Agent

Sites risk-scored

Horizon 2 monitoring_agent

Per-site KRIs z-scored across the study; statistical outliers get a proposed on-site visit.

Escalates: Sites whose key risk indicators breach threshold, with a proposed on-site visit a CRA must confirm (high priority) — to the clinical research associate / clinical lead.

Agents

Runs

Escalations

Failures

Avg duration

4.5 s

Literature & benchmarks

ACRO RBQM landscape survey (Barnes et al. 2021) — KRI set: query rate, AE rate, protocol deviations, data-entry lag
Centralised statistical monitoring (ICH E6(R2) §5.18.3) — sites compared against the study distribution rather than a fixed cut-off

Run history (3 across all studies)

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

When

Study

Outcome

Model

Duration

Reasoning

2026-09-29 23:42 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

5.5 s

Centralized statistical monitoring reviewed 34 sites and 140 patients across 11 KRIs (as of 2014-12-15), following the TransCelerate RBM KRI set and Barnes et al. 2021 RBQM approach. No site reached the composite threshold of 1.5, but three sites triggered the single-KRI rule (|z| ≥ 2.5, per the study's threshold): Royal Perth Hospital (visit-window compliance 50% vs study mean 88%, z=-2.92; missed-visit rate 12% vs mean 3%, z=2.73; risk score 0.496), State Health Centre Oncology Department, Budapest (enrollment 2.11 vs mean 0.67, z=3.36; risk 0.359), and Lviv State Oncological Center (lab flags 18.00 vs mean 9.74, z=2.54; risk 0.34). On-site visits have been proposed for these three sites, pending CRA confirmation; remaining 31 sites are assessed as adequate for remote/centralized monitoring. A human reviewer is asked to confirm or decline the proposed on-site visits for these three flagged sites.

Input: 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 — as_of="2014-12-15", benchmarks=["Barnes et al. 2021 (ACR

Evidence

As of: 2014-12-15
Deterministic summary: Centralized statistical monitoring across 34 site(s), 140 patient(s), 11 KRI(s) z-scored as of 2014-12-15 (18 site(s) with fewer than 3 patients reported but kept out of the peer comparison). 3 outlier site(s): Royal Perth Hospital (Perth, Australia): visit-window compliance 50% vs study mean 88%, z=-2.92, missed-visit rate 12% vs study mean 3%, z=2.73 (trigger: single KRI |z| 2.92 ≥ 2.5; risk 0.496). State Health Centre Oncology Department (Budapest, Hungary): enrollment per open month 2.11 vs study mean 0.67, z=3.36 (trigger: single KRI |z| 3.36 ≥ 2.5; risk 0.359). Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine): lab flags per patient 18.00 vs study mean 9.74, z=2.54 (trigger: single KRI |z| 2.54 ≥ 2.5; risk 0.34). On-site visit(s) proposed for 3 site(s), pending CRA confirmation. Remaining 31 site(s): remote/centralized monitoring adequate.
Method: Each KRI z-scored across the study's sites (population sd; skipped when fewer than 3 sites or sd = 0). Composite = weighted mean of |z|. risk_score = 1 - exp(-composite/2): a heuristic 0–1 scale, not a calibrated probability. Deviations in either direction count — under-reporting is a signal too.
Patients: 140
Planned visits: 16
Review opened: yes
Sites: 34

Benchmarks

Barnes et al. 2021 (ACRO) RBQM model: initial + ongoing risk assessment, QTLs, KRIs, centralized statistical monitoring, remote monitoring, reduced SDV; 93% remote visits in 2020 with no loss of protocol-deviation detection.
Amatya & Edgerton 2021 (JSCDM): data-review SLA of 14 days — queries open longer are the aging KRI.
TransCelerate RBM KRI set: SAE rate, deviation rate, query aging, visit-window compliance, enrollment rate, withdrawal rate.

