Step 4: Create Rules
You can create data validation rules by using the rules engine to validate data in Vault EDC. Vault can then perform certain tasks based on the evaluation of the rule.
Types of Rules
Vault EDC includes both system-managed rules and custom rules, that study designers create on a study-by-study basis.
System-Managed Rules (Univariate)
Data validation rules can enforce constraints on single Items. Vault EDC uses the properties you define in the Properties panel for Item Definitions to create system-managed data validation rules. Vault EDC automatically creates data validation rules for the following properties:
- Required field (Required checkbox)
- Range validation (Minimum Value and Maximum Value)
- Future date validation (Future Date)
Custom Rules (Multivariate)
You can also create custom rules (sometimes called “multivariate” rules) to evaluate data against. In the current release, there are six (6) types of rules available in Vault EDC. See the table below for a list of rule types.
|Query||When the expression evaluates as True, Vault will create a query on the selected Item or Event Date with the entered Query Message.|
|Add Event Group||When the expression evaluates as True, Vault will add the selected Event Group to the casebook schedule.|
|Add Event 1||When the expression evaluates as True, Vault will add the selected Event to the casebook schedule.|
|Add Form 1||When the expression evaluates as True, Vault will add the selected Form to the casebook schedule.|
|Disable||When the expression evaluates as True, Vault will disable the selected Item.|
|Set Item Value 1||Vault populates the selected Item with the calculated result of the expression.|
|1 Contact Veeva Support to enable this feature.|
Minimum Required Rules
At a minimum, you must create an Add Event Group rule to add each of your Event Groups to a casebook. Vault automatically adds the first Event Group (typically a pre-screening or screening Event Group) to the Casebook. After that first Event Group, Vault can only add additional Event Groups to the study based on a rule.
If you simply want to display all of your Event Groups for a Study at once, you can configure rules to do so. See the example below:
To display all Event Groups, use an Item on the first Form in your Study. You can check that the Item is not blank. Once a site user completes that first Form, Vault then adds all of the remaining Event Groups to the casebook. You’ll need to configure a rule for each Event Group you want to display. For example, if a study has two cohorts, and the cohorts are split into Event Group A and Event Group B, you must create one rule to add Event Group A and another rule to add Event Group B.
How to Create a Rule
To create rules in your study:
- Navigate to Studio > Rules.
- Click + New Rule.
- Enter a Name for your rule.
- Fill the required fields, enter your rule expression, and configure the rule action. (See more detailed instructions here) to set your rule’s properties and create a rule expression.
- Click Save.