Before you work with this feature

Users assigned to a study role with the Receive the Subject Rescreening Notification permission receive the new Rescreening [Success/Failure] text format notification, informing them whether a subject has been successfully rescreened or not.

Additionally, users assigned the Receive the Rescreening Limit Notification permission receive the Subject has reached rescreening limit text format notification that informs them when a site has reached the rescreening limit for a subject.

More details about these notifications can be found in the Notifications and Permissions Guide after the Release Assessment Environment (RAE) upgrade completes.

Details for study designers

As a study designer, here's what's new for you when creating an event type:

• You can now select the new unscheduled event type, Rescreening Event.
  • If a screening visit is not present, the option to create a rescreening visit is unavailable.
  • While defining a rescreening event, when Use Screening Visit as Template is selected, the screening visit is copied, including all forms and their sequence defined in the screening visit.
  • When you choose to use the screening visit as the template for the rescreening visit, any kits assigned to the screening visit are also copied to the newly created rescreening visit.
  • You cannot create a rescreening visit if randomization is included in the original screening visit.
  • You can assign kits to the rescreening visit and dispense from it during the study conduct period.
• Like other unscheduled visits, rescreening visits cannot be a dynamic visit, cannot be marked as Required, and cannot trigger a branch visit.

More information can be found in the Study Designer User Guide after the RAE upgrade completes.

Details for sponsor users

As a sponsor user, here's what's new for you when defining rescreen settings for subjects:

• On the Study Settings tab, under the Subject Management section, the new Allow Rescreening setting allows you to determine whether or not a subject can be rescreened.

  Note:

  The Allow Rescreening setting is set to No by default.
  When a rescreen visit is present and this setting is set to Yes, the following settings appear:
  • Maximum Rescreening Attempts: This setting prompts you to enter the amount of times a subject can be rescreened. If left blank, then the subject can be rescreened an unlimited number of times.
  • Lock All Screening/Rescreening Data after Screen Failure: When the checkbox for this setting is selected, all questions in the visit are locked in the Screening/Rescreening visit if the subject is auto or manually screen failed.

More information and step-by-step instructions on limiting a subject's rescreening can be found in the Sponsor and CRO User Guide after the RAE upgrade completes.

Details for site users

As a site user, here's what's new for you in your workflow:

• In the Manage drop-down menu, the Rescreen option is available for subjects that have been auto or manually screen failed when at least one rescreening event is permitted.
• The Rescreen option does not appear in the Manage drop-down for the following scenarios:
  • A rescreen visit has not been created in the study's design.
  • The subject has reached the maximum number of rescreen attempts.
  • The subject is successfully screened, randomized, or enrolled.
  • The screen fail event is started.
  • The subject has been withdrawn from the study.

  Note:

  If all data is cleared during the screen fail event or an undo withdrawal is performed, if additional rescreen attempts remain, the Rescreen option becomes available again in the Manage drop-down.
• You are able to undo manual screen failures or update data that generated an auto-screen fail, as long as you have not moved on to another rescreen visit.

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

Impact on rule design

As a rule designer, be aware that when you are referencing a rescreening visit, the event type property value returns UnScheduleAbleVisit as opposed to ScreeningVisit. ScreeningVisit is reserved for the first occurrence of a screening event.

More information can be found in the Rules Developer Guide after the RAE upgrade completes.

Impact on reports, archives, and datasets

More information and specific descriptions on modified report values can be found in the Reporting Guide and the Analytics User Guide after the RAE upgrade completes.

Impact on integrations

If your study is integrated with Oracle Clinical One Digital Gateway, see Oracle Clinical One Digital Gateway integrations support rescreen visits.

Already working in a live study?

Once the RAE upgrade completes, this functionality is applied to all studies. By default, the Allow Rescreen setting is set to No, having no impact on the study conduct for live studies. If there is no rescreen window included in the study design, site and sponsor users do not see any change.