Kri table

Composite	Drivers	In peer comparison	Kris	Outlier	Patients	Risk score	Site	Site id
0.47	missed_visit_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.63 Weight 0.00 Z 0.77 Enrollment per month Value 0.89 Weight 1.00 Z 0.52 Grade3 rate Value 1.38 Weight 0.00 Z 0.13 Lab flag density Value 8.81 Weight 1.00 Z -0.28 Major deviation rate Value 0.13 Weight 2.00 Z 0.16 Minor deviation rate Value 0.44 Weight 0.00 Z 0.24 Missed visit rate Value 0.00 Weight 1.50 Z -1.00 Open findings Value 2.00 Weight 0.00 Z 1.98 Sae rate Value 0.75 Weight 2.00 Z 0.34 Visit window compliance Value 0.77 Weight 1.50 Z -0.88 Withdrawal rate Value 0.13 Weight 1.00 Z 0.08	no	16	0.21	Sarcoma Oncology Center (Santa Monica, CA)	50cf7a9a-b936-4932-b39f-bd9e70ccaba0
0.54	missed_visit_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.80 Weight 0.00 Z 1.47 Enrollment per month Value 0.40 Weight 1.00 Z -0.62 Grade3 rate Value 1.80 Weight 0.00 Z 0.89 Lab flag density Value 10.80 Weight 1.00 Z 0.33 Major deviation rate Value 0.00 Weight 2.00 Z -0.79 Minor deviation rate Value 0.20 Weight 0.00 Z -0.40 Missed visit rate Value 0.00 Weight 1.50 Z -1.00 Open findings Value 0.00 Weight 0.00 Z -0.90 Sae rate Value 0.60 Weight 2.00 Z -0.05 Visit window compliance Value 0.91 Weight 1.50 Z 0.26 Withdrawal rate Value 0.00 Weight 1.00 Z -0.89	no	5	0.24	Stanford University (Stanford, CA)	84e3a04e-ac9e-41eb-87b0-6e5699bda16f
0.49	missed_visit_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.40 Weight 0.00 Z -0.12 Enrollment per month Value 0.31 Weight 1.00 Z -0.82 Grade3 rate Value 1.40 Weight 0.00 Z 0.18 Lab flag density Value 9.60 Weight 1.00 Z -0.04 Major deviation rate Value 0.00 Weight 2.00 Z -0.79 Minor deviation rate Value 0.20 Weight 0.00 Z -0.40 Missed visit rate Value 0.06 Weight 1.50 Z 0.98 Open findings Value 0.00 Weight 0.00 Z -0.90 Sae rate Value 0.60 Weight 2.00 Z -0.05 Visit window compliance Value 0.88 Weight 1.50 Z 0.01 Withdrawal rate Value 0.00 Weight 1.00 Z -0.89	no	5	0.22	University of Iowa (Iowa City, IA)	409eab2c-3894-47f9-85db-ce7522d124da
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 1.00 Weight 0.00 Z — Enrollment per month Value 0.21 Weight 1.00 Z — Grade3 rate Value 0.50 Weight 0.00 Z — Lab flag density Value 8.50 Weight 1.00 Z — Major deviation rate Value 0.00 Weight 2.00 Z — Minor deviation rate Value 0.50 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value 0.50 Weight 2.00 Z — Visit window compliance Value 1.00 Weight 1.50 Z — Withdrawal rate Value 0.00 Weight 1.00 Z —	no	2	0.00	Pennsylvania Hematology Oncology Associates (Philadelphia, PA)	0fa943e9-2242-49cc-870d-9a853ad9f74e
0.75	sae_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.55 Weight 0.00 Z 0.46 Enrollment per month Value 0.84 Weight 1.00 Z 0.41 Grade3 rate Value 1.82 Weight 0.00 Z 0.92 Lab flag density Value 10.18 Weight 1.00 Z 0.14 Major deviation rate Value 0.09 Weight 2.00 Z -0.10 Minor deviation rate Value 0.18 Weight 0.00 Z -0.45 Missed visit rate Value 0.02 Weight 1.50 Z -0.38 Open findings Value 1.00 Weight 0.00 Z 0.54 Sae rate Value 1.54 Weight 2.00 Z 2.44 Visit window compliance Value 0.98 Weight 1.50 Z 0.74 Withdrawal rate Value 0.09 Weight 1.00 Z -0.18	no	11	0.31	CTRC Institute for Drug Development, University of Texas (San Antonio, TX)	4f404d5e-fba8-4cc7-9e7c-ac5c122a596c
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.50 Weight 0.00 Z — Enrollment per month Value 0.20 Weight 1.00 Z — Grade3 rate Value 1.00 Weight 0.00 Z — Lab flag density Value 11.00 Weight 1.00 Z — Major deviation rate Value 0.00 Weight 2.00 Z — Minor deviation rate Value 0.50 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value 0.50 Weight 2.00 Z — Visit window compliance Value 0.83 Weight 1.50 Z — Withdrawal rate Value 0.00 Weight 1.00 Z —	no	2	0.00	Royal North Shore (St Leonards, Australia)	7c128891-7ca6-4acc-b013-9f1ccce7c014
0.99	major_deviation_rate withdrawal_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.00 Weight 0.00 Z -1.72 Enrollment per month Value 0.69 Weight 1.00 Z 0.04 Grade3 rate Value 0.67 Weight 0.00 Z -1.13 Lab flag density Value 10.67 Weight 1.00 Z 0.29 Major deviation rate Value 0.33 Weight 2.00 Z 1.75 Minor deviation rate Value 0.33 Weight 0.00 Z -0.04 Missed visit rate Value 0.00 Weight 1.50 Z -1.00 Open findings Value 1.00 Weight 0.00 Z 0.54 Sae rate Value 0.33 Weight 2.00 Z -0.75 Visit window compliance Value 1.00 Weight 1.50 Z 0.93 Withdrawal rate Value 0.33 Weight 1.00 Z 1.70	no	3	0.39	Epworth HealthCare Clinical Trials and Research Centre (Richmond, Australia)	909e1581-bb8b-4438-b32c-e3d2fddb8ba4
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 1.00 Weight 0.00 Z — Enrollment per month Value 0.11 Weight 1.00 Z — Grade3 rate Value 1.00 Weight 0.00 Z — Lab flag density Value 12.00 Weight 1.00 Z — Major deviation rate Value 0.00 Weight 2.00 Z — Minor deviation rate Value 1.00 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value 0.00 Weight 2.00 Z — Visit window compliance Value 1.00 Weight 1.50 Z — Withdrawal rate Value 0.00 Weight 1.00 Z —	no	1	0.00	Border Medical Oncology (Wodonga, Australia)	d1c3851a-fc13-4fe6-9701-5b9c4e79a3c6
