AEGIS
// LIFE SCIENCES
WORKBENCH/CASES/MEDTRONIC-ICM-001/02 EVID
TRIAGE OPEN
priya.nair@medtronic
STAGE 02 · CLINICAL EVIDENCE
Resolve 3 inconsistencies in the LINQ-NEXT clinical evidence corpus.
⬢ VECTOR·clinical evidence agent·847 patients · 22 sites · 24-mo follow-up
⚕
DSMB safety status · packet 04 · CLEARED
Independent monitoring board reviewed safety profile through 24-month window. No findings. No halt recommended. Dr. Hiroshi Sato (CMO) is the only person authorized to halt the trial if a signal emerges. Click DSMB HALT above to invoke that path.
TRIAGE QUEUE · YOUR CALL
VECTOR caught 3 inconsistencies in the evidence corpus.
During cross-validation of 847 patient records against the locked SAP, DSMB packets, and PMCF protocol, VECTOR flagged three documentation inconsistencies. Each one needs your sign-off to seal — some you can approve as-is, one needs Hiroshi's medical judgment. The CER cannot ship downstream to Stage 04 (Submission) until all three are resolved.
Critical 1Warning 1Info 1Resolved 0 of 3Blocks downstream 04 SUBM
INC-02-001Adverse event re-classification · M18 follow-up window
CRITICAL · MEDICAL JUDGMENT▶
Discrepancy detected
Patient DBSubject 0418-22 · AE-2024-0117 · classified as Serious AE (related)
Safety summary v6Subject 0418-22 · AE-2024-0117 · listed as Non-serious (unrelated)
Source docDSMB packet 03 narrative section §4.2 · Investigator Brochure v8 §6.1
⬢ VECTOR · recommendationThis is a medical judgment call, not a documentation cleanup. The Patient DB entry was made by the local site investigator at the time of the event. The safety summary was updated 11 days later after CMO consultation but the rationale isn't captured in the audit trail. Escalate to Dr. Hiroshi Sato (CMO) for definitive classification. If Hiroshi rules "serious related," DSMB packet 04 needs re-issuing — adds 2 weeks.
Action required from Priya
INC-02-002Primary endpoint definition mismatch · CER §3.1 vs SAP §2.4
WARNING · DOC CLEANUP▶
Discrepancy detected
CER §3.1"AF detection sensitivity at 24 months, ITT population"
SAP §2.4 (locked)"AF detection sensitivity at 24 months, per-protocol population"
Locked sinceSAP v3 lock · 02 Mar 2026 · receipt 8c12...0e44
⬢ VECTOR · recommendationSAP is the source of truth (locked pre-data-lock). CER §3.1 should be updated to match: "per-protocol population". VECTOR can auto-apply the edit to CER v17 draft on your approval. Receipt chain preserves both versions for audit. No statistical re-analysis required — the actual analysis used per-protocol throughout.
Action required from Priya
INC-02-003PMCF sample-size calculation uses outdated reference population
INFO · METHODOLOGY▶
Discrepancy detected
PMCF protocol v2Sample size n=420 · uses APAC AF prevalence baseline from WHO 2019 dataset
Current standardWHO Global Burden of Disease 2024 update · APAC AF prevalence revised down 8%
ImplicationRecomputed sample size = n=455 · adds ~35 patients to PMCF
⬢ VECTOR · recommendationUpdate PMCF v2 → v3 with WHO 2024 reference. Adds ~35 patients to post-market follow-up cohort. Cost impact: ~$280k additional PMCF spend. Lin Wei should review the statistical methodology before approval.
