March 2022: CTIS Training Update

European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on March 22, 2022, by updating the below documents in Module 08- Evaluate a clinical trial application- Assessment and decision-making:

  1. Section 2.17: This section was revised by adding information for documents to be provided in FAR in case of substantial modifications
  2. Section 4.3: This section was revised by adding information for the tasks to be performed in the decision phase in case the sponsor had applied for a deferral
  3. Section 4.6: This section was newly added providing information if any standard European forms must be filled while submitting a decision