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Enrollment is the process of adding new participants to your study. Sites create participant records and assign them to pathways for data collection.

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Enrollment Methods

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Manual Enrollment

Site team creates participant records directly:
1

Navigate to Participants

Open Site > Participants or Study > Participants.
2

Add Participant

Click “Add Participant”.
3

Enter Information

Provide required information:
  • Pseudonym (study identifier)
  • PHI fields (if enabled)
  • Initial status
4

Assign Pathway

Select the participant pathway.
5

Create

Create the participant record.
Participants cannot register themselves. All participant onboarding is controlled by the study and site teams.

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Enrollment Information

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Required Fields

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Optional Fields (Study-Configured)

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Pseudonym Format

Pseudonyms uniquely identify participants within the study:
  • Typically formatted as “Site-Sequence” (e.g., “001-001”)
  • Must be unique within the study
  • Cannot be changed after creation
Choose pseudonym formats carefully before enrollment begins. Changing formats mid-study creates inconsistency.

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Initial Status

Select the appropriate starting status: The default initial status is configured at the study level.

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Arm Assignment

If your study has multiple arms:
1

During Enrollment

Optionally assign the arm during enrollment if known.
2

After Randomization

Update arm assignment after randomization occurs.
Arm assignment can be updated after enrollment if the study design allows.

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Pathway Assignment

Pathways define the participant’s schedule of activities:
1

Select Pathway

Choose from available pathways during enrollment.
2

Pathway Creates Activities

The pathway generates scheduled questionnaires and visits.
3

Modify if Needed

Pathways can be adjusted for individual participants if needed.
Different arms may have different pathways. Ensure the correct pathway is selected for the participant’s arm.

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Enrollment Validation

The system validates enrollment data:
  • Pseudonym uniqueness
  • Required field completion
  • PHI format validation (if applicable)

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Enrollment Metrics

Track enrollment progress:

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Best Practices

Confirm eligibility criteria before creating participant records.
Train all site staff on enrollment procedures for consistency.
Verify pseudonym accuracy before creating the record.

Participant Status

Status transitions after enrollment.

Participant Pathways

Configure participant journeys.