European Medicines Agency updated the page Clinical Trials Information System: training programme, on July 06, 2021, by adding new versions of the below documents in CTIS Training Module 15 (Search, view and download a clinical trial and clinical trial application) and Module 16 (Supervise a Clinical Trial and a Clinical Trial: Inspection records):
- Instructor’s Guide: How to search, view and download a CT and a CTA (Authority)-Module 15
- FAQs: How to search, view and download a CT and a CTA (Authority)– Module 15
- Quick guide:How to search, view and download a CT and a CTA (Authority)– Module 15
- Step-by-step guide: How to search, view and download a CT and a CTA (Authority)– Module 15
- Process puzzle exercise : Supervise a Clinical Trial and a Clinical Trial: Inspection records– Module 16
- Step-by-step guide: Supervise a Clinical Trial and a Clinical Trial: Inspection records– Module 16
- FAQs: Supervise a Clinical Trial and a Clinical Trial: Inspection records– Module 16
- Instructor’s guide: Supervise a Clinical Trial and a Clinical Trial: Inspection records– Module 16
These are guidance documents for authority users and contains an overview of the training materials available with explicit explanation provided for each section, and a suggested methodology for disseminating the materials. It also explains different case by case scenarios with possible solutions, justifications, and screenshots for better understanding.