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FAQs Introduction to the Clinical Trials Regulation (EU) No 536/2014 CTIS Training Programme Module 01 Version October 2021 What you will find Answers to general questions regarding relevant definitions. Answers to questions regarding the transition from the regime of the Clinical Trials Directive to the Clinical Trials Regulation. Answers to questions regarding the rules of transparency of clinical trials data, established in the Clinical Trials Regulation. European Medicines Agency, 2021 Reproduction and/or distribution of the content of these training materials for non-commercial or commercial purposes is authorised, provided the European Medicines Agency is acknowledged as the source of the materials.

the Clinical Trials Regulation, if the sponsor opts for the regime of the Clinical Trials Directive. From the end of the third year since the entry into application of the Clinical Trials Regulation, only the Clinical Trials Regulation will apply, and all trials will have to switch to the Clinical Trials Regulation regime. 2.2.

  Regime

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