Study Settings report

With this report, you can get a view of all current study settings for all studies and an optional audit trail.

With this report you can regularly verify the consistency and integrity of the study settings, compare settings at the beginning and end of a validation cycle, resolve issues by identifying changes, and maintain a reliable record that can be included in the study Trial Master File.

The Study Settings report provides detailed information, including:
  • A comprehensive overview of all current settings, which encompasses every modification made to the study settings configuration throughout the studies, as well as the user responsible for each change.
  • The option to generate an audit trail for specific settings within a defined date range.
  • The flexibility to run the report with either all tabs or a selection of specific tabs. At least one tab must be selected in order to generate the report.

Note:

Scheduling of the Study Settings report is not supported, and it must be run on-demand. The report will be available only in XLSX format.

Modes

Available in all study modes: Testing, Training, and Production.

Permission required to run the report

Any user who's assigned the Run the Study Settings Report permission can generate this report. Access to the Study Settings report allows you to run only for the tabs that you have been granted permission to view.

Filters

Fields in the Filter headers Description
Include Audit Trail Depending on whether you want to include audit trail data in your report, choose one of the following:
  • Select Yes to run the report with audit trail for one, a specific number, or all sections.
Audit Trail Date Range Specify a period of time to show the audit trail data for.

Field descriptions

Note:

All report columns that are empty or contain optional values that have not been completed in the study's settings display as N/A.
Fields in the report headers Description
Customer Name A customer's name used to purchase the cloud subscription.
Study Name A study's ID as entered by the study manager when they created the study.
Mode The study mode in which the report is generated. For example, you may run a report for Testing, Training, or Production mode.
Transaction date Period of time indicated to show the audit trail.
Report Generated By User name of the user who generated this report.
Created Date Time UTC time and date of when this report was run.
Include Audit Trail Select to either include or exclude the Audit Trail in the report, from the options:
  • Yes

Parent topic: Report descriptions