{
  "title": "Coding of EU DCT recommendation V02 (1 October 2025), page 23",
  "checked": "2026-09-18",
  "sourceUrl": "https://health.ec.europa.eu/system/files/2023-03/mp_decentralised-elements_clinical-trials_rec_en.pdf",
  "sha256": "198896638070c6e30b31b9d8524dab36aa8b4eca54e96e12f3e07c2380081966",
  "page": 23,
  "unit": "Published jurisdiction cells, not current permissions or trial counts",
  "q11": "Is a physical face-to-face meeting always mandatory during consent?",
  "q12": "Are electronic signatures possible instead of wet ink?",
  "method": "Manual transcription checked against rendered PDF and positional text. Asterisk-only and empty cells remain unstated; footnote marks retained. Each question has 30 jurisdiction cells. National footnotes and subsequent laws must be checked separately.",
  "rows": [
    {
      "country": "AT",
      "q11Raw": "No",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "BE",
      "q11Raw": "No",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "BG",
      "q11Raw": "Yes*",
      "q12Raw": "Yes*",
      "q11": "yes",
      "q12": "yes"
    },
    {
      "country": "CY",
      "q11Raw": "Yes",
      "q12Raw": "Yes",
      "q11": "yes",
      "q12": "yes"
    },
    {
      "country": "CZ",
      "q11Raw": "No*",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "DE",
      "q11Raw": "Yes*",
      "q12Raw": "Yes*",
      "q11": "yes",
      "q12": "yes"
    },
    {
      "country": "DK",
      "q11Raw": "No*",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "EE",
      "q11Raw": "*",
      "q12Raw": "Yes*",
      "q11": "unstated",
      "q12": "yes"
    },
    {
      "country": "EL",
      "q11Raw": "*",
      "q12Raw": "*",
      "q11": "unstated",
      "q12": "unstated"
    },
    {
      "country": "ES",
      "q11Raw": "No*",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "FI",
      "q11Raw": "No",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "FR",
      "q11Raw": "No*",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "HR",
      "q11Raw": "Yes*",
      "q12Raw": "Yes*",
      "q11": "yes",
      "q12": "yes"
    },
    {
      "country": "HU",
      "q11Raw": "Yes*",
      "q12Raw": "Yes*",
      "q11": "yes",
      "q12": "yes"
    },
    {
      "country": "IE",
      "q11Raw": "No",
      "q12Raw": "Yes",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "IS",
      "q11Raw": "blank",
      "q12Raw": "blank",
      "q11": "unstated",
      "q12": "unstated"
    },
    {
      "country": "IT",
      "q11Raw": "No*",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "LI",
      "q11Raw": "blank",
      "q12Raw": "blank",
      "q11": "unstated",
      "q12": "unstated"
    },
    {
      "country": "LT",
      "q11Raw": "No",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "LU",
      "q11Raw": "Yes",
      "q12Raw": "No",
      "q11": "yes",
      "q12": "no"
    },
    {
      "country": "LV",
      "q11Raw": "No",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "MT",
      "q11Raw": "No",
      "q12Raw": "Yes",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "NL",
      "q11Raw": "No*",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "NO",
      "q11Raw": "No",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "PL",
      "q11Raw": "No*",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "PT",
      "q11Raw": "Yes*",
      "q12Raw": "Yes*",
      "q11": "yes",
      "q12": "yes"
    },
    {
      "country": "RO",
      "q11Raw": "No",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "SE",
      "q11Raw": "No",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    },
    {
      "country": "SI",
      "q11Raw": "*",
      "q12Raw": "*",
      "q11": "unstated",
      "q12": "unstated"
    },
    {
      "country": "SK",
      "q11Raw": "No",
      "q12Raw": "Yes*",
      "q11": "no",
      "q12": "yes"
    }
  ],
  "counts": {
    "q11": {
      "no": 18,
      "yes": 7,
      "unstated": 5
    },
    "q12": {
      "yes": 25,
      "unstated": 4,
      "no": 1
    }
  },
  "bothYesCountries": [
    "BG",
    "CY",
    "DE",
    "HR",
    "HU",
    "PT"
  ],
  "limitations": [
    "Historical published matrix, not a 2026 legal-permission census.",
    "Yes to electronic signatures does not establish permission for a wholly remote consent process.",
    "No to mandatory face-to-face does not settle other requirements.",
    "Unstated is not a negative response.",
    "Germany shipping footnotes mention a 2023-expiring exception: use current AMG 47(2a) instead."
  ]
}