Access data not collected in forms

Rule developers can now access subject information and other data not collected directly in a forms and include it in the rule processing or as a return value.

In some scenarios, a custom rule's logic requires you to reference data not collected in a form, such as the subject number and status or site related information. With the introduction of the Subject Object you can now access different attributes for data that is not included in any form.

The Subject Object has the following attributes:

SubjectNumber
SubjectStatus
ScreeningDate
ScreenFailureDate
CompletionDate
WithdrawalDate
RandomizationDate
TreatmentArm
CohortName
SiteNumber
SiteName
Country (of the site)
Region (of the site)

All these attributes are available with their descriptions, using the predictive text feature in the Rule Editor and can be used for rule processing or as a result for a calculated value. This last scenario can be suitable to drive Show Visit, Show Form, and Show Question predefined rules or as a form question base for branching.

Caution:

Some of these attributes allow access to potentially unblinding information, so use them with caution and with assigned queries to limit access to this information.

Remember that you can lessen the burden on site and sponsor users, and increase overall efficiency by using Oracle Clinical One Platform's custom JavaScript rules and query management functionality. Leverage these core features using subject-related data in your custom rules' logic, and gain better control over a subject's visit schedule, country-specific privacy regulations, and many other protocol requirements.

You can find additional information in the Rules Developer Guide after the Release Assessment Environment (RAE) upgrade.