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

Important: The video is currently being updated, but the steps below are accurate.

Instructions

1. From Orchestrator for a Study, click the Add Rule icon.
2. When the Add Rule window opens, there are two steps:
   1. Step 1: Build (Rule Information and Condition Builder)
      1. Basic Rule Information:
         • Type Rule Name - Subjects with Low K and High Na
         • Select Tags (Optional)
         • Type Description (Optional)
         • Select Status - Active

      2. Condition Builder:

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

         • Select Data Store - Clinical
         • Select Domain - LB_Chem
         • Select Field - POTAS
         • Select Operator - Include Selections Less Than or Equal To
         • Type Value - 3
         • To add another condition, click the plus icon and click Add Condition.

         • 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.

         • Select Data Store - Clinical
         • Select Domain - LB_Chem
         • Select Field - SODIUM
         • Select Operator - Include Selections Greater Than
         • Type Value - 150
   2. Step 2: Action (Issue & Query Creation)
      1. Issue Information:
         • Toggle to Enable Issue Creation
         • 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.
         • Select Related Fields (Optional): Clinical.LB_Chem.Sodium and Clinical.LB_Chem.Subject

      2. Query Information:

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

         • Toggle to Enable Query Creation
         • Select Category (Optional)
         • Select Domain - LB_Chem
         • Select Field - POTAS
         • Select Notification Group - Safety to Site
         • 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.