Related Accreditation Elements: I.1.D., I.1.F., I.7.B., II.2.G., II.3.F., II-4, II.4.C., III.1.C., III.1.E., III.1.F., III-2, III.2.B., and III.2.D. Related Accreditation Table: II.3.F.1.
ICH-GCP is an ethical and scientific quality guidance document that is used internationally in the conduct of clinical trials. It includes areas for designing, conducting, recording, and reporting research that involves the participation of human participants. The guidance has its origins in the Declaration of Helsinki and was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization (WHO). ICH-GCP provides a unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate mutual acceptance of data from clinical trials by regulatory authorities in these jurisdictions. ICH-GCP contains guidelines for quality, safety, efficacy, and additional multidisciplinary guidelines. AAHRPP Standards include requirements under ICH-GCP (E6). The current version of the ICH-GCP guideline is (R2) but is referred to as the ICH-GCP (E6) guideline in this Tip Sheet.
In addition to general recommendations when following the ICH-GCP (E6) guideline, this Tip Sheet contains an Appendix that groups all the requirements consistent with AAHRPP’s Domains. The Tip Sheet has sections for the organization (Domain I), Institutional Review Board (IRB) or Ethics Committee (EC) (Domain II), and researcher (Domain III). All of these sections have requirements that are unique to this guideline and above those required in AAHRPP’s Essential Requirements. AAHRPP has identified those unique ICH-GCP (E6) requirements and has included them in its Standards outlined in the Evaluation Instrument for Accreditation for those organizations that follow ICH-GCP (E6).
An organization should determine ICH-GCP (E6)'s applicability. That is,
- Is ICH-GCP (E6) applied to all research conducted by the organization or limited to certain types of research (e.g., industry-sponsored clinical trials)? (Element I.1.A.)
- Are all requirements of ICH-GCP (E6) followed or limited to certain areas (e.g., IRB/IEC section only)? (Element I.1.A.)
- If the sponsor requires ICH-GCP (E6) be followed, the organization should inform the sponsor if the organization does not follow all of ICH-GCP (E6).
- If there is a contract or funding agreement that requires ICH-GCP (E6) be followed, the contract should include the extent or limit that the organization follows ICH-GCP (E6). (Standard I-8)
- Organizations that do not apply ICH-GCP (E6) to all research may want to create a separate policy, reviewer form, or other materials specifically focused on ICH-GCP (E6). (Element I.1.A.)
- Organizations should ensure researchers and research staff, IRB or EC members, and contracts and grants staff are knowledgeable about requirements of ICH-GCP (E6). (Element I.1.E.)
- Organizations may want to create researcher and research staff manuals or educational materials that explain the additional requirements when following ICH-GCP (E6). (Element I.1.E.)
- Organizations should create workflows so that grants and contracts staff can communicate to the IRB or EC when sponsors require compliance with ICH-GCP (E6) so that the IRB or EC considers this when conducting its review. (Standard I-8)
- Indicate how IRB or EC chairs, vice-chairs, members, staff, and researchers and research staff are educated about ICH-GCP (E6) requirements and to which research ICH-GCP (E6) is applied. (Element II.1.A.)
- Organizations may want to add documentation that the IRB or EC reviewed the study in compliance with ICH-GCP (E6), such as in the IRB or EC approval letter or in an electronic system so that monitors can confirm the IRB or EC considered this in its review. (Element II.5.B.)
- If the sponsor does not provide source documents, the study team may want to create study-specific source documents to assist with protocol compliance. (Element III.2.C)