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Provenance & Explainability

Can you defend every decision?

The protocol is the anchor.

The reference never disappears.

Every regulated output in PrismCDM carries its lineage forward - from protocol requirement through operational decision, evidence, submission, and inspection.

The protocol establishes intent. Approved rules and human decisions carry that intent through execution. PrismCDM preserves the complete chain.

Don't trust us. Verify us.
  • Every decision is attributable.
  • Every transformation is versioned.
  • Every artifact is traceable to its source, governing rule, and approval history.
Decision Lineage

Every regulated decision carries its authority forward.

The protocol is the primary anchor. As recommendations become operational decisions, evidence records, and submission artifacts, PrismCDM preserves the protocol reference together with every governing rule, system version, operator, approval, and transformation.

AI reasoning remains available inside each recommendation. This page shows what happened after that recommendation entered regulated execution.

NCT02******
Click any step to see details
1
Protocol Requirement

A specific protocol section - eligibility criterion, endpoint, Schedule of Activities row, or safety requirement - establishes the study intent.

Anchor
2
Recommendation
REC-*

A structured recommendation cites the protocol requirement, supporting evidence, priority, and expected operational impact.

Explainability
3
Operational Decision

A qualified operator accepts, modifies, defers, or rejects the recommendation. Identity, timestamp, rationale, and approval are recorded.

Operator + Time
4
Evidence Record

The decision becomes part of the Inspection Evidence Package, preserving its source, rationale, approval, and resulting operational event.

Evidence Package
5
Submission Artifact

Evidence is transformed into Define-XML, SDRG, ADRG, CSR content, and TFLs, with lineage preserved through each mapping and transformation.

Submission Ready
6
Inspection Traceback

A reviewer can trace any submitted claim backward through its evidence, decision history, recommendation, and originating protocol requirement.

Traceable
The protocol reference never disappears.
Why was REC-021 recommended?expand
Protocol section
Sec 6.2 · Eligibility
Supporting evidence
3 findings cited
Finding IDs
FIND-014, FIND-019, FIND-022
Assessment rule
PTII v1 · PCI band
Engine version
CIE v1.2 · build v1.6.3
Human review
Approved · 2026-04-24

Reasoning below is Explainability, not Provenance. It shows how the recommendation was reached. Provenance above shows everything that happened because of it.

ExtractionClinical Intelligence Engine

Structured intelligence extracted from the protocol - complexity dimensions, operational burden, eligibility characteristics.

AssessmentPTII™

Composite index and sub-indices computed from the extracted intelligence.

FindingFIND-*

Structured observation surfaced from the extraction and assessment layers, cited by the recommendation.

Demonstration generated by PrismCDM using publicly available ClinicalTrials.gov protocol information (NCT02******). This analysis was independently produced by PrismCDM and has not been reviewed or endorsed by the study sponsor.

Central-Lab Reconciliation Workflow

What Decision Lineage actually looks like end to end.

A concrete example: a lab assessment captured at Cycle 1 Day 8, traced from the protocol Schedule of Activities row that requires it, through data capture, query, reconciliation, and SDTM emission, all the way to the inspector who reviews the CSR.

Central-Lab Reconciliation
Cycle 1 Day 8 · Representative
  1. 1
    Protocol Requirement

    The Schedule of Activities requires a laboratory assessment within the Cycle 1 Day 8 visit window.

  2. 2
    Lab eCRF Drafted

    Engine drafts required lab fields mapped to the protocol row.

  3. 3
    eCRF Schema Approved

    CDM Lead reviews, accepts, and e-signs. Fields carry protocol reference.

  4. 4
    Subject Visit Completed

    Site performs visit. Data entry tied to approved fields.

  5. 5
    Vendor Result Imported

    Central-lab file imported. Each value inherits its eCRF-field reference.

  6. 6
    Query Raised and Resolved

    Out-of-window. Query cites the protocol window and the edit-check rule. Site resolves.

  7. 7
    Reconciliation Approved

    Central-lab and EDC records are reconciled against the protocol requirement and approved reconciliation rules.

  8. 8
    SDTM LB Generated

    Reconciled result flows into SDTM LB domain with mapped lineage.

  9. 9
    Submission Artifacts Updated

    Define-XML entry, SDRG section, and CSR lab table refresh with preserved lineage.

  10. 10
    Inspection Traceback

    Inspector picks the CSR lab table and traces back to the protocol row.

Every arrow is a stamped provenance event - capturing the operator or system, timestamp, version, governing rule, and resulting artifact.

Explainability vs Provenance

Two distinct questions. One platform answers both.

Explainability

Why was this recommendation made?

  • Shows the reasoning
  • Identifies supporting evidence
  • Cites relevant protocol requirements
  • Supports scientific and operational review
Provenance

How did it become a regulated outcome?

  • Records each decision and transformation
  • Preserves operators, approvals, versions, and timestamps
  • Connects every resulting artifact
  • Supports QA review, submission preparation, and inspection traceback

Explainability defends the reasoning. Provenance defends the record.

The distinction that matters

Trial Intelligence answers why. Provenance shows what happened, who approved it, and where it ended.

Early Access

See a decision walked back to its source.

Bring one of your studies. We'll select a real operational decision and trace it backward through its evidence, approvals, transformations, and governing rules until it reaches the protocol requirement that initiated the chain.

Amendment approval traceback
Query resolution lineage
Coding sign-off proof
Reconciliation disposition lineage