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).
Read the pdf