European Union (EU) uploaded a document Questions and Answers Document – Regulation (EU) 536/2014 – Version 5 on its official site European Commission on February 01, 2022:
The document comprises detailed answers for 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: 1.12, 3.3, 3.7, 3.9, 3.11, 4.2, 5.8, 9.5 (new), 9.6 (new), 9.7 (new), 9.8 (new), 9.9 (new), 9.10 (new), 10.1, 10.2, 11.2, 11.3 (new), 11.4, 11.6, 11.7, 11.8, 11.10, 11.12 (new), 11.17 (new), 11.18 (new):
- Section 1.12: This section has been added newly to provide information about clinical trials that involves medical devices
- Section 3.3: This section has been updated by adding a note that Article 81.9 is under development and broader use of non-substantial modifications functionality will be provided at the time of first release after go-live of CTIS
- Section 3.5: This section has been updated by adding a note that the process of Part I and Part I + Part II will be changed in line with the future approach mentioned in section 3.6
- Section 3.7: This section has been updated by adding information for adding urgent safety measures while the assessment is still ongoing
- Section 4.2: This section has been updated by adding more information on re-submission
- Section 5.8: This section has been updated by adding more information regarding the ethical consideration relating to clinical trials.
- Section 9.5 to Section 9.10: This section has been added newly providing more information on medical condition, subject population, placebo, informed consent, secondary and corresponding objectives in an emergency clinical trial
- Section 10.1 and Section 10.2: It was updated by adding the note that in the current version of CTIS, Clinical trial should be filled in by using “Start Trial” button in notification tab
- Section 11.2: This section was updated by adding a note for sponsors to consider chapter 2 of CTR for submission of clinical trial application and transition period
- Section 11.2, 11.3 (new), 11.4, 11.6, 11.7, 11.8, 11.10, 11.12 (new), 11.17 (new), 11.18 (new): These sections were updated by providing more information regarding the transition period and CTD deadlines
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