Oversight and outputs
Safety Surveillance
Section titled “Safety Surveillance”Objects: SafetyIntake, SafetyCase, AdverseEvent, SeriousnessAssessment,
CausalityAssessment, ExpectednessAssessment, FollowUp, ReportingObligation,
SafetyReport.
Behaviours: intake, accept or merge a case, assess, follow up, determine reportability, approve a case version, submit a report, and reconcile with clinical data.
Monitoring and Site Oversight
Section titled “Monitoring and Site Oversight”Objects: MonitoringStrategy, MonitoringPlan, MonitoringVisit, RemoteReview,
MonitoringActivity, MonitoringFinding, FollowUpLetter, SiteActionItem.
Behaviours: plan, conduct, review, raise a finding, issue follow-up, verify resolution, escalate, and close a monitoring cycle.
Risk-Based Quality Management
Section titled “Risk-Based Quality Management”Objects: CriticalToQualityFactor, Risk, RiskAssessment, KeyRiskIndicator,
QualityToleranceLimit, Signal, Mitigation, RiskReviewDecision.
Behaviours: identify, assess, set a threshold, evaluate a signal, mitigate, accept residual risk, escalate a breach, and retire a risk.
Deviations and CAPA
Section titled “Deviations and CAPA”Objects: ProtocolDeviation, Classification, ImpactAssessment, RootCause,
Disposition, QualityEvent, CAPAPlan, CAPAAction, EffectivenessCheck.
Behaviours: report, confirm, classify, assess impact, investigate, determine root cause, approve CAPA, implement, verify effectiveness, and close.
eTMF and Essential Records
Section titled “eTMF and Essential Records”Objects: FilingPlan, EssentialRecordDefinition, RecordExpectation, FilingSlot,
TrialArtifact, Classification, QualityReview, FinalizationDecision, Exception,
InspectionReadinessAssessment.
Behaviours: define expectations, ingest, classify, associate, review quality, finalize, supersede, approve an exception, evaluate completeness, and archive.
Analysis and Reporting
Section titled “Analysis and Reporting”Objects: StatisticalAnalysisPlan, AnalysisDefinition, AnalysisPopulationDecision,
DatasetSpecification, AnalysisDataset, DerivationProvenance, StatisticalResult,
ClinicalStudyReport, DataCitation, ReportApproval.
Behaviours: define, derive, validate, analyze, independently verify, cite, author, review, approve, and publish.
Disclosure and Submission
Section titled “Disclosure and Submission”Objects: RegistryRegistration, DisclosureObligation, ResultsDisclosure,
SubmissionPlan, SubmissionUnit, ContentRequirement, DatasetPackage,
ValidationResult, Dispatch, AuthorityAcknowledgement.
Behaviours: determine obligation, register, update, disclose results, assemble, validate, approve, dispatch, acknowledge, and correct.