Site Confirmation report (for site and sponsor users)

Sponsor and site users can generate this report (CSV or PDF) to view an audit history of confirmation actions performed by site users.

Sponsor users can share the Archival PDF (for sponsor users), Custom PDF, and the Kit Chain of Custody (Blinded) report with site users and request that they confirm they have downloaded and reviewed the content.

This report includes the confirmation date and time, the user name of the person who performs the action, and the status (Confirmed and Not Confirmed) of each archive shared with sites where confirmation is requested.
  • For sponsor users, the report includes confirmation details for all sites in a study, but site users can only see details for their assigned sites.
  • Requests shared with sites and later deleted by the sponsor appear in the report with the status of Not Confirmed.
  • The pluggable database (PDB) package, provided to the customer during the study decommission process, includes a final version of this report. For more information, see Decommission a production study.

Modes

Available only in Testing and Production mode. To get started, Access the Reports & Archives page.

Required permissions

Users assigned to one of the following permissions can generate this report.
  • Sponsor users: Run and download all PDF request types and Audit reports. Enable Share with Sites, and Site Confirmation
  • Site users: Confirm download of Archival PDFs and content (Site)

Report settings

Enter a name and select a file type.

Table 4-12 Site Confirmation report settings

Setting Details
Name Enter a unique name (alphanumeric characters only) that does not exceed 64 characters.
File Type Select the output file format, CSV or PDF.

Report filters

Use the following filters to include specific details in the report output.

Table 4-13 Site Confirmation report filters

Filter Details
Request Name

Enter the name of an Archival PDF, Custom PDF, or Kit Chain of Custody (Blinded) request to view confirmation details for a specific request.

Request Type

The filter defaults to None, and no filter is applied; the output includes all request types.

You can also select Archival PDF, Custom PDF, or Kit Chain of Custody (Blinded).

Published Date

If you are looking for specific requests, enter the date the user generated the request.

Note: In the output file this is called Published Time (GMT).

Site Name

The filter defaults to None, and no filter is applied; the output includes requests for all sites.

The drop-down menu also allows you to select a single site from a list of all sites in the study.

Confirmed By

Enter the user name or a portion of the user name of the person who confirmed the request.

Confirmation Date

If you are looking for specific requests, enter the date the user confirmed the request.

Note: In the output file this is called Confirmation Time (GMT).

Confirmation Status

The filter defaults to All. The output includes requests with a status of Confirmed and Not Confirmed.

You can also filter by Confirmed and Not Confirmed before generating the report.