Category: Study Design
Labels: framework
Creation date and Author: Unknown, October 22nd 2024
Last Update and Author: Merry K., July 2nd 2025
Related questions:
- Why are you not registered as a clinical trial in the EU?
- What type of study are we conducting?
The ROSALIND study has been classified as a purely retrospective and observational study of secondary use of clinical data without human intervention, in compliance with the CNIL MR004 methodology.
As the ROSALIND study is retrospective and does not involve investigational drugs, it is not subject to CTIS requirements. CTIS (Clinical Trials Information System) is the EU's centralized platform for regulatory submission, authorization, and supervision of interventional drug trials within the EU and EEA.