It will define which, when and how clinical trial data should be returned to study participants. OBJECTIVES OF THE FULL PROJECT
-Implement best practice for handling personal data protection regulations.
-Nurture the harmonization of an ethical and legal framework
applicable to medical research in the Member States;
-Deliver a prototype process for returning clinical trial data to study parti
cipants and to facilitate the conduct of health research projects, during and after the study;
-Generate recommendations on which, when and how data should be returned to study participant;
-Develop insights on how this data could be used in health care decision making and for future research;
-Ensure that the whole data process is legally compliant and aligned with the study participants’ voice
