Clinical Trial Specimen Cold Chain Audit Form
Study Title
Site Name/ID
Audit Date
Auditor Name
Storage Location(s) Audited
Specimen Types
Temperature Monitoring Device Used
Temperature Records Reviewed
Cold Chain Audit Checklist
Audit Item
Compliant
Non-Compliant
N/A
Comments
Specimens stored at correct temperature
Temperature records complete and up-to-date
Action taken for temperature excursions
Backup cold chain equipment available
Audit Findings / Observations
Corrective Actions Required
Auditor Signature
Date