Conduct and data
Recruitment, Consent, and Enrollment
Section titled “Recruitment, Consent, and Enrollment”Objects: Candidate, Referral, ContactPermission, PreScreeningAssessment,
ConsentVersion, ConsentPresentation, ConsentDecision, ScreeningEpisode,
EligibilityDecision, Enrollment.
Behaviours: refer, contact, pre-screen, present consent, assess comprehension, grant or withdraw consent, screen, determine eligibility, enroll, rescreen, and withdraw.
Participant Conduct
Section titled “Participant Conduct”Objects: StudyParticipant, ProtocolAssignment, ParticipantSchedule,
ParticipantScheduleItem, ActivityOccurrence, ParticipantOutcome.
Behaviours: derive schedule, schedule activity, record performance, record missed or partial activity, transfer site, discontinue intervention, complete, and withdraw.
Randomization and Trial Supply
Section titled “Randomization and Trial Supply”Objects: RandomizationDesign, Stratum, TreatmentAssignment, BlindPartition,
SupplyProduct, Lot, Kit, Depot, Inventory, Shipment, Dispensation,
AccountabilityReconciliation.
Behaviours: randomize, authorize unblinding, release supply, ship, receive, quarantine, dispense, return, destroy, and reconcile.
Objects: DataCollectionDesign, FormDefinition, FieldDefinition, FormPlacement,
Casebook, FormInstance, Datapoint, DatapointRevision, MissingAssertion.
Behaviours: design, publish, assign, open a form, record and correct data, assert missing, complete, review, sign, freeze, and lock.
Objects: InstrumentDefinition, LicensedInstrumentRevision, AssessmentSchedule,
AssessmentInstance, Response, AssessmentCompletion, DeviceAssignment.
Behaviours: configure administration, assign, present, respond, complete, document missed assessment, and assess compliance.
eSource and Devices
Section titled “eSource and Devices”Objects: SourceConnection, DeviceModelQualification, DeviceInstance,
ParticipantDeviceAssignment, AcquisitionDefinition, RawMeasurement, Transmission,
ProcessedMeasurement.
Behaviours: qualify, assign, acquire, transmit, process, detect loss, correct metadata, and decommission.
Laboratory and Biospecimens
Section titled “Laboratory and Biospecimens”Objects: LabOrder, SpecimenCollection, Specimen, Container, Aliquot,
ChainOfCustodyEvent, TestPerformance, LabResult, ResultAmendment.
Behaviours: order, collect, accession, aliquot, ship, receive, reject, test, release, amend, and reconcile.
Imaging and Endpoint Assessment
Section titled “Imaging and Endpoint Assessment”Objects: ImagingCharter, AcquisitionDefinition, ImageSet, QualityAssessment,
Read, ReaderAssignment, AdjudicationCase, EndpointAssessment.
Behaviours: acquire, submit, assess quality, read, adjudicate, and finalize.
Data Management and Coding
Section titled “Data Management and Coding”Objects: ValidationRule, ValidationFinding, DataQuery, ExternalDataTransfer,
ReconciliationDefinition, ReconciliationItem, DictionaryRelease, CodingTask,
CodingDecision, FreezeDecision, DatabaseLockDecision.
Behaviours: validate, query, respond, reconcile, code, review, freeze, unfreeze, lock, and reopen.