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 –
- 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
- Section 2.16: This section was revised by providing information for users to add filters for ease of searching for information
- Section 2.18: This section was newly added informing if the inclusion of IMPD documents is mandatory
- 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
- Section 2.24: This section was revised by updating the information for the limitation of the initial clinical trial application (CTA)
- 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
- Section 4.3: This section was revised by adding more information for the scope of substantial modification
- 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
- Section 4.6: This section was newly added by providing information for descriptions of changes made in the CTA