The Rules Designer lets you create custom checks tailored to your organization and run them alongside Pinnacle 21's built-in rules. This walkthrough takes you from a blank rule to one that's live in your validations.
🔑 Before you start: authoring rules requires membership in the Rule Designers group. See Managing Groups in P21E to set that up.
Step 1: Create the rule
On the Rules page, click + Create, choose a Rule Target (see Understanding Rule Targets in P21E for which to pick), and enter a Rule ID.
📝 Note: P21 adds the X- prefix for you, so you only type the rest: enter AE001 to create X-AE001. The full ID, including X-, can be up to 20 characters.
Step 2: Define the rule properties
Describe the rule in plain language: the Message a reviewer sees when it fires (keep it short and actionable), a fuller Description, the Publisher, and the Message Type, which is the severity: Error, Warning, or Notice. For a field-by-field walkthrough, see Understanding rule properties and assignments.
Step 3: Write the rule logic
Write your check in Pinnacle Query Language (PQL). See Writing Rules in P21 Rules Designer for the full syntax, functions, and more examples.
Step 4: Assign the rule
On the Assignments tab, control where the rule runs: the standard, class, and dataset (for example, SDTM, the AE dataset). Scope it tightly so it only fires where you intend. More detail in Understanding rule properties and assignments.
Step 5: Test the rule
Run the rule against a sample dataset right in the Designer and confirm it flags only the records you expect. See How to test Rules created with the Rules Designer.
Step 6: Publish the rule
Make the rule active from the Actions menu.
🚀 Don't forget: a rule that's only saved won't run in validations. You have to publish it. This is the most common reason a new rule doesn't fire.
Step 7: Manage versions
Every rule is versioned, so you can safely update or archive it over time without losing its history. See How versions work in the P21E Rules Designer.
Related: Rules in P21E (overview) · Understanding Rule Targets in P21E · Writing Rules in P21 Rules Designer · How to test Rules created with the Rules Designer · How versions work in the P21E Rules Designer · Managing Groups in P21E