Action required from Priya
EVIDENCE CORPUS · STAGE 02
Live state of all artifacts
▣
SAP v3
847 pts · per-protocol · locked 02 Mar
LOCKED
▣
DSMB packet 01
M6 review · no findings
LOCKED
▣
DSMB packet 02
M12 review · 1 protocol amend
LOCKED
▣
DSMB packet 03
M18 review · 1 AE narrative
LOCKED
▣
DSMB packet 04
M24 final review · cleared
LOCKED
◇
CER v17 draft
312 pages · 1 inc pending
DRAFT
◇
PMCF protocol v2
3-yr follow-up · 1 inc pending
DRAFT
◇
Safety summary v6
All AEs · 1 inc pending
DRAFT
▣
Investigator Brochure v8
22 sites · final
LOCKED
▣
Patient-level data export
847 pts · SDTM v3.3
LOCKED
10 artifacts · 7 locked · 3 draftOpen evidence explorer →
STAGE OWNERS
Who's accountable
P
Priya Nair
Clinical Affairs Lead · Singapore
PRIMARY
L
Dr. Lin Wei
Regulatory Lead · Hong Kong
STATS
H
Dr. Hiroshi Sato
CMO · Medical Affairs
MEDICAL · HALT
WORKFLOWVECTOR's substages5 of 7 complete · week 4 of ~6
▶
W1
W2
W3
W4
W5
W6
W7
Trial data ingest
847 pts · 22 sites · SDTM v3.3
DONE
SAP lock
v3 · per-protocol pop
DONE
DSMB packet build
4 packets · M6 M12 M18 M24
DONE
CER drafting
v17 · 312 pages · 6 writers
DONE
Cross-validation scan
VECTOR · 3 inconsistencies surfaced
DONE
Triage queue
Priya · 3 open · 0 resolved
GATE
Corpus seal → VECTOR handoff
queued · blocked on triage
PENDING
When all 3 are resolved →
Case attributes · MEDTRONIC-ICM-001
Case IDMEDTRONIC-ICM-001
Device nameLINQ-NEXT
Device classClass III · implantable cardiac monitor
Intended useAF detection · adults · ambulatory
Trial size847 patients · 22 sites
Follow-up window24 months · per-protocol
Primary endpointAF detection sensitivity
DSMB ChairExternal · Dr. K. Yamamoto
Clinical AffairsP. Nair · Singapore
BiostatisticsDr. L. Wei · Hong Kong
Regulatory bodies · evidence requirements
Each regulator will read this evidence corpus differently. Locked artifacts will be re-formatted for each in Stage 04 (Submission · HERMES).
PMDA · JPJapanese subgroup expectations · ICH-E17 alignment
NMPA · CNLocal trial required · this corpus = supporting evidence only
KFDA · KRHTA dossier requires per-protocol + ITT (we have only per-protocol)
HSA · SGReliance on PMDA · this corpus passes via reference
TGA · AUCO-OR scheme · accepts PMDA-reviewed corpus
TFDA · TWReliance · accepts PMDA-cleared evidence
HKMDD VRS · accepts any major regulator
Trust + audit · stage 02 receipt chain · 14 events
d927...3f12VECTOR · 3 inconsistencies surfaced to triage17 May · 14:22
c81e...7b30VECTOR · cross-validation scan complete · 847 pts17 May · 13:48
9a4f...2c91CER v17 draft committed · 312 pages14 May · 17:30
4b2e...e108DSMB packet 04 cleared · no findings10 May · 11:00
8c12...0e44SAP v3 lock · per-protocol population02 Mar · 09:00
7e91...41b8DSMB packet 03 cleared · 1 AE narrative noted15 Jan · 14:00
1f0c...9d56Trial data SDTM v3.3 export · 847 pts locked04 Jan · 16:00
091d...4f8aHandoff received from MERIDIAN · Stage 01 sealed12 Mar · 17:30
⚠ DSMB HALT · TRIAL EMERGENCY STOP

