EMA – CTIS: Update of training materials
EMA provides an online modular training programme to help clinical trial sponsors, national competent authorities, ethics committees, European Commission and EMA staff use the Clinical Trials Information System (CTIS). The programme contains modules and audience-targeted materials covering all clinical trial lifecycle stages, from submission through authorisation to supervision.
The EMA published updated version of the following CTIS training materials:
- Clinical Trials Information System (CTIS) common features – CTIS Training Programme – Module 02
- Roles and permissions matrix summary – Authority workspace – CTIS Training Programme – Module 07
- Step-by-step guide : Create, submit and withdraw a clinical trial application and nonsubstantial modifications – CTIS Training Programme – Module 10
- Checklist of required fields per application type – CTIS Training Programme – Module 10
- FAQs: How to create, submit and withdraw a Clinical Trial Application – CTIS Training Programme – Module 10
- Step-by-step guide: How to respond to requests for information received during the evaluation of a Clinical Trial Application – CTIS Training Programme – Module 11
More information on the EMA Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (19 octobre 2024). EMA – CTIS: Update of training materials. ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/12j9l





