# Skills tagged "ICH GCP"

2 skills with this tag.

URL: https://rakenne.app/skill-tags/ich-gcp/index.md

- [Clinical Trial Protocol (ICH E6(R3) GCP)](https://rakenne.app/skills/ich-gcp-clinical-trial-protocol/index.md) — Draft and validate clinical trial protocols per ICH E6(R3) Good Clinical Practice and ICH E8(R1) General Considerations for Clinical Studies. Ensures the protocol contains all required elements for …
- [eCTD Cross-Module Verifier](https://rakenne.app/skills/ectd-cross-module-verifier/index.md) — Verify consistency and data integrity of eCTD pharmaceutical dossiers. Cross-checks Module 2 (Summaries) against Module 5 (Clinical Study Reports) to ensure study references, p-values, N-counts, …

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