CRA monitoring aid
Pre-visit readiness checklist
Blank checklist for monitoring visits — no site data required, no login. Print or save as PDF and leave with the site if useful. Administrative reference only; follow protocol and site SOPs.
Pre-Visit Readiness Without a Portal Login
Monitoring visits go smoother when sites can show kit closet FIFO discipline, destruction or disposition logs, calibration binders, and deviation/NTF hygiene without scrambling mid-tour. Shared spreadsheets and ad-hoc emails rarely give CRAs a clean, printable readiness view.
Pre-visit readiness checklist is a blank, Zero-PHI monitoring aid you can print or save as PDF — no site data entry, no account, no cloud storage.
Walk the kit/IP closet, destruction log, equipment calibration binder, and deviation/NTF log sections with the site team. Do not record subject names, MRNs, DOBs, or other identifiers on the sheet.
Who this is for: CRAs preparing for monitoring visits and site staff who want a printable Zero-PHI readiness sheet before the CRA arrives.
CRA Pre-Visit Readiness Checklist
- Site ID
- ________________
- Protocol
- ________________
- Date generated
- 29 Jul 2026
- Zero-PHI
- Client-side logistics only
Zero-PHI logistics review only. Do not record subject names, MRNs, DOBs, or other identifiers on this sheet.
Kit / IP closet
- Expiration dates spot-checked on shelf (FIFO / earliest-out visible)
- Quarantined / short-dated stock segregated from active dispense stock
- Accession / lot labels match site inventory records for a sample pull
- Temperature / storage conditions consistent with protocol (visual check)
Destruction / disposition log
- Log present for expired, damaged, or destroyed kits/supplies
- Entries include lot/kit ID, quantity, reason, and date
- Signature / printed name lines completed where site SOP requires
- Quarantine → destruction path documented without subject identifiers
Equipment calibration binder
- Asset list matches equipment in use (centrifuge, freezer, pipette, etc.)
- Next due / certificate dates current for assets used this visit
- Overdue assets flagged out of service or documented with CAPA/NTF
- Certificates or vendor reports filed and findable for sampled assets
Deviation / note-to-file log
- Deviation or NTF log available for review (site file / eTMF pointer)
- Entries follow site format (what / immediate action / prevention)
- PI / CRC sign-off present where required by SOP
- No PHI in logistics-only drafts shared for administrative review
Site / protocol (optional): _______________________________ Date: ______________
CRA initials: ______________ CRC / site contact: _______________________________
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