CDM SOP Library

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CDM SOP Library — Complete Edition

All 27 SOPs in one purchase. The complete CDM quality system — from departmental charter and study start-up through database lock, archiving, and decentralised trials. Every SOP cites the specific ICH E6(R3) section, GCDMP chapter, or regulatory article it implements.

27 Word documents Approval pages included Expert Tips in every SOP Regulatory references throughout ICH E6(R3) Annex 2 ready 30-day money-back guarantee

$2,999 27 SOPs · Comparable consulting: $5,000–$25,000 Buy Complete Edition →

All 27 SOPs included

001Roles, Responsibilities & Charter

004Project Management for CDM

005Risk-Based Quality Management (RBQM)

006Training & Qualification

007CDM Metrics & KPI Reporting

008Vendor Qualification & Due Diligence

009Vendor Oversight & Performance

014CDM at Investigator Meetings

015Data Standards & Controlled Terminology

016EDC System Configuration & Study Build

019User Access Management

021Electronic Systems Validation (SDLC)

022Audit Trail Management & Review

023Electronic Data Entry & ALCOA+

024Source Data Management & SDV

025Data Review Plan

026Query Management

027Data Cleaning & Review Procedures

028Irresolvable Query Management

029Protocol Deviation Tracking

031Data Quality Metrics & Reporting

032Clinical Data Archiving & Retention

038Safety Data Management (ICH E2A)

039Data Privacy & Confidentiality (GDPR)

040Data Security, Storage & Access

044eTMF Filing Requirements

045Decentralised Trials & Real-World Data

Thematic bundles

Buy what you need

Each bundle targets a specific compliance need. Upgrade to the Complete Edition at any time — email to receive a discount equal to the bundle price paid.

SOP BUNDLE · 6 SOPs

ICH E6(R3) Readiness Pack

EU Mandatory 23 July 2025

The 6 SOPs that address what changed in ICH E6(R3). Every organisation that updated SOPs for R2 needs to update them again for R3.

005Risk-Based Quality Management (RBQM)
022Audit Trail Management
024Source Data Management & SDV
039Data Privacy (GDPR/HIPAA)
040Data Security & Storage
044eTMF Filing Requirements

$999 Save $695 vs individual

Buy ICH E6(R3) Pack →

SOP BUNDLE · 7 SOPs

Study Start-Up Essential Pack

Everything CDM needs before first patient in. The set-up foundation for a compliant CDM operation.

001Roles, Responsibilities & Charter
006Training & Qualification
015Data Standards & Controlled Terminology
016EDC System Configuration & Build
019User Access Management
021Electronic Systems Validation
025Data Review Plan

$1,199 Save $944 vs individual

Buy Start-Up Pack →

SOP BUNDLE · 6 SOPs

Data Quality & Operations Pack

Day-to-day CDM study conduct — from first data entry to database lock.

023Electronic Data Entry & ALCOA+
026Query Management
027Data Cleaning & Review
028Irresolvable Query Management
029Protocol Deviation Tracking
031Data Quality Metrics

$999 Save $695 vs individual

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SOP BUNDLE · 5 SOPs

Governance & Oversight Pack

CDM department management — project oversight, vendor relationships, metrics, and safety data.

004Project Management for CDM
007CDM Metrics & KPI Reporting
008Vendor Qualification & Due Diligence
009Vendor Oversight & Performance
038Safety Data Management (ICH E2A)

$899 Save $346 vs individual

Buy Governance Pack →

SOP BUNDLE · 5 SOPs

Systems & Validation Pack

Technical compliance — EDC build, user access, 21 CFR Part 11 validation, audit trails, and data security.

016EDC System Configuration & Build
019User Access Management
021Electronic Systems Validation
022Audit Trail Management
040Data Security & Storage

$999 Save $246 vs individual

Buy Systems Pack →

Individual SOPs

Buy a single SOP

Each SOP is $449 and includes cover page, approval page, version history, full procedure, Expert Tips, regulatory reference tables, and related documents. All in Microsoft Word format.

