European Medicines Agency updated the page Clinical Trials Information System (CTIS): online modular training program on October 28, 2022, by adding new versions for the below documents in Module 13 – Clinical study reports submissions:
- Quick guide: Clinical Study Reports submission (v1.1): Updated by providing information on the process to request the Marketing Authorisation Holder (MAH) admin role in CTIS. Users can request the MAH admin role by raising a service desk ticket to CTIS and by attaching the affiliation letter signed by a representative of the MAH/Marketing Authorisation (MAA) to the ticket. MAH admin users, once appointed by EMA admin after validating the affiliation letter can then assign roles of CTIS Submitter or Viewer to other CTIS users.
- FAQs: Clinical Study Reports submission (v1.1): The questions and answers that are updated in this version are –
- Section 4.2: Details of the CSR-related tasks (view, create, edit, submit, update, and withdraw a CSR) that a MAH admin can perform were added.
- Section 4.3: Information on the process to request the MAH admin role in CTIS has been added.