CLINICAL EXECUTION REQUIRES MORE THAN A PROTOCOL.
A protocol, consent record, safety assessment or batch document can establish important domain facts. None of them alone creates an execution right. immo.quick resolves encoded, source-bound conditions before a capability can exist.
One clinical action can depend on several independent states.
The sector surface does not collapse protocol, consent, safety, regulatory and product conditions into one score. Each state remains separately attributable and can become an authorization dependency where the defined action requires it.
Protocol State
Version, amendment, applicable procedural conditions and protocol-bound dependencies.
Consent & Subject State
Encoded conditions around consent status and other defined subject-bound prerequisites.
Safety State
Adverse-event and safety-reporting facts remain evidence-bearing states and must not be suppressed by an authorization path.
Regulatory State
Applicable approvals, authorisations, jurisdiction and time-bound regulatory conditions.
Product / Batch State
Where relevant, product, batch, release, serialisation or conformity conditions can enter as dependencies.
Time & Evidence
The resolved state is bound to the relevant point in time and to attributable evidence rather than a generic compliance label.
Determination first. Execution rights second.
Two sector gates. Different purposes.
Evidence can strengthen accountability. It does not create medical or regulatory authority.
CAN
- Deterministically evaluate encoded, source-bound conditions.
- Bind domain determinations to a defined transaction or clinical state.
- Surface missing or conflicting authorization dependencies.
CANNOT
- Create ethics, regulatory or medical authority.
- Replace investigators, ethics committees, regulators, QPs or other competent roles.
- Turn a gate result into execution permission by itself.