European Medicines Agency updated the page Clinical Trials Information System: training programme, on May 25, 2021, by adding the below supporting materials for Module 8, Module 10 and Module 11:
- Instructor exercise: How to evaluate an Initial clinical trial application: Assessment and decision CTIS training programme – Module 08
- How to create, submit and withdraw a clinical trial application – CTIS Training Programme – Module 10
- Checklist of required fields per application type – CTIS Training Programme – Module 10
- How to respond to Requests for Information received during the evaluation of a CTA – CTIS Training Programme – Module 11