About
CDM Library was created because the resources that CDM professionals actually need — compliant, specific, primary-source-referenced SOPs and templates — didn't exist at a price accessible to independent consultants and small biotechs.
The author
Sarah is an independent CDM consultant specialising in clinical research data management, CRO ecosystem management, and hands-on EDC platform work. Her experience spans Phase I–IV clinical trials across multiple therapeutic areas, CRO vendor management, and direct API development with platforms including Medrio.
With over 25 years in clinical data management, she has participated in regulatory inspections, contributed to SOP frameworks at multiple organisations, and trained CDM teams across sponsor and CRO environments.
CDM Library grew from a simple observation: the gap between what ICH E6(R3) requires and what most small organisations actually have in place is enormous — not because they don't care, but because building a compliant SOP library from scratch takes months and the alternatives (consultants, enterprise software) are priced for large organisations. These products fill that gap.
Connect on LinkedInWhy these resources are different
Every SOP in the library cites the specific ICH E6(R3) section, GCDMP chapter, or regulatory article it implements. When an inspector asks where a procedure comes from, there is a clear answer — not "it's based on best practices" but "it implements ICH E6(R3) §3.10.1 and GCDMP: Assuring Data Quality."
Expert Tips throughout
Each SOP includes inspection-experience Expert Tips — the specific findings, common misunderstandings, and practical distinctions that experienced CDMs learn at inspection but that no regulatory guideline documents. These are the things that make the difference between a SOP that satisfies an inspector and one that prompts a finding.
ICH E6(R3) Annex 2
The SOP library includes CDM-SOP-045 — the only commercially available CDM SOP for decentralised clinical trial and real-world data management, aligned to the ICH E6(R3) Annex 2 draft (consultation closed February 2025, finalisation expected 2025–2026).
The resources
Covering every CDM function from departmental charter to decentralised trials. Available as a complete library, thematic bundles, or individual SOPs.
Browse SOPs →Word and Excel templates for every major CDM deliverable. DMP, DVS, UAT, DRP, database lock, SAE reconciliation, and more.
Browse Templates →12 questions inspectors ask. One page. Free download, no signup required.
Download Checklist →12 questions. One page. Find out where your CDM quality system stands against ICH E6(R3).