This is a subset of different listings providing regulatory information about the study and its data. The following Reports are provided:

  • Site/User Audit
  • Study Version Difference
  • Subject Record Transactions
  • Subject Record Changes

Below are more detailed definitions of each and the purpose each one serves.

Site/User Audit

Similar to the same report in Clinical Studio on the web, this report shows who has been added or removed to the study/sites and when. Keep in mind, this is not a log of when users actually logged in, but rather when an Administrator gave them access to log in and what role they were given. The detailed permissions of each role, as is tailored in each study, can be seen and exported separately in Role Security.

Study Version Difference

Related to Version control, this listing shows the structural changes made to the study from one version to the next. It tracks any changes made to a form in the form builder and any changes made to the visit schedule.

Subject Record Transaction Audit

A listing of when existing records have been saved or reviewed and who performed the action, along with the status of the record when the action was done. Several filters are available to drill down on specific events or users.

Subject Record Change Audit

As a more detailed list of the transaction audit above, when a user saves a record, this report will list each change made individually, along with the reason for change.