1.05	sae_rate major_deviation_rate withdrawal_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.33 Weight 0.00 Z -0.39 Enrollment per month Value 0.90 Weight 1.00 Z 0.55 Grade3 rate Value 2.67 Weight 0.00 Z 2.42 Lab flag density Value 10.00 Weight 1.00 Z 0.08 Major deviation rate Value 0.33 Weight 2.00 Z 1.75 Minor deviation rate Value 0.33 Weight 0.00 Z -0.04 Missed visit rate Value 0.05 Weight 1.50 Z 0.59 Open findings Value 1.00 Weight 0.00 Z 0.54 Sae rate Value 1.33 Weight 2.00 Z 1.88 Visit window compliance Value 0.88 Weight 1.50 Z -0.03 Withdrawal rate Value 0.33 Weight 1.00 Z 1.70	no	3	0.41	Royal Hobart Hospital (Hobart, Australia)	8f16fbab-437a-4283-b962-7ce75c4550df
1.37	visit_window_compliance missed_visit_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.00 Weight 0.00 Z -1.72 Enrollment per month Value 0.35 Weight 1.00 Z -0.74 Grade3 rate Value 0.75 Weight 0.00 Z -0.98 Lab flag density Value 5.75 Weight 1.00 Z -1.23 Major deviation rate Value 0.00 Weight 2.00 Z -0.79 Minor deviation rate Value 0.00 Weight 0.00 Z -0.94 Missed visit rate Value 0.12 Weight 1.50 Z 2.73 Open findings Value 0.00 Weight 0.00 Z -0.90 Sae rate Value 0.50 Weight 2.00 Z -0.31 Visit window compliance Value 0.50 Weight 1.50 Z -2.92 Withdrawal rate Value 0.25 Weight 1.00 Z 1.05	yes	4	0.50	Royal Perth Hospital (Perth, Australia)	0d883291-bccc-4399-a391-5632bf05da34
0.00	none	no	Aged query rate Value — Weight 1.00 Z — Death rate Value — Weight 0.00 Z — Enrollment per month Value — Weight 1.00 Z — Grade3 rate Value — Weight 0.00 Z — Lab flag density Value — Weight 1.00 Z — Major deviation rate Value — Weight 2.00 Z — Minor deviation rate Value — Weight 0.00 Z — Missed visit rate Value — Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value — Weight 2.00 Z — Visit window compliance Value — Weight 1.50 Z — Withdrawal rate Value — Weight 1.00 Z —	no	0	0.00	Mount Medical Centre (Perth, Australia)	8ec70322-679f-46c9-a3c3-b183cf9c90c3
0.65	lab_flag_density	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.40 Weight 0.00 Z -0.12 Enrollment per month Value 0.47 Weight 1.00 Z -0.47 Grade3 rate Value 1.40 Weight 0.00 Z 0.18 Lab flag density Value 5.60 Weight 1.00 Z -1.27 Major deviation rate Value 0.00 Weight 2.00 Z -0.79 Minor deviation rate Value 0.60 Weight 0.00 Z 0.68 Missed visit rate Value 0.04 Weight 1.50 Z 0.32 Open findings Value 0.00 Weight 0.00 Z -0.90 Sae rate Value 0.80 Weight 2.00 Z 0.48 Visit window compliance Value 0.95 Weight 1.50 Z 0.54 Withdrawal rate Value 0.00 Weight 1.00 Z -0.89	no	5	0.28	The Crown Princess Mary Cancer Centre Westmead (Sydney, Australia)	781c777e-0b3b-4d98-8ed8-f7ae9476d27a
0.89	enrollment_per_month	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.47 Weight 0.00 Z 0.14 Enrollment per month Value 2.11 Weight 1.00 Z 3.36 Grade3 rate Value 0.87 Weight 0.00 Z -0.77 Lab flag density Value 8.13 Weight 1.00 Z -0.49 Major deviation rate Value 0.03 Weight 2.00 Z -0.54 Minor deviation rate Value 0.30 Weight 0.00 Z -0.13 Missed visit rate Value 0.03 Weight 1.50 Z 0.06 Open findings Value 1.00 Weight 0.00 Z 0.54 Sae rate Value 0.27 Weight 2.00 Z -0.93 Visit window compliance Value 0.76 Weight 1.50 Z -0.90 Withdrawal rate Value 0.20 Weight 1.00 Z 0.67	yes	30	0.36	State Health Centre Oncology Department (Budapest, Hungary)	70b2d866-f929-4c12-860a-0f9127f4e5b9
0.00	none	no	Aged query rate Value — Weight 1.00 Z — Death rate Value — Weight 0.00 Z — Enrollment per month Value — Weight 1.00 Z — Grade3 rate Value — Weight 0.00 Z — Lab flag density Value — Weight 1.00 Z — Major deviation rate Value — Weight 2.00 Z — Minor deviation rate Value — Weight 0.00 Z — Missed visit rate Value — Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value — Weight 2.00 Z — Visit window compliance Value — Weight 1.50 Z — Withdrawal rate Value — Weight 1.00 Z —	no	0	0.00	Hemato Oncology Clinic, Vedanta Institute of Medical Science (Thaltej, India)	2f346df6-548a-446f-8f0e-6de00e88c82c
0.77	lab_flag_density	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.75 Weight 0.00 Z 1.27 Enrollment per month Value 0.45 Weight 1.00 Z -0.51 Grade3 rate Value 1.00 Weight 0.00 Z -0.53 Lab flag density Value 6.00 Weight 1.00 Z -1.15 Major deviation rate Value 0.00 Weight 2.00 Z -0.79 Minor deviation rate Value 0.25 Weight 0.00 Z -0.26 Missed visit rate Value 0.05 Weight 1.50 Z 0.67 Open findings Value 0.00 Weight 0.00 Z -0.90 Sae rate Value 0.25 Weight 2.00 Z -0.97 Visit window compliance Value 0.93 Weight 1.50 Z 0.42 Withdrawal rate Value 0.00 Weight 1.00 Z -0.89	no	4	0.32	Hemato Oncology Clinic, Vedanta Institute of Medical Science (Ahmedabad, India)	c21d4c9a-b417-47f7-abc4-a5a99fb15f35
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 1.00 Weight 0.00 Z — Enrollment per month Value 0.12 Weight 1.00 Z — Grade3 rate Value 1.00 Weight 0.00 Z — Lab flag density Value 6.00 Weight 1.00 Z — Major deviation rate Value 0.00 Weight 2.00 Z — Minor deviation rate Value 1.00 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value 0.00 Weight 2.00 Z — Visit window compliance Value 1.00 Weight 1.50 Z — Withdrawal rate Value 0.00 Weight 1.00 Z —	no	1	0.00	M.S. Ramaiah Medical College and Hospitals (Bangalore, India)	63943174-6233-4f3d-bccc-83bd6dad25d0
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 1.00 Weight 0.00 Z — Enrollment per month Value 0.14 Weight 1.00 Z — Grade3 rate Value 0.00 Weight 0.00 Z — Lab flag density Value 3.00 Weight 1.00 Z — Major deviation rate Value 0.00 Weight 2.00 Z — Minor deviation rate Value 0.00 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value 0.00 Weight 2.00 Z — Visit window compliance Value 1.00 Weight 1.50 Z — Withdrawal rate Value 0.00 Weight 1.00 Z —	no	1	0.00	Curie Manavata Cancer Centre (Nashik, India)	942fc5d1-aea8-453d-94e3-6b260a9101ad
