14 Templates · Word & Excel · ICH E6(R3) Aligned
Ready-to-use Word and Excel templates for every major CDM deliverable. Each pairs with a corresponding SOP in the CDM SOP Library for complete process documentation.
All 14 templates in one purchase. Every major CDM document — from Data Management Plan to Vendor Oversight Tracker. Word and Excel formats, immediately customisable.
Individual templates — $99–$249 each
Complete DMP template covering all GCDMP-required sections. Pairs with CDM-SOP-002.
Data Validation Specification with all required fields for edit check design and review.
Lock checklist (Excel) + Lock Form (Word) + Unlock/Relock Form (Word). Everything for database lock.
Full DRP template with 11 standard listing categories, review schedule, and escalation pathways.
eCCG template with field-by-field guidance, date format standards, and missing data conventions.
External data transfer specifications for lab, IRT, ePRO, and other vendor data sources.
UAT Plan (Word) + Test Script (Excel) for EDC database validation. Entry/exit criteria included.
SAE reconciliation procedure template aligned to ICH E2A and the clinical/safety database interface.
MedDRA and WHODrug coding conventions template. Dictionary version, verbatim coding rules, review workflow.
CRF design guide covering CDASH alignment, field standards, controlled terminology, and common design errors.
Mid-study database change control log. Request, impact assessment, approval, and test evidence tracking.
Pre-FPI CDM checklist. All deliverables, owners, and sign-off requirements before first patient in.
Protocol deviation tracking log with classification, Medical Monitor sign-off, and regulatory reporting status.
Vendor performance scorecard and oversight log. KPIs, issue tracking, escalation history.
Every template pairs with a corresponding SOP in the CDM SOP Library. The DMP template pairs with CDM-SOP-002, the UAT bundle pairs with CDM-SOP-018, and the database lock bundle pairs with CDM-SOP-041/042.Browse the SOP Library →
Every template has a corresponding SOP. Buy them together for a complete CDM quality system.