Regulatory pathway · all topics

ICH-GCP E6(R3) Good Clinical Practice

ICH Good Clinical Practice E6(R3) (final version Jan 2025) is the international ethical and scientific quality standard for clinical investigations involving human subjects. Establishes responsibilities for sponsors, investigators, and IRBs/ECs. Covers protocol design, informed consent, data integrity, risk-based monitoring, and quality management. Adopted by FDA, EMA, PMDA, and other ICH regulators. Pivotal trials supporting US PMA or EU MDR clinical evaluation must comply.

Source

ICH E6(R3) 'Good Clinical Practice (GCP)' (final 2025)

https://www.ich.org/page/efficacy-guidelines

How MedTek OS handles this

Compass drafts the ich-gcp e6(r3) good clinical practice workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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