?? New Release: Updated Q&A on EU Clinical Trials Regulation 536/2014 (Version 6.9, July 2024)

Dear Network,

The European Commission has recently released an updated version of the Q&A document for the EU Clinical Trials Regulation 536/2014. This version 6.9, dated 09 July 2024, brings significant clarifications and new information essential for professionals involved in clinical trials. Here are the key changes and additions:

Key Changes and Additions:

1. Revised Points 108 and 256:

These revisions align with the revised CTIS transparency rules, ensuring greater clarity and compliance in clinical trial documentation and data sharing practices.

2. New Point 255:

Introduced to support the revised CTIS transparency rules, this addition emphasizes the importance of maintaining transparency in clinical trial processes and data management.

3. Revised Q3.13:

Change of Principal Investigator: This revision provides updated guidance on the procedures and requirements when there is a change in the principal investigator during a clinical trial.

4. Revised Q6.1:

- Paediatric Clinical Trial Results: This question now includes references to the results of paediatric clinical trials, highlighting the need for specific considerations and compliance when involving paediatric subjects in clinical trials.

5. New Q6.6:

- Intermediate Data Analysis: This new question addresses the procedures and guidelines for conducting and reporting intermediate data analyses during clinical trials, ensuring that interim findings are managed and reported appropriately.

6. Annex II:

- Footnote (2): Now explicitly applies to EE (European Economic Area) countries, ensuring consistent application of the guidelines across all member states.

7. Annex III:

- Updated Contact Information: Includes new email addresses and national websites for enquiries related to Part I and Part II clinical trial applications in Hungary (HU), Finland (FI), and Romania (RO).

8. Annex IV:

- Extension of Validity Decision: Clarifies the process for extending the validity of decisions related to substantial modifications (SM), either for Part I+II or Part II only, streamlining the approval process for ongoing trials.

9. Annex V:

- Deletion of SmPC Requirement for Authorised AxMPs: Removes the requirement for the Summary of Product Characteristics (SmPC) for authorised auxiliary medicinal products (AxMPs), reducing the administrative burden and simplifying compliance requirements.

These updates are crucial for ensuring that clinical trials conducted under the EU Clinical Trials Regulation 536/2014 are compliant with the latest regulatory standards. By staying informed about these changes, you can ensure that your clinical trial practices are aligned with current guidelines, enhancing the efficiency and success of your trials.

?? Stay Informed: Review the updated document to understand the new and revised guidelines thoroughly.

?? Join the Discussion: Share your thoughts and questions in the comments below. Let’s discuss how these updates impact our clinical trial processes.

?? Enhance Your Compliance: Use this updated guidance to improve your clinical trial submissions and regulatory compliance strategies.

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