in substance: the autofill test, 流程图 to 流程, and the scope examples. [4] The guideline calls itself the authority's current view and 不具有强制性的法律约束性. China's GCP, in force on 1 September 2026, is the normative text and an enforcement basis. [5] [6] Four duties are in the guideline and, in these terms, absent from that GCP and from ICH E6(R3) section 4: the contractual right to access a supplier's validation documents, the audit-trail minimum field list, testing before formal exchange, and the ePRO clarification rule. [7] The table marks every other row reworded or unchanged.

What took effect on 22 September 2026

Takeaway: The notice takes effect on publication. The guideline states the authority's current view and the non-binding sentence. GCP, in force since 1 September 2026, is the normative text.

中国食品药品网 reprinted the notice on 23 September 2026 and linked the attachment. The title is 国家药监局药审中心关于发布《药物临床试验计算机化系统和电子数据指导原则》的通告（2026年第44号）. The body says the center drew up the guideline to accompany ICH E6(R3) and 《药物临床试验质量管理规范（2026年修订）》, then: 经国家药品监督管理局审查同意，现予发布，自发布之日起施行. The signature is 国家药监局药审中心, 2026年9月22日. [1] Sohu carried the same notice on 24 September. [2]

The attachment is a 34-page PDF headed 国家药品监督管理局药品审评中心, 2026年9月. The file linked by 中国食品药品网 and the file at cpi.ac.cn are one file. [3] Printed pages 1-2 say:

本指导原则仅代表药品监管部门当前的观点和认识，不具有强制性的法律约束性。随着科学研究的进展，本指导原则中的相关内容将不断完善与更新。应用本指导原则时，还请同时参考GCP、ICH和其他国内外已发布的相关指导原则。

Sohu has that sentence and then a 凡默谷 republisher credit. The credit is absent from the PDF and from the draft. [2] [3] [4]

Two other dates sit beside the notice. NMPA Announcement 2025 No. 125 says drug trials implemented after 31 March 2026 are subject to E6(R3): 自2026年3月31日后实施的药物临床试验，均适用E6（R3）指导原则. [8] China GCP, attachment 1 of Announcement 2026 No. 50, takes effect on 1 September 2026: 本规范自2026年9月1日起施行. [5] The Q&A, attachment 2, calls GCP a normative document and a basis for enforcement, 《药物临床试验质量管理规范》是规范性文件……是监管执法依据. Operational detail in E6(R3) was left to the technical guidelines that connect implementation to GCP and to E6(R3). [6] The sentences below are read under that account.

Read 应 and 应当 in the guideline with the sentence on printed pages 1-2. Where this article says "must", the issued Chinese is 必须. That word is used for the written contingency plan, revalidation after a critical failure, the readable audit trail, and the change-control steps. [3] GCP articles 36, 48, 51 and 53 use 应当 in the document the Q&A calls an enforcement basis. [5] [6]

Printed page 2 defines 责任方 as generally the sponsor, the investigator and the clinical-trial institution, and says 若委托供应商，委托方应承担最终责任. [3] The draft defined 责任方 as generally the sponsor or the investigator. [4] GCP article 36 still has the sponsor supervising the provider, bearing ultimate responsibility, and signing a contract that states roles, rights and obligations. [5]

How to mark a control before configuring it

Takeaway: Mark each issued sentence changed, reworded or unchanged against the November 2025 draft, and record whether ICH E6(R3) section 4 or the 2026 China GCP already states that duty.

The labels belong to this comparison. Each one is a reading of sentences present in the issued PDF, the November 2025 draft, ICH E6(R3) Step 4 section 4 (6 January 2025), and the GCP articles cited below. [3] [4] [7] [5]

Changed means the issued sentence is the one to configure, and the draft used a different sentence: autofill, 流程 in place of 流程图, and the scope examples. Reworded means the same control, with a different verb, example, timing or clause. Configure the issued wording. A draft example missing from the issued sentence is a difference between the texts. Unchanged, apart from a comma where the table notes one, is configured and briefed as carried forward.

The three sentences that changed

Takeaway: The autofill exception, the transfer noun and the scope examples changed. The protocol sentence that names the collector, the time point and the tool is the draft's sentence.

