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TechSol Clinical Domain

Complete domain landscape

Domain library map

Section titled “Domain library map”

The complete library is organized by clinical meaning rather than commercial product names.

Group Domain module Principal objects
Strategy Development Portfolio DevelopmentProgram, EvidenceNeed, StudyConcept
Intent Protocol and Study Design Protocol, ProtocolVersion, Objective, Endpoint, Activity
Standards Clinical Standards StandardConcept, Instrument, CodeList, StandardsPackage
Planning Study Operations Planning OperationalPlan, Milestone, Responsibility, OperationalRisk
Intelligence Country and Site Intelligence FacilityProfile, InvestigatorProfile, CapabilityAssertion
Feasibility Feasibility and Selection FeasibilityCampaign, CandidateSite, SelectionDecision
Startup Approvals and Activation ApprovalRequirement, Submission, ApprovalDecision, ReadinessAssessment
Commercial Agreements and Payments Agreement, Budget, PaymentRule, Payable, Payment
Partners Vendor and Service Management ServiceRequirement, VendorQualification, ServiceAward
Site Site and Study Team Operations StudySite, SiteParticipation, StudyTeamParticipation, Delegation
Qualification Training TrainingRequirement, LearningAssignment, QualificationDecision
Collaboration Sponsor–Site Collaboration DistributionPackage, SiteRequest, ActionItem
Recruitment Recruitment and Pre-screening Campaign, Referral, Candidate, PreScreeningAssessment
Consent Informed Consent ConsentVersion, ConsentPresentation, ConsentDecision, ReconsentRequirement
Conduct Participant Conduct StudyParticipant, ScreeningEpisode, Enrollment, ParticipantSchedule
Assignment Randomization and Blinding RandomizationDesign, TreatmentAssignment, BlindPartition
Supply Trial Supply SupplyProduct, Lot, Kit, Shipment, Dispensation, Accountability
Capture EDC CollectionDesign, Form, Casebook, Datapoint, Query
Outcomes eCOA Instrument, AssessmentSchedule, AssessmentInstance, Response
Digital eSource and Devices SourceConnection, Device, AcquisitionDefinition, Measurement
Labs Laboratory and Biospecimens LabOrder, Specimen, Aliquot, Test, LabResult
Imaging Imaging and Adjudication ImageSet, Read, AdjudicationCase, EndpointAssessment
Safety Safety Surveillance SafetyIntake, SafetyCase, AdverseEvent, ReportingObligation
Data Clinical Data Management ValidationFinding, Query, Reconciliation, Freeze, Lock
Coding Medical Coding DictionaryRelease, CodingTask, CodingDecision
Monitoring Site Monitoring MonitoringPlan, MonitoringVisit, MonitoringFinding, SiteAction
Risk Risk-Based Quality Management CriticalToQualityFactor, Risk, Indicator, Signal, Mitigation
Deviations Protocol Deviations Deviation, ImpactAssessment, Disposition
Quality Quality Events and CAPA QualityEvent, RootCause, CAPAPlan, EffectivenessCheck
Records eTMF FilingPlan, RecordExpectation, TrialArtifact, QualityReview
Analysis Analysis and Biostatistics AnalysisPlan, Dataset, PopulationDecision, StatisticalResult
Reporting Clinical Study Reporting ClinicalStudyReport, Section, DataCitation, Approval
Disclosure Registration and Results Registration, DisclosureObligation, ResultsDisclosure
Submission Regulatory Submission Assembly SubmissionPlan, SubmissionUnit, Validation, Dispatch

What is shared

Section titled “What is shared”

All modules reuse the same foundation concepts where their meaning is genuinely identical:

  • Study and Protocol references
  • Organization, Person, Facility, and Study Site
  • Study Participant references with explicit privacy boundaries
  • Clinical dates, intervals, units, and controlled terms
  • Governed definition and revision semantics
  • Occurrence, observation, finding, decision, and evidence semantics
  • Blind and privacy classifications
  • Reasons, provenance, and correction lineage

What remains specialized

Section titled “What remains specialized”

Shared foundations do not erase specialized behaviours.

Finding
├── DataQuery             — asks for data clarification
├── MonitoringFinding     — records oversight concern
├── ProtocolDeviation     — assesses departure from protocol intent
├── QualityEvent          — investigates systemic quality failure
└── SafetyCase            — evaluates and reports participant safety information

These objects may share fields but they do not share one lifecycle or authority.