March 2022: CTIS Training Update

European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on March 25, 2022, by updating the below documents in Module 05- Manage a clinical trial through CTIS and Module 11- Respond to requests for information received during the evaluation of a clinical trial application:

  1. Section 4.1 – This section was revised by adding the links of reference material for creating a request for information (RFI) response
  2. Section 4.2 – This section was revised by updating information for responding to RFIs
  3. Section 4.3 – This section was newly added providing information if users can modify cover letter as part of RFI response
  4. Section 4.4 – This section was newly added providing information if users can modify deferrals as part of the RFI response
  5. Section 5.8 – This section was revised by adding the links of reference material for viewing the changes applied to the clinical trial application dossier data
  6. Section 5.10 – This section was revised by adding the links of reference material for viewing the previous version of a document