The protocol sentence was already in the draft

Printed page 3:

临床试验方案中应明确需要收集的数据内容和数据采集的过程，如数据采集方、采集时间点和使用的工具。

The draft has the same instruction on draft pages 3-4. [3] [4] EMA section 4.7 already says the protocol should specify what is collected and the capture process, including by whom, when and by which tools. [9] Section 4.2.1 and articles 51 and 53 leave the trio to that protocol sentence and to section 4.7. [7] [5]

The calculation exception is the sentence that moved

The issued sentence begins on printed page 3 and ends on page 4:

数据点一般不应被设置为自动填充的形式，除非此数据点不允许被编辑或是已填充数据点的衍生数据。

[3] [2] The modal is 一般不应. The sentence gives the editability test and the derivation test, and it gives no worked example.

The draft, printed page 4:

除需要依靠计算生成的数据，数据点录入一般不应设置为自动录入的形式。

[4] EMA section 4.7 states the same structure as the issued sentence: "Data fields should not be prepopulated or automatically filled in, unless these fields are not editable and are derived from already entered data (e.g. body surface area)." [9] The Chinese sentence adds 一般, says 不允许被编辑, and leaves the body-surface-area example in the EMA text. The reference list cites the March 2023 EMA guideline. The autofill paragraph itself names no source sentence. [3] Section 4.2.1 and articles 51 and 53 state validation, metadata and correction duties, and the autofill exception is the guideline's sentence. [7] [5]

Reading for the specification. An editable calculated field, such as a clearance the user can still overwrite, sits inside the draft's exception and outside the issued test. A value the form locks, derived from values already entered, sits inside the issued exception. EMA's example of that structure is body surface area. The draft covered that locked value as a calculation and stated no editability test. The issued sentence uses the test under 一般不应. The body-surface-area example stays in section 4.7. The reading is of the words, and it is silent on any named trial.

流程, while EMA still asks for a diagram

Printed page 3 asks for 流程和相关描述. [3] The draft, printed page 4, asks for 流程图和相关描述. [4] EMA section 4.7 still asks for a detailed diagram and a description. [9] Write 流程 in the Chinese sentence. Keep a diagram when the text being applied is section 4.7.

The scope examples are an open list

Printed page 1:

包括但不限于采集试验数据的电子系统、进行随机分组与药物分配的系统、临床试验电子文档管理系统等。

[3] The draft's examples, printed page 2, were the electronic medical record as source, the eCRF, and other systems for storage, analysis, processing, reporting and management. [4] 包括但不限于 keeps the issued list open. Randomization, drug assignment and electronic documents go through the configuration check both CDE texts already contain. The electronic medical record and the eCRF stay inside the same generation-to-management scope.

Validation, release, and the supplier's validation file

Takeaway: The pre-production test, the signed release, the training material and change control match the draft. The issued principle states the sufficiency assessment and final responsibility. The report sentence now says 系统方可发布. The supplier sentence puts validation-document access in the contract.

Printed page 4 requires a validated state, a risk-based process, a protocol check on trial-specific configuration, supervision of the supplier's validation, and validation documents for the system and for that configuration. [3] Printed page 5:

责任方需充分评估供应商执行的验证活动及相关文件是否充分，以及是否还需要开展额外的验证活动。责任方对临床试验中使用的计算机化系统的验证承担最终责任。

[3] The draft, printed page 6, said that once that assessment finds the file sufficient, the responsible party may rely on it. [4] The issued principle states the assessment and final responsibility. The permission to rely remains the draft's sentence.

Printed page 6 matches the draft apart from punctuation: the draft's enumeration comma in 接口、或者 is dropped, giving 接口或者:

试验特定的配置和定制应在生产环境发布前进行质控与测试（如适用）。建议让用户参与相关测试活动。同样的流程也适用于方案修订所需的修改。如果需要开发新的功能或接口或者添加新的代码，则应在使用前进行验证。

[3] [4] Section 4.3.4(e) already requires validation of protocol-specific configuration and interfaces. Article 53(3) requires a validated state throughout the trial. [7] [5]

Printed page 8 moves the report verb:

应评估系统发布时所有未解决的偏差和任何已知问题，后续决策应记录在验证报告中，验证报告应经责任方批准后，系统方可发布。

[3] The draft said 验证报告应经责任方批准后再投入使用. [4] Section 4.3.4(i) justifies unresolved issues and, where relevant, mitigating their risks before or during continued use. [7] Approval of the validation report before release is the issued sentence. On the same page, formal use still follows the draft's 签署批准方可正式投入使用, with training material and the user guide at release to production. [3] [4] Section 4.3.5 is the site-approval gate. [7] 系统方可发布 and 方可正式投入使用 are two sentences.

