January 2023: EudraCT and EU CTR Frequently Asked Questions

On January 31, 2023, European Medicines Agency uploaded a document Frequently Asked Questions on the EU Clinical Trials Register:

The document comprises detailed answers to all the frequently asked questions related to the EudraCT database and Clinical Trials Regulation (EU CTR) No 536/2014.

The questions and answers that are added in this version related to clinical trials transparency are 2, 3, 6 to 10, 26, 28, 81, 85 to 87, 91, and 100 to 104:

  • Sections 2 and 3: These sections were added to provide information on the actions that can be performed on EudraCT after January 31, 2023, and the transition of EudraCT trials to CTIS.
  • Sections 6 to 10: These sections were added to answer questions related to CTIS.
  • Sections 26 and 28: These sections were added to provide information on creating new EU/EEA CTAs and the CTA/third country file that was previously created using EudraCT.
  • Section 81: This section differentiates ‘summary attachment’ and ‘full data set’.
  • Sections 85 to 87: These sections were added to provide information on including endpoints of a trial, issues related to the number of subjects in the subject disposition, and non-serious adverse events sections.
  • Section 91: This section provides information on saving the results data.
  • Sections 100-104: These sections were added providing information on generating a EudraCT number for a third-country file.

All initial clinical trial applications in the EU/EEA must be submitted through the Clinical Trials Information System as of January 31, 2023. Sponsors are advised to communicate with the relevant National Competent Authority (NCA) directly for trials’ uploading and updating on EudraCT/EU CTR (insertion of pending NCA decision and/or Ethics Committee opinion, CTA amendments, and updating of the trial status) for trials for which the CTA was submitted before 31 January 2023.