The following information applies to the conduct of clinical research at the University of Michigan under ICH-GCP E6 Guidelines.
The ICH-GCP E6 Efficacy Guideline
- represents a set of ethical and scientific quality guidelines
- is based on the Declaration of Helsinki
- applies only to drug clinical trials
- does not represent a regulatory requirement in the United States
- may be required by industry sponsors, especially for multi-site or international trials
The ICH-GCP E6 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. It is no longer a requirement that the study teams complete and upload this checklist into the eResearch IRB application. At the same time, it is still the principal investigator’s responsibility to meet the elements of ICH-GCP E6 as outlined in the checklist.
In addition to the checklist, IRBMED modified its Standard Informed Consent Template to include special instructions and template language in a unique color to represent elements specific to ICH-GCP. IRB staff will verify the consent includes these elements as part of application processing. Furthermore, as of June 2016, the eResearch application system added a new question with accompanying help text to identify studies requiring ICH-GCP compliance.
Notice that completion of this checklist does not meet the standards for required ICH GCP training. The checklist is provided informational purposes only.
For further information about ICH-GCP compliance at the University of Michigan, see the HRPP Operations Manual Part 11.I.C.2 and the U-MIC presentation “International Council on Harmonisation: Good Clinical Practice (ICH-GCP).”