ABSTRACT
Both the GCP and other FDA regulations discuss the transfer of obligations of the sponsor to a CRO. They both state explicitly that regulations apply to CROs as much as they do to sponsors. But the sponsor is still legally liable for the data. GCP says in Section 5.2.1: “A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.” In this chapter, we will discuss how to work with CROs when they perform data management activities to assure that data is processed in compliance with regulations and results in datasets that meet the sponsor’s standards for its own data.
