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Version: 0.2 Draft 3

Namespace: x-eu-ctr:

EU Clinical Trials Regulation​

Jurisdiction: European Union (EU) Frameworks addressed: Regulation (EU) No 536/2014 on Clinical Trials (CTR), applicable from 31 January 2022. Read with GDPR, EDPB Opinion 3/2019, and EMA CTIS implementation materials. Registration tier: Open Review status: ai_reviewed Review date: 2026-03-20

Overview​

The CTR governs clinical trial conduct, consent, and CTIS reporting. CTR informed consent under Article 29 is a clinical trial participation and ethics requirement. It is not the same as the GDPR lawful basis for processing personal data. EDPB Opinion 3/2019 expressly distinguishes CTR informed consent from GDPR Articles 6 and 9 legal basis analysis. PCT tokens for clinical trial data must address both the CTR clinical obligations and the applicable GDPR processing basis separately.

Fields​

FieldTypeRequiredDescription
x-eu-ctr:trial_idstringCONDITIONALRequired where data is from an EU clinical trial. The EudraCT number or CTIS trial identification number.
x-eu-ctr:gdpr_lawful_basis_refstring (URI)REQUIREDReference to the GDPR Article 6 lawful basis and, where applicable, the Article 9 condition relied on for processing trial personal data. Note: CTR Article 29 informed consent is a separate clinical ethics requirement and is not itself a GDPR lawful basis.
x-eu-ctr:ctis_submission_statusenumOPTIONALThe CTIS submission status for this trial. Permitted values: not_submitted, application_submitted, authorised, summary_results_submitted, lay_summary_submitted.
x-eu-ctr:low_intervention_trial_flagbooleanOPTIONALSet to true where the trial is a low-intervention clinical trial under CTR Article 2(3).
x-eu-ctr:informed_consent_flagbooleanCONDITIONALRequired for all processing of clinical trial participant data. true indicates free, informed, and specific CTR-compliant consent under Article 29 and applicable ICH GCP guidelines. Note: this is clinical ethics consent, not GDPR lawful basis.
x-eu-ctr:participant_categoryarray of enumOPTIONALThe participant category under applicable CTR safeguards provisions. Permitted values: adult_capable, minor, incapacitated_subject, pregnant_subject, breastfeeding_subject, emergency_subject.
x-eu-ctr:sponsor_idstring (URI)OPTIONALIdentifier for the clinical trial sponsor as registered in CTIS.
x-eu-ctr:results_publication_flagbooleanOPTIONALSet to true where data is within scope of CTR results publication obligations under Article 37. Summary results and a layperson summary are due within 12 months of trial completion (6 months for paediatric trials).

Revision notes (from ai_reviewed pass, 2026-03-20)​

  • gdpr_lawful_basis_ref added: CTR consent and GDPR lawful basis are separate requirements per EDPB Opinion 3/2019.
  • ctis_submission_status added: CTIS filing is a central compliance obligation since CTR became applicable January 2022.
  • informed_consent_flag description updated to clarify it is clinical ethics consent, not GDPR lawful basis.
  • vulnerable_population_flag replaced by participant_category array with correct CTR references.
  • trial_phase note added: conventional phases are industry/clinical categories, not CTR legal classifications.
  • cross_border_transfer_basis removed: cross-border transfers are governed by GDPR Chapter V, not a separate CTR regime.

Citations​

  • Regulation (EU) No 536/2014, Articles 2, 29, 37
  • EDPB Opinion 3/2019 on the interplay between CTR and GDPR
  • EMA CTIS materials on trial documents and results

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