Creating a Criteria Check Rule Template

This template allows you to configure an action that site staff can use to analyze participant data and display outputs that inform decision-making during the study.

Prerequisites

• Ensure that you have a criteria check event created. See the Creating a New Event section on the Managing Events page for more information.
• Ensure that all survey names, schedule names, event names, group type names, and group name fields are named correctly.
• Ensure that the survey and schedule are already created.

Create Criteria Check Rule

Complete the following steps to create a criteria check rule:

1. In eCOA Studio, open the Rules tab.
2. Select Create Rule.
3. Select Criteria Check and select Select Template.
4. Enter a Name for the rule. For example: Rule_1
5. Enter a Description. For example, Rule_1. The description helps other Studio users identify what the rule is when they see it in the Rules tab.
   1. Example: This rule enables sites to check the average value of select survey answers and see the submission datetime of the surveys associated with the answers.
6. Select the event name of the check event you want to use to trigger the check. For example, hads_check.
7. Optionally, enter the Preconditions using references or variables to define the conditions you want to be evaluated as TRUE before the criteria check can be run. See Creating a Reference and Creating a Variable on the Understanding Rules page for more information.
   1. Example: You can use STAT1 and STAT2 variables to require that two successful submissions of the HADS survey have been received from a participant before a site user can run the check. The following expression would return TRUE if the HADS survey has had two submissions with compliant statuses.
   2. Variable definitions:
      1. STAT1: $survey.hads.[*].[*].[-1].Status
      2. STAT2: $survey.hads.[*].[*].[-2].Status
   3. Expression: (STAT1 = "COMPLIANT") && (STAT2 = "COMPLIANT")
8. If you want the system to display a message to users when the preconditions are not met, enter the message in the Missing Preconditions field. For example: This participant must submit at least two HADS survey responses.
9. Select whether the rule should protect restricted data.
10. Add the criteria you want to include in the check:
    1. Enter the Criteria Name.
    2. If you only want the criteria to be hidden from site staff, select Hide from Site Users.
    3. Enter the Display Label.
    4. Enter the Display Expression.
    5. Select Save.
    6. To add more criteria, select Add > Criteria, and repeat the steps above. You can also drag criteria to change their order in the list.
    7. To group criteria in eCOA and Study Home, select Add > Section. Enter a Section Title and select Save. You can drag the Section Title or Criteria to change it’s position in the list.
       1. Criteria Name: Criteria_1
          Display Label: The average answer for Question one across two instances was:
          Display Expression: Average(Value(ANS1INST1), Value(ANS1INST2))
       2. Criteria Name: Criteria_2
          Display Label: Average answer is above the threshold:
          Expression: If(Average(Value(ANS1INST1), Value(ANS1INST2))>50,true,false)
       3. Criteria Name: Criteria_3
          Display Label: The datetime for the submission of the most recent instance of the HADS was:
          Display Expression: $survey.hads.[*].[*].[-1].datetime
       4. Criteria Name: Criteria_4
          Display Label: The datetime for the submission of the second most recent instance of the HADS was:
          Display Expression: $survey.hads.[*].[*].[-2].datetime

11. To make events available or trigger an FTP export based on criteria check results, add them as Conditional Actions:
12. Enter an Action Expression that evaluates as a boolean. The configured Conditional Actions will run if the Action Expression evaluates to TRUE. You can reference survey data or criteria results from the criteria you created above, and you can also use survey identifiers in the expression. See the following examples:
    1. @criteria.Criteria_2.result < 50, for this action, the selected event will become available if the average value of ANS1 from the last two survey instances is less than 50.
    2. @criteria.Criteria_3.result < $survey.hads.[*].[epro-activated].[-1].datetime, for this action the criteria results are compared against a different survey data set.
13. From the Add Action list, select the actions you want the rule to trigger: Make Events Available or Trigger FTP Export.
    1. Trigger FTP Export: See Using FTP Connections to Export Data for more information on how to connect the FTP export to this rule. Note the event name in the Trigger FTP Export box. The Triggered Rule Export will become available after the rule has been approved in a major or minor collection version.
    2. Make Events Available: To make an event available as part of a conditional action, select the event name from the Select Events list. Each event can only have one associated criteria check rule. See Managing Events for more information.
       

12. Select Save.

Saving a Rule

Draft template changes are automatically saved as you make updates. If you sign out and back in, when you access the templates, you can continue working on your draft. If you choose to create a new draft before manually saving an in-progress draft, your changes will be lost.

You can save a rule by selecting the Save button.

Editing a Rule

You can edit a rule when the collection is in a Draft state.

Complete the following steps to edit a rule:

1. Open the collection, select the Rules tab, and select the Edit Rule icon () next to the rules you want to edit.
2. Make any changes you want to see, and select Save. Your changes are saved.

Deleting a Rule

You can only delete rules that have not been included in an approved collection. Once a rule is deleted, it cannot be recovered.

Complete the following steps to delete a rule:

1. Open the collection, select the Rules tab, and select the Delete Rule icon () next to the rule you want to delete. A confirmation box opens.
2. Select Delete. The rule is deleted.