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Figure 2: Sample Database Closure Checklist
Task | Role Responsible | Date Completed | Signature |
|---|---|---|---|
Study team and stakeholders notified of database lock/closure. | |||
All applicable CRFs/data received, entered, and source verified. | |||
All external data received and reconciled. | |||
All queries sufficiently resolved. | |||
Final database lock approved and performed. | |||
SAE database reconciled. | |||
Coding list reviewed and approved. | |||
Final review of edit check outputs performed. | |||
Final review of data listings and patient profiles performed. | |||
Final statistical review for data anomalies performed. | |||
Quality audit of data completed. | |||
Database release authorized. | |||
Database release completed. | |||
Database archived. | |||
All required database lock and closure documents present. |
Although some elements of a database closure checklist should be relatively universal, other elements may be specific to the organization, study, CDMS, or database. In creating the checklist, the following documents and personnel should be consulted to determine the applicable items to include on the checklist.
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