10.1 The sponsor may transfer or the investigator may delegate their tasks, duties or functions (hereafter referred to as activities), but they retain overall responsibility for their respective activities.
10.2 Agreements should clearly define the roles, activities and responsibilities for the clinical trial and be documented appropriately. Where activities have been transferred or delegated to service providers, the responsibility for the conduct of the trial, including quality and integrity of the trial data, resides with the sponsor or investigator, respectively.
10.3 The sponsor or investigator should maintain appropriate oversight of the aforementioned activities.