Definition

International ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Ensures rights and safety of subjects and data reliability.

Example

Protocols, informed consent, and monitoring must comply with ICH GCP; deviations can invalidate data and trigger inspections.

Regulatory source

ICH E6(R2), FDA 21 CFR 312, EU Directive 2001/20/EC

Common mistakes

Treating GCP as optional in some regions. Inadequate oversight of CROs and sites.

Inspector question

How do you ensure CROs and sites comply with ICH GCP? Show your oversight and audit plan.

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