Biomedical Engineering Reference
In-Depth Information
(ICH) has developed harmonized guidelines on good clinical practices (GCP).
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The conduct of a clinical trial according to good clinical practices has been adopted
by the USA, European Union, Japan, Australia and most other countries.
Good Clinical Practice Guidelines
These guidance documents outline in detail requirements which include:
•
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approval
of the clinical study
-
composition of the IRB/IEC member
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procedures of the IRB/IEC
-
records
•
Investigational qualification and agreements
-
medical care of subjects in the clinical trial
-
adequate resources to conduct the clinical trial
-
communication with the IRB/IEC
-
compliance with the protocol
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compliance with investigational product regulations
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randomization and unblinding
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informed consent of clinical trial subjects
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records and reports
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progress reports to the IRB/IEC and sponsor
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safety reporting
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premature termination or suspension of a clinical trial
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final reports by the investigator/institution
•
Sponsor
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quality assurance and quality control systems to ensure clinical trials are
reported in compliance with the protocol, good clinical practices and any
applicable regulatory requirement
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contract research organizations
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medical expertise
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clinical trial design
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Clinical Trial Management, Data Handling, Record Keeping and Independ-
ent Data Monitoring Committee
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selection of investigators
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establish trial related duties and functions
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compensation for subjects and investigators
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financing
-
notification/submissions to regulatory authorities
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confirmation of review by IRB/IEC
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information on investigational products
