📝 Note: Running custom rules in a validation requires P21E 6.5.0 or later. You can author custom Data rules in 6.4.0, but they won't actually run in a validation until 6.5.0. You'll also need a custom Data rule you've already created and tested in the Rules Designer (see Writing rules for the Data target and How to test Rules created with the Rules Designer).
Once you've built and tested a custom Data rule, the last step is seeing it run against real data, right alongside the standard CDISC and agency rules. This article shows you how to get your rule into a validation and where to find it in the results.
✅ Before you start: publish your rule
Only published rules run in a validation. In the Rules Designer, open your rule and choose Actions → Publish.
🚨 Important: Custom rules only run on the P21 Engine (shown in some screens as the P21 (Next Generation) Engine). The agency-specific engines (FDA, PMDA, NMPA) do not include custom rules, so your Data Package must be set to the P21 Engine.
1. Set your Data Package to the P21 Engine
The engine is chosen in Data Package Configuration. From Home → Actions (⋯) → Configure Data Package, select the P21 Next Generation Engine as the Validation Engine and save.
For full steps and guidance on picking an engine, see Configuring Data Packages and Choosing the right Validation Engine.
2. Confirm the engine on the Validate Data screen
From the left sidebar, open Validate Data for your Data Package. The engine currently in use is shown in the summary panel as the Engine field. Confirm it reads P21 (Next Generation) before you validate. If it shows an agency engine instead, go back and update the configuration (Step 1).
3. Validate your data
Upload your data and run the validation the way you normally would. There's nothing extra to switch on. Your published custom rule runs automatically as part of that validation.
4. Find your rule in the results
Open the validation results on the Validate Data screen. Your custom rule appears alongside the standard CDISC rules, using the rule ID you gave it. Custom rule IDs carry the X- prefix (for example, X-AE001), which makes them easy to spot.
💡 Tip: Search or filter the issues list by your rule's ID or message to jump straight to it.
5. Work the issue like any other
Select your rule's issue to open the issue details below. Everything you already do with standard issues works here too:
Assign it to a team member
Populate the source
Leave comments
Track it through your review workflow
📊 How custom rules affect your scores
Custom rules are treated a little differently from agency rules:
They don't affect your Data Fitness Score, since that score reflects the rules the agencies care about.
They do count toward your progress, so you get credit for reviewing and resolving them just like any other issue.