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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.

Zero-PHI Architecture

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: _______________________________

Physical signature (PI / CRC)

 

Signature

 

Printed name / date

Generated with crctoolbox.com — free, Zero-PHI clinical site tools

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Administrative reference only. Browser-local tools — not a medical device, CDSS, or Part 11 system. Verify outputs against protocol SOPs and primary site records. Zero-PHI local mode: do not enter names, MRNs, DOBs, or subject IDs. Study / kit / lab / deviation / IP accountability / equipment / regulatory / visit drafts use this workstation's localStorage until you clear them. On shared clinic PCs, clear all local site data when finished.