Study documents

• Checklists
• Database Lock
• DB Lock Check list
• Electronic Trial Master File (eTMF)
• Final Approval forms

Start-Up Templates

• CDM SOP template
• Clinical Trial Overview
• GCDM handbook
• Introduction to Clinical Data Management
• Lab ref Module
• Meeting Agenda template
• Standard CRFs
• Timelines

Conduct Templates

• DB Lock Check list
• Discrepancy Management
• External Data Reconciliation
• SAE Reconciliation

Close-Out Templates

• 21 eCFR Part 11
• CDISC
• DIA
• FDA
• SCDM

SOPs and Works Instructions

• Data review plan template
• DTA template
• eCRF specifications with time and event schedule
• Timelines template – All required line items for CDM for CRO or sponsor
• Vendor specs for reconciliation

General CDM

• Data Management Plan (DMP)
• Data Transfer Agreements
• eCRF Completion Guidelines (CCGs)
• eCRF Specifications
• EDC Integrations
• Edit Check Specifications
• Electronic Trial Master File (eTMF)
• IRT Randomization & Stratification
• Kick-Off Meeting
• Protocol Review
• User Acceptance Testing (UAT)

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Close-out

• Checklists
• Database Lock
• Electronic Trial Master File (eTMF)

Conduct

• Data Review
• Discrepancy Management
• External Data Reconciliation
• Medical Coding
• SAE Reconciliation
• Study Team Meetings

Start-up

• CRF Completion Guidelines template
• Data Management Plan (DMP)
• Data review plan template
• Data Transfer Agreements
• DMP Template
• DTA template
• eCRF Completion Guidelines (CCGs)
• eCRF Specifications
• eCRF specifications with time and event schedule
• EDC Integrations
• Edit Check Specifications
• Electronic Trial Master File (eTMF)
• IRT Randomization & Stratification
• Kick-Off Meeting
• Protocol Review
• Timelines template – All required line items for CDM for CRO or sponsor
• User Acceptance Testing (UAT)
• Vendor specs for reconciliation

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Setup

• Articles coming soon

CDM General

• CDM SOP template
• Clinical Trial Overview
• DIA ref model for TMF
• GCDM handbook
• Introduction to Clinical Data Management
• Lab ref Module
• Meeting Agenda template
• Note to File
• Standard CRFs
• Study Team Meeting
• Timelines
• Timelines

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Other

• Articles coming soon

CRF Completion Guidelines templates

• Articles coming soon

eCRF specifications with time and event schedules

• Articles coming soon

Vendor specs for reconciliations

• Articles coming soon

DMP Templates

• Articles coming soon

DTA templates

• Articles coming soon