Clinical Trial Data Integrity Monitoring Checklist Form
Complete this checklist to assess and document the integrity of clinical trial data. Review each item carefully and provide your assessment.
Are all required data fields completed in the trial records?
*
Yes
No
Not Applicable
Rate the accuracy of data entries in the current review period.
*
1
2
3
4
5
Is data consistent across all source documents and databases?
*
Consistent
Some discrepancies
Major inconsistencies
Timeliness of data entry
*
Delayed
1
2
3
4
On Time
5
1 is Delayed, 5 is On Time
Protocol adherence assessment
*
Poor
1
2
3
4
Excellent
5
1 is Poor, 5 is Excellent
Data Source Verification
*
Verified
Partially Verified
Not Verified
Audit readiness of trial documentation
*
Not Ready
1
2
3
4
Fully Ready
5
1 is Not Ready, 5 is Fully Ready
Corrective actions required?
*
Yes
No
Clinical Trial Data Integrity Review Table
*
Rows
Completed
Partially Completed
Not Completed
Informed Consent Documentation
1
2
3
Adverse Event Reporting
4
5
6
Visit Schedule Adherence
7
8
9
Submit Checklist
Should be Empty: