Available archives and history reports

Available archives and history reports and what's included in each request

Table 1-1 Site archive and history report details

Request type	Description	Included in the .zip file
Create an archive of study data	Generate this request for mid-study data analysis or a final archive of study data. You can then share it with auditors, sponsors, sites, and regulatory agencies when applicable.	One folder per site included in the request, each containing one PDF per subject. Note: Subject Record Transfer History files (prth.pdf) are included for transferred subjects. For more information, see Transferred subject data. Table of Contents (TOC) Request Settings Blank forms with active controls for each study version.
Create an Audit Trail Report (ATR)	Generate this report to view an audit history for item-level inserts and edits, query changes, form status changes, Source Verification (SV) changes, and comment and signature history. Sponsor users can also generate this report and share it with site users.	One folder per site included in the request, each containing one CSV per subject. Table of Contents Request Settings A cumulative CSV file containing details for all subjects.
Create the User Assignment History report	Generate this report to view a history of changes made to users at a site. The report output includes details about changes made to the following: User status changes, for example, created, activated, deactivated, and terminated. Query Groups Reporting Groups Rights Groups Signature Groups Site Associations Sponsor users can also generate this report and share it with site users.	One folder per site, each containing one CSV file with details about users at the site. Table of Contents Request Settings
Download the Site Confirmation report	Download this report to view details about archive and history report requests, generated by a sponsor user and shared with sites where site confirmation was required. Note: Site users only see requests generated for their site(s) and rights group. For more information about the confirmation process, see Confirm archives and reports.	You can download this report in CSV or PDF format.