Clinical Trial Data Accuracy Audit Form
Use this form to review trial data accuracy, record discrepancies, and capture audit findings and follow-up actions.
Audit Identification
Audit ID
*
Audit date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Trial/site identifier
*
Auditor name
*
Accuracy Review
Source data reviewed
*
eCRF
Source documents
Lab records
Protocol notes
Monitoring logs
Other
Data accuracy rating
*
Poor
1
2
3
4
5
6
7
8
9
Excellent
10
1 is Poor, 10 is Excellent
Number of discrepancies found
*
Severity of discrepancies
*
None
Minor
Moderate
Major
Findings and Follow-up
Summary of Key Findings
*
Corrective Action Required?
*
Yes, corrective action required
No corrective action required
Follow-up Due Date
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Auditor Notes / Recommendations
Submit Form
Should be Empty: