Pharma & drug development · Reference
What is Good Clinical Practice (GCP)?
Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. It protects participants’ rights and safety and assures the integrity of the data a trial produces.
What GCP sets out to do
GCP has two linked purposes: protecting the people who take part in research and assuring the quality of the data the research produces. It defines the responsibilities of the parties to a trial — the sponsor that initiates it, the investigator who runs it at a site, and the independent ethics committee or institutional review board that reviews it. The standard requires a written protocol, documented informed consent from every participant, and traceable records so that what was done can be reconstructed and audited. By fixing these expectations in advance, GCP makes a trial both ethically defensible and scientifically reproducible.
ICH E6 and where GCP comes from
The authoritative articulation of GCP is the ICH E6 guideline, produced by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH brings together regulators and industry from major regions to harmonise expectations, so that a trial run to ICH-GCP is recognised across the United States, the European Union, the United Kingdom, Japan and many other jurisdictions. Regulators such as the FDA, the EMA and the MHRA adopt or reference the standard, which is why GCP underpins the data packages submitted in the drug-approval process.
GCP in the development pipeline
GCP applies wherever an investigational medicine is tested in people — across the phases of drug development, from first-in-human studies to large comparative trials. Compliance is verified through monitoring and inspection: sponsors monitor sites, and regulators may inspect to confirm that consent, eligibility, dosing records and adverse-event reporting were handled correctly. Findings of serious non-compliance can invalidate data or delay an approval, which is why GCP is treated as a foundational, non-negotiable requirement rather than a procedural formality.
Key facts
At a glance
- Definition: Ethical and scientific quality standard for trials
- Defined in: ICH E6 guideline (ICH-GCP)
- Protects: Participant rights, safety and well-being
- Assures: Credibility and accuracy of trial data
- Recognised: FDA, EMA, MHRA and other ICH regions
- Verified by: Sponsor monitoring and regulatory inspection
Common questions
FAQ
What does Good Clinical Practice mean?+
Good Clinical Practice is an internationally agreed quality standard governing how clinical trials are designed, run, recorded and reported. Its aim is to protect participants and to ensure trial data are trustworthy. It is a research and regulatory standard, not clinical or treatment guidance.
What is the difference between GCP and ICH-GCP?+
People usually mean the same thing. “ICH-GCP” simply names the specific authoritative version of Good Clinical Practice published by the ICH as guideline E6, which most regulators adopt or reference.
Who has to follow GCP?+
Everyone involved in an interventional clinical trial — the sponsor, investigators, study staff and contract research organisations — works to GCP, and ethics committees review against it. Regulators may inspect for compliance before accepting trial data in a marketing application.
The step most authors miss
Doing CRediT right? Don’t stop at the statement.
A CRediT statement credits you inside one paper. The recognition CRediT was built for happens when those roles are tied to you, persistently. Sign in with your ORCID — free — and claim your CRediT contributions on casrai.org, the home of the standard. They become a verified, portable part of your identity, not a line that disappears into one PDF.
Free: claim your contributions, then export a journal-ready CRediT statement, schema.org structured data, JATS XML, CSV or BibTeX — and preview your public profile. A membership publishes that profile publicly and verifies the journals you serve.
