Enroll a participant

Goal

Establish that an eligible, consenting person has entered the Study under a specific Protocol Version at a Study Site that is permitted to enroll.

Object progression

Candidate
  -> ContactPermission
    -> ConsentPresentation
      -> ConsentDecision
        -> ScreeningEpisode
          -> EligibilityEvidence
            -> EligibilityDecision
              -> Enrollment
                -> ProtocolAssignment
                  -> ParticipantSchedule

Enrollment behaviour

participant.enroll({
  site: openStudySite,
  consent: effectiveConsent,
  eligibility: positiveEligibilityDecision,
  protocolAssignment: applicableProtocolVersion,
  enrollmentDate: clinicalDate,
});

Preconditions

• The Study Site is currently open for enrollment.
• Consent is effective for the activities and data uses required at enrollment.
• Eligibility was positively determined by an authorized person.
• Eligibility evidence and criteria belong to the applicable Protocol Version.
• No conflicting enrollment exists for the participant identity.
• Applicable cohort, country, site, and Study enrollment limits permit enrollment.

Outcome

ParticipantEnrolled records:

• Study Participant identity;
• Study and Study Site;
• enrollment date;
• exact Protocol Version assignment;
• consent and eligibility decisions relied upon;
• actor, authority, and evidence.

Follow-on domain behaviour

Enrollment makes the participant eligible for downstream setup. It does not itself create EDC, eCOA, randomization, laboratory, or supply state.

ParticipantEnrolled
├── ParticipantSchedule may be derived
├── EDC Casebook may be initiated
├── eCOA assessments may be assigned
├── Randomization readiness may be evaluated
└── Laboratory participant reference may be established

Product review questions

• Is enrollment a distinct decision or a consequence of positive eligibility?
• Which consent purposes are required at enrollment versus later activities?
• How are screening numbers and participant numbers corrected?
• When can a screening failure be rescreened under the same identity?