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Confirming a sponsor-created archival PDF or History request has been received and reviewed

Site users can confirm receipt and download of sponsor-requested PDFs and History requests. The U.S. Food and Drug Administration requires evidence that sites have downloaded the archival data for all subjects as part of the process for study decommission. Confirmation of receipt of History requests is optional.

Both end-of-study archival PDF requests and History requests can only be made by a sponsor user. The sponsor user must specify that the output is to be shared with your site. Site users must be part of a group that has the Confirm Archival right to be able to confirm the downloads. This right cannot be assigned to a sponsor user.

  1. From the My Requests section of the navigation pane, select Confirmation Pending.

    All the requests that are pending confirmation appear. For each request, the application displays the request name, the request type, who created the request, the date and time the request was completed, and the site name.

  2. Select the checkbox for the request and click Confirm Archival.

    The application asks you to acknowledge that you have downloaded and reviewed the request output.

  3. To confirm the download and approve the output, select the checkbox and click Submit.

    The application confirms that your confirmation operation was successful.

  4. Click Ok.

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