Finally, in conclusion and to further prove the relevance of the adage “specialia generalibus derogant”, let us just review a few facts :
- The investigator is responsible for the information about people who may be taking part in a trial and, following a cooling-off period, for obtaining their consent.
- The investigator, in his capacity as doctor or qualified person, remains at all times bound by the requirement of confidentiality regarding the state of health of the person taking part in the trial and can only agree to share this information with people who are expressly authorised by law.
- As such, the investigator is the sole and exclusive contact for people taking part in clinical trials and the volunteer can only exercise the rights granted by the GDPR through the investigator
Therefore, to ensure the protection of data about people taking part in clinical trials and to comply with the GDPR, the contact details of the sponsor’s DPO must not be stated on the information forms !