是
Review Sensitive data result and confirm no comment
Request Vendor to transfer sensitive data
Release dataset
Assess discrepant dataset If data change is needed
Lock Data in EDC
Request signature of DM-FOR-022 Prepared Study Dataset Checklist and Approval Form
Study Team
否
Document the discrepancy and decision
Request Signature of DM-FOR-023 Released Study Dataset Checklist and Approval Form
Approve DM-FOR-023
Send Limit Write Access Email Notification
Approve DM-FOR-022
SLT
DM-FOR-028 Study Dataset change assessment and approval form to be signed by CMO and Biometrics Lead
Release/Merge Randomization Code
Data Manager
