Sponsor & CRO GCP Obligations: Designing Oversight That Protects Participants and Produces Defensible Evidence
Sponsor & CRO GCP Obligations: Designing Oversight That Protects Participants and Produces Defensible Evidence What Sponsors and CROs Must Do Under GCP: From Quality System to Day-to-Day Oversight Accountability by Design: Sponsor Duties, CRO Delegation, and a Fit-for-Purpose QMS Under Good Clinical Practice (GCP), the sponsor is accountable—always. Contracting a Contract Research Organization (CRO) does…