Database closure is the final step in the data management process for a clinical trial. It involves locking the study database to prevent further changes to the data, and ensuring that the data is complete, accurate, and consistent. The process of database closure is critical because it forms the basis for the analysis and reporting of the study results.
Database closure typically involves the following steps:
- Final Data Entry: All data that has been collected from the study sites is entered into the database.
- Data Validation: The data is reviewed to ensure that it is complete and accurate, and that it meets the predefined quality standards.
- Query Resolution: Any queries that were generated during the data review process are resolved with the study sites to ensure that the data is complete and accurate.
- Database Lock: Once all queries have been resolved, the database is locked, preventing any further changes to the data.
- Audit Trail Review: The audit trail of the database is reviewed to ensure that all changes to the data have been properly documented and that there is a clear record of who made the changes.
- Database Backup: The final database is backed up and stored in a secure location to ensure that it is not lost or corrupted.
- Data Transfer: The final database is transferred to the statistician for the analysis of the study results.
The process of database closure is typically conducted by the data management team in collaboration with the study statistician and the clinical trial sponsor. The data management team is responsible for ensuring that the data is complete, accurate, and consistent, while the statistician is responsible for analyzing the data to produce the study results. The sponsor is responsible for ensuring that the study was conducted in accordance with the protocol and regulatory requirements, and that the results are reported accurately and transparently.
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