All terms
Good Clinical Practice
International quality standard for designing and conducting clinical trials.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
GCP is an international ethical and scientific quality standard for clinical investigations. ICH E6(R3) and ISO 14155 (devices) define expectations for protocol, monitoring, data integrity, and subject protection. What the regulation says
Good Clinical Practice, or GCP, is an international ethical and scientific quality standard specifically concerning the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. The FDA enforces GCP through its Bioresearch Monitoring (BIMO) program to ensure the quality and integrity of data and the protection of human subjects, as outlined in regulations like 21 CFR Parts 50, 56, and 312. For medical devices, ISO 14155:2020 provides specific requirements for good clinical practice.What this means in practice
GCP compliance is verified during sponsor and investigator-site inspections (FDA BIMO, EMA GCP). Findings can invalidate trial data.Examples
- A sponsor implements a robust monitoring plan with regular site visits and source data verification to ensure adherence to the clinical investigation plan and protect patient safety.
- An investigator ensures all study staff complete GCP training and maintain documentation of their qualifications before participating in the trial.
- Before commencing a clinical trial, an ethics committee (Institutional Review Board in the US) reviews and approves the protocol, informed consent form, and other study documents, ensuring ethical conduct and subject protection.
Common pitfalls
- •Failing to adequately document investigational site monitoring visits can lead to questions about data integrity and subject safety.
- •Using an outdated or unapproved version of the clinical investigation plan invalidates trial conduct and data.
- •Not ensuring that all research personnel are qualified and adequately trained for their assigned tasks is a common non-compliance.
- •Inadequate informed consent processes, such as missing signatures or dates, can compromise ethical standards and data validity.
- •Failure to report adverse events promptly and accurately to regulatory authorities and ethics committees is a serious violation of GCP.
Frequently asked questions
The primary goal of GCP is to ensure the protection of the rights, safety, and well-being of human subjects while also ensuring the integrity and credibility of clinical trial data.
Related terms
Shared paths + categoryClinical & Trials
Informed Consent
Voluntary, informed agreement to participate in research after disclosure of risks and benefits.
Clinical Trials & Evidence · adjacent
Standards
ISO 14155
Good clinical practice for clinical investigations of medical devices.
Clinical Trials & Evidence · adjacent
Clinical & Trials
Investigational Device Exemption(IDE)
FDA authorization to use an investigational device in a clinical study.
Clinical Trials & Evidence
Clinical & Trials
Adaptive Trial Design
Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Clinical Trials & Evidence
Clinical & Trials
Adverse Event(AE)
Any untoward medical occurrence in a subject, whether or not related to the device.
Clinical Trials & Evidence
Clinical & Trials
Clinical Evaluation Report(CER)
Documented assessment of clinical data demonstrating EU MDR conformity for a device.
Clinical Trials & Evidence
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Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
ICH·1AdvaMed·1AHRMM·1
- 1ICH E6(R3)VerifiedICHich.org
- 2AdvaMed Code of EthicsVerifiedAdvaMedadvamed.org
- 3AHRMM - Healthcare Supply ChainVerifiedAHRMMahrmm.org
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