CDM-SOP-005

Risk-Based Quality Management (RBQM)

CtQ factors, KRIs, QTLs, Risk Register, signal detection, escalation. ICH E6(R3) §3.10.

ICH E6(R3) §3.10.1 · GCDMP: Assuring Data Quality

$449

Buy SOP-005

CDM-SOP-021

Electronic Systems Validation (SDLC)

Risk-based validation, documentation matrix, study build validation, change control, decommissioning.

21 CFR Part 11 · EU Annex 11 · ICH E6(R3) §3.16.1

$449

Buy SOP-021

CDM-SOP-026

Query Management

Query text standards, tiered response timelines, aging escalation, irresolvable query handling, metrics.

ICH E6(R3) §4.2.3, §4.2.4 · GCDMP: EDC Study Conduct

$449

Buy SOP-026

CDM-SOP-006

Training & Qualification

Training curriculum, competency assessment (5 domains), training records, refresher triggers.

ICH E6(R3) §3.4 · GCDMP: Training

$449

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CDM-SOP-022

Audit Trail Management

UTC timestamp configuration, quarterly review, anomaly investigation, retention requirements.

21 CFR Part 11.10(e) · ICH E6(R3) §4.2.2 · EU Annex 11 §9

$449

Buy SOP-022

CDM-SOP-039

Data Privacy & Confidentiality

GDPR Article 9, data subject rights in clinical research, cross-border transfer, breach response.

GDPR Art. 9 · HIPAA · ICH E6(R3)

$449

Buy SOP-039

CDM-SOP-001

Roles, Responsibilities & Charter

Department charter, 6 role descriptions, RACI matrix for 12 core activities, escalation paths.

ICH E6(R3) §3.2, §3.3, §3.4

$449

Buy SOP-001

CDM-SOP-027

Data Cleaning & Review Procedures

5-phase workflow, manual review activities, clean room period, pre-lock checklist.

GCDMP: Assuring Data Quality · ICH E6(R3) §4.2.3

$449

Buy SOP-027

CDM-SOP-045

Decentralised Trials & Real-World Data

eSource, wearables, EHR integration, ALCOA+ in DCT context. ICH E6(R3) Annex 2 ready.

ICH E6(R3) Annex 2 (2025/2026)

$449

Buy SOP-045

CDM-SOP-038

Safety Data Management

AE/SAE CRF requirements, mandatory edit checks, SUSAR support, safety database interface.

ICH E2A · ICH E6(R3) §3.13

$449

Buy SOP-038

All 27 SOPs are included in the Complete Edition ($2,999) — saving $9,174 compared to purchasing individually. Upgrade from any bundle at any time: email to receive a discount equal to the bundle price paid.

View Complete Edition →

Frequently asked questions

Are these ready to use out of the box? +

Yes. Add your organisation name, effective date, and approver names on the cover page. All procedures are written generically and apply to any sponsor or CRO. Some organisations add study-specific detail, but the regulatory framework and procedure logic are complete.

Are these ICH E6(R3) compliant? +

Yes. All SOPs were written against ICH E6(R3) Step 4 (January 2025). The RBQM, audit trail, source data, data privacy, data security, and eTMF SOPs address the specific new requirements in E6(R3) that were not in E6(R2). Each SOP references specific E6(R3) sections.

What format are the files? +

Microsoft Word (.docx). Fully editable. Compatible with Microsoft Word 2016+ and LibreOffice Writer.

Can I upgrade from a bundle to the full library? +

Yes. Email with proof of purchase and receive a discount on the Complete Edition equal to the bundle price you paid.

Is there a money-back guarantee? +

Yes — 30-day money-back guarantee on all products, processed through Gumroad.

CDM SOP Library — Complete Edition

All 27 SOPs included

Buy what you need

Buy a single SOP

Frequently asked questions

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