Trial Master File Inspection Readiness Checklist Form
Use this checklist to assess whether the Trial Master File is organized, complete, and ready for inspection.
Study Identification
Study/Protocol ID
*
Study Title
*
Sponsor/Company Name
*
CRO or Site Organization Name
Primary Contact Name and Role/Title
*
Inspection Context
Inspection Type
*
Routine
For-cause
Pre-inspection readiness review
Sponsor audit
Other
Expected Inspection Date or Date Range
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Current TMF Location/System
*
Please Select
eTMF
Paper TMF
Hybrid
Inspection Scope or Authority (if applicable)
Document Quality and Gaps
Overall document quality readiness
*
Poor
1
2
3
4
5
6
7
8
9
Excellent
10
1 is Poor, 10 is Excellent
Major gaps or issues identified
Corrective actions in progress
Responsible owner and remediation deadline
Access and Final Confirmation
Is the TMF searchable and accessible for inspectors?
*
Yes
Partially
No
Access restrictions or special instructions
Is the team’s final assessment that the TMF is inspection ready?
*
Yes
No
Needs Review
Submit
Should be Empty: