Free Pre-Monitor Source Review Checklist

The Pre-Monitor Source Review Checklist

A free checklist for the coordinator who wants the monitor to find nothing.

Monitor visits go well when the site has already caught and closed the issues the CRA would have flagged. This is the checklist for that self-review — a per-subject pass through the two areas monitors examine most closely.

One page per subject. Editable Word and print-ready PDF.

What's inside:

• Header info block — protocol ID, visit date and window, subject ID, reviewed by
• Informed Consent & Subject Eligibility — consent version and dates verified before any study-specific procedure, and source-documented inclusion and exclusion criteria
• Data Entry & Safety Review — EDC log progression, adverse event alignment between chart notes and EDC, concomitant medication reconciliation

Meant to be run in the days leading up to the visit, one copy per subject. Adapt to your protocol's specific eligibility criteria — it's a scaffold, not a compliance certification.

Free to download. Built by The CRC Toolkit.