March 2022: CTIS Training Update

European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on March 15, 2022, by adding the below updated documents in Module 07- Management of registered users and role matrix:

  1. Instructor’s guide: Management roles and permissions  – Module 07 (v1.2): It includes updated information in the materials available section with the addition of a step-by-step guide and two new video clips for requesting and approving administrator roles via identity and access management (IAM) and to remove CTIS admin role.
  2. Step-by-step guide (high level CTIS administrator): Management of roles and permissions – Module 07 (v1.2): It includes added information in the Appendix section enlisting member states and European Commission
    administrator organizations for each European country with organization IDs.

FAQs: How to evaluate a CT application (v1.2) was also updated in Module 6 -Evaluate a clinical trial application: Selection of reporting Member State (RMS) and validation of the clinical trial application.