April 2022: CTIS Training Update

European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on April 11, 2022, by updating the below document in Module 10- Create, submit and withdraw a clinical trial:

FAQs: How to create, submit and withdraw a Clinical Trial Application – Module 10 (v1.2): The questions and answers that are added or revised in this version are –

  1. Sections 2.8, 2.9, 2.12, and 2.13: These sections were newly added providing information for maximum publication deferral, deferral of publication for unauthorized trials, associated clinical trials, and publishing the contact point on sponsors’ subsection
  2. Section 2.16: This section was revised by providing information for users to add filters for ease of searching for information
  3. Section 2.18: This section was newly added informing if the inclusion of IMPD documents is mandatory
  4. Section 2.22: This section was revised by adding information that can be included in Part II by users and by adding a link for a reference template
  5. Section 2.24: This section was revised by updating the information for the limitation of the initial clinical trial application (CTA)
  6. Sections 2.27 and 2.28: These sections were newly added providing information on an option that sponsors have to appeal against the decision after receiving the receipt of the decision and if sponsors can start a clinical trial before receiving a positive response from all Member States concerned
  7. Section 4.3: This section was revised by adding more information for the scope of substantial modification
  8. Section 4.4: This section was revised by adding the example of different fields in the substantial modification CTA and stating that sponsors can upload a new version of documents as well as the original version with track changes
  9. Section 4.6: This section was newly added by providing information for descriptions of changes made in the CTA