This section dives into the basics of clinical research, reviewing what a clinical trial is, which laws govern clinical ⦁ We now delve into the heart of the RoIPD topic. The Key message is: Let’s explore how Returning of Individual Participant Data is reshaping the EU clinical research landscape, driving transparency, accountability, and a model that truly puts people at its center.
First, the concept of data return is introduced, then the meaning of the term Individual Participant Data, and the benefits of RoIPD for the participant’s health, as well as the recognition and appreciation they receive are introduced.
The discussion then moves on to the ethical and legislative framework that must underpin RoIPD, leading to the three core concepts of RoIPD: people-centered, by design, and flexible.
