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

Glossary · GxP: good practices

Good clinical practice (GCP)

Also known as: GCP, ICH GCP

Good clinical practice (GCP) is the international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials involving human participants. It protects the rights, safety and well-being of participants and the reliability of trial results; for medicinal products it is set out in ICH E6(R3), for medical devices in ISO 14155.

  • GxP
  • Pharma

In one sentence

GCP is the ethical and scientific standard for clinical trials: ICH E6(R3) for medicines, ISO 14155 for medical device clinical investigations.

Example

A sponsor running a phase III trial in five EU countries submits it through CTIS, uses a risk-based monitoring plan under ICH E6(R3), and keeps a trial master file that inspectors can use to reconstruct the conduct of the trial.

How it applies

  • Medicinal products: ICH E6(R3) was adopted by ICH on January 6, 2025 and has been effective at EMA since July 23, 2025; its Annex 2 follows separately. It emphasizes quality by design and risk-proportionate trial conduct.
  • EU law: The Clinical Trials Regulation (EU) No 536/2014 governs authorization and conduct of trials; applications run through CTIS, and the transition from the former directive ended on January 31, 2025.
  • Medical devices: Clinical investigations under the MDR follow ISO 14155; IVD performance studies under the IVDR follow ISO 20916.
  • Technical documentation: Protocol, informed consent records, case report forms, monitoring reports and the trial master file are GCP evidence. Computerized systems used in trials must be fit for purpose and keep an audit trail.

GCP vs. GLP

GLP applies to non-clinical safety studies in laboratories and animals before human exposure. GCP applies once human participants are involved. The two differ in roles (study director vs. sponsor and investigator) and in the ethical safeguards GCP adds, such as ethics committee approval and informed consent.