In the context of the Return of Individual Participant data (RoIPD), it refers to the recognition that there is no single approach to data return that applies to all clinical trials. Instead, RoIPD adapts to different diseases, study phases, and local contexts, ensuring consistent yet flexible implementation.
RoIPD is not a universal requirement and does not necessarily need to be implemented in all studies, by all sponsors, or in all research settings. What is important is that decisions to implement or not implement RoIPD are based on ethical considerations, scientific integrity, feasibility assessments, and safeguards for participants.
- FACILITATE White Paper. https://facilitate-project.eu/white-paper-on-roipd-full-text/
- D2.10