0.00	none	no	Aged query rate Value — Weight 1.00 Z — Death rate Value — Weight 0.00 Z — Enrollment per month Value — Weight 1.00 Z — Grade3 rate Value — Weight 0.00 Z — Lab flag density Value — Weight 1.00 Z — Major deviation rate Value — Weight 2.00 Z — Minor deviation rate Value — Weight 0.00 Z — Missed visit rate Value — Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value — Weight 2.00 Z — Visit window compliance Value — Weight 1.50 Z — Withdrawal rate Value — Weight 1.00 Z —	no	0	0.00	Delhi State Cancer Institute (Pune, India)	dd4f6268-aacd-4f52-af2b-5bdfd8792b76
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.00 Weight 0.00 Z — Enrollment per month Value 0.15 Weight 1.00 Z — Grade3 rate Value 1.00 Weight 0.00 Z — Lab flag density Value 10.00 Weight 1.00 Z — Major deviation rate Value 0.00 Weight 2.00 Z — Minor deviation rate Value 0.00 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value 1.00 Weight 2.00 Z — Visit window compliance Value 1.00 Weight 1.50 Z — Withdrawal rate Value 0.00 Weight 1.00 Z —	no	1	0.00	Jehangir Clinical Development Centre Pvt Ltd (Pune, India)	0077c08d-5a27-4482-ac0c-0ba818636a11
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 1.00 Weight 0.00 Z — Enrollment per month Value 0.80 Weight 1.00 Z — Grade3 rate Value 2.00 Weight 0.00 Z — Lab flag density Value 11.00 Weight 1.00 Z — Major deviation rate Value 0.50 Weight 2.00 Z — Minor deviation rate Value 0.50 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 1.00 Weight 0.00 Z — Sae rate Value 1.50 Weight 2.00 Z — Visit window compliance Value 0.57 Weight 1.50 Z — Withdrawal rate Value 0.50 Weight 1.00 Z —	no	2	0.00	Delhi State Cancer Institute (Mandoli, India)	fb28fe3f-7559-42e9-a917-550e0c15ee1c
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.00 Weight 0.00 Z — Enrollment per month Value 0.09 Weight 1.00 Z — Grade3 rate Value 1.00 Weight 0.00 Z — Lab flag density Value 20.00 Weight 1.00 Z — Major deviation rate Value 0.00 Weight 2.00 Z — Minor deviation rate Value 0.00 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value 0.00 Weight 2.00 Z — Visit window compliance Value 1.00 Weight 1.50 Z — Withdrawal rate Value 0.00 Weight 1.00 Z —	no	1	0.00	Noble Hospital Clinical Research Department 1st Floor (Hadapsar, India)	4226242d-8ff3-4448-8898-9da6b4e51822
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 1.00 Weight 0.00 Z — Enrollment per month Value 0.66 Weight 1.00 Z — Grade3 rate Value 0.50 Weight 0.00 Z — Lab flag density Value 9.00 Weight 1.00 Z — Major deviation rate Value 0.00 Weight 2.00 Z — Minor deviation rate Value 0.50 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value 0.00 Weight 2.00 Z — Visit window compliance Value 1.00 Weight 1.50 Z — Withdrawal rate Value 0.00 Weight 1.00 Z —	no	2	0.00	Christian Medical College (Vellore, India)	8064d7f4-219b-4de6-bbf3-cf8218693bc2
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.00 Weight 0.00 Z — Enrollment per month Value 0.59 Weight 1.00 Z — Grade3 rate Value 0.50 Weight 0.00 Z — Lab flag density Value 7.50 Weight 1.00 Z — Major deviation rate Value 0.00 Weight 2.00 Z — Minor deviation rate Value 0.50 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value 0.00 Weight 2.00 Z — Visit window compliance Value 0.86 Weight 1.50 Z — Withdrawal rate Value 0.50 Weight 1.00 Z —	no	2	0.00	Tata Memorial Hospital, Department of Medical Oncology (Mumbai, India)	00ff0831-c1dd-4a5a-a048-9b84a2d1ec21
0.97	lab_flag_density	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.67 Weight 0.00 Z 0.94 Enrollment per month Value 0.30 Weight 1.00 Z -0.86 Grade3 rate Value 2.00 Weight 0.00 Z 1.24 Lab flag density Value 14.33 Weight 1.00 Z 1.42 Major deviation rate Value 0.00 Weight 2.00 Z -0.79 Minor deviation rate Value 1.67 Weight 0.00 Z 3.57 Missed visit rate Value 0.00 Weight 1.50 Z -1.00 Open findings Value 0.00 Weight 0.00 Z -0.90 Sae rate Value 1.00 Weight 2.00 Z 1.00 Visit window compliance Value 1.00 Weight 1.50 Z 0.93 Withdrawal rate Value 0.00 Weight 1.00 Z -0.89	no	3	0.38	Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca (Cluj-Napoca, Romania)	437b3542-47a2-4cb9-a7a6-e8a628e68c69
0.75	major_deviation_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.00 Weight 0.00 Z -1.72 Enrollment per month Value 0.36 Weight 1.00 Z -0.72 Grade3 rate Value 1.00 Weight 0.00 Z -0.53 Lab flag density Value 9.50 Weight 1.00 Z -0.07 Major deviation rate Value 0.25 Weight 2.00 Z 1.11 Minor deviation rate Value 0.25 Weight 0.00 Z -0.26 Missed visit rate Value 0.05 Weight 1.50 Z 0.51 Open findings Value 1.00 Weight 0.00 Z 0.54 Sae rate Value 0.25 Weight 2.00 Z -0.97 Visit window compliance Value 0.94 Weight 1.50 Z 0.48 Withdrawal rate Value 0.25 Weight 1.00 Z 1.05	no	4	0.31	Clinical County Hospital Mures, Medical Oncology Department (Târgu Mureş, Romania)	d24d30f8-2ade-478d-a80a-9d21966eb7d0
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.00 Weight 0.00 Z — Enrollment per month Value 0.30 Weight 1.00 Z — Grade3 rate Value 2.50 Weight 0.00 Z — Lab flag density Value 13.50 Weight 1.00 Z — Major deviation rate Value 0.00 Weight 2.00 Z — Minor deviation rate Value 0.50 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value 2.00 Weight 2.00 Z — Visit window compliance Value 0.83 Weight 1.50 Z — Withdrawal rate Value 0.00 Weight 1.00 Z —	no	2	0.00	Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie (Baia Mare, Romania)	a6fb69b1-6d86-42f8-8a14-926132ca9df6
