https://top.scientix.ai/onto/clinical/v1#
This page is the resolution target for every class in the top: namespace. When a JSON-LD or RDF tool follows a URI like https://top.scientix.ai/onto/clinical/v1#Sponsor, it lands here, and the fragment #Sponsor scrolls to the matching section below. Eight top-level classes form the founding clinical-research reference graph: Sponsor, Study, Site, Participant, Visit, Investigational Product, Oversight Body, Event. The full set of attributes, relationships, and SHACL invariants for each class lives in the source intermediate and the emitted artifacts linked below; this page is the operator-readable index.
Artifacts
Machine-readable
context.jsonld · JSON-LD @context for this namespace, NGSI-LD compatible
shapes.ttl · SHACL shapes in Turtle, including domain invariants (SHACL-SPARQL)
Human-readable specs
Source of truth
Top-level classes
top:Study
The trial design and definition. Schedule of assessments, protocol, arms. Each Sponsor entity is scoped to exactly one Study. Source of truth for the per-Study System bindings (eTMF, EDC, CTMS, IRT, safety database) once the Study spec is lifted.
Cross-walks: fhir:ResearchStudy · usdm:Study · cdash:DM
Sub-objects: Protocol, Arm
top:Site
Where conduct happens. A clinical location operating one or more Studies, optionally part of a Site Network or SMO. Backed by an Organization (the legal/operational entity) via belongsToOrganization. Site Network membership lives on partOfSiteNetwork (e.g., Elevate Research locations).
Cross-walks: fhir:Organization · usdm:StudySite · cdash:DM.SITEID
top:Participant
An individual enrolled in a Study (subject in CDISC terms). Distinct from Person (a horizontal): Participant carries the trial-bound subject identity, randomization, screening status, enrollment, and visit attendance. Person is the cross-cutting identity reference.
Cross-walks: fhir:ResearchSubject · usdm:StudySubject · cdash:DM.USUBJID
top:Visit
A scheduled or unscheduled encounter between a Participant and a Site for trial-related activities. Top-level because operators carry "today's visits" as a primary mental anchor. Sub-object Visit Observation captures routine, non-reportable observations during the visit; promotion to Other Clinical Event preserves the audit chain via derivedFrom.
Cross-walks: fhir:Encounter · usdm:Encounter · cdash:VS
Sub-objects: Visit Observation, Visit Activity
top:InvestigationalProduct
Investigational Product
Queued ¶The product being tested or used in a clinical trial. Top-level because lots, devices, and components anchor the AE-pattern scenario independently of the protocol. Carries the supply chain (Sponsor.supplies, Lot, Shipment) and the dosing relationships into Visit Activity.
Cross-walks: fhir:MedicinalProductDefinition · usdm:InvestigationalIntervention · cdash:EX
top:OversightBody
An organization responsible for governing and ensuring compliance with clinical trial regulations: IRB, EC, DSMB, IDMC, scientific review board. Sponsor.interfacesWith targets this top-level. Distinct from RegulatoryAuthority (which approves the trial overall).
Cross-walks: fhir:Organization · usdm:Organization (with type=ReviewBoard)
top:Event
A single container holding occurrences related to a clinical trial: AE, SAE, Deviation, Discrepancy, Safety Signal, Safety Report, Other Clinical Event. Discriminated by an eventCategory enum rather than split into separate classes. Other Clinical Event carries derivedFrom back to a Visit Observation when a routine observation is escalated.
Cross-walks: fhir:AdverseEvent (for AE/SAE) · usdm:Event · cdash:AE
Sub-objects: Adverse Event, Serious Adverse Event, Deviation, Discrepancy, Safety Signal, Safety Report, Other Clinical Event
Sub-objects
top:Protocol
Sub-object of Study. The versioned protocol document with semver and status (draft, in_review, approved, amended, superseded).
Cross-walks: fhir:PlanDefinition · usdm:Protocol
top:Arm
Sub-object of Study. A treatment, comparator, placebo, control, or observational arm.
Cross-walks: fhir:ResearchStudy.arm · usdm:StudyArm · cdash:DM.ARM
Status
This namespace is at v1.0.0-strawman as of May 2026. Sponsor is the first complete top-level. The remaining seven top-levels are queued; lift order is documented in the roadmap. Cross-cutting horizontals (Organization, Document, Person, Audit Trail Entry, Contract, etc.) live in the commons namespace at https://top.scientix.ai/onto/commons/v1#.
