The Clinical Trials Information System is a harmonised and simplified end-to-end single entry point for clinical trials information in the European Union and in the European Economic Area and will go live on 31 January 2022.
As a single entry point, it will be used for the submission, management and assessment of information throughout the life cycle of a clinical trial. The exchange of information between sponsors and Member States will be fully electronic.
In a recent EMA training webinar, the EMA advise the following to prepare for the CTIS go live date:
- Read the CTIS Sponsor Handbook
- Read the CTIS Training Modules, particularly Module 19 (CTIS for SMEs and academia)
- Ensure the organisation is registered and correct in SPOR
- Familiarise yourself with the CTIS User Personas
- Register Users in the EMA account management
- Register the first Sponsor Administrator
- Ensure your product is registered in the Article 57 database (XEVMPD)
- Prepare your CTA and supporting documents in accordance with CTR requirements
- Sign up to the CTIS Highlights Newsletter (write to email@example.com )
EMA has launched the CTIS training webpage containing a substantial amount of training materials and information for the users and organisations to facilitate their preparedness.
Should you need any support in clinical trial application just contact us and the Ivowen team will be here to help.
Written by Fiona Downey