DBL

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