Protocol Deviation & CAPA Log (Excel Tracker)

Protocol deviations need to be logged the moment they're identified, categorized consistently, and tracked through to a documented corrective and preventive action (CAPA) — not buried in emails or forgotten after the site call. This Excel workbook gives you one linked system for both.

What's inside:

• A Site Setup tab to record each participating site
• A Deviation Log capturing Deviation ID, date identified, subject ID, description, category, severity (Minor / Major / Critical), whether it was reported to the IRB/EC, and whether a CAPA is required
• A standard deviation category list (informed consent process, inclusion/exclusion criteria, visit schedule/window, study procedure not performed, investigational product handling/dosing, concomitant medication violation, lab/sample handling, source documentation, other)
• A CAPA Log linked to each Deviation ID, tracking corrective action, preventive action, CAPA owner, date opened, target close date, date closed and status, with automatic overdue flagging
• A live Dashboard showing total deviations by severity, IRB/EC-reportable deviations, deviations by category, CAPA performance (open, overdue, closed, closure rate, average days to close) and site-level deviation summaries
• Color-coded input cells, a full color legend and key definitions, and pre-filled example deviations and CAPAs

Who it's for: CRAs, quality/compliance staff, and clinical project managers who need a defensible, linked record of protocol deviations and corrective actions without building a spreadsheet from scratch.

Format: One Excel workbook (.xlsx), fully editable, in English. Works in Excel and Google Sheets. Instant download after purchase.