Free ICH E6(R3) CDM Readiness Checklist

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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."

— Sarah Huntley, 25+ years CDM experience

What's on the checklist

Risk-Based Quality Management

CtQ factors formally identified for primary and secondary endpoints, with written Medical Monitor approval

RBQM Risk Register active — current KRI values documented and any threshold breach has a recorded escalation response

Escalation procedure documented: what happens when a KRI enters alert territory or a QTL is breached

Data Governance & Integrity

Source Data Agreement specifying eSource vs. transcribed data for every data type in the study

Data correction procedure ensuring original values are preserved with a mandatory reason-for-change

Data Review Plan linking each CtQ factor to a specific review listing, frequency, and responsible party

Audit Trails & System Compliance

Audit trails configured with UTC timestamps, user identity, original value, and mandatory reason-for-change — across all GxP systems

Documented periodic audit trail review — signed quarterly report: what was reviewed, anomalies found, actions taken

Audit trail anomaly investigation procedure with defined escalation path and timelines

Access, Privacy & Vendor Oversight

Current user access list — training currency confirmed for each user, access removal documented when staff depart

GDPR data processing basis documented; data subject rights in clinical research addressed in writing

Vendor oversight records demonstrating active performance monitoring — not just a signed contract on file

How does your team score?

0–4 checked
Significant gaps — prioritise before next inspection

5–8 checked
Partially compliant — identify and address gaps

9–12 checked
Inspection-ready — maintain as guidance evolves

Free download

ICH E6(R3) CDM Readiness Checklist

A one-page PDF checklist. 12 items, 4 categories, a score guide, and a link to the SOP library for everything you need to close any gaps.