Resources
Practical guides on ICH E6(R3) compliance, RBQM, audit trails, and clinical data management SOPs — written from 25 years of CDM inspection experience.
ICH E6(R3) · RBQM
Risk-Based Quality Management became a mandatory element of every sponsor's quality system under ICH E6(R3). This guide explains CtQ factors, KRIs, QTLs, and the Risk Register — and what your RBQM SOP must document.
Read article →ICH E6(R3) · Audit Trails · 21 CFR Part 11
ICH E6(R3) §4.2.2 and 21 CFR Part 11.10(e) together require more than a configured audit trail — they require documented governance of it. Here is what inspectors ask for, and what most CDM audit trail SOPs are missing.
Read article →Templates · DMP · GCDMP
The Data Management Plan is the foundational CDM document for every study. This guide covers all required sections under GCDMP 2013 and ICH E6(R3), including the additions E6(R3) introduced that most existing DMP templates do not yet address.
Read article →SOPs · Small Biotech · Study Start-Up
Small biotechs hiring their first CDM lead face a common problem: they need a complete SOP library immediately, with no time to build one. This guide covers the minimum CDM SOP set required before a study can go live — and what happens at inspection without it.
Read article →ICH E6(R3) · Compliance · SOP Updates
ICH E6(R3) Step 4 was finalised in January 2025. This guide covers every meaningful change from R2 to R3 that affects CDM teams — which sections are new, which are substantially revised, and what your SOPs must now address that they probably do not yet.
Read article →27 ICH E6(R3) compliant CDM SOPs — built from primary regulatory sources, grounded in 25 years of inspection experience.