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Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that…

What Good Clinical Practice (GCP) requires

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Based on the ICH E6(R2) guideline, compliance provides public assurance that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible.

Pillar: Medical & Healthcare · Authority: European Medicines Agency (EMA) · Version: 1.1.0 · Last updated:

Primary source: https://www.ema.europa.eu/en/ich-e6-good-clinical-practice-scientific-guideline

SHA-256 integrity: 6fd99ae8e74d88b134aaf0fc8325425f5523658e5bb02959322e69b86c230543

Primary Citations — 6 traced to source

  • ICH E6(R2) Guideline for Good Clinical Practice (CPMP/ICH/135/95)
  • World Medical Association (WMA) Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects

+ 4 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.

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