Pre-General Availability: 2025-07-15

New Study Settings report

Study managers and other sponsor users can now run a report that captures all the study settings configured for your studies.

The new Study Settings report allows you to view all of a study's configured settings in one place. Use this report to regularly verify the consistency and integrity of the study settings, compare the beginning and end of a validation cycle, identify and resolve issues, and maintain a reliable record, which can be included in the study Trial Master File.

Before you work with this feature

To use this report, a user administrator must assign the new permission, Run the Study Settings Report.

This new permission was added to the existing Study Manager and View Only for Unblinded Support Users template study roles.

About the Study Settings report

As with any other report, you can locate the Study Settings report in the Reports & Archives screen within a study, on the Reports tab.

Note:

This report cannot be scheduled and can only be generated in XLSX format.
You can use the Settings sidebar on the right to filter data in your report to do the following:
  • Select a specific study mode (Production, Testing, and Training)
  • Include an audit trail of changes made to study settings by entering a date range in the From and To settings. The audit trail shows the user who made the change, the operation, and when the change happened for one, specific, or all sections.

    Note:

    Enabling the audit trail provides an informative report output, displaying the last entered email address in the General Default Email Address row, instead of 'N/A'.
  • Select one or more tabs that you want to include in the report.
  • You can only include the tabs that you have access to. For example, you can include the Study Settings tab in the generated report, but only if you have the Edit Study Settings or View Study Settingspermissions, either of which give you access to it.
The Study Settings report output is broken down into sections, each section corresponds to a different tab and displays on a separate XLSX sheet. The report can include details from the following tabs:
Tabs in the Study Settings report
Sites Enrollment Settings Predictive Resupply
Site Settings Screening and Randomization Limit Country Do Not Dispense Settings
Site Address Cohort Limits by Cohort SDV Settings
Site Kit Shipping Custom Enrollment Settings SDV Strategies
Site Study Version Audit Visit Settings Signature Configurations
Site Resupply Audit Randomization Regions Archives Settings
Site SDV Audit Resupply Schedule Archives Notification Body
Labs Blinded Group Notifications
Lab Address Locally Sourced Kits --
Depots Partial Kit Dispensation --
Depot Resupply Audit Dose Hold Settings --
Study Settings Minimum/Maximum Resupply --

This report will be available for new and existing studies as soon as the upgrade completes.

You can find additional information in the Reporting Guide after the Release Assessment Environment (RAE) upgrade.

Parent topic: Reporting, archives and analytics