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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.

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Participant Self-Registration

When the participant registration portal is enabled:
  1. Potential participants access the public registration page
  2. Participants provide contact and screening information
  3. Record is created as a “Candidate”
  4. Site team reviews and contacts qualified candidates
  5. Site converts candidate to enrolled participant
Self-registration reduces site burden for initial screening while maintaining control over final enrollment decisions.

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Enrollment Information

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Required Fields

FieldDescription
PseudonymStudy-specific participant identifier
StatusInitial participant status
PathwayAssigned participant pathway

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Optional Fields (Study-Configured)

FieldWhen Available
Subject NameIf PHI enabled
Medical Record NumberIf PHI enabled
Date of BirthIf PHI enabled
Year/Month of BirthIf PHI enabled
Subject InitialsIf PHI enabled
Arm AssignmentIf study has multiple arms

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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:
StatusWhen to Use
CandidateFor potential participants pending screening
ScreeningFor participants entering formal screening
On StudyFor direct enrollment without screening
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:
MetricDescription
Total EnrolledAll participants added to the study
By SiteEnrollment counts per site
By StatusDistribution across statuses
Over TimeEnrollment rate trends

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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.