Guided Notes

Data Entry, Data Review & Source Data Verification

How data flows from source to EDC, timeliness expectations, manual data review with listings, SDV and SDR by monitors, risk-based monitoring and protocol deviations.

Source to EDC

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• Source documents are where data is first recorded: hospital records, clinic notes, lab reports, worksheets — or the EDC itself when used as eSource. • Sites transcribe source into eCRFs, ideally within a few days of the visit (DMP sets targets, e.g. 5 business days). • Late entry delays cleaning and hides safety signals. • Data managers track entry timeliness by site and escalate delays.