Examples
Worked examples
- Is an instance
A university sponsored-programs office confirms an investigator has completed current GCP training before an NIH-funded clinical trial begins enrolling participants.
Counter-examples
Looks similar, but isn't
- Not an instance
Treating GCP as identical across all ICH member regulators without checking each regulator's specific adoption/effective date for a given E6(R3) element.
Editorial commentary
ICH GCP (Good Clinical Practice) is the international ethical and scientific quality standard for designing, conducting, recording, and reporting interventional clinical trials involving human subjects, issued by the International Council for Harmonisation (ICH) and incorporated into the regulatory frameworks of ICH member and observer regulators, including the FDA, EMA, MHRA, PMDA, and Health Canada. Compliance is what gives regulators and the public confidence that a trial’s subjects were protected and its data are credible.
The current core guideline is ICH E6(R3), which reached ICH Step 4 (final adoption) on 6 January 2025. It restructures GCP around a set of overarching Principles plus modular annexes, shifts toward a risk-based, quality-by-design approach to trial oversight, and directly addresses decentralised trial elements and electronic data sources that the prior E6(R2) revision (2016) did not contemplate. Core obligations under GCP span investigator qualifications and responsibilities, sponsor oversight and monitoring, independent ethics committee/IRB review, informed consent, protocol compliance, investigational-product handling, source-document and case-report-form integrity, safety reporting, audit and inspection readiness, and essential-document retention.
Core principles: eleven, not thirteen
E6(R3) restructures GCP around a Principles section containing eleven overarching principles — not thirteen, a figure that circulates in some secondary sources by conflating E6(R3)’s Principles section with the differently-structured core-principles list in Section 2 of the prior E6(R2) (2016) revision. E6(R3) consolidated and restructured that list and added two principles not present in E6(R2): Quality by Design (building quality into trial design and processes from the outset, rather than relying on inspection and correction after the fact) and Proportionality (calibrating the rigor of oversight, monitoring, and documentation to the actual risk a given trial or trial element presents, rather than applying uniform maximum scrutiny everywhere). The full principle-by-principle list is covered in the dedicated guide linked below.
Because GCP compliance is a large, operational topic in its own right — not something a short reference definition can responsibly cover — CASRAI treats it in two dedicated guides rather than growing this entry into a third, competing summary:
- Good Clinical Practice: the full guide covers the complete set of E6(R3) principles, how they map to trial roles and responsibilities, and a comparison of free GCP certification/training options.
- ICH E6(R3): what changed covers specifically what moved between E6(R2) and E6(R3) — the principles/annex restructuring, the risk-based quality-by-design shift, and the new decentralised-trial and electronic-data provisions — for readers who already know E6(R2) and need to know what’s different.
See also the dedicated ICH E6(R3) entry for the revision’s adoption/effective-date timeline across regulators.
References
- ICH, E6(R3) Guideline for Good Clinical Practice, ICH Step 4 finalised 6 January 2025 (ich.org).
- ICH, E6(R2) Guideline for Good Clinical Practice (2016), prior core revision, retained as historical reference.
- Regulation (EU) No 536/2014 (EU Clinical Trials Regulation).
- US FDA regulations implementing GCP-equivalent requirements: 21 CFR Parts 50, 54, 56, 312.
Also known as
ICH E6 · GCP · Good Clinical Practice · ICH E6(R3)
Machine-readable encodings
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