The ICH-GCP E6 Efficacy Guideline applies only to drug clinical trials, and does not represent a regulatory requirement in the United States; but may be required by industry sponsors, especially for multi-site or international trials. The ICH-GCP Guideline is an international standard established to promote the ethical and scientifically sound design, conduct, recording, and reporting of human clinical trials.
The ICH-GCP E6(R2) on GCP Guideline in many points mirrors U.S. regulations and University of Michigan policy, but imposes several additional responsibilities on investigators. When U-M agrees to a research contract indicating a study will be conducted in full compliance with ICH-GCP guidelines, the sponsor, oversight agencies such as FDA, and U-M will apply ICH-GCP requirements in their compliance review of that study.
To assist investigators with identifying full ICH-GCP responsibilities, IRBMED developed an ICH GCP checklist. The checklist is provided for informational purposes only. It is the principal investigator’s responsibility to meet the elements of ICH-GCP E6 as outlined in the checklist. There is no requirement to upload the checklist into the eResearch application. Completion of the checklist does not meet the requirements under NIH Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; U-M HRPP offers training to fulfill this requirement.
The IRBMED Standard Informed Consent Template includes special instructions and template language in a unique color to represent elements specific to ICH-GCP. When applicable, IRB staff will verify the consent includes these elements as part of application processing. Furthermore, the eResearch application system includes a question with accompanying help text to identify studies requiring ICH-GCP compliance.