Clinical Trial Observation Checklist
Trial & Observer Information
Study Title
Protocol Number
Site
Date
Observer Name
Role
Checklist
Item
Yes
No
Not Applicable
Comments
Informed Consent obtained and documented
Study drug/device administered as per protocol
Eligibility criteria verified
Adverse events monitored and recorded
Protocol deviations noted
CRF completed and up to date
General Observations
Action Items / Follow-Up
Observer Signature
Date