--- title: "GCP, ICH E6 Good Clinical Practice | MedTech Terms" description: "International standard for the design, conduct, and reporting of clinical trials. 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However, its principles are widely accepted globally as best practices for any clinical research involving human subjects, influencing regulations such as those from the FDA and EU MDR for clinical investigations." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. ICH E6 Good Clinical Practice [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence)GCP # ICH E6 Good Clinical Practice International standard for the design, conduct, and reporting of clinical trials. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ICH E6(R3) provides an internationally accepted standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials, ensuring data credibility and subject protection. What the regulation says ICH E6 [Good Clinical Practice](/terms/gcp) provides a unified standard for clinical trials, ensuring the protection of human subjects and the integrity of clinical data. While initially focused on drug trials, its principles are widely referenced and adapted for medical device clinical investigations, often in conjunction with [ISO 14155](/terms/iso-14155), by regulatory bodies such as the FDA and those in the European Union. ## What this means in practice While developed for drug trials, [GCP](/terms/gcp) principles are widely applied to device clinical investigations alongside [ISO 14155](/terms/iso-14155). ## Examples - A medical device company conducting a pre-market clinical investigation for a novel implantable device implements an ICH E6 compliant quality management system for trial oversight. - A clinical research organization performing a post-market clinical follow-up study for an approved MedTech product ensures that informed consent processes align with ICH E6 guidelines. - During an FDA audit of a medical device clinical trial, the sponsor is asked to demonstrate adherence to ICH E6 principles for data management and record-keeping. Common pitfalls - • Failing to recognize that ICH E6, while primarilyfor drug trials, is a foundational document influencing medical device clinical investigation expectations. - • Assuming that adherence to ICH E6 alone is sufficient for medical device trials without considering device-specific standards like ISO 14155. - • Overlooking the criticality of a robust quality management system, as outlined in ICH E6, for all clinical trial activities. ## Frequently asked questions How does ICH E6 relate to medical device clinical trials? While ICH E6 was developed for pharmaceutical clinical trials, its core principles regarding ethics, data integrity, and subject protection are frequently applied or adapted to medical device clinical investigations, often complementing device-specific standards such as [ISO 14155](/terms/iso-14155). What is the primary goal of ICH E6 GCP? Is compliance with ICH E6 mandatory for all clinical trials? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ ALCOA+ ](/terms/alcoa-plus) ### Used by Things that build on this term. - [ ISO 14155 ](/terms/iso-14155) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials Investigational Device Exemption(IDE) FDA authorization to use an investigational device in a clinical study. ](/terms/ide)[ Standards ISO 14155 Good clinical practice for clinical investigations of medical devices. ](/terms/iso-14155) ### More in Clinical & Trials · Same category [ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event)[ Clinical & Trials ALCOA+ Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available). ](/terms/alcoa-plus)[ Clinical & Trials Analytical Sensitivity An IVD's ability to detect small quantities of an analyte. ](/terms/analytical-sensitivity) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ICH· 2 ISO· 1 1. [1 ICH E6(R3) Verified ICH · ich.org ](https://www.ich.org/page/efficacy-guidelines) 2. [2 ICH Guidelines Verified ICH · ich.org ](https://www.ich.org/page/ich-guidelines) 3. [3 ISO 14155 Standard Page Verified ISO · iso.org ](https://www.iso.org/standard/71690.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Clinical & Trials Acronym GCP Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=ich-gcp) Learn in 60 seconds Card Lesson Quiz International standard for the design, conduct, and reporting of clinical trials. - · While developed for drug trials, GCP principles are widely applied to device clinical investigations alongside ISO 14155. Remember this Watch out: Failing to recognize that ICH E6, while primarilyfor drug trials, is a foundational document influencing medical device clinical investigation expectations. Related terms - [ISO 14155 ](/terms/iso-14155) - [Investigational Device Exemption(IDE) ](/terms/ide) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Good Clinical Practice(GCP) ](/terms/gcp) - [ISO 20916 ](/terms/iso-20916) - [Risk-Based Monitoring(RBM) ](/terms/risk-based-monitoring) - [ICH E6(R3) Good Clinical Practice(E6(R3)) ](/terms/ich-e6-r3) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Clinical Evaluation Report(CER) ](/terms/cer) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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