When would I create a history report?

Some regulatory agencies require the following reports:

• Audit Trail Report—Includes traceability for item-level inserts/edits, query changes, form status changes, SV status changes, and comment and signature history. This report is only available in CSV format.
• User Assignment History—This report includes the following for each user:
  • User status changes; e.g., created, activated, deactivated, terminated.
  • Query Group changes.
  • Reporting Group changes.
  • Rights Group changes.
  • Signature Group changes.
  • Site association changes.

Sponsors can generate these reports by going to the My Requests - Processing page and selecting Create History Request from the Create Request drop-down menu.

By selecting the Share with Sites option and Site Confirmation Required option, you can request the sites to acknowledge the receipt of the file.

The file is in CSV format for import into Microsoft Excel.

• For the Audit Trail Report, one CSV file is created per subject. The files are then zipped per site and the entire request can be downloaded as one zipped file or by subject.
• For the User Assignment History report, one CSV file is generated per site and the entire request can be downloaded as one zipped file.