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EC Q&A Guidance: Questions & Answers: Clinical Trials Regulation

Recently this Friday (29-Sepetember, 2023), the European Commission's Clinical Trials Coordination and Advisory Group released an updated document titled "Questions & Answers: Clinical Trials Regulation" which provides critical guidance and clarifications on the application of the Clinical Trials Regulation.

Clinical trials are the cornerstone of medical research, driving innovation and ensuring the safety and efficacy of new medicines and treatments.

To facilitate its implementation, the EMA periodically releases guidance documents, including the updated "Questions & Answers: Clinical Trials Regulation."

Key Highlights of the Updated Document

  1. Scope and Application: The document provides clarity on the scope and application of the Clinical Trials Regulation, ensuring that researchers and sponsors understand when and how it applies to their studies.

  2. Submission and Assessment: It outlines the procedures for submitting clinical trial applications, including how sponsors can submit their proposals through the EU portal and how assessments will be carried out.

  3. Patient Safety: The document emphasizes the importance of patient safety in clinical trials, addressing questions related to the reporting of adverse events, risk assessment, and the role of ethics committees.

  4. Transparency and Data Sharing: It provides guidance on the transparency requirements of the Clinical Trials Regulation, including the publication of clinical trial results and data sharing with the public.

  5. Sponsor Responsibilities: The document clarifies the responsibilities of clinical trial sponsors, including their obligations to ensure data quality and comply with reporting requirements.

  6. Adaptive Pathways: It discusses the use of adaptive pathways in clinical trials, where early access to innovative treatments is granted while collecting additional data post-authorization.

By providing clear guidance and addressing key questions, this document supports the efficient and safe conduct of clinical trials, ultimately benefiting patients and advancing medical science.

Click this LINK to know in detail the answers to the most common questions asked by the applicants.


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