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.00 Weight 0.00 Z — Enrollment per month Value 0.39 Weight 1.00 Z — Grade3 rate Value 1.00 Weight 0.00 Z — Lab flag density Value 12.00 Weight 1.00 Z — Major deviation rate Value 0.00 Weight 2.00 Z — Minor deviation rate Value 0.00 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value 0.00 Weight 2.00 Z — Visit window compliance Value 1.00 Weight 1.50 Z — Withdrawal rate Value 0.00 Weight 1.00 Z —	no	1	0.00	Medisprof SRL (Cluj-Napoca, Romania)	3354ea1b-6850-4b81-ab0f-d5e4424611a9
0.57	withdrawal_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.33 Weight 0.00 Z -0.39 Enrollment per month Value 0.88 Weight 1.00 Z 0.49 Grade3 rate Value 0.50 Weight 0.00 Z -1.42 Lab flag density Value 8.17 Weight 1.00 Z -0.48 Major deviation rate Value 0.17 Weight 2.00 Z 0.48 Minor deviation rate Value 0.33 Weight 0.00 Z -0.04 Missed visit rate Value 0.03 Weight 1.50 Z 0.02 Open findings Value 2.00 Weight 0.00 Z 1.98 Sae rate Value 0.25 Weight 2.00 Z -0.97 Visit window compliance Value 0.82 Weight 1.50 Z -0.49 Withdrawal rate Value 0.25 Weight 1.00 Z 1.05	no	12	0.25	State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia)	f0172b9a-0216-4b68-a6f1-a5cdcd60525b
0.71	lab_flag_density	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.57 Weight 0.00 Z 0.56 Enrollment per month Value 0.55 Weight 1.00 Z -0.27 Grade3 rate Value 1.57 Weight 0.00 Z 0.48 Lab flag density Value 13.57 Weight 1.00 Z 1.18 Major deviation rate Value 0.00 Weight 2.00 Z -0.79 Minor deviation rate Value 0.14 Weight 0.00 Z -0.55 Missed visit rate Value 0.05 Weight 1.50 Z 0.51 Open findings Value 0.00 Weight 0.00 Z -0.90 Sae rate Value 0.43 Weight 2.00 Z -0.50 Visit window compliance Value 0.76 Weight 1.50 Z -0.94 Withdrawal rate Value 0.00 Weight 1.00 Z -0.89	no	7	0.30	Blokhin Cancer Research Center (Moscow, Russia)	c7e7cd26-792e-403a-9308-f09202702d7c
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 1.00 Weight 0.00 Z — Enrollment per month Value 0.27 Weight 1.00 Z — Grade3 rate Value 0.00 Weight 0.00 Z — Lab flag density Value 5.00 Weight 1.00 Z — Major deviation rate Value 0.00 Weight 2.00 Z — Minor deviation rate Value 1.00 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value 0.00 Weight 2.00 Z — Visit window compliance Value 1.00 Weight 1.50 Z — Withdrawal rate Value 0.00 Weight 1.00 Z —	no	1	0.00	Municipal institution "Chernivtsi Regional Clinical Oncologic Dispensary" (Chernivtsi, Ukraine)	b4381495-e90d-4c75-91eb-34b1979347d1
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.00 Weight 0.00 Z — Enrollment per month Value 0.17 Weight 1.00 Z — Grade3 rate Value 0.50 Weight 0.00 Z — Lab flag density Value 7.50 Weight 1.00 Z — Major deviation rate Value 0.00 Weight 2.00 Z — Minor deviation rate Value 0.00 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value 0.00 Weight 2.00 Z — Visit window compliance Value 0.60 Weight 1.50 Z — Withdrawal rate Value 1.00 Weight 1.00 Z —	no	2	0.00	Municipal Institution "Dnipropetrovsk City Multi-Field Clinical Hospital #4" of Dnipropetrovsk Regional Councel (Dnipropetrovsk, Ukraine)	93412061-286b-4bf2-b0b3-a84e8bc1b5df
1.02	major_deviation_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.67 Weight 0.00 Z 0.94 Enrollment per month Value 0.45 Weight 1.00 Z -0.51 Grade3 rate Value 0.67 Weight 0.00 Z -1.13 Lab flag density Value 6.67 Weight 1.00 Z -0.95 Major deviation rate Value 0.33 Weight 2.00 Z 1.75 Minor deviation rate Value 0.00 Weight 0.00 Z -0.94 Missed visit rate Value 0.00 Weight 1.50 Z -1.00 Open findings Value 1.00 Weight 0.00 Z 0.54 Sae rate Value 0.33 Weight 2.00 Z -0.75 Visit window compliance Value 1.00 Weight 1.50 Z 0.93 Withdrawal rate Value 0.00 Weight 1.00 Z -0.89	no	3	0.40	State Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine" (Kharkiv, Ukraine)	d367ec3b-da08-4875-aade-5f8df1006571
0.83	lab_flag_density	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.33 Weight 0.00 Z -0.39 Enrollment per month Value 0.73 Weight 1.00 Z 0.15 Grade3 rate Value 1.33 Weight 0.00 Z 0.06 Lab flag density Value 18.00 Weight 1.00 Z 2.54 Major deviation rate Value 0.00 Weight 2.00 Z -0.79 Minor deviation rate Value 0.33 Weight 0.00 Z -0.04 Missed visit rate Value 0.00 Weight 1.50 Z -1.00 Open findings Value 0.00 Weight 0.00 Z -0.90 Sae rate Value 0.67 Weight 2.00 Z 0.13 Visit window compliance Value 1.00 Weight 1.50 Z 0.93 Withdrawal rate Value 0.00 Weight 1.00 Z -0.89	yes	3	0.34	Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine)	3a5af3bf-6e29-4f3c-b686-14a3f46cff0f
0.00	none	no	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.00 Weight 0.00 Z — Enrollment per month Value 0.10 Weight 1.00 Z — Grade3 rate Value 1.00 Weight 0.00 Z — Lab flag density Value 6.00 Weight 1.00 Z — Major deviation rate Value 0.00 Weight 2.00 Z — Minor deviation rate Value 0.00 Weight 0.00 Z — Missed visit rate Value 0.00 Weight 1.50 Z — Open findings Value 0.00 Weight 0.00 Z — Sae rate Value 2.00 Weight 2.00 Z — Visit window compliance Value 1.00 Weight 1.50 Z — Withdrawal rate Value 0.00 Weight 1.00 Z —	no	1	0.00	Vinnytsya Regional Clinical Oncologic Dispensary, Surgical Department (Vinnytsia, Ukraine)	75666c5b-0e47-4fc1-9ef2-9e5099669bea

