A sponsor wants to transfer duties to a CRO.

When a sponsor transfers specific tasks to a Contract Research Organization (CRO), it must be documented in writing. This formal documentation clearly delineates responsibilities and ensures that both parties are aware of their roles and obligations. Verbal agreements are not sufficient forregulatory compliance.

ICH E6(R2) GCP guidelines mandate that all delegated tasks must be documented formally to ensure clarity and compliance.

"The sponsor should document in writing any responsibilities transferred to a CRO to ensure clear delineation of roles."

Objectives:

Maintain clear documentation of delegated tasks.

Ensure compliance with regulatory standards.