Understanding the Study Events Report, Which Provides a Comprehensive List of Events for Subject Records, Including Review and Signature
Prerequisite: User has Access to Study Events Report
The Study Events Report is a filterable table that contains a log of every subject-level transaction made in a study. This is a great tool for unlocking reviewed records in batches.
The Study Events Report is found in the reports menu.
Open the Form Data Audits from the Reports menu and the Study Events Report is accessed from the >> LINK TO AUDIT REPORTS menu on found on the lower right of the screen.
Report Content and Review Signatures
The primary objective of the Study Events Report is to see record saving and reviewing transactions made over time.
This is the report which shows electronic signatures on signed review levels. The electronic signatures are also shown in the PDF casebook exports and the individual CRFs within TrialKit.
The following events are tracked on this report:
- Record Saved as Draft
- Record Inserted without Errors on Handoff
- Record Deleted
- Record Inserted Without Errors
- Record Inserted With Errors
- Record Updated without Errors
- Record Updated because of Computed Field Change During Migration
- Record Updated with Errors
- Table Rows Inserted from Web Service
- Subject Migrated to New Version
- Workflow Review level
- Workflow Review levels unlocked
The report will show the following for each record:
- Event date/time
- Participant ID
- Form Name
- Visit Name
- Visit Date
- Current form status
- Signature type
Some rows in the report may be hidden if the user viewing the report does not have viewing permissions for a specific form(s).
Batch Unlock Records
The Study Events Report has a unique capability to allow for batch unlocking of records that have gone through review. This action will only unlock the records current review level. To unlock records through more than one level, the steps would need to be repeated for each level.
Prerequisite: Along with access to the report itself, the user must also have permissions for Subject Record management, Unlock Records
Filter for the group of records that need to be unlocked, this is normally primarily based on the current form status. Then select the applicable records and the button to Batch unlock them.
Once completed, the filters can be set based on the current date to verify which records were just unlocked. This is also exportable for any record keeping purposes.