After predefining a list of essential DM processes, the members of the network each prepared two SOPs which were presented and reviewed during the 2nd ADMIT workshop, December 2011. A harmonisation process ensured uniform structure across the SOPs.
The alignment of the individual processes provided an overall lifecycle for DM in clinical research.
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001 SOP General Data Management
001 Template Requirements Checklist
002 SOP CRF design
003 SOP eCRF Design
003 Example Data Dictionary
004 SOP System Validation
004 Template User Requirement Specs
004 Template Installation Qualification
004 Template IQ Retest
004 Template Operation Qualification
004 Template OQ Retest
004 Template Perform Qualification
004 Template Validation Report
004 Template Change Control
005 SOP Information Security
005 Template Information Asset
005 Example Confidentiality & Conduct
006 SOP Training
006 Template Training confirmation
007 SOP Data Management Plan
007 Template DM Plan
008 SOP Data Collection & Data Entry
009 SOP Data Cleaning
009 Template Data Clarification Form
009 Example Data Clarification Form
010 SOP Data Coding
011 SOP SAE Reconciliation
011 Template SAE Reconciliation Check
012 SOP Data Tracking
012 Template-Batch-cover
012 Template Tracking Log Template
013 SOP-Database-Lock
013 Template Dbase Lock Check
013 Template Dbase Lock Approval
013 Template Dbase Unlock Approval