Division of responsibilities (DoR)
The aim of this document is to outline the duties undertaken in MHRA regulated clinical trial/device study and some higher risk non-MHRA regulated studies. It allows for the sponsor, CI and CTU (where relevant) to clarify who will be responsible for specific duties. Once signed it is an agreement between these parties confirming who is responsible for each activity.
RGEA will advise if a DoR is required for the study when conducting the sponsorship review and will issue the study-specific DoR for signatures.
