What should I do if my study cannot collect data on a subject's race?

If you can't collect any data on a subject's race, you can design your study in a way that allows you to continue collecting lab data successfully without having to collect a subject's race.

Several types of users should work together to ensure that a site user can successfully collect lab data.

Study designers

Note:

If you plan to apply this change to a live study version, make sure you select the appropriate live study version from the Apply Changes to Study Version drop-down for the question on a subject's race. For step-by-step instructions, see Update a form during the study conduct period.

In your study's design, follow the steps below:

1. In the form that you use to collect a subject's demographic data, create a question with radio buttons.
   1. Name the question "Race".
   2. Mark the question as Hidden and Read-Only.
   3. From the Data Classification drop-down, select the appropriate label to use for classifying the data collected for this question.
   For step-by-step instructions, see the following:

   • Create a question with checkboxes or radio buttons
   • Classify a hidden question
2. Next to the question, click Code List and add a new custom code list that contains only one value that is according to your protocol (for example, "No Race"). Make sure that you specify the appropriate label and code for that value, and that you tag the Race Lab Normals tag for this newly created code list.

   For step-by-step instructions, see Create a code list.

Rule designers, testers, and publishers

Note:

When you design the calculation rule, make sure you include JavaScript logic that clears the selection for the Race field when the Gender field is cleared.

In a study's Testing mode, create a calculation rule that allows the Race field in a form to be automatically populated when the Gender field is filled in.

For step-by-step instructions, see the following topics in the Rules Developer Guide:

• Create a rule for a calculated value
• Prepare your rule for testing and approval
• Publish a single rule

Data managers and site users

Whether you're a data manager or a site user working with lab normals, you might have to go into your study's settings, on the Sites & Labs tab. From there, go to the appropriate lab and update its lab normal value for the Race column to All.

For step-by-step instructions, see Define lab normals in the Sponsor and CRO User Guide (as a data manager) or Define lab normals in the Site User Guide (as a site user).