In the context of the Return of Individual Participant Data (RoIPD), it refers to the process where all affected stakeholders participate in shaping decisions about what data are returned, when, and how. It transforms RoIPD into a trust-building mechanism, ensuring transparency, comprehension, and sustainability.
- FACILITATE White Paper. https://facilitate-project.eu/white-paper-on-roipd-full-text/
- D2.10
To go in depth
The main principles of co-creation are
- Inclusiveness. Engage all relevant voices: patient organizations (POs), patient experts, investigators, sponsors, ethical committees, and Data Protection Officers (DPOs).
- Early integration. Initiate co-creation at the protocol synopsis stage and finalise before first-patient-included (FPI).
- Proportionality. Degree of co-creation to depend on the trial complexity, participant vulnerability, and any other pertinent factor.
- Transparency. Document contributions and feedback at every stage.
- Iteration. Use feedback to refine subsequent RoIPD plans.
Following the co-creation process, participants will be offered a clear and informed choice as to whether they wish to engage with the RoIPD pathway.
- D2.10
