December 2021: CTIS Training Update

European Medicines Agency (EMA) updated the pages Clinical Trials Information System: training and support and Clinical Trials Information System (CTIS): online modular training programme on December 16, 2021, by adding the below documents:

  1. Clinical Trial Information System (CTIS) structured data form – Annual Safety Report (ASR): This document provides guidance on the data fields Sponsors will have to fill in CTIS when creating an ASR and also contains screenshots of different sections of the system (CTIS software version 0.18.35.3).
  2. Clinical Trial Information System (CTIS) structured data form – Request for information (RFI): This document provides guidance on the data fields Sponsors will have to fill in CTIS when responding to an RFI and also contains screenshots of different sections of the system (CTIS software version 0.18.35.3).
  3. Clinical Trial Information System (CTIS) list values: This document contains the terms of all the lists present in the CTIS structured data forms for an initial application (IN), additional MSC application, substantial modification, and non-substantial modification applications, notifications, ASR, and RFIs.
  4. Step-by-step guide: How to manage a CT – Module 05: It provides a stepwise guidance to create notifications, respond to RFIs, respond to request for opinion regarding corrective measures and to submit trail results and results summary for lay person.
  5. Quick guide: How to manage a CT – Module 05: It provides information on the four system functionalities i.e. notifications, RFIs raised, results summary and summary for lay person along with CTIS insights.

Also an updated version of FAQs: How to create, submit and withdraw a Clinical Trial Application РModule 10 was uploaded with an addition of Section 7-Roles and Permission.