The Clinical Trials Information System (CTIS) newsletter Issue 3 of June 2021 has now been published.
This issue includes information on the following topics:
- Key organisation models in CTIS
- The organisation-centric approach – is used by authority users (EU Member States and EEA countries) and by sponsors,
- The trial-centric approach – is only available for sponsor users
- CTIS system functionalities – CTIS allows sponsor users to manage a clinical trial during its life cycle through the following different system functionalities
- Sponsor views on CTIS and how to prepare for it
- CTIS training for SMEs & Academia – On 22 February & 4 March 2021 EMA organised a CTIS training for SMEs & Academia. A recording of the webinars is available here (Day 1) and here (Day 2).
- Initial clinical trial application process in CTIS
- Training Programme update
- CTIS User Personas
- Audit update
Source: EMA website