16.3.2 Create Rules from Rule Designer

Select Build Study > Create Rule > Rule Designer icon 

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The Rule Designer screen contains three sections: 

• Left hand: View CRF, View CRF by Version, View CRF in Visit. This section helps you drag and drop OID of Item in CRF into Rules
• Center: Make Rules
• Right hand: information about Items,...

Left Hand: View CRF, View CRF by Version, View CRF in Visit

Section 1: Click on View by CRF, the system shows all items in all CRFs of the current study. If you want to see OID names for the Items under the CRF name, press on the check box on the top right as in the image below

Section 2: Click on View by CRF Version, the system displays all versions of all CRFs in the current study. If you want to see OID names for the Items under the CRF name, press on the check box on the top right as in the image below 

Section 3: Click on View by Visit, the system displays all CRFs under all Visits in current study. If you want to see OID names for the Items under the CRF name, press on the check box on the top right as in the image below

Center: Make Rules

Target: The Item that will be affected by the Rule or for which the RuleAction is being performed. Target can be dragged and dropped in the left hand:

• Drag and drop Item OID from a CRF
• Drag and drop Item OID from a specified version of CRF
  
• Drag and drop Item OID from a CRF of a Visit

Rule OID: A user-defined, unique OID for the Rule. This must be entered in all upper-case alphanumeric characters. Underscores are also allowed.

Expression: The expression element appears in RuleDef Element. It is an expression that evaluates to a result when it is run

To select action type, click on the Action dropdown

• Email Action: You have to enter data for the email field, a warning message pops up when the Item cannot pass Edit Checks. Also, you have to specify the conditions for when the Rule runs. There are 3 options: Admin Data Entry if you change data when the CRF has a Completed status, Initial Data Entry when you save data into the CRF, Batch when you run Rules

• Discrepancy Note Action: you create a warning message when the Item cannot pass Edit Checks. Also, you have to specify the conditions for when the Rule runs. There are 3 options: Admin Data Entry if you change data when the CRF has a Completed status, Initial Data Entry when you save data into the CRF, Batch when you run Rules.

• Show Action: The Show Action is used to show previously hidden CRF Items or groups. A Show Action Rule must be written in combination with a Hide Action Rule. A Rule with a Show Action will not work properly if there is no Hide Action associated with it. Both actions must be created under the same Rule OID. The Show Action displays the DestinationProperty field when clicking on . This property is an OID of either an Item or a group. When an action is triggered, the Items or groups specified will be shown

• Hide Action: The Hide Action is used to hide previously shown CRF Items or groups. A Hide Action Rule must be written in combination with a Show Action Rule. A Rule with a Hide Action will not work properly if there is no Show Action associated with it. Both actions must be created under the same Rule OID. The HideAction displays the DestinationProperty field when clicking on . This property is an OID of either an Item or a group. When an action is triggered, the Items or groups specified will be shown
  
  

• Insert Action
  • The Insert Action is used to insert data into CRF Items.
  • When you click on (), the system displays DestinationProperty OID. The DestinationProperty OID contains: DestinationProperty OID, Value - a static value you want inserted into the DestinationProperty, Value Expression that allows you to calculate a new value or copy a value from one field to another
  • InsertAction is not supported across event definitions
    

• Event Action: is used to schedule a future Visit or Visits. This is also known as scheduling or calendaring, and allows you to schedule one or multiple Visits based on the current Visit

To define an EventAction, user must identify the Target, the EventDestination, and ValueExpression, and specify the conditions for when to run the Rule (RunOnStatus). Following are three different techniques for implementing an EventAction:

Schedule all subsequent events based on the date of the first event

• • There is ONE Target (trigger) in this option - the Rule is triggered only for that Target
  • If an Event STARTDATE is changed, this Rule does not update future Events

Schedule all subsequent events based on the date of the current event

• • There are MULTIPLE Targets (triggers) in this option - the Rule is triggered for any of the Targets
  • If an Event STARTDATE is changed, this Rule dynamically updates all subsequent events

Schedule the next event (and only the next event) based on the status of the current event

• • This option does not display the entire Visit schedule. Initially it only displays the first event. Once the first event is started or completed, it displays the next event - and only the next event. Once the next event data entry is started or completed, it displays the next event, and so on.

Right Hand: View Information about Item

There are two ways to view item's information:

Option 1: Click on the Item in the left hand → the system displays the Item's information in the Item Metadata tab

Option 2: Bold item OID in Rule Expression then click on <..> →  the system displays the Item's information in the Item Metadata tab

Validate Rule

You can Validate the current Rule by clicking on Validate

If the Rule has something wrong, the system displays a red message.

Test Rule

You can test the Rule by clicking on Test

Select value to perform actions for this Item. If the Rule is erroneous, the system cannot test the Rule.