Details for study designers

As a study designer, when it comes to your workflow, here's what's new for you:

• When creating a form question, in the Question Details side panel, new options allow you to determine what type of visit action the question is required for:

  Required for	Description
  Screening	A question marked as Required for Screening in the Screening Visit must be completed before a subject can be screened. Note: This does not impact the ability to manually screen fail a subject.
  Randomization	A question marked as Required for Randomization in the Randomization Visit must be completed before a subject can be randomized. Note: If the visit action also includes dispensation, assigned kits for the subject are dispensed at this time, as well.
  Dispensation	A question marked as Required for Dispensation in the Dispensation or Screening and Dispensation Visits must be completed before the subject can be dispensed to. Note: If the visit action is a Randomization and Dispensation Visit, these marked questions are not considered, and only questions marked Required for Randomization are considered.

• If no questions are selected as required for an RTSM action for the visit, then the corresponding options (Screen, Dispense, or Randomize) aren't included on the Subjects page in the Manage Subjects drop-down, and the user must complete all required questions on the Visits page.
• Questions required for dosing calculations, cohorts, and stratum factors must be marked as Required for Visit Completion in order for them to be available for selection in Study Design mode.
• This functionality does not apply to the Drug Reconciliation form, although the options are available for the form's questions.
• Repeating and two-section form questions cannot be marked as Required for RTSM events; only flat form questions are eligible for being marked with these new settings.
• Hidden and Data Classified questions can be marked as required for RTSM events, and they must be completed before the user can complete the event, even if they are not visible.

More information can be found in the Study Designer User Guide after the Release Assessment Environment (RAE) upgrade.

Details for site users

As a site user, your workflow is dependent on how your sponsor configures this function. Here's what you should be aware of:

• On the Subjects page, in the Manage Subjects drop-down, the Screen, Randomize, and Dispense options are only available when:
  • The selected subject has a visit with the related action in the Next Visit column, and
  • The sponsor has identified questions required for that action.

  Note:

  If a required RTSM action exists in a visit listed under the Previous Visits column and has not yet been completed, you must open that visit and review the action in the visit's focused view.

  After completing the questions in the focused view, you'll be able to complete the related RTSM event. However, you must still complete any questions designated as Required for Visit Completion before you can proceed to the next visit.

More information can be found in the Site User Guide after the RAE upgrade.

Impact on reports

For more information, see the Reporting Guide.

Impact on integrations

For more information on the impact on integrations, see Screen, randomize, and dispense data can be integrated before visit completion.

Already working in a live study?

Once the Release Assessment Environment (RAE) upgrade has completed, and the updated study design has been moved to the appropriate container, these new functions will be applied to actions that have not yet been completed in your study; there is no impact to RTSM actions that were completed prior to the RAE upgrade.