European Medicines Agency (EMA) updated the page Clinical Trials Information System: training and support, on December 02, 2021, by adding a new version of the CTIS – Sponsor handbook (v2.0).
The 2.0 version of CTIS – Sponsor handbook included the following updates:
- Section 3.2.1-Updated the process of registration in organization management service (OMS)
- Section 4.5- Added new links for CTIS user personas and principles for sponsor organization modeling in CTIS
- Section 5- Updated information for product management in CTIS
- Section 6- Updated information for the transition from directive to regulation
- Section 7.1.3- Added a new section ‘Data fields and documents specifications’ that includes all the data fields required in CTIS along with the character limits. It also provides the characteristics of documents to be uploaded on CTIS
- Section 8.1- Updated information for suspected unexpected serious adverse reactions (SUSARs) reporting
- Section 10.4- Added a new section ‘CTIS training environment for user training and organization preparedness’ which describes the CTIS sandbox, its purpose, and the two secure workspaces (authority and sponsor) intended for its access. It also describes, in brief, the three waves and the timeline in which access to the CTIS Sandbox will be provided
Along with the above updates some editorial changes were made across the document.
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