Outliers

Composite	Drivers	Risk score	Site	Site id	Trigger
1.37	visit-window compliance 50% vs study mean 88%, z=-2.92 missed-visit rate 12% vs study mean 3%, z=2.73	0.50	Royal Perth Hospital (Perth, Australia)	0d883291-bccc-4399-a391-5632bf05da34	single KRI \|z\| 2.92 ≥ 2.5
0.89	enrollment per open month 2.11 vs study mean 0.67, z=3.36	0.36	State Health Centre Oncology Department (Budapest, Hungary)	70b2d866-f929-4c12-860a-0f9127f4e5b9	single KRI \|z\| 3.36 ≥ 2.5
0.83	lab flags per patient 18.00 vs study mean 9.74, z=2.54	0.34	Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine)	3a5af3bf-6e29-4f3c-b686-14a3f46cff0f	single KRI \|z\| 2.54 ≥ 2.5

Remote adequate

Sarcoma Oncology Center (Santa Monica, CA)
Stanford University (Stanford, CA)
University of Iowa (Iowa City, IA)
Pennsylvania Hematology Oncology Associates (Philadelphia, PA)
CTRC Institute for Drug Development, University of Texas (San Antonio, TX)
Royal North Shore (St Leonards, Australia)
Epworth HealthCare Clinical Trials and Research Centre (Richmond, Australia)
Border Medical Oncology (Wodonga, Australia)
Royal Hobart Hospital (Hobart, Australia)
Mount Medical Centre (Perth, Australia)
The Crown Princess Mary Cancer Centre Westmead (Sydney, Australia)
Hemato Oncology Clinic, Vedanta Institute of Medical Science (Thaltej, India)
Hemato Oncology Clinic, Vedanta Institute of Medical Science (Ahmedabad, India)
M.S. Ramaiah Medical College and Hospitals (Bangalore, India)
Curie Manavata Cancer Centre (Nashik, India)
Delhi State Cancer Institute (Pune, India)
Jehangir Clinical Development Centre Pvt Ltd (Pune, India)
Delhi State Cancer Institute (Mandoli, India)
Noble Hospital Clinical Research Department 1st Floor (Hadapsar, India)
Christian Medical College (Vellore, India)
Tata Memorial Hospital, Department of Medical Oncology (Mumbai, India)
Oncological Institute "Prof. Dr. I. Chiricuta", Cluj-Napoca (Cluj-Napoca, Romania)
Clinical County Hospital Mures, Medical Oncology Department (Târgu Mureş, Romania)
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia-Mare, Sectia Oncologie (Baia Mare, Romania)
Medisprof SRL (Cluj-Napoca, Romania)
State Healthcare Institution "Republican Clinical Oncological Center of the Ministry of Health of Republic of Tatarstan" (Kazan', Russia)
Blokhin Cancer Research Center (Moscow, Russia)
Municipal institution "Chernivtsi Regional Clinical Oncologic Dispensary" (Chernivtsi, Ukraine)
Municipal Institution "Dnipropetrovsk City Multi-Field Clinical Hospital #4" of Dnipropetrovsk Regional Councel (Dnipropetrovsk, Ukraine)
State Institution "Institute of Medical Radiology named after S.P.Grygoryev of National Academy of Medical Sciences of Ukraine" (Kharkiv, Ukraine)
Vinnytsya Regional Clinical Oncologic Dispensary, Surgical Department (Vinnytsia, Ukraine)

Study stats

Aged query rate

Mean: 0.00
Median: 0.00
N: 16
Scored: no
Sd: 0.00

Death rate

Mean: 0.43
Median: 0.43
N: 16
Scored: yes
Sd: 0.25

Enrollment per month

Mean: 0.67
Median: 0.51
N: 16
Scored: yes
Sd: 0.43

Grade3 rate

Mean: 1.30
Median: 1.35
N: 16
Scored: yes
Sd: 0.56

Lab flag density

Mean: 9.74
Median: 9.55
N: 16
Scored: yes
Sd: 3.25

Major deviation rate

Mean: 0.10
Median: 0.02
N: 16
Scored: yes
Sd: 0.13

Minor deviation rate

Mean: 0.35
Median: 0.28
N: 16
Scored: yes
Sd: 0.37

Missed visit rate

Mean: 0.03
Median: 0.03
N: 16
Scored: yes
Sd: 0.03

Open findings

Mean: 0.63
Median: 0.50
N: 16
Scored: yes
Sd: 0.70

Sae rate

Mean: 0.62
Median: 0.55
N: 16
Scored: yes
Sd: 0.38

Visit window compliance

Mean: 0.88
Median: 0.92
N: 16
Scored: yes
Sd: 0.13

Withdrawal rate

Mean: 0.12
Median: 0.05
N: 16
Scored: yes
Sd: 0.13

Thresholds

Composite: 1.50
Composite effective: 1.50
Default visit window days: 7
Min patients for csm: 3
Min sites for csm: 3
Query aging sla days: 14
Single kri min peers: 8
Single kri z: 2.50
Visit lead days: 14

Visits already pending

none

Visits proposed

Scheduled on	Site	Site id	Visit id
2026-10-13	Royal Perth Hospital (Perth, Australia)	0d883291-bccc-4399-a391-5632bf05da34	058d6893-009d-47ec-828c-e7514c796719
2026-10-13	State Health Centre Oncology Department (Budapest, Hungary)	70b2d866-f929-4c12-860a-0f9127f4e5b9	02692f7d-cc0d-48d7-b437-8306b1ca97b7
2026-10-13	Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine)	3a5af3bf-6e29-4f3c-b686-14a3f46cff0f	3e45a73e-9efe-45c5-af98-d3062f00d834

Weights

Aged query rate: 1.00
Enrollment per month: 1.00
Lab flag density: 1.00
Major deviation rate: 2.00
Missed visit rate: 1.50
Sae rate: 2.00
Visit window compliance: 1.50
Withdrawal rate: 1.00

Open study

2026-09-29 21:13 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

4.1 s

Across 15 sites (317 patients), centralized statistical monitoring flagged 2 outliers per the single-KRI rule (|z| ≥ 2.5, threshold 2.5). SITE006 (GBR): withdrawal rate 11% vs study mean 2%, z=3.01, exceeding threshold 2.5; also SAE rate 0.68 vs study mean 0.31, z=2.29, and enrollment per open month 1.46 vs study mean 1.71, z=-1.64. Composite 1.173 (below composite threshold 1.5); risk_score 0.444. SITE009 (AUS): lab flags per patient 24.05 vs study mean 16.95, z=2.64, exceeding threshold 2.5. Composite 0.979; risk_score 0.387. Neither breaches the composite threshold of 1.5, but both trip the single-KRI rule. On-site visits are already pending CRA confirmation for both sites; no new review was opened. Remaining 13 sites show remote/centralized monitoring adequate per the deterministic summary. Human decision needed: confirm/schedule the pending CRA on-site visits for SITE006 and SITE009 and review the flagged withdrawal, SAE, and lab-flag patterns.

Input: A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer — as_of="2026-09-19", benchmarks=["Barnes et al. 2021 (ACRO) RBQM model: initial + ongoing risk assessment, QTLs, KRIs, centralized

Evidence

As of: 2026-09-19
Deterministic summary: Centralized statistical monitoring across 15 site(s), 317 patient(s), 12 KRI(s) z-scored as of 2026-09-19. 2 outlier site(s): SITE006 (GBR): withdrawal rate 11% vs study mean 2%, z=3.01, SAE rate 0.68 vs study mean 0.31, z=2.29, enrollment per open month 1.46 vs study mean 1.71, z=-1.64 (trigger: single KRI |z| 3.01 ≥ 2.5; risk 0.444). SITE009 (AUS): lab flags per patient 24.05 vs study mean 16.95, z=2.64 (trigger: single KRI |z| 2.64 ≥ 2.5; risk 0.387). On-site visits already pending CRA confirmation for SITE006 (GBR), SITE009 (AUS); nothing new opened. Remaining 13 site(s): remote/centralized monitoring adequate.
Method: Each KRI z-scored across the study's sites (population sd; skipped when fewer than 3 sites or sd = 0). Composite = weighted mean of |z|. risk_score = 1 - exp(-composite/2): a heuristic 0–1 scale, not a calibrated probability. Deviations in either direction count — under-reporting is a signal too.
Patients: 317
Planned visits: 52
Review opened: no
Sites: 15

Benchmarks

Barnes et al. 2021 (ACRO) RBQM model: initial + ongoing risk assessment, QTLs, KRIs, centralized statistical monitoring, remote monitoring, reduced SDV; 93% remote visits in 2020 with no loss of protocol-deviation detection.
Amatya & Edgerton 2021 (JSCDM): data-review SLA of 14 days — queries open longer are the aging KRI.
TransCelerate RBM KRI set: SAE rate, deviation rate, query aging, visit-window compliance, enrollment rate, withdrawal rate.

