Specify Randomization and Trial Supply Management (RTSM) actions that require complete answers

Specify which questions are required to be completed for screening, randomization, and dispensation visits.

What study designers must know

In some cases, a question may require a valid answer, or require a response for all subjects in order for screening, randomization, and dispensation to occur. As a study designer, here's what you should be aware of before working with this feature:

Form items marked as Required for Screening are required for the completion of the screening event. Furthermore, these forms serve as a Data Collection form if they're used in a non-screening event.
Form items marked as Required for Randomization are used as the minimum amount of data collected for a visit containing a randomization event. Furthermore, these forms serve as a Data Collection form if they're used in a non-randomization event.
Form items marked as Required for Dispensation are used as the minimum amount of data collected for a visit that contains dispensation in the visit schedule, both for scheduled and unscheduled events. Furthermore, these forms serve as a Data Collection form if they're used in a non-dispensation event.
Note:
This setting has no impact on the visit status for questions used in visits unrelated to screening, randomization, or dispensation.
For Open Label Randomization events containing dispensation, only the items marked as Required for Randomization are considered and required to be complete before the dispensation. Any questions that are marked Required for Dispensation at these visits must be marked as Required for Randomization, as well. If they are also used for dispensation at subsequent visits, then they should also be marked as Required for Dispensation. If these events do not include dispensation, then the event serves as a Data Collection visit.
The Required for Visit Completion option is selected by default.

Note:
Questions marked as Required for Visit Completion impact visit status.
Repeating, two-section, lab form, and Drug Reconciliation form questions cannot be tagged; only flat form questions are eligible for tagging. If you are working in a repeating, two-section, or lab form, these RTSM options do not appear. Instead, the Required for Visit Completion toggle displays.
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.
Hidden and Data Classified items 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.
If the next visit is a dynamic visit, that visit must be initiated in order for it to appear.

Determine which type of randomization and trial supply management (RTSM) action(s) the question is required for:

Required for	Description
Screening	Select Required for Screening if the question 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	Select Required for Randomization if the question 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	Select Required for Dispensation if the question 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.

Required for

Description

Screening

Select Required for Screening if the question 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

Select Required for Randomization if the question 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

Select Required for Dispensation if the question 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.

Parent topic: Question types and settings