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Audit trail

The Audit Trail shows all changes that are made to your study. This includes changes both during building the form and during data entry. The Audit Trail will be visible if a study team member has all management rights.

The Audit Trail

The audit trail enables you to review changes to study settings and study data. You can filter the Audit trail on various events such as, but not limited to: survey package is opened, a study is set to live or changing of user rights. Beside this you can see who performed the action and what record was affected. For all filtering options please view the "Filter on event type" drop down in the Audit Trail tab.

To see all changes made in the eCRF, navigate to the 'Audit Trail' tab:

All the changes that are made to the study are displayed at the "Audit Trail" tab.

  1. Here you can filter the Audit Trail on the event type, user or secondary information (the variable name).
  2. An overview of all events are given relating to the filter. If no filter is selected all events are show.

See changes made in a single field

You can also view the audit trail for a single field from within the study view:

 

To see the changes that are made to a specific field click the cogwheel next to a field in the study overview. A popup will appear detailing the changes to the field. The date, the user who changed the field, and the new value are all displayed:

Please note that the test institute and the institute that is set up in the study creation form are not counted as "institute created" event. Therefore, only the institutes added after the creation of the study have this event.

Exporting the Audit Trail 

The audit trail export typically does not include the study build, i.e., creation of phases, steps, fields, etc. We provide audit trail export for free once at the end of the study in the CSV format. Please note that for additional audit trail exports there will be an additional fee.

Events that are included in the audit trail export are:

  • record created and archived
  • data entry events (only study and reports)
  • comments and queries
  • report created and archived
  • verifications (and drops)
  • signatures (and drops)
  • locks and unlocks (phases/steps/records)
  • user permissions
  • export created

To request an audit trail export, please send a request to support@castoredc.com including the study title for which the export should be created.

Audit_trail_events.pdf

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  1. Tonya

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