Configuring and Using Sex/Gender in EnrollNow

EnrollNow automatically includes the following default options for the Sex/Gender field:

• Male
• Female
• Other

Study teams may add options or modify these labels to better align with the demographics, terminology, or requirements of a specific study. However, before changing these options, it is important to understand that Sex/Gender is a global variable in EnrollNow.

What Is a Global Variable?

A global variable is participant information that follows the participant across all studies within the same EnrollNow site.

For example, an EnrollNow site may contain 10 studies, and each study may configure the Sex/Gender field differently. If a participant is assigned a Sex/Gender value in one study, that value remains associated with the participant when they are added to another study on the same site.

This means that Sex/Gender options should be configured consistently across studies whenever possible.

Example of Inconsistent Sex/Gender Configurations

Consider the following example:

• Study A includes Ambiguous as a configured Sex/Gender option.
• A participant in Study A is assigned the value Ambiguous.
• The same participant is later added to Study D.
• Study D only includes the default options of Male, Female, and Other.

Because Sex/Gender is a global variable, the participant’s profile may continue to display Ambiguous. However, because Study D does not have Ambiguous configured as an available option, reports and exports generated for Study D will display the participant’s Sex/Gender as Unknown.

This inconsistency may affect reporting accuracy and exported study data.

Recommended Configuration

EnrollNow recommends using the same Sex/Gender labels across all studies within a site.

Before adding or modifying Sex/Gender options, Site Administrators and study teams should review the needs of all studies that use the site and establish a consistent set of values.

When a study requires additional or study-specific demographic information, consider creating a Custom Variable instead of modifying the global Sex/Gender field. Custom Variables can be configured to capture the terminology required by the study protocol without affecting the participant’s global Sex/Gender value across other studies.  The custom variable can be marked as Global or can remain study-specific.

Correcting Mismatched Sex/Gender Values

If participants have joined a study with Sex/Gender values that are not configured for the current study, the information can be corrected using either of the following methods.

Update an Individual Participant

To correct a single participant:

1. Open the participant’s profile.
2. Locate the Sex/Gender field.
3. Select a value that is configured for the current study.
4. Save the participant’s profile.

Update Multiple Participants

To correct multiple participant records:

1. Export the participant data from the study.
2. Update the Sex/Gender values in the exported spreadsheet so they match the options configured for the study.
3. Import the corrected spreadsheet back into the study.
4. Include the appropriate participant identifier, such as the Global ID, so EnrollNow updates the existing participant profiles instead of creating duplicate records.
5. Review the imported records to confirm that the values were updated correctly.

Before importing a large number of updates, EnrollNow recommends testing the import with one or two participant records.

Important Considerations

Changes made to the Sex/Gender field may affect participants across multiple studies because the field is global.

Before updating Sex/Gender labels or participant values, teams should:

• Coordinate configuration decisions across studies.
• Review how the changes may affect reports and exports.
• Confirm that the selected terminology meets study and institutional requirements.
• Consider using a Custom Variable for study-specific demographic classifications.

Maintaining consistent Sex/Gender options across all studies helps prevent participants from appearing as Unknown in reports and exports and supports more accurate data management throughout the EnrollNow site.