Design and startup
Development Portfolio
Section titled “Development Portfolio”Objects: DevelopmentProgram, EvidenceNeed, StudyConcept, PortfolioScenario,
InvestmentDecision.
Behaviours: propose a Study, compare scenarios, approve a Study Concept, prioritize, defer, stop, and revise an evidence plan.
Protocol and Study Design
Section titled “Protocol and Study Design”Objects: Protocol, ProtocolVersion, Objective, Endpoint, Population, Arm,
Cohort, Epoch, EligibilityCriterion, ActivityDefinition, ActivityPlacement.
Behaviours: author, validate, approve, amend, assess impact, and supersede protocol intent.
Clinical Standards
Section titled “Clinical Standards”Objects: StandardConcept, Question, Instrument, CodeList, UnitSet,
ActivityTemplate, StandardsPackage.
Behaviours: revise, approve, publish, adopt, derive, deprecate, and assess usage.
Study Operations Planning
Section titled “Study Operations Planning”Objects: OperationalPlan, CountryPlan, SitePlan, EnrollmentPlan, MonitoringPlan,
VendorPlan, OperationalMilestone, OperationalRisk.
Behaviours: baseline, forecast, assign responsibility, replan, accept variance, and close.
Intelligence and Feasibility
Section titled “Intelligence and Feasibility”Objects: InvestigatorProfile, FacilityProfile, CapabilityAssertion,
PerformanceObservation, FeasibilityCampaign, CandidateSite, FeasibilityResponse,
SelectionDecision.
Behaviours: nominate, invite, respond, assess, select, reserve, reject, and withdraw.
Intelligence facts retain their source, observation time, effective period, and confidence. They are evidence used in selection—not timeless truth.
Startup and Approval
Section titled “Startup and Approval”Objects: StartupPackage, ApprovalRequirement, Submission, AuthorityQuestion,
Response, ApprovalDecision, ApprovalCondition, SiteReadinessAssessment.
Behaviours: derive requirements, prepare and submit, answer, record approval, satisfy a condition, assess readiness, activate, and suspend activation.
Agreements and Payments
Section titled “Agreements and Payments”Objects: Agreement, AgreementVersion, Budget, BudgetItem, PaymentRule,
PayableItem, Invoice, Payment, Adjustment.
Behaviours: negotiate, approve, execute, propose a payable, verify, invoice, pay, hold, adjust, and reverse.
Site Team and Qualification
Section titled “Site Team and Qualification”Objects: SiteParticipation, StudyTeamParticipation, DelegationOfDuty,
TrainingRequirement, LearningAssignment, TrainingCompletion, QualificationDecision.
Behaviours: assign responsibility, delegate duty, train, assess competence, qualify, expire, and require retraining.