After release the issued text says 需要有完善的升级流程. [3] The draft said an upgrade is validated and tested before it is executed. [4] The change-control sentence is identical on issued page 11 and draft page 12: any patch, upgrade or configuration change 必须遵循严格的变更控制规程（评估、批准、测试、验证、记录）. [3] [4] The five steps stay beside the shorter upgrade sentence. Section 4.3.4(g) requires systems built by others to be validated and the documents retained. [7]

Printed page 11 is the supplier sentence:

若使用供应商系统（包括但不限于如电子数据收集系统（EDC）、电子化临床结局评估工具），应通过合同或协议确保供应商符合GCP要求，并有权访问验证文档。

[3] The draft, printed page 12, named those two examples and also 医院计算机化系统, placed ultimate responsibility in this sentence, and named access to 稽查报告和验证文档. [4] The list is still 包括但不限于, so the hospital example and 稽查报告 remain the draft's wording. Article 36 and printed page 2 already state the contract and ultimate responsibility. [5] Section 4.3.4(g) requires the documents retained. The contractual access right is what the issued sentence adds, and the tool's name is the draft's as well. A product name in the example is an example. [7]

Audit-trail fields and user access

Takeaway: Five fields apply to all data changes. The draft attached them to query changes and required the trail to stay on. The field list is the guideline's. Section 4.2.2 still protects trails against disablement.

Printed pages 3-4 say any-source data, including direct capture, carry metadata such as an audit trail: 应当附带相应的元数据，如稽查轨迹. [3] The draft attached 包括稽查轨迹 to data entered into the system. [4] Article 51(1) keeps 包括. [5] Section 4.2.1(b) says "relevant metadata". [7]

Printed pages 16-17 require an audit trail on creation and later modification, stored in the system, 必须由计算机生成并带有时间戳, exportable as a dynamic file, and containing at least the original value, the new value, the time, the user and the reason. Review is periodic. The record 必须是可读的 and is kept with the source data and the trial master file. Blind-threatening information stays out of a blinded user's trail. [3] Printed page 18 adds review of the access log, event log and queries, and an introduction so the investigator can browse the site trail. [3]

The draft already had the five fields, periodic review and blind protection, attached to query or clarification changes. On draft page 18 it also said 稽查轨迹功能必须始终开启，仅“管理员用户”可操作该功能, and that the trail is visible at data-point level. [4] Those sentences remain in the draft. Section 4.2.2 says the approach should entail keeping audit trails, reports and logs protected against disablement. [7] Articles 51 and 53(5) require an audit trail and review. The five-field list is the guideline's. [5]

Printed pages 12-13 grant access after the training record is confirmed, review roles periodically, apply least privilege 其工作范围内, and reject a shared account because it conflicts with attributability. [3] The draft, pages 13-14, waited for all trial approvals and the signed protocol and investigator agreement, said permissions are 定期验证, and gave 设置账户休眠期（如90天未使用自动停用）. [4] Those sentences remain in the draft. Section 4.3.8 and article 53(5) already require authorised, role-based, reviewed access. [7] [5]

Transfer testing and migration

Takeaway: Testing, including stress testing, finishes before formal exchange. Migration validation refers to complexity and feasibility. The interface sentence matches the draft. Section 4.2.5 and article 51(4) require a validated transfer. The timing is the guideline's sentence.

Printed pages 19-20 define every transfer in advance and require a validated process, with encryption among the measures. The timing sentence is:

应在临床试验数据正式传输或交换开始前完成测试，包括恰当的压力测试，并确保该流程在整个临床试验运行过程中可用且正常运行。

The examples are diary data, laboratory data and safety-committee adverse-event data. [3] The draft put that stress test at the start of the trial. [4] The transfer is documented, checked between systems, and kept with its audit trail by role. Cross-border transfer follows the applicable laws, and the participant is informed. Article 51(4) and section 4.2.5 require a validated transfer. The "before formal exchange" timing is the issued sentence. [5] [7]

Printed pages 20-21 define migration as a move of existing data and metadata. Validation considers 过程的复杂性和可行性. Before migration there is a risk analysis, a risk plan tested with test data, then a check of key data. The mapping is kept. Data, context and the audit trail stay together. [3] Sohu omits the risk-analysis paragraph. The draft contains it, calls migration 永久迁移, and lists checksums, case counts and data quality control. [2] [4] Those words remain in the draft. Section 4.3.4(e) already says interfaces are defined and validated. [7]

Source data and the ePRO clarification rule

Takeaway: The ePRO rule is three paragraphs on printed page 19. The draft's phone note stays in the draft and in EMA Annex A5.1.1.4. Section 4.2.4 and article 51(3) require traceable correction.

