Chapter 02 · Use Cases

Use Cases as a reviewable surface.

Use cases in Clinical Trials are sorted by the decision they affect and the evidence they require, not by the attractiveness of the tool demonstration.

Focus: trial evidence · GCP · recordsRisk: untraceable influenceBridge: protocol · data · decision record
Clinical Trials traceProtocolSiteDataSafetyAnalysisRecordAIsystemsource to workflow to evidence to review
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Use Cases chapter.

Clinical Trials

Use cases in Clinical Trials are sorted by the decision they affect and the evidence they require, not by the attractiveness of the tool demonstration.

/ A

What this page maps.

operating content
Low-impact support

Low-impact support

Drafting, search, summarisation, and internal preparation where users retain full accountability.

Decision influence

Decision influence

Prioritisation, classification, prediction, recommendation, detection, or triage that changes what a team does next.

Controlled operation

Controlled operation

Repeated workflow use where records, owners, training, monitoring, and escalation are needed.

/ B

Governance questions.

review logic
Question

What decision or record does this use cases surface influence, and who owns that decision?

Question

Which evidence is needed before routine use in Clinical Trials, and where is it retained?

Question

What signal triggers review, restriction, escalation, or retirement?

/ evidence

Evidence-ready minimum record.

iFeed use
Minimum record
OwnerNamed operational, clinical, technical, and governance owners.
UseClear intended use, user group, workflow point, and excluded use.
RiskRisk tier, rationale, residual risks, controls, and escalation route.
EvidenceSource claims, validation basis, limitations, approval decision, and review date.
/ sources

Source anchors and claim boundary.

official first

These anchors support the source layer for this page. iFeed interpretation remains separate from source facts and does not replace legal, regulatory, clinical, or product-specific advice.