ICH E6(R3) - Good Clinical Practice P10: Make roles and responsibilities clear and documented, keep overall responsibility when transferring or delegating activities, define them in agreements and oversee them

What does P10 require?

Sponsors may transfer, and investigators delegate, tasks, duties or functions, but each keeps overall responsibility for its activities, including the quality and integrity of data handled by service providers. Agreements should define roles, activities and responsibilities clearly and be documented, and whoever transferred or delegated activities should oversee them appropriately.