What should be documented if sponsor transfers trial-related activities to a service provider?

• A. All activities are automatically transferred.
• B. Any transferred activities should be documented in an agreement, while non-transferred activities remain the sponsor's responsibility.
• C. Service provider must take full responsibility for all data.
• D. Nothing needs to be documented.

Answer: (B)

When trial activities are handed to a service provider, you must put it in a formal written agreement that clearly documents what is being transferred, to whom, and the exact scope of responsibilities. This ensures there is a clear allocation of tasks while the sponsor remains accountable for the trial’s integrity and for regulatory compliance. The agreement should spell out oversight expectations, data handling and access to source data, monitoring and safety reporting duties, accountability for data integrity, and how changes or issues will be managed. Activities that are not transferred stay the sponsor’s responsibility, so the contract should reflect which parts remain under sponsor control. Without documenting the transfer, there can be ambiguity about who is responsible for quality, data, and compliance.