TOP / OversightBody / spec / v1

2026-05-09 · backed by source/top-strawman.json (v0.5.1-strawman) · seventh top-level · IRB / EC / DSMB / IDMC / Steering Committee / CEC · 2 new SHACL invariants (36 total)

1.TL;DR a foundation primitive — every regulated trial has oversight bodies

OversightBody is the regulatory / ethics / safety committee with review authority over a Study or StudySite. Per first-principles.md, OversightBody is a foundation primitive (every regulated trial has oversight bodies regardless of therapeutic area; not specialization). Six types via oversightBodyType enum: IRB (US institutional review), EC (EU ethics committees), DSMB / IDMC (sponsor-level safety review), Steering Committee (cross-site governance), CEC (clinical events adjudication). PROV: prov:Agent (committees bear responsibility); members act on behalf of the body via prov:actedOnBehalfOf. Status is a NGSI-LD temporal property — bodies can be SUSPENDED (regulatory hold) or DISBANDED (post-trial). Un-flag-misses three existing relationships: Sponsor.interfacesWith, StudySite.hasIRB, Study.hasOversightBody.

2.Architectural anchor

┌─→ Sponsor (interfacesWith — sponsor-engaged oversight) │ OversightBody ────────────┼─→ Study (reviewsStudy — multi-Study scope possible) │ ├─→ StudySite (reviewsStudySite — site-level IRB review) │ └─→ Person[*] (hasMember + chair)

OversightBody is reached from three existing entities: Sponsor (DSMB/IDMC engagement), Study (sponsor-level oversight bodies), StudySite (site-level IRB review). Each role is a separate OversightBody record per the per-Org-per-Role pattern from Sponsor — the same human committee can play different oversightBodyType roles on different studies (a hospital IRB serves as central IRB for some, local IRB for others).

3.Model summary

OversightBody attributes (~14)

Attribute	Type	Notes
oversightBodyId	NGSI-LD URI	Globally unique
oversightBodyName	string	Display name
oversightBodyType	enum (7) — IRB / EC / DSMB / IDMC / STEERING_COMMITTEE / CEC / OTHER	Operator-grounded discriminator
scope	enum (5) — LOCAL / CENTRAL / SPONSOR / REGULATORY / OTHER	SHACL invariants enforce type/scope alignment
registrationNumber	string · optional	FDA OHRP IRB number, EU EC reference, etc.
registrationAuthority	string · optional	FDA OHRP, EU CTIS, NHS HRA, etc.
registrationCountry	ISO 3166-1 alpha-3 · optional
address / phone / email / website	various · optional	Contact
operatingProcedure	URI · optional	Reference to charter / SOP Document
establishedDate	date · optional
status	enum (3) — ACTIVE / SUSPENDED / DISBANDED	NGSI-LD temporal property
validFrom / validUntil	dateTime · optional	Operational validity bracket

OversightBody relationships (5)

Relationship	Target	Card.	Notes
belongsToOrganization	Organization	0..1	The hosting Organization (when one exists)
hasMember	Person	0..N	Committee members; prov:actedOnBehalfOf the body
chair	Person	0..1	Committee chair (0..1 because some bodies use co-chairs / rotating chairs)
reviewsStudy	Study	0..N	Studies under review authority
reviewsStudySite	StudySite	0..N	Site-level review (IRB / EC)

4.Architectural decisions

Decision 1 — Single OversightBody entity with type discriminator (universal foundation)

Per FIRST-PRINCIPLES universal-foundation posture: don't split into separate IRB / EC / DSMB / IDMC entities. One TOP entity shape; oversightBodyType enum carries the operator-grounded discrimination. Same architectural moat as the Activity + Task pattern in Visit: standards-up vendors model N entity types per oversight category; TOP carries one universal pattern.

Decision 2 — Per-Role-per-Study records (Sponsor pattern applied)

The same human committee (e.g., MSKCC IRB) can play different oversightBodyType roles on different studies. Each role gets a separate OversightBody record. Mirrors the Sponsor per-Organization-per-Study pattern — the foundation carries operational reality, not corporate ledger.

