Clinical Trials Regulation - Version 6.4 of the Q&As

The European Commission (EC) published an updated Version 6.4 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). The Q&As entered into force together with the application of the CTR on 31 January 2022. 

Changes in Version 6.4

Compared to the previous Version 6.3 the following has been changed:
  • Additional Q&A 2.15 for the case where the sponsor of a clinical trial is not the product owner (PO) of the IMP and should not have access to the quality IMPD in order to protect commercially confidential information (CCI). What options do exist for the PO and the sponsor?  
    -  In case the PO is also the sponsor of another clinical trial with the same IMP ongoing under the CTR, a reference between the two trials should be made.
    - In case the PO is also the sponsor of another clinical trial with the same IMP ongoing under the CTD, the PO/sponsor should transition the trial to the CTR. After the transition is completed, a reference between the two trials should be made.
    - In case the product owner is not a sponsor of a clinical trial in the EEA, two applications in CTIS can be submitted in parallel, e.g.:
    The PO can submit the quality IMPD to CTIS via an initial application for Part I only (“IMPD-Q-only application”). The “IMPD-Q-only application” must be submitted at the same time as the initial application of the trial for which the IMP is intended (“sponsor trial”). It is recommended that both submissions are not more than 24 hours apart. However, full cooperation between PO and trial sponsor is required for this approach. In addition, contractual agreements can be in place to define bilateral responsibilities and sharing of information.

  • Revised Q&As:
    - 6.5: What is the recommended strategy for the publication of trial documents with proprietary information? (concerning the approach of using redaction instead of requesting long deferrals for their publication)
    - 11.6/ 11.7: How shall a sponsor proceed in case of mono-national/ multinational clinical trials? (regarding additional documentation in the transitioning clinical trial application) 
    - 11.9: When is a sponsor expected to update trial documents and labels? The sponsor should bring documents related to the clinical trial in line with the CTR requirements at the latest at the time of authorization of the first Substantial Modification of a given document. It should be noted that all such substantial amendment applications completing Part I and Part II dossiers should be authorized at the very latest on 30 January 2025.  

  • Revised Annex II (Language requirements for part I documents):
    - FR: Protocol synopsis, Patient facing documents as part of the protocol, Fields of the application form;
    - NO: Labelling.

More information can be found in the CLINICAL TRIALS REGULATION (EU) NO 536/2014 - QUESTIONS & ANSWERS VERSION 6.4 in EudraLex - Volume 10 - Clinical trials guidelines.

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