MSU HRPP Manual Section 2-4

2-4, International Conference on Harmonization Good Clinical Practice E6 (R2)

Good clinical practice provides standards for the conduct of all aspects of a clinical investigation, including the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting. Clinical trials regulated by the U.S. Food and Drug Administration (FDA) are required to adhere to applicable FDA regulations, including those regulations that imply good clinical practices, e.g. 21 CFR 11, 50, 54, 56, 58, 310, 312, 812, 814. The International Conference on Harmonization’s (ICH) Guidance for Industry E6 Good Clinical Practice (GCP): Consolidated Guidance provides a unified, international standard for the conduct of clinical trials involving human subjects. This harmonised guideline was amended in 2016 with an integrated Addendum. The FDA utilizes ICH-GCP as guidance for GCP. Clinical trials that follow ICH-GCP E6(R2) guidance are conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with GCP and applicable regulatory criteria.

A sponsor of a clinical investigation (e.g., multi-site clinical trials, international clinical trials) may require ICH-GCP (E6(R2)) compliance. In those instances, the Compliance office will review the research plan submitted to identify aspects that may be inconsistent with ICH-GCP and provide the information to the investigator and/or the Institutional Review Board as appropriate. Such review will include evaluation by the reviewing IRB of the adequacy of the available information in the protocol to support the proposed research study and include a review that proposed research is scientifically sound and answers the proposed questions. See HRPP Manual 6-2-A, Minimization of Risks: Sound Research Design. If an investigator in the research contract agrees to conduct an investigation in full compliance with the investigator obligations under ICH-GCP, any ICH-GCP review conducted by the Compliance office will be done using the complete set of ICH-GCP requirements.  Prior to a participant’s participation in the research study, the investigator should ensure that the written informed consent form is signed and personally dated by the participant or by the participant's legally authorized representative, and by the person who conducted the informed consent discussion.

The Compliance office or the IRB will bring any issues of concern to the attention of the investigator, who may in turn ask for clarification from the sponsor. A standard form will be completed to document the ICH-GCP review.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 7-19-2011. Revision 1 approved by Assistant VP Regulatory Affairs on 11-20-2015. Revision 2 approved by Assistant VP Regulatory Affairs on 4-3-2018. Revision 3 approved by Assistant VP Regulatory Affairs on 11-15-2021.

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