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Close the Study

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A study will end or close certain activities at different points in time. For example:

  • When each study site has reached its accrual target, then the study will stop enrolling participants.
  • When the last participant has completed the last step of the study protocol, then the study can close operations.

When a study ends its operations, the IRB stops authorization for study; the funding agency and regulatory agencies are notified; and the registries are updated. The study may need to prepare for regulatory audits.

The study data are then checked for completeness. If the data are incomplete, then the researcher may request the IRB to re-authorize the study to collect additional data, or the incomplete data are taken into consideration when conducting the analysis of the data.

What happens to your data?

When a study ends, the data collected are then reviewed for completeness. When the dataset is considered "complete," then it is electronically stored or archived. Any papers and documents related to the study are also archived. The archive is locked, and no one can change the data or accompanying information. Access to the archive is restricted. The specific details of the archive (such as who has access, how long it is maintained, etc.) depends on the policies of the study sponsor.

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Last Updated Date: 01/31/2008
Last Reviewed Date: 01/31/2008
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