How does GCP differ for drugs and devices?

While the core principles are similar, drug trials often refer to ICH E6, while device trials have specific guidance in ISO 14155:2020, which addresses unique aspects of device performance and risk management.

Who is responsible for ensuring GCP compliance?

The sponsor is ultimately responsible for ensuring that a clinical trial is conducted in accordance with GCP, but investigators and other site personnel also have significant responsibilities.

Can GCP violations lead to study invalidation?

Yes, significant GCP violations can lead to the invalidation of clinical trial data, rejection of regulatory submissions, and even withdrawal of marketing authorization.

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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.

Grouped by theme

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· Hand-selected related concepts

Clinical & Trials

Informed Consent

Voluntary, informed agreement to participate in research after disclosure of risks and benefits.

Standards

ISO 14155

Good clinical practice for clinical investigations of medical devices.

Clinical & Trials

Investigational Device Exemption(IDE)

FDA authorization to use an investigational device in a clinical study.

Clinical Trials & Evidence

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Clinical & Trials

Adaptive Trial Design

Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.

Clinical & Trials

Adverse Event(AE)

Any untoward medical occurrence in a subject, whether or not related to the device.

Clinical & Trials

Clinical Evaluation Report(CER)

Documented assessment of clinical data demonstrating EU MDR conformity for a device.

Clinical & Trials

Feasibility Study

Small clinical study evaluating initial safety, usability, and design parameters of an investigational device.

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AdvaMed Code of Ethics

Industry code governing interactions between U.S. medical-device companies and healthcare professionals.

Primary references

3 sources

Link health: 3 verified· last checked 2026-06-20

ICH·1AdvaMed·1AHRMM·1

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On this term

Category: Commercialization
Acronym: GCP
Sources: 3
Updated: 5/5/2026

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Learn in 60 seconds

International quality standard for designing and conducting clinical trials.

·GCP compliance is verified during sponsor and investigator-site inspections (FDA BIMO, EMA GCP).
·Findings can invalidate trial data.
·ICH E6(R3) and ISO 14155 (devices) define expectations for protocol, monitoring, data integrity, and subject protection.

Remember this

Watch out: Failing to adequately document investigational site monitoring visits can lead to questions about data integrity and subject safety.

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