Automatically Create Issues or Queries for Subjects with Abnormal Lab Values using Orchestrator

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Permissions: User must have the Study Configure privilege to complete the actions seen in this video.

Important: In version 24.2, Orchestrator was renamed from "eIQ Orchestrator." All functionality is the same.

Instructions

  1. From Orchestrator for a Study, click the Add Rule icon.
  2. When the Add Rule window opens, there are three steps:
    1. Step 1: Build - Condition Builder

      Note: To configure rules programmatically, use the SQL Editor.

      1. Select Data Store - Clinical
      2. Select Domain - LB_Chem
      3. Select Field - POTAS
      4. Select Operator - Include Selections Less Than or Equal To
      5. Type Value - 3
      6. To add another condition, click the plus icon and click Add Condition.
      7. Choose the function - AND
         

        Tip: And generates rules when both conditions are true. If you wanted rules generated when either condition is true, select OR.

      8. Select Data Store - Clinical
      9. Select Domain - LB_Chem
      10. Select Field - SODIUM
      11. Select Operator - Include Selections Greater Than
      12. Type Value - 150
    2. Step 2: Information (Rule and Issue Information)
      1. Basic Rule Information:
        • Type Rule Name - Subjects with Low K and High Na
        • Select Tags (Optional)
        • Type Description (Optional)
        • Select Status - Active
      2. Issue Information:
        • Select Primary Field - Clinical.LB_Chem.POTAS
        • Select Priority - Major
        • Select to Assign to User, Role, or User Group - Role
        • Select a User, Role, or User Group - Medical Monitor Role
        • Type Due in Days - 1
        • Select to Send Notifications to User, Role, or User Group (Optional) - Check and Send Immediately
        • Type Issue Text - The subject had a potassium level <= 3 and sodium level > 150.
      3. Select Related Fields (Optional): Clinical.LB_Chem.Sodium and Clinical.LB_Chem.Subject
    3. Step 3: Action (Optional)
      1. To automatically create a query, toggle on Enable query creation.

        Important: Only works with EDC systems that support bi-directional queries.

      2. Select Category (Optional)
      3. Select Domain - LB_Chem
      4. Select Field - POTAS
      5. Select Notification Group - Safety to Site
      6. Type Query Text - Please follow institutional protocol to verify data.
  3.  To create the rule, click Save.
  4. To run the rule immediately, select it and click the Run button.

    Note: Issues generated automatically by Orchestrator can be identified as Auto in the Opened By column within the Issues Listing.

 

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