ICH E6(R3) Step 4 · January 2025 · GCDMP 2013
27 ICH E6(R3) compliant SOPs and 14 ready-to-use templates. Built from primary regulatory sources. Grounded in 25 years of CDM inspection experience.
From a recent ICH E6(R3) inspection
"I was asked directly: 'Can you show me your documented process for periodic audit trail review — and produce a signed review report?' The question wasn't whether the audit trail existed. It was whether we had systematically reviewed it. This is the gap that catches even experienced CDM teams."
— Sarah Huntley, 25+ years CDM experience
The complete CDM quality system. Every SOP references the exact regulatory section. Cover to database lock, audit trails to decentralised trials — all 27 are here.
The 6 SOPs that directly address what changed in ICH E6(R3). RBQM, audit trails, source data, privacy, security, eTMF. EU mandatory 23 July 2025.
Everything CDM needs before first patient in. Roles, training, data standards, EDC build, system validation, user access, data review plan.
14 ready-to-use Word and Excel templates: DMP, DVS, UAT, DRP, eCCG, database lock bundle, SAE reconciliation, coding conventions and more.
About the author
These resources were written by Sarah Huntley — an independent CDM consultant with over 25 years of experience spanning Phase I–IV clinical trials, CRO ecosystem management, and hands-on EDC platform work including Medrio API development.
Every SOP and template in this library references the specific ICH E6(R3), GCDMP, or 21 CFR Part 11 section it is based on — not paraphrased summaries, but the actual regulatory text inspectors use when they review your documentation.
Read more about the author →Why buy this
Every SOP cites the specific ICH E6(R3) section, GCDMP chapter, or regulatory article it implements. When an inspector asks where a procedure comes from, you have an answer.
Word format (.docx). Add your organisation name, effective date, and approver names. Each SOP is structured with the exact sections quality and regulatory teams expect.
Each SOP includes inspection-experience Expert Tips — the nuances and common findings that regulatory guidelines don't document but experienced CDMs learn the hard way.
"Comparable consulting engagement to write CDM SOPs: $5,000–$25,000. The Complete SOP Library: $2,999. Every SOP built from ICH E6(R3) Step 4, GCDMP 2013, and 21 CFR Part 11 — with Expert Tips based on 25 years of inspection experience."Value comparison — CDM Library vs. consultant-written SOPs
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Download the free 12-item readiness checklist — no signup required. Then explore the SOP library for the documentation that backs every item on it.