What Is ICH E6(R2)?

ICH E6(R2) is an addendum to the International Council for Harmonisation E6(R1) that provides Good Clinical Practice (GCP) guidance and “a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.”

The guidance was updated in March 2018 and one section outlines sponsors’ oversight responsibilities when clinical studies are outsourced to contract research organizations (CROs). Section 5.2.1 of the guidance states “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.”

Regulatory bodies can issue major or critical findings for non-compliance, so study oversight is critical for outsourced clinical trials.