Data Entry, Validation, and Access Control

Data Entry Workflows

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30-45 minutes Foundational Step 6 of 7

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Workflow	Advantages	Risks	Appropriate controls
Paper CRF then database entry	Works during connectivity problems; familiar to many sites	Transcription errors, delayed availability, paper storage risks	Double checks, entry timelines, secure filing, source verification
Direct eCRF entry	Real-time validation, faster availability, fewer transcription steps	Device and connectivity dependence, user access risks	User training, offline plan, validation rules, audit review
Participant survey	Reduces staff entry burden; captures patient-reported data	Incomplete responses, privacy concerns, misunderstanding questions	Clear wording, survey testing, secure links, helpdesk process
Spreadsheet import	Efficient for batch laboratory or operational data	Mapping errors, version confusion, invalid formats	Import templates, validation, import logs, reconciliation
eSource integration	Reduces duplicate entry and supports automation	System mapping errors, governance complexity	Data transfer agreements, system validation, reconciliation checks