Glossary Updates12 new terms added to the glossaries · October 2, 2026, 22:44 CEST
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Glossary · ICH guidelines

ICH E6(R3) (good clinical practice)

Also known as: ICH E6, E6(R3), ICH GCP, Guideline for Good Clinical Practice

ICH E6(R3) is the third revision of the ICH guideline for good clinical practice in clinical trials of medicines, adopted by ICH on January 6, 2025 and effective at EMA since July 23, 2025. It sets principles and responsibilities for sponsors, investigators and ethics committees to protect trial participants and to ensure reliable trial results, with a risk-proportionate approach.

  • ICH
  • Pharma
  • GxP

In one sentence

ICH E6(R3) is the current ICH guideline for good clinical practice in drug trials: participant protection, reliable results, risk-proportionate quality.

Example

A sponsor designs a phase III trial under ICH E6(R3), identifies the factors critical to quality in its protocol, focuses monitoring on those data, and documents its oversight of the CRO and the electronic data capture system.

How it applies

  • Structure: Overarching principles, Annex 1 on interventional clinical trials, and a separate Annex 2 with additional considerations for trial designs and data sources such as decentralized elements and real-world data. Annex 2 follows its own adoption timeline; check its current status.
  • Quality by design: Sponsors identify the factors critical to quality in a trial and focus planning, monitoring and oversight on them, proportionate to the risks to participants and to the reliability of results.
  • Responsibilities: The guideline sets out the roles of institutional review boards and ethics committees, investigators and sponsors, including sponsor oversight of service providers.
  • Data governance: A dedicated section covers data integrity, computerized systems, audit trails, metadata and the validation of systems used in trials, in line with ALCOA+.
  • EU law: In the EU, clinical trials of medicines are governed by the Clinical Trials Regulation (EU) No 536/2014 and submitted through CTIS; ICH E6(R3) is the GCP guideline applied within that framework. See good clinical practice.
  • Technical documentation: Protocol, investigator's brochure, trial master file and essential records must allow the conduct of the trial and the quality of the data to be reconstructed.

ICH E6(R3) vs. ISO 14155

ICH E6(R3) applies to clinical trials of medicinal products. ISO 14155 is the GCP standard for clinical investigations of medical devices, used with MDR Articles 62 to 82 and Annex XV. The ethics and data principles are similar; the device standard adds device-specific topics such as device deficiencies and the link to the risk management file.

By knowledge.aitechdoc.world · Published September 25, 2026 · Last reviewed

Source: ICH E6(R3), Guideline for Good Clinical Practice

Definitions follow the cited standards and specifications. Where a source is a copyrighted publication, such as an ISO, IEC or EN standard, the definition is a close paraphrase, not a verbatim quotation, so as not to infringe copyright. We recommend reading the original publication. The sections “How it applies” are editorial commentary by AI TechDoc Blog and are not part of any standard.

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