European Medicines Agency (EMA) updated the page Clinical Trials Information System (CTIS): online modular training program on September 23, 2022, by adding a new version for the below document in Module 10- Create, submit and withdraw a clinical trial:
FAQs: How to create, submit and withdraw a Clinical Trial Application (v1.3): The questions and answers that are added or revised in this version are –
- Section 1.10: This section was added newly and provides information if it is mandatory to upload all documents required by the Clinical Trials Directive (CTD) to CTIS.
- Section 2.3: This section was revised by adding information regarding the ‘Best Practice Guide for Sponsors of document naming in CTIS’, which is available in the ‘Key document list’ section on the Clinical trials Coordination Group page to be referred to upload documents on CTIS.
- Sections 2.4 and 2.5: These sections were newly added and provide information on the steps to upload a document, not for publication, edit, update and add additional documents.
- Section 2.9: This section was newly added specifying if the cover letter and financial arrangements need to be ink signed.
- Sections 2.11 and 2.14: These sections were newly added providing information on how users and the Member States Concerned can request a deferral.
- Sections 2.19, 2.20, and 2.29: These sections were newly added providing information on how users can add a third-party contact, populate the dose box, and Advanced Therapy Medicinal Products (ATMPs).