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Developed by:
U-MIC
1
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
o
o
o
European Union
Japan
United States
Developed by:
U-MIC
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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
o 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
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ICH-GCP
Investigator ICH-GCP Checklist
•
•
Some requirements mirror federal and institutional requirements.
Some requirements are specific to ICH-GCP.
o
o
o
o
o
o
o
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
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ICH-GCP
Investigator ICH-GCP Checklist
consent requirements
• Some mirror federally required elements of informed consent.
• Some are ICH-GCP–specific:
o
o
o
o
o
impartial witnesses
subject responsibilities
prorated payment (as applicable)
providing subjects with signed and dated copy of consent document
other requirements
Developed by:
U-MIC
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ICH-GCP
IRB review of research subject to ICH-GCP requirements
•
IRB staff
o
o
o
o
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
7
ICH-GCP
ICH-GCP Certification Letters
• certify that research has been reviewed per ICH-GCP guidelines
• IRBMED issues letters only as necessary for
o
o
o
o
study team
contract research organization (CRO)
sponsor
other party
Developed by:
U-MIC
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ICH-GCP
International Council
on Harmonisation:
Good Clinical Practice
(ICH-GCP)
Developed by:
U-MIC
9
THANK YOU.
Diana Miller
Judy Birk
IRBMED
Developed by:
U-MIC
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