New rule helper functions

Rule designers can now retrieve dispensation information, visit windows and form submit dates, using the new rule helper functions available. These enable new Randomization and Trial Supply Management (RTSM) scenarios, as well as broader data collection use cases.

New Visit Information variable

Before you work with new helper functions getDispensationInfo() and getVisitWndw(), you must become familiar with the new Visit Information variable. This is a new global variable that you can define to refer to a specific visit's information, instead of a specific form question. Using the Visit information variable with either of these two helper functions, allows you set the context of the rule to a specific visit, instead of using the visit from the rule target.

The getDispensationInfo() rule helper function

Caution:

This helper function may return unblinding information. Use the returned information carefully to preserve the study's blind.

The new getDispensationInfo() helper function supports the retrieval of dispensation details from different contexts:

• Last dispensation.
• All previous dispensations.
• Dispensation from a specific visit (Requires using the Visit Information variable).

This new rule helper function is critical for titration studies, safety integrations, and advanced dispensation rules. For example, details of the last dose may be required to project the next kit type. In general, referencing detailed dispensation information with this helper function enables you to:

• Ensure protocol requirements are met by verifying dispensation transactions.
• Facilitate advanced strategies for dispensation, such as forced titration, by accessing last and all previous dose information.
• Provide necessary medication details for safety integrations.

The returned data is system-generated and recorded at the time of dispensation. This includes visit details, the kit type, kit description, dispensed date, dosage, quantity, and dose hold status. Additionally, rule designers can customize the returned output with optional parameters, as well as by specifying the context.

The getVisitWndw() rule helper function

The new getVisitWndw() helper function allows rule designers to evaluate visit scheduling windows and program other rules that require the visit window information. Key use cases include alerting site users when an unscheduled dispensation visit is needed or adjusting kit quantities when an unscheduled visit occurs. For example, if a subject is due for dispensation today and the next visit window is more than 21 days away, the site user should be notified that an unscheduled dispensation visit may be required before the next visit.

This rule helper function uses a parameter that allows you to specify which visit to reference. Rules can reference:

• Current visit.
• Next visit.
• All previous visits.
• A specific visit (Requires using the Visit Information variable).

The rule then returns the visit window for the specified visits, even if a visit was skipped. The returned data includes the visit's name, event instance number, scheduled visit date, window start and end dates, and whether the visit was skipped.

The getFormSubmitDate() rule helper function

With the new getFormSubmitDate() rule helper function, rule designers can now retrieve different dates associated with form updates. This new function uses a parameter that allows you to specify and retrieve the following:

• The date the form was started.
• The date the form was completed.
• The date the form was last updated.

These dates can then be used in your rule's logic for comparison with any other dates, such as dates captured by site users in the given forms and other system dates. For instance, to monitor site compliance when reporting adverse events, you can compare the form start date, when the form was initially submitted, with the date reported for a serious adverse event.

You can find additional information about these new rule helper functions in the Rules Developer Guide after the Release Assessment Environment (RAE) upgrade.