Finding, Decision, and Evidence

Category: Findings, decisions, and evidence objects
Review status: Proposed

Finding

A Finding is an identified concern that requires evaluation. It does not assume the concern is correct or prescribe a universal resolution workflow.

Field	Type	Meaning
`identity`	`FindingIdentity`	Stable identity within its owning domain
`subject`	`FindingSubject`	Object, occurrence, observation, or evidence concerned
`detectedBy`	`DetectionSource`	Person, rule, comparison, or external report
`detectedAt`	`ClinicalDateTime`	When the concern was identified
`statement`	`FindingStatement`	Precise concern requiring evaluation
`evidence`	`EvidenceReference[]`	Evidence available at detection
`assessmentHistory`	`FindingAssessment[]`	Confirmations, classifications, and impact assessments

Specializations include DataQuery, MonitoringFinding, ProtocolDeviationCandidate, QualitySignal, SafetyIntake, and ReconciliationDiscrepancy.

Decision

A Decision records an authoritative conclusion.

class DomainDecision<TQuestion, TOutcome> {
  identity: DecisionIdentity;
  question: TQuestion;
  outcome: TOutcome;
  authority: DecisionAuthority;
  decisionMaker: ActorReference;
  evidenceConsidered: EvidenceReference[];
  rationale: Rationale;
  decidedAt: ClinicalDateTime;
  effectiveAt: ClinicalDateTime;
  supersedes?: DecisionReference;
}

Important specializations:

SiteSelectionDecision
SiteActivationDecision
ConsentDecision
EligibilityDecision
TreatmentAssignment
UnblindingDecision
CodingDecision
DeviationDisposition
QualityDecision
DatabaseLockDecision

Evidence

An EvidenceRecord is durable proof that allows an action, occurrence, observation, or decision to be reconstructed.

Field	Type	Meaning
`subject`	`EvidenceSubjectReference`	What is evidenced
`actor`	`ActorReference`	Who performed or decided
`authority`	`AuthorityReference`	Why the actor could act
`statement`	`EvidenceStatement`	Meaning being attested or recorded
`occurredAt`	`ClinicalDateTime`	When the evidenced event occurred
`recordedAt`	`ClinicalDateTime`	When the evidence was captured
`reason`	`Reason?`	Required explanation where applicable
`source`	`EvidenceSource`	Originating source or instrument
`integrity`	`IntegrityProof`	Means of detecting alteration
`provenance`	`ProvenanceChain`	Derivation and transfer history

Trial Artifact

A TrialArtifact assigns trial-record meaning to evidence or content. It is not merely a file. It may represent a document, dataset, certified copy, signed record, or structured evidence package.

Rules

Closing a finding does not erase the original concern.
A decision identifies the exact question and evidence considered.
Corrected decisions supersede rather than rewrite prior decisions.
An electronic signature binds a signer and statement to an exact object version.
Evidence must remain interpretable after the originating application is replaced.
A Trial Artifact’s filing classification does not redefine the underlying clinical fact.