Decision 3 — PROV typing: prov:Agent (the body), prov:actedOnBehalfOf (members)

OversightBody is prov:Agent — committees bear responsibility for review decisions. The hasMember relationship carries prov:actedOnBehalfOf semantics (members act on behalf of the body). When ReviewDecision lifts as a sub-object (deferred to v0.6+), it becomes prov:Activity with prov:wasAssociatedWith linking to the OversightBody.

Decision 4 — Type/scope SHACL alignment

SHACL #35: IRB and EC must have scope LOCAL or CENTRAL (review boards have geographic / institutional scope). SHACL #36: DSMB and IDMC must have scope SPONSOR (sponsor-convened safety boards). Catches operational mismatches at validation time.

Decision 5 — Defer ReviewDecision sub-object to v0.6+

ReviewDecision (the Activity capturing a single review event with decision, conditions, next-review-date) is operationally meaningful but not blocking. v0.5.1 lifts the body itself; the review-event foundation adds when sponsors / IRBs need explicit decision tracking. Until then, IRB approvals are tracked on StudySite.irbApprovalStatus + irbApprovalDate (already in source).

5.SHACL invariants 2 new (36 total)

#	Severity	Constraint
35	Hard	IRB / EC scope must be LOCAL or CENTRAL. Review boards have geographic / institutional scope; SPONSOR or REGULATORY indicates a typing mismatch.
36	Hard	DSMB / IDMC scope must be SPONSOR. These are sponsor-convened safety review boards.

6.Stress-test scenarios

Local hospital IRB reviewing a study at one StudySite

Common case

MSKCC IRB reviews ONCO-423 at the MSKCC site.

OversightBody (oversightBodyType=IRB, scope=LOCAL, registrationNumber populated). belongsToOrganization → MSKCC. reviewsStudy → ONCO-423. reviewsStudySite → MSKCC's StudySite. SHACL #35 satisfied. (Mirrored in worked example.)

Central IRB serving multiple sites in an SMO network

Multi-site

Advarra Central IRB covers Elevate Network's three sites for ONCO-423.

One OversightBody (oversightBodyType=IRB, scope=CENTRAL). Each of the three StudySite records (Boston, Phoenix, Miami) references the same OversightBody via hasIRB. Avoids the per-site-per-IRB pattern when central IRB applies. (Mirrored in elevate-network worked example.)

Sponsor-convened DSMB for sponsor-level safety review

DSMB

Pfizer convenes an IDMC for ONCO-423 to review interim safety data.

OversightBody (oversightBodyType=IDMC, scope=SPONSOR, no belongsToOrganization since DSMBs are typically convened ad-hoc). reviewsStudy → ONCO-423. SHACL #36 satisfied. Members are external experts in oncology, biostatistics, ethics.

Same hospital committee, different roles on different studies

Per-Role pattern

MSKCC's IRB committee serves as local IRB for ONCO-423 (multi-site sponsored trial) AND as central IRB for IIT-ONCO-001 (MSKCC's own IIT).

Two OversightBody records: OversightBody:mskcc-irb (scope=LOCAL, reviewing ONCO-423) and OversightBody:mskcc-irb-iit (scope=LOCAL, reviewing IIT-ONCO-001). Same registration number, same hosting Organization. Per-Role-per-Study pattern preserved. (Both mirrored in worked examples.)

7.Open issues

ReviewDecision sub-object (v0.6+). Captures individual review events: decision (APPROVED / DISAPPROVED / SUSPENDED / TABLED), decisionDate, conditions, nextReviewDate, recordedBy. prov:Activity with prov:wasAssociatedWith the OversightBody. Lifts when sponsors / IRBs need explicit decision tracking beyond the existing StudySite.irbApprovalStatus.
Member terms (validFrom/validUntil on hasMember relationship). Members rotate on/off committees; tracking term boundaries requires per-relationship temporal semantics. Defers; current per-entity validFrom captures body-level validity.
Adjudication workflow integration. When CEC (Clinical Events Committee) adjudicates an endpoint or AE, the adjudication chain ties to Endpoint (when adjudication-result attribute lifts) or Event (when Event lifts in v0.7+).
FHIR Organization profile alignment. FHIR has Organization with type=committee code values. The TOP→FHIR adapter projects OversightBody as Organization with appropriate type Code per the cross-walks in the source intermediate.