This is the irreversible emergency stop path. If the DSMB has flagged a safety signal that requires halting the LINQ-NEXT trial, this action records a permanent halt receipt and notifies PMDA, KFDA, NMPA, TGA, HSA, TFDA, and HK regulators within statutory windows.

This action is restricted to Dr. Hiroshi Sato (CMO). Neither VECTOR nor any other agent can invoke this. The system requires two-factor confirmation and a brief medical rationale that becomes part of the permanent audit record.

CURRENT STATUS
DSMB packet 04 reviewed and cleared 10 May 2026.
No active safety signals detected.
Halt path is dormant. No reason to invoke at this time.
Stage ThreadVECTOR · LIVE
02 EVID · 14 events · triage open
VECTOR → TRIAGE17 May · 14:22
Surfacing 3 inconsistencies. INC-02-001 is critical (AE classification, medical judgment needed). INC-02-002 is documentation cleanup (CER vs SAP wording). INC-02-003 is methodology (PMCF reference data outdated). Routing to Priya. INC-02-001 likely escalates to Hiroshi.
d927...3f12· TRIAGE GATE
VECTOR17 May · 13:48
Cross-validation scan complete. 847 patients × 312-page CER × DSMB packets × SAP × PMCF protocol. Found: 1 critical (subject 0418-22 classification), 1 warning (endpoint definition wording), 1 info (PMCF reference data). All other artifacts internally consistent.
VECTOR14 May · 17:30
CER v17 draft committed. 6 writers contributed across 4 weeks. 312 pages. Cross-references verified internally before queuing the SAP/DSMB/PMCF reconciliation scan.
VECTOR10 May · 11:00
DSMB packet 04 (M24 final review) prepared and cleared. Dr. K. Yamamoto (DSMB Chair) found no safety signals. Trial completed per protocol.
VECTOR02 Mar · 09:00
SAP v3 locked. Per-protocol population. Primary endpoint: AF detection sensitivity at 24mo. Receipt 8c12...0e44.
Coming soon

This surface ships in the next demo cut.

For the LINQ-NEXT walkthrough, the agent's reasoning trace and the sealed receipts are the proof — every action you've seen so far is governance-traceable.

Ask Ujjwal what you'd like to see next.

Handoff packet · VECTOR · 02 Clinical Evidence → ATLAS · 03 Health Economics
FROMVECTOR · 02 Clinical Evidence
TOATLAS · 03 Health Economics
RECEIPT3e7c…8b29
CER VERSIONv17 locked · 312 pages
EVIDENCE BASE847 patients · 22 sites · 24-mo follow-up
DSMB STATUSPacket 04 cleared · no findings · no halt
SAFETY PROFILEAE rate 2.3% · serious related 0.4% · within Reveal LINQ envelope
INC-02-001Escalated to Hiroshi Sato (CMO) · classification pending
INC-02-002Resolved · CER §3.1 aligned with SAP §2.4
INC-02-003Resolved · PMCF sample-size methodology updated
Evidence corpus · LINQ-NEXT · 10 artifacts · 7 sealed
ArtifactTypeStatusReceiptLast updated
SAP v3Statistical Analysis PlanLOCKEDf12b…77e022 Apr · Lin Wei
DSMB packet 01Data Safety MonitoringLOCKED7a3c…2018M6 review
DSMB packet 02Data Safety MonitoringLOCKED8b4d…3129M12 · 1 amendment
DSMB packet 03Data Safety MonitoringLOCKED9c5e…4230M18 · 1 AE narrative
DSMB packet 04Data Safety MonitoringLOCKEDd45a…c901M24 · cleared
CER v17 draftClinical Evaluation ReportDRAFTbuilding…312 pages · 1 inc pending
PMCF protocol v2Post-Market Clinical Follow-upDRAFTbuilding…3-yr · 1 inc pending
Safety summary v6Safety SummaryDRAFTbuilding…All AEs · 1 inc pending
Investigator Brochure v8Investigator DocLOCKEDe62f…534122 sites · final
Patient-level data exportSDTM v3.3LOCKEDf73a…6452847 patients
Download full corpus (SDTM) →