How to Get Started with Labs

This page provides a quickstart guide for users getting started with the Labs module.

Before using Labs, you should reference your list of analytes needed for protocol and their associated units and unit conversions. If units are unknown, refer to the following spreadsheet for guidance:

Labs Common Conventional Units Reference Sheet

Please note that the list in this spreadsheet is not validated and is only meant to be used as a reference.

Adding Units, Analytes, Lab Locations, and Normal Ranges

You should begin using the Labs module by adding any necessary units and analytes. To add units, navigate to Labs > System General Settings > + New Unit. To add analytes, navigate to Labs > Analyte Library > Add New Analyte.

Refer to the step-by-step guide below to easily get started with the Labs Analyte Library:

  1. Have all analytes and associated units ready and available. If you’re unsure of what units you need, see the reference sheet above.
  2. Add units by navigating to System General Settings in the Labs module and clicking + New Unit.
  3. Add any codelists that aren’t units in the Codelists subtab of System General Settings.
  4. Add analytes in the Analyte Library tab and associate them with unit conversions. Note the Standard Unit (the Unit that sponsors will use to report data) for each analyte. Analyte labels should be user-friendly for Sites while Analyte names must be unique (CDISC name).
  5. Before moving on, ensure that everything is accurate (e.g. Data Type, Precision, Unit Association/Measurement Type, etc.)
  6. Add Lab Locations and addresses in the Lab Locations & Normal Ranges tab.
  7. Import Normals to your newly added Lab Locations. You can only import Normals that are measured in existing Units. Note that Lab Locations & Normals are environment-specific and not part of deployments.
  8. Associate the proper Site with its corresponding Lab Location.

Please note that analytes may have different conversion factors but analytes and units should have a 1:1 relationship.

For more information about adding units, analytes, lab locations, and normal ranges, see Viewing and Updating Analytes and Labs Settings.

Creating Lab Panels and Forms in Studio

Once all necessary analytes and units have been added in the Labs module, you can create Lab Panels and Forms in Studio.

To create a Lab Panel:

  1. Navigate to Studio > Lab Panels > + New Lab Panel.
  2. Fill out the Name and Label fields and select analytes from the Available Analytes list to use in your Lab Panel.
  3. Click Save.

When you’ve finished creating your Lab Panels, you can add them to a form and to the schedule.

To add a Lab Panel to a form:

  1. Navigate to Studio > Forms.
  2. Click on the form that you’d like to add a Lab Panel to.
  3. Select Lab Panel from the list of Component Types.
  4. Click and drag your analyte(s) to the top of the grid to create a Lab Header and Lab Header Item Group.

For more information about Lab Panels and how to utilize Labs in Studio, see Configuring Labs in Studio.

Frequently Asked Questions

Can Sites add new Lab Locations and Normals during Study conduct?

Sites can add new Lab Locations and Normals, but the Normals won’t be pulled into the Labs module. The newly added Normals must be added to the new Lab Location in the Labs module by a Data Manager.