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on [INSERT Day Month Year]

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Protocol Approval Criteria

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To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC

International council on harmonisation: Good clinical practice (ICH-GCP) Developed by: U-MIC University of Michigan IRB Collaborative

ICH-GCP International Council on Harmonisation (ICH) launched 1990 regulatory authorities and the pharmaceutical industry European Union Japan United States Developed by: U-MIC

ICH-GCP International Council on Harmonisation (ICH) benefits to regulatory authorities and the pharmaceutical industry protection of public health guidelines developed through scientific consensus with regulatory and industry experts E6 introduced in 1996 defines good clinical practice (GCP) in drug clinical trials Sponsor indicates in the protocol whether the study must comply with ICH-GCP guidelines. Reference to good clinical practice without the ICH designation does not indicate that a study must satisfy ICH-GCP requirements. Developed by: U-MIC

ICH-GCP Investigator ICH-GCP Checklist Some requirements mirror federal and institutional requirements. Some requirements are specific to ICH-GCP. investigator qualifications/agreement to comply with ICH-GCP standards adequate resources randomization, blinding, and unblinding (as applicable) records and reports progress reports safety reporting final reports to IRB or other regulatory authorities Developed by: U-MIC

ICH-GCP Investigator ICH-GCP Checklist consent requirements Some mirror federally required elements of informed consent. Some are ICH-GCP–specific: impartial witnesses subject responsibilities prorated payment (as applicable) providing subjects with signed and dated copy of consent document other requirements Developed by: U-MIC

ICH-GCP IRB review of research subject to ICH-GCP requirements IRB staff provides study team with Investigator ICH-GCP Checklist instructs study team to complete and sign checklist instructs study team to upload checklist to eResearch section 44 checks informed consent document against the checklist to ensure it contains all appropriate elements Developed by: U-MIC

ICH-GCP ICH-GCP Certification Letters certify that research has been reviewed per ICH-GCP guidelines IRBMED issues letters only as necessary for study team contract research organization (CRO) sponsor other party Developed by: U-MIC

ICH-GCP International Council on Harmonisation: Good Clinical Practice (ICH-GCP) Developed by: U-MIC

Thank you. Diana Miller Judy Birk IRBMED Developed by: U-MIC