The source-data and direct-capture paragraphs are reworded as well. Printed page 15 says source data are captured and retained where first generated, and that every source-data location is defined before the trial and updated as needed. [3] The draft also said 必须清晰定义何为特定数据点的原始电子记录. [4] That sentence remains in the draft. The general correction section on printed pages 18-19 still requires a traceable actor, a source record and a reason: 有原始记录来证明和支持. [3]

Printed page 16 is conditional. If an electronic diary, an eCRF or a connected device is used, the record carries device version, identifier, firmware, last calibration, 数据生成者 and the event timestamp. The draft said 鼓励使用 and 数据发起者. [3] [4]

Printed page 19, matched on Sohu, is the clarification rule. The three paragraphs read:

电子化患者报告结局（ePRO）数据更正通常与其他数据采集工具的数据更正不同，因为试验参与者通常无法在应用程序中自主更改数据。因此，需要制定数据澄清流程，以便在有合理理由的前提下实施更正，不应禁止在合理的情况下更正试验参与者数据。

更正应基于合理的和特定于试验的风险评估，并且任何更正都由试验参与者或研究者及时启动。

试验参与者直接输入数据可以让回忆偏倚最小化。因此，更正一般应及时进行。为了避免输入错误，ePRO的设计既要适当地确保试验参与者正确理解，又需要对试验参与者进行适当的培训。

[3] [2] The draft, printed page 22, added a phone note or email and said correction is timely 在没有充分理由的情况下. [4] EMA Annex A5.1.1.4 still describes that phone note. [9] The issued subsection is the three paragraphs above. Section 4.2.4 and article 51(3) require traceable correction, and the general correction section still requires a source record. [7] [5]

Security, the contingency plan, and the archive

Takeaway: Revalidation after a critical failure, and read-only archiving, match the draft. The security paragraph, the plan's status and the retention sentence are reworded. The draft already put the country-of-submission requirement on 归档时间. The issued sentence puts it on the retention period.

Sohu leaves the security heading empty. Printed page 5 requires security processes, periodic checks, access records, phishing training, timely backup, and contingency measures on failure. [3] The draft added 并覆盖数据全生命周期. [4] Article 53(2) and section 4.3.3 keep that life-cycle duty. [5] [7]

Printed page 8 uses 必须 for the written plan:

必须制定书面化的应急计划，明确系统故障时的备用流程、备份及恢复策略和沟通机制。

[3] The order is 备用流程, then 备份及恢复策略, then the communication mechanism. The draft, printed page 9, added the parentheticals "business-continuity plan" and "temporary use of an approved alternative record", and said 数据恢复策略. [4] Printed page 9, in the same words as the draft: 关键系统故障后，必须重新验证受影响的系统功能或模块. [3] [4] Section 4.3.6 requires contingency procedures. The revalidation sentence is the one both CDE texts share. [7]

Printed pages 26-27, blank in Sohu under the core-content heading, include 恢复时间目标和恢复数据点目标, a standby system or a manual record, and training and drills, so that data stay reliable and 业务的持续运行. The plan 必须纳入质量管理体系，并确保其符合申办者的质量要求. [3] The draft said 并获得申办者批准. [4]

Printed pages 27-28 keep the draft's read-only sentence: 试验数据和相关元数据应以可检索和只读的方式归档，并应在整个保存期间防止未经授权的访问和更改. [3] [4] The retention sentence now says 保存期限要符合临床试验数据递交国家的监管要求. [3] The draft, printed page 31, followed 数据保护原则的存储限制 and already applied the country requirement to 归档时间. [4] The issued text puts that requirement on the retention period, and it says 数据库退役 where the draft says 数据库下线. Section 4.2.7 requires retrievable archives. The read-only form is the CDE sentence. [7] Article 48(5) requires retention as regulation requires, and written notice of that requirement. [5]

Mark the specification from this table

Takeaway: Mark each control changed, reworded or unchanged. Apply the issued autofill test and the word 流程 on the rows that moved.

