GalenOps prod · 0.1.0

Agent

TMF inspection-ready

Horizon 1 tmf_agent

Trial master file audited against the DIA TMF Reference Model; gaps filed as QA findings.

Escalates: Missing essential artefacts become open QA findings; the file is audited continuously rather than at inspection — to the quality assurance.

Agents

Runs

3

Escalations

2

Failures

0

Avg duration

4.6 s

Literature & benchmarks

  • DIA TMF Reference Model v3.0 — expected essential-artefact set by zone
  • ICH E6(R2) §8 — essential documents for the conduct of a clinical trial

Run history (3 across all studies)

Newest first, 50 per page. Expand a row for the recorded reasoning and evidence.

Expand When Study Outcome Model Duration Reasoning
2026-09-29 23:43 UTC A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma escalated human claude-sonnet-5 4.4 s This TMF self-audit against the DIA TMF Reference Model v3.2.1 at closeout stage shows completeness of 0.6, below the 0.8 threshold, triggering escalation. Of 18 auditable artifacts, 8 are fully present, 5 partial, and 5 missing. Top missing items: 03.01.01 Regulatory Submission (none on file, score 0.0), 07.02.01 Expedited Safety Report (5 serious events past the expedited-reporting due date, score 0.0), and 02.03.01 Clinical Study Report (on file but not final, score 0.5). Additional concerns include 05.04.03 Monitoring Visit Report missing for 0 of 31 sites, 05.04.07 Financial Documentation missing for 0 of 31 sites, and 10.02.04 with 86 open data queries older than 30 days (score 0.02). 10 findings have been filed, 0 updated, 0 resolved; 31 artifacts require manual upload. A human reviewer is asked to decide how to proceed with the TMF review given completeness of 0.6 versus the 0.8 threshold.
2026-09-29 21:14 UTC A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer completed claude-sonnet-5 4.9 s This TMF self-audit against the DIA TMF Reference Model v3.2.1 (conduct stage) shows completeness of 0.66 against a threshold of 0.8, with 8 of 16 auditable artifacts present and 5 partial. The three top missing items are all critical or near-critical: Expedited Safety Report (07.02.01) is missing, with 11 serious event(s) past the expedited-reporting due date and a score of 0.0; Protocol (02.01.02) is only partial (score 0.5) because it is on file but not approved; and Regulatory Submission (03.01.01) is partial (score 0.5) as it was drafted but not submitted. Additionally, SAE Report (07.02.02) shows 12 of 98 serious events not yet assessed (score 0.88), Monitoring Visit Report (05.04.03) is missing for 0 of 15 sites, and Financial Documentation (05.04.07) is present for only 1 of 15 sites (score 0.07). One finding (07.02.01) was updated; review is pending since completeness is below the 0.8 threshold. A human should decide whether to open/escalate the pending TMF review given the missing Expedited Safety Reports and unapproved Protocol/Regulatory Submission.
2026-09-19 08:59 UTC A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer escalated human claude-sonnet-5 4.6 s This TMF self-audit against the DIA TMF Reference Model v3.2.1 (conduct stage) reports completeness of 0.65 against a threshold of 0.8, with 8 of 16 auditable artifacts fully present and 5 partial, triggering escalation for TMF review since completeness is below 0.8. The top missing items are critical: 07.02.01 Expedited Safety Report shows "4 serious event(s) past the expedited-reporting due date"; 02.01.02 Protocol is "on file but not approved"; and 03.01.01 Regulatory Submission is "drafted but not submitted." Additional gaps include 05.04.03 Monitoring Visit Report missing for 0 of 15 sites, 05.04.07 Financial Documentation present for only 1 of 15 sites (score 0.07), 07.02.02 SAE Report with 12 of 98 serious events unassessed, and 10.02.04 showing 4 open data queries older than 30 days. 8 findings were filed, 0 resolved, and 26 artifacts require manual upload. A human reviewer must decide how to prioritize remediation and whether the outstanding expedited safety reporting and protocol/regulatory approval gaps warrant immediate corrective action before the TMF review is closed.