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Rule Studio Configuration

Configure Rule Studio for validation rules and business logic in clinical trials.

Last updated: 04/14/2026

Overview

Rule Studio is configured at the study level. Access the configuration from:

Home → select your study → Installed AppsRule StudioSetting

Configuration URL: https://[instance]/home/study/[studyId]/apps/rule-studio


Installing Rule Studio

Rule Studio must be installed on a study before rules can be created for it.

  1. Go to Home → select your study.
  2. In the Installed Apps section, find Rule Studio and click Install (or it may already be included in your app bundle).
  3. Once installed, the study becomes available in the Select Study dropdown when creating study-scoped rules.

Creating a Rule: Step-by-Step

Step 1 — Open the Rules page

Navigate to your study → BuildManage Rules, then click Create Rule.

URL: https://[instance]/home/study/[studyId]/build/rules

Step 2 — Fill in basic information

FieldDescription
ScopeScope for CRF (form-level) or Scope for Study (study-level)
Select CRFChoose the CRF the rule applies to (if CRF scope)
Rule NameA unique descriptive name (e.g., "Calculate BMI")
DescriptionOptional — explain the rule's purpose

Click Submit. You are taken to the rule editor.

Step 3 — Configure the Action

In the Action section, define what the rule does:

  1. Select Action Type — for calculated fields, choose Set value to an Item using Calculate Expression.
  2. Select the Target Item — the CRF field that will receive the computed value.
  3. Enter the Expression — type directly in the code editor. The editor supports all functions, constants, and operators listed in Expression Reference.
  4. Click Submit to confirm the action. A visual block preview appears showing the parsed expression.

If the block preview does not appear, the expression is invalid. Check syntax and try again.

Step 4 — Configure Triggers

In the ConditionTrigger section:

  1. Select a Trigger action from the dropdown (e.g., Item On Change).
  2. The trigger drop zone appears below the selection.
  3. In the Items panel on the right, find the field(s) that should trigger the rule.
  4. Drag each field from the Items panel into the drop zone.

Step 5 — Save

Click SAVE at the top of the editor. A success toast ("Rule updated") confirms the rule is saved and active.


Rule Scopes

ScopeWhen to Use
CRFApply the rule to a specific CRF. Evaluated when data is entered or updated on that form. Most calculation and validation rules use CRF scope.
StudyApply the rule across the entire study, affecting all subjects and events. Use for study-wide logic.

Rule Settings

Stop Other Rules

When checked, if this rule fires, no subsequent rules in the execution chain will run. Use for priority-based logic — e.g., a critical validation that should block all lower-priority rules.

Enabled / Disabled

Rules can be enabled or disabled individually. A disabled rule remains saved but is not evaluated at runtime. Useful for drafting and testing rules before activating them.


Access

Access to Rule Studio is role-based. Typically, Study Administrators and Data Managers have permission to create, edit, and delete rules. Contact your system administrator to adjust role permissions.