ICH GCP (Good Clinical Practice)

The International Council for Harmonisation E6 guideline establishing an international ethical and scientific quality standard for the design, conduct, recording, and reporting of clinical trials involving human participants, compliance with which provides public assurance that the rights, safety, and wellbeing of trial participants are protected and that trial data are credible.

ByCASRAI Editorial Board

· Last updated 21 May 2026

Worked examples

Is an instance

A sponsored Phase III drug trial conducts a GCP-compliant initiation visit before the first participant is screened, verifying that the investigator's site file, regulatory approvals, and investigational-product accountability records are in place.

Is an instance

A clinical-research coordinator documents an unanticipated serious adverse event in the source notes and reports it to the sponsor within the timelines specified by ICH GCP and the protocol's safety plan.

Looks similar, but isn't

Not an instance

An observational research project that does not assign participants to an intervention and does not test a regulated medical product is generally outside ICH GCP scope, though local research-governance standards still apply.

Not an instance

Casual recording of trial data in a personal notebook without source-document attribution is not GCP-compliant documentation.

ICH GCP applies to all interventional clinical investigations of regulated medical products and is incorporated into the regulatory frameworks of ICH member regulators including the FDA, EMA, MHRA, PMDA, and Health Canada. The current E6(R3) revision (2023) restructures the guideline around principles and annexes, emphasises a risk-based, quality-by-design approach, and clarifies expectations for decentralised trials and electronic clinical-data sources. Core requirements address investigator qualifications and responsibilities, sponsor oversight and monitoring, IRB/IEC review, informed consent, protocol compliance, investigational-product handling, source-document and case-report-form integrity, safety reporting, audit and inspection, and essential-document retention.

References

ICH GCP E6(R3) Guideline (2023)
ICH E6(R2) Guideline (2016) historical reference
EU Clinical Trials Regulation (EU) 536/2014
US FDA 21 CFR Parts 50, 54, 56, 312 (GCP-equivalent regulatory framework)

Use in your systems

JATS XML <role> element

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Schema.org DefinedTerm (JSON-LD)

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