The Study Events Report serves two purposes:

It is a comprehensive listing of all actions ever taken on a study, and It can be used to perform bulk unlocking of records (e.g. If an Investigator accidentally signed several records accidentally).

Events/Actions that are tracked in this report are:

  • Record Saved as Draft
  • Record Inserted without Errors on Handoff
  • Investigator Review
  • Record Deleted
  • Record Inserted Without Errors
  • Record Inserted With Errors
  • Record Updated without Errors
  • Record Updated because of Computed Field Change During Migration
  • Monitor Review
  • Record Updated with Errors
  • Table Rows Inserted from Web Service
  • Subject Migrated to New Version.

To access the report under the Reports menu, you must have the appropriate permissions in Role Security.

    1) Select Reports Icon in the navigation bar

    2) Select Study Events Report from the list

Once open, the following functions can be accomplished:

1) Filter the Report

2) Export

3) Unlock records in bulk (permission based)

4) View event histories and signatures from review levels

The Filters option (accessible at the top right corner) allows for filtering on specific events, date ranges, or user who performed the events (filters shown below).

Exporting this report using the iOS app will export the file to the device's iCloud folder.

Another Report that may help with related information is the Regulatory Audit Report - Subject Record Transaction Audit.