Kri table

Composite	Drivers	In peer comparison	Kris	Outlier	Patients	Risk score	Site	Site id
0.38	sae_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z -0.60 Death rate Value 0.14 Weight 0.00 Z -0.07 Enrollment per month Value 1.76 Weight 1.00 Z 0.34 Grade3 rate Value 0.43 Weight 0.00 Z -0.58 Lab flag density Value 17.38 Weight 1.00 Z 0.16 Major deviation rate Value 0.05 Weight 2.00 Z -0.18 Minor deviation rate Value 0.33 Weight 0.00 Z 0.44 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 1.00 Weight 0.00 Z -0.35 Sae rate Value 0.43 Weight 2.00 Z 0.72 Visit window compliance Value 0.97 Weight 1.50 Z -0.02 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	21	0.17	SITE001 (USA)	41c36a32-fc47-4d50-b051-7b1fc3aba362
0.67	aged_query_rate	yes	Aged query rate Value 0.05 Weight 1.00 Z 1.59 Death rate Value 0.00 Weight 0.00 Z -1.74 Enrollment per month Value 1.80 Weight 1.00 Z 0.63 Grade3 rate Value 0.23 Weight 0.00 Z -1.58 Lab flag density Value 18.09 Weight 1.00 Z 0.43 Major deviation rate Value 0.05 Weight 2.00 Z -0.24 Minor deviation rate Value 0.41 Weight 0.00 Z 0.94 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 2.00 Weight 0.00 Z 0.95 Sae rate Value 0.14 Weight 2.00 Z -1.08 Visit window compliance Value 0.96 Weight 1.50 Z -0.50 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	22	0.28	SITE002 (USA)	8a690aec-cb7a-4afc-be29-7b7ada67ff8f
0.55	sae_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z -0.60 Death rate Value 0.09 Weight 0.00 Z -0.68 Enrollment per month Value 1.72 Weight 1.00 Z 0.08 Grade3 rate Value 0.36 Weight 0.00 Z -0.90 Lab flag density Value 17.36 Weight 1.00 Z 0.16 Major deviation rate Value 0.05 Weight 2.00 Z -0.24 Minor deviation rate Value 0.23 Weight 0.00 Z -0.27 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 2.00 Weight 0.00 Z 0.95 Sae rate Value 0.09 Weight 2.00 Z -1.36 Visit window compliance Value 0.98 Weight 1.50 Z 0.46 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	22	0.24	SITE003 (CAN)	6a85d978-a1b2-4f02-9ac0-7b4b2451fbe0
0.30	aged_query_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z -0.60 Death rate Value 0.14 Weight 0.00 Z -0.07 Enrollment per month Value 1.70 Weight 1.00 Z -0.06 Grade3 rate Value 0.62 Weight 0.00 Z 0.37 Lab flag density Value 15.90 Weight 1.00 Z -0.39 Major deviation rate Value 0.05 Weight 2.00 Z -0.18 Minor deviation rate Value 0.00 Weight 0.00 Z -1.78 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 1.00 Weight 0.00 Z -0.35 Sae rate Value 0.33 Weight 2.00 Z 0.13 Visit window compliance Value 0.97 Weight 1.50 Z 0.24 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	21	0.14	SITE004 (DEU)	57d3f212-59b6-4da2-9c5e-c0dc0574edea
0.79	major_deviation_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z -0.60 Death rate Value 0.19 Weight 0.00 Z 0.48 Enrollment per month Value 1.61 Weight 1.00 Z -0.63 Grade3 rate Value 0.67 Weight 0.00 Z 0.60 Lab flag density Value 16.81 Weight 1.00 Z -0.05 Major deviation rate Value 0.00 Weight 2.00 Z -1.58 Minor deviation rate Value 0.19 Weight 0.00 Z -0.51 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 0.00 Weight 0.00 Z -1.64 Sae rate Value 0.38 Weight 2.00 Z 0.43 Visit window compliance Value 0.95 Weight 1.50 Z -1.08 Withdrawal rate Value 0.05 Weight 1.00 Z 1.07	no	21	0.33	SITE005 (FRA)	b6661047-7201-40ac-aee9-8576a2852400
1.17	withdrawal_rate sae_rate enrollment_per_month	yes	Aged query rate Value 0.00 Weight 1.00 Z -0.60 Death rate Value 0.37 Weight 0.00 Z 2.55 Enrollment per month Value 1.46 Weight 1.00 Z -1.64 Grade3 rate Value 1.00 Weight 0.00 Z 2.25 Lab flag density Value 13.42 Weight 1.00 Z -1.31 Major deviation rate Value 0.05 Weight 2.00 Z -0.03 Minor deviation rate Value 0.26 Weight 0.00 Z -0.03 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 1.00 Weight 0.00 Z -0.35 Sae rate Value 0.68 Weight 2.00 Z 2.29 Visit window compliance Value 0.96 Weight 1.50 Z -0.63 Withdrawal rate Value 0.11 Weight 1.00 Z 3.01	yes	19	0.44	SITE006 (GBR)	04ef3bb0-3f20-44e7-a597-df5918e0d1d1
0.58	enrollment_per_month	yes	Aged query rate Value 0.00 Weight 1.00 Z -0.60 Death rate Value 0.11 Weight 0.00 Z -0.51 Enrollment per month Value 1.48 Weight 1.00 Z -1.47 Grade3 rate Value 0.79 Weight 0.00 Z 1.21 Lab flag density Value 16.00 Weight 1.00 Z -0.35 Major deviation rate Value 0.05 Weight 2.00 Z -0.03 Minor deviation rate Value 0.05 Weight 0.00 Z -1.43 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 1.00 Weight 0.00 Z -0.35 Sae rate Value 0.37 Weight 2.00 Z 0.35 Visit window compliance Value 0.99 Weight 1.50 Z 1.30 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	19	0.25	SITE007 (JPN)	43501c4e-f296-4706-87b8-1f842849e42d