The last column reads the quoted sentences onto a study specification. Where one control contains both a reworded sentence and an unchanged sentence, the table splits them. Pages are printed pages of the issued PDF unless the cell says "draft".

Apply the rows that move a specification

Takeaway: On a blank specification, mark the issued autofill test, write 流程, put the named systems through the configuration check, and agree the validation-document right in the contract. Brief unchanged rows as carried forward.

The build is hypothetical. An editable clearance stays off autofill. Locked body-surface area, derived from values already entered, meets the issued exception. [3] [4] [9] The protocol names who collects, when, and with which tool. The transfer line uses 流程. A diagram is added when section 4.7 is also applied. [9] The capture system, the randomization and drug-assignment system, and the electronic document system take the pre-production test the draft already states. The supplier contract states 有权访问验证文档. Article 36 already requires the contract, and section 4.3.4(g) already requires the documents retained. The access right is the clause to agree before build. [3] [5] [7] The audit trail stores original value, new value, time, user and reason on every change. Transfers are stress-tested before formal exchange. The diary follows the three paragraphs on printed page 19, with a source record on correction. The contingency plan states 备用流程, then 备份及恢复策略, then the communication mechanism. Retention follows the country of submission. [3]

The text this comparison uses

Takeaway: The classification above compares sentences in the issued PDF, the November 2025 draft, ICH E6(R3) section 4 and the 2026 GCP. No count of systems still built to the draft was made.

The CDE notice page, opened in a browser on 28 September 2026, shows the same title, the release date 20260922 and the same effective sentence as the reprints, and lists the guideline PDF as its attachment. The attachment text used here is the PDF the two public hosts share. [10] [1] [2] The reprints agree on the effective sentence. The PDF's document properties record creation on 16 September 2026. A later CDE file that revises a sentence in the table replaces that row.

Sohu leaves the security paragraph, the contingency-plan core content, and the migration risk analysis to the PDF. The draft contains all three. [2] [4] nmpa.gov.cn returned HTTP 412, so Announcement 2025 No. 125 and the GCP attachments were read from the Shanghai Medical Products Administration. [8] [5] Article 51 matches the Hong Kong Trade and Industry Department excerpt of the NMPA text. [11] Articles 36, 48 and 53 rest on the Shanghai file alone. The reference list names the FDA Part 11 scope guidance of September 2003, which this comparison leaves unread. [3] The October 2024 Q&A was opened for its nonbinding statement. A full-text search found none of: prepopulated, automatically filled, autofill, not editable. [12] The European Commission URL and the EMA URL are one file. [9] Sponsor specifications were unavailable, so the calculation exception has no rate among live builds.

Where the scope examples meet a study build

Takeaway: Map the scope examples and the supplier sentence onto the systems in the build, and agree access to the vendor's validation documents in the contract before configuration starts.

EClinCloud sells EDC, RTSM, eTMF and eCOA as separate products. Under 包括但不限于, EDC sits with the capture example and with 电子数据收集系统（EDC）. RTSM sits with randomization and drug assignment. eTMF sits with the electronic-document example. eCOA sits with 电子化临床结局评估工具, which the November 2025 draft already named. [3] [4] ICH E6(R3): Clinical trials enter the era of risk-driven digital governance (10 March 2026) is a governance overview. FDA Warning Letters, BIMO Computerized Systems and 21 CFR 312.62 Records in 2026 (26 August 2026) is about public inspection citations. The supplier clause on printed page 11 is the line to agree up front: the vendor meets GCP, and the sponsor can reach the validation documents.

Sources

1. 中国食品药品网, "CDE发布《药物临床试验计算机化系统和电子数据指导原则》", 23 September 2026. Reprint of CDE Notice 2026 No. 44, dated 22 September 2026, including 自发布之日起施行 and the link to the attachment. https://www.cnpharm.com/c/2026-09-23/1107746.shtml (accessed 28 September 2026).

