About required questions for Randomization and Trial Supply Management (RTSM) events
Learn more about specified data points required for Randomization and Trial Supply Management (RTSM) events.
Your sponsor user is responsible for identifying specific questions as being required for screening, randomization, and dispensation in addition to questions required for visit completion. If your sponsor has done this, you are able to access a focused view that allows you to complete these actions without needing to complete the questions required only for visit completion. You will still need to complete questions identified as Required for Visit Completion by your sponsor before moving to the next visit.
Managing RTSM actions on the Subject List page
- The Screen, Randomize, and Dispense options are located on the Subjects page in the Manage Subjects drop-down. These 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. These options can also be accessed from the Manage Subjects menu within a visit that includes an RTSM event.
Note:
If there is a required RTSM action in a visit in the Previous Visits column that has not yet been completed, you must open the visit and review the action in the visit's focused view. - If your sponsor did not select any question items for an RTSM action, such as randomization, then the option for the RTSM action (for example, Randomize) is not available in the Manage Subjects drop-down menu, and you must complete the action on the Visits page after completing all required questions for the visit.
- Any outstanding required question(s) for an RTSM action can be located and completed in the event's focused view.
- The visit date is required for all RTSM events, including visit completion.
Available RTSM actions
- For screening visits, the Screen button becomes active once the form items required for screening are completed. If the screening event contains dispensation as well, a Dispense button becomes active once the required questions for Dispensation have been completed.
Note:
If any of the required form items contain a validation error, the subject will be automatically screen failed. - For randomization events, the Randomize button becomes active once the form items required for randomization are completed. If the Randomization Event also includes dispensation, this will occur at this time, as well.
- For dispensation visits, both scheduled and unscheduled, the Dispense button becomes available once the form items required for dispensation are completed.
Parent topic: Enter data and dispense kits