eTMF domain model

eTMF responsibility

eTMF owns the plan, expectations, classification, quality, finality, completeness, timeliness, and inspection availability of essential trial records. It does not own the operational event evidenced by a record, and a generic document lifecycle cannot substitute for TMF semantics.

Object separation

TMFPlan
├── taxonomy version
├── applicable study processes
├── roles and timeliness rules
└── ExpectedArtifact set

ExpectedArtifact
└── expects zero or more EssentialRecord instances

EssentialRecord
├── classifies against ArtifactDefinition
├── files at Study | Country | Site scope
├── references one current DocumentVersion
├── receives QualityReview decisions
└── may supersede another EssentialRecord

ArtifactDefinition describes a class of content. ExpectedArtifact says that content is expected for a particular study scope and time. EssentialRecord is the regulated record instance. DocumentVersion is the immutable content evidence. Filing expresses why and where the record belongs. Collapsing these into “Document” loses the model.

Core objects

Object	Required fields	Behaviour and invariant
TMFPlan	study, taxonomy version, effective version, roles, quality/timeliness policy	approve, revise, retire; revisions preserve prior expectations
ArtifactDefinition	taxonomy, version, code, name, purpose, recommended level	reference definition; never mutated locally
ExpectedArtifact	artifact, study scope, applicability, expected milestone/window, owner	applicable, not applicable, expected, waived; every exception has a decision
EssentialRecord	artifact, filing scope, state, finality, content reference	receive, classify, review, finalize, supersede, withdraw
DocumentVersion	content identity, version, rendition, checksum, issued time	immutable after issue; correction produces another version
Filing	record, artifact, exact study/country/site scope, filed time	one record may have governed multiple filing associations without content duplication
QualityReview	record version, reviewer, criteria, result, defects	applies to an exact content/classification revision
TMFException	expectation/record, rule, rationale, approver, effective period	never represented by blank content or a generic note
CompletenessAssessment	expected set, present set, cut-off time, result	distinguishes not expected, missing, late, rejected, and final
InspectionRequest	authority/auditor, request scope, due time	assemble, provide, clarify, close while preserving disclosed set

EssentialRecord lifecycle

expected
  └─ received
       └─ quality-review
            ├─ rejected ──> corrected version received
            └─ accepted ──> final
                              └─ superseded

withdrawn is a governed terminal outcome, never deletion.

Finalization requires:

• a current immutable DocumentVersion;
• an accepted quality decision against that exact version and classification;
• one valid filing scope;
• required metadata and signatures/certification where applicable;
• no unresolved blocking defect.

Completeness and timeliness

Completeness is derived against ExpectedArtifact, not a count of uploaded documents.

ExpectedArtifact status
├── not-applicable     governed applicability decision
├── not-yet-due        expectation exists, window has not opened
├── due                expected now, no acceptable record
├── received           content exists, quality not accepted
├── rejected           content/classification failed review
├── final              acceptable final record fulfills expectation
└── overdue            due window passed without fulfillment or exception

TMF health metrics must retain the assessment cut-off time, plan version, expected population, and rule version. A percentage without those inputs is not durable evidence.

Cross-product contracts

eTMF consumes: StudyVersionApproved, StudyCountryIncluded, StudySiteSelected, StudySiteActivated, ApprovalGranted, MonitoringVisitCompleted, SafetyReportSubmitted, CasebookLocked, FinalCRFPackageGenerated, SiteClosed, and StudyClosed.

These facts may create or mature artifact expectations; they do not automatically create an accepted Essential Record.

eTMF publishes: EssentialRecordReceived, EssentialRecordRejected, EssentialRecordFinalized, EssentialRecordSuperseded, ExpectedArtifactOverdue, TMFCompletenessAssessed, and InspectionPackageProvided.

Product evidence → TechSol decision

Observed product concept	TechSol domain concept	Modelling decision
EDL	RecordExpectationPlan	a scoped, versioned set of record expectations
EDL Item / Expected Document	ExpectedRecord	requiredness, expected count, milestone, person/organization/product scope
Matched document	ExpectationFulfillment	relationship between expectation and exact Document Version; not object identity
Document steady state	ContentFinality	platform state is evidence used by the TMF acceptance decision
Completeness matching	CompletenessAssessment	derived at cut-off against plan/rule versions
Document Inbox / classification	RecordIntake and FilingDecision	receipt and classification remain distinct from acceptance
Quality Issue	RecordQualityIssue	an assigned defect against exact record/content revision
TMF Homepage metrics	TMFHealthAssessment	quality, timeliness and completeness retain calculation provenance

Mature eTMF products count matched steady-state documents against expected counts. TechSol retains that useful mechanism but models the match as a governed fulfillment relationship so one content version, duplicate content, supersession and multi-filing scenarios can be reasoned about explicitly.

Product decisions requiring review

1. Can one Essential Record fulfill several Expected Artifacts, and under what classification rule?
2. Is Filing an entity with its own history or a value owned by Essential Record?
3. How are records shared across study, country, and site scope without uncontrolled duplication?
4. Which quality defects block finalization and which permit conditional acceptance?
5. Does supersession operate at content version, record instance, expectation fulfillment, or all three?
6. How is investigator-site-file responsibility represented without assuming one physical system?
7. Which operational milestones create expectations, change due dates, or close applicability?

Standards alignment

Artifact taxonomy and filing-level semantics are cross-checked against the TMF Reference Model resources.