Regulatory aspects
Specifically pertaining to CRO teams providing clinical-trials services, the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH-GCP) (E6 1.20) defines a Contract Research Organization (CRO) as: "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions."
- (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. The CRO should implement quality assurance and quality control.
- (5.2.2) Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing.
- (5.2.3) Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
- (5.2.4) All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.