FAQs: How to Evaluate a CTA – CTIS Training Program Module 06

5 October 2022 — EMA published version 1.4 FAQs on how to evaluate a CTA.

This FAQ guidance provides:

  • Answers to questions regarding the different types of Clinical Trials Applications (CTAs) according to the CT Regulation.
  • Answers to questions regarding the different phases in the evaluation of an application and how to monitor the progress.
  • Answers to questions related to the first steps in the evaluation of an initial CTA (RMS selection and validation).
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