Tips & Best Practices for Labs

This page lists various tips and best practices to help you navigate and effectively use the Labs module.

• For quick configuration and introductory information about using the Labs module, see How to Get Started with Labs.

General Tips

Here are some general tips to keep in mind while navigating the Labs module:

• If your Study was created before the 20R3 release (December 2020), you’ll need to update your data model to version 2 to use the Labs module. Version 2 allows for better performance and helps you avoid any issues during Labs setup. A Vault Owner can verify which version your Study is using from Admin > Business Admin > Study Configurations. Contact your Veeva Enablement Lead to discuss upgrading. Studies created after the 20R3 release are automatically on version 2.
• Before enabling Labs for your Study, remove any codelists for the Sex item from any forms that you’re copying from another study. Removing codelists for the Sex item ensures that you’ll be able to use the standard Lab_Sex codelist that Vault creates when you enable Labs. You can assign the new Lab_Sex codelist to the Sex item on your copied forms to replace your previous codelist.
• For analytes where a codelist value or text is always acceptable, and you don’t want any value entered to indicate out of range, you don’t need to add a normal range.
• Be aware of SAS length restrictions when creating analyte names.

Analytes and Units

Analytes created in the Analyte Library should have a “one-to-many relationship,” meaning that there should be one analyte and many units for all studies. We recommend not creating one analyte for one study or one analyte for every unit.

When adding normals in the Labs module, you can see multiple units available for a single analyte. After you select the correct unit for that normal and affiliate the lab location with the site, the eCRF will default to the lab normal unit selected. Sites can change the unit based on the available unit options associated with the analyte. If you want the site to only see one unit in the eCRF and not make changes to that unit, make sure the Disable Unit selection for Lab Results when Lab Normals are present option is set to “Yes” in Study General Settings.

Questions to Ask Before Designing Lab Panels for Your Study

It’s important to ask the following questions before creating Lab Panels so that you can be assured that you have all necessary information ready for use.

• Do I need to add any new analytes?
• Do my current analytes have the correct Name, Data Type, Length, and Precision?
• Are the codelist items (values) correct?
• Are the Unit items and their conversion formulas correct?

Duplicate Analytes

You may end up with duplicate analytes if a certain item is collected differently across Sites or Studies. In this case, you can use the same Label but should use Names that are applicable to the use. For example, if you have multiple analytes related to Glucose, the analyte label would be Glucose while the analyte name should reflect more specific aspects of the analyte, like GLUC_U for urine. Vault uses the Name in any extracts and the Label for forms in EDC.

Future Date Rules for Collection Date

You can create a future date rule against the collection date by navigating to Studio > User Defined Rules. You can use the Query Rule Action to open a query on the Collection Date item.