2. Sohu, "全文版 | CDE发布《药物临床试验计算机化系统和电子数据指导原则》的通告（2026年第44号）", 24 September 2026. Second reprint of the notice and a transcription of most of the guideline. The 凡默谷 credit is on this page and absent from the PDF. The security heading, the contingency-plan core-content heading, and the migration risk-analysis paragraph are left to the PDF. https://www.sohu.com/a/1080126657_121123705 (accessed 28 September 2026).

3. 国家药品监督管理局药品审评中心, 《药物临床试验计算机化系统和电子数据指导原则》, September 2026, 34-page PDF. Header dated 2026年9月. The file linked by 中国食品药品网, https://www.cnpharm.com/upload/resources/file/2026/09/23/195283.pdf, is byte-identical to https://www.cpi.ac.cn/zx/xyzl/202609/P020260923345649167779.pdf (SHA-256 b258a0220c9599142e1896e8a2d3f81e9e496955cafd36513435c2ea1baa7147). Document properties record creation on 16 September 2026. Printed pages as cited. (Accessed 28 September 2026.)

4. 国家药品监督管理局药品审评中心, 《药物临床试验计算机化系统和电子数据指导原则（征求意见稿）》, November 2025. Cover marked 征求意见稿. https://cs.cnpharm.com/upload/resources/file/2025/11/25/180949.pdf (accessed 28 September 2026).

5. NMPA, 《药物临床试验质量管理规范（2026年修订）》, Announcement 2026 No. 50, attachment 1. Articles 36, 48, 51, 53 and 54. Read from the Shanghai Medical Products Administration copy: https://yjj.sh.gov.cn/cmsres/01/019e5e2d868c470f9927c3a9672fc59c/203167cf5e796696423edf05cb8c3174.doc. Landing page: https://yjj.sh.gov.cn/qtgzwj/20260608/89cbf084b5cb4eab8fd0fb56d8538a1d.html. The stated NMPA address, https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20260608103856150.html, returned HTTP 412 on 28 September 2026. (Accessed 28 September 2026.)

6. NMPA, 《药物临床试验质量管理规范（2026年修订）》问答, Announcement 2026 No. 50, attachment 2, items 1 and 2. Shanghai Medical Products Administration copy: https://yjj.sh.gov.cn/cmsres/6c/6c38f69ae6a942e684221c90927db3c1/b6bd1d09af642f8f1107a80d3e0a3f59.doc (accessed 28 September 2026).

7. ICH, "E6(R3) Guideline for Good Clinical Practice", Step 4, 6 January 2025. Section 4, PDF pages 46-51, including 4.2.1-4.2.5, 4.2.7, 4.3.3, 4.3.4(e), 4.3.4(g), 4.3.4(i), 4.3.5, 4.3.6 and 4.3.8. https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf (accessed 28 September 2026).

8. NMPA Announcement 2025 No. 125, on application of ICH E6(R3). Paragraph 1: trials implemented after 31 March 2026 are subject to E6(R3). Shanghai Medical Products Administration mirror: https://yjj.sh.gov.cn/qtgzwj/20251225/0ad0d30639e24be2b53065903468e293.html. The page gives https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20251224111804135.html. (Accessed 28 September 2026.)

9. European Medicines Agency, "Guideline on computerised systems and electronic data in clinical trials", EMA/INS/GCP/112288/2023, 9 March 2023. Section 4.7, pages 14-15, and Annex A5.1.1.4, pages 41-42. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf. The European Commission URL in the CDE reference list, https://health.ec.europa.eu/document/download/5170c32d-757e-4bdc-9f09-d6693e76c668_en?filename=mp_ctr-guideline-computerised_en.pdf, is the same file (SHA-256 43a7673c4125519160c159b9c117a7a2437e93a51af39da47a8fe3f9c34b85b2). (Accessed 28 September 2026.)

10. 国家药品监督管理局药品审评中心, 国家药监局药审中心关于发布《药物临床试验计算机化系统和电子数据指导原则》的通告（2026年第44号）, 发布日期 20260922. Opened 28 September 2026.

11. Hong Kong Trade and Industry Department, circular reproducing NMPA Announcement 2026 No. 50, appendix excerpt, Article 51. https://www.tid.gov.hk/en/tradecircular/files/2026/ci5162026a.pdf (accessed 28 September 2026).

12. FDA, "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers", Guidance for Industry, October 2024, Revision 1. Introduction, printed page 1. https://www.fda.gov/media/166215/download (accessed 28 September 2026).