Agreements with the investigator or institution, service providers and other parties such as an IDMC or adjudication committee should be documented before the activities begin and updated for significant changes. The sponsor should obtain commitments to conduct the trial under the approved protocol, GCP and regulation, follow data recording and reporting procedures, keep essential records for the required period or until told they are no longer needed if later, and allow monitoring, audit, domestic and foreign inspection and IRB/IEC review, giving direct access to source records and to facilities (service providers' included). Transferred activities should be documented (anything not transferred stays with the sponsor); information on sponsor-identified providers working for the investigator should be given to the investigator. The sponsor keeps ultimate responsibility for transferred activities, should assess and select providers able to do the work, give them the protocol and documents they need, have access to information such as SOPs and performance metrics, oversee important transferred activities including subcontracted ones, accept provider processes that are fit for purpose even if not designed for GCP, and require providers to run quality management and report incidents affecting safety or results. Multiple sponsors should document their respective responsibilities, with unassigned responsibilities shared by all.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.