April 2022: Questions and Answers on Clinical Trials Regulation (EU) No 536/2014 Update

European Union (EU) uploaded a document Questions and Answers Document – Regulation (EU) 536/2014 – Version 6 on its official site European Commission on April 13, 2022:

The document comprises detailed answers to all the questions related to Clinical Trials Regulation (EU CTR) No 536/2014 including the scope of CTR in the EU, articles related to its application procedure, substantial modification, withdrawals, roles, submission of clinical trials, start, end, temporary halt, and early termination of a clinical trial, transitional period, informed consent and other substantial modifications.

The questions and answers that are added or revised in this version are 1.4, 1.5, 1.22 (new), 1.23 (new), 5.8, 6.5 (new), 11.10:

  1. Section 1.4: This section has been revised by updating information for documents or information required and not required for submission with an application
  2. Section 1.5: This section has been updated by adding more information on ways to proceed if there is a discrepancy found between the CTR and ICH good clinical practice guidelines
  3. Section 1.22 (new): This section has been added newly to provide information about the legal warranties for the validity of decisions by tacit approval
  4. Section 1.23 (new): This section has been added newly to provide information about the change of decision due to an appeal and its implementation
  5. Section 5.8: This section has been updated by making minor grammatical changes
  6. Section 6.5 (new): This section has been added newly to provide information about the recommended strategy for the publication of trial documents with proprietary information
  7. Section 11.10: This section has been updated by adding more information on the consequences of switching the regulatory framework applicable to a clinical trial

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