0.71	major_deviation_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z -0.60 Death rate Value 0.11 Weight 0.00 Z -0.51 Enrollment per month Value 1.55 Weight 1.00 Z -0.99 Grade3 rate Value 0.58 Weight 0.00 Z 0.17 Lab flag density Value 16.47 Weight 1.00 Z -0.18 Major deviation rate Value 0.00 Weight 2.00 Z -1.58 Minor deviation rate Value 0.63 Weight 0.00 Z 2.42 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 0.00 Weight 0.00 Z -1.64 Sae rate Value 0.26 Weight 2.00 Z -0.30 Visit window compliance Value 0.98 Weight 1.50 Z 0.66 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	19	0.30	SITE008 (KOR)	153ca95d-26c6-4b48-a1a5-caccd6cd02d0
0.98	lab_flag_density	yes	Aged query rate Value 0.00 Weight 1.00 Z -0.60 Death rate Value 0.05 Weight 0.00 Z -1.15 Enrollment per month Value 1.66 Weight 1.00 Z -0.31 Grade3 rate Value 0.30 Weight 0.00 Z -1.22 Lab flag density Value 24.05 Weight 1.00 Z 2.64 Major deviation rate Value 0.10 Weight 2.00 Z 1.37 Minor deviation rate Value 0.20 Weight 0.00 Z -0.45 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 2.00 Weight 0.00 Z 0.95 Sae rate Value 0.10 Weight 2.00 Z -1.30 Visit window compliance Value 0.98 Weight 1.50 Z 0.40 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	yes	20	0.39	SITE009 (AUS)	02237f20-8790-4fd0-b21a-43bb77345d68
0.96	aged_query_rate	yes	Aged query rate Value 0.05 Weight 1.00 Z 1.81 Death rate Value 0.15 Weight 0.00 Z 0.01 Enrollment per month Value 1.78 Weight 1.00 Z 0.50 Grade3 rate Value 0.40 Weight 0.00 Z -0.72 Lab flag density Value 14.45 Weight 1.00 Z -0.93 Major deviation rate Value 0.10 Weight 2.00 Z 1.37 Minor deviation rate Value 0.35 Weight 0.00 Z 0.55 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 2.00 Weight 0.00 Z 0.95 Sae rate Value 0.15 Weight 2.00 Z -1.00 Visit window compliance Value 0.96 Weight 1.50 Z -0.87 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	20	0.38	SITE010 (ESP)	f186499d-e4f9-4087-bf86-8f859f5ca742
0.73	enrollment_per_month	yes	Aged query rate Value 0.00 Weight 1.00 Z -0.60 Death rate Value 0.13 Weight 0.00 Z -0.28 Enrollment per month Value 1.90 Weight 1.00 Z 1.27 Grade3 rate Value 0.42 Weight 0.00 Z -0.64 Lab flag density Value 17.54 Weight 1.00 Z 0.22 Major deviation rate Value 0.08 Weight 2.00 Z 0.88 Minor deviation rate Value 0.25 Weight 0.00 Z -0.12 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 2.00 Weight 0.00 Z 0.95 Sae rate Value 0.21 Weight 2.00 Z -0.64 Visit window compliance Value 0.98 Weight 1.50 Z 0.88 Withdrawal rate Value 0.04 Weight 1.00 Z 0.87	no	24	0.31	SITE011 (ITA)	4d6aa2db-c00e-41d7-84fd-45c11af9b683
0.97	enrollment_per_month missed_visit_rate	yes	Aged query rate Value 0.04 Weight 1.00 Z 1.25 Death rate Value 0.19 Weight 0.00 Z 0.50 Enrollment per month Value 2.05 Weight 1.00 Z 2.28 Grade3 rate Value 0.62 Weight 0.00 Z 0.35 Lab flag density Value 15.58 Weight 1.00 Z -0.51 Major deviation rate Value 0.08 Weight 2.00 Z 0.69 Minor deviation rate Value 0.27 Weight 0.00 Z 0.01 Missed visit rate Value 0.00 Weight 1.50 Z 1.56 Open findings Value 2.00 Weight 0.00 Z 0.95 Sae rate Value 0.27 Weight 2.00 Z -0.26 Visit window compliance Value 0.95 Weight 1.50 Z -1.22 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	26	0.38	SITE012 (BRA)	cccce890-9716-475d-b932-9cd0a8f91415
1.26	missed_visit_rate major_deviation_rate sae_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z -0.60 Death rate Value 0.13 Weight 0.00 Z -0.22 Enrollment per month Value 1.83 Weight 1.00 Z 0.84 Grade3 rate Value 0.78 Weight 0.00 Z 1.18 Lab flag density Value 13.83 Weight 1.00 Z -1.16 Major deviation rate Value 0.00 Weight 2.00 Z -1.58 Minor deviation rate Value 0.35 Weight 0.00 Z 0.54 Missed visit rate Value 0.01 Weight 1.50 Z 2.16 Open findings Value 0.00 Weight 0.00 Z -1.64 Sae rate Value 0.56 Weight 2.00 Z 1.56 Visit window compliance Value 0.98 Weight 1.50 Z 0.53 Withdrawal rate Value 0.04 Weight 1.00 Z 0.93	no	23	0.47	SITE013 (USA)	a997faca-aa8b-45f9-9831-20fd3de47882
1.15	missed_visit_rate visit_window_compliance aged_query_rate	yes	Aged query rate Value 0.05 Weight 1.00 Z 1.93 Death rate Value 0.16 Weight 0.00 Z 0.10 Enrollment per month Value 1.66 Weight 1.00 Z -0.32 Grade3 rate Value 0.42 Weight 0.00 Z -0.62 Lab flag density Value 15.68 Weight 1.00 Z -0.47 Major deviation rate Value 0.11 Weight 2.00 Z 1.52 Minor deviation rate Value 0.11 Weight 0.00 Z -1.08 Missed visit rate Value 0.01 Weight 1.50 Z 2.23 Open findings Value 2.00 Weight 0.00 Z 0.95 Sae rate Value 0.32 Weight 2.00 Z 0.03 Visit window compliance Value 0.94 Weight 1.50 Z -1.98 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	19	0.44	SITE014 (NLD)	d2d661bb-ff20-4ba4-beab-ba501fb96fd0
0.74	visit_window_compliance lab_flag_density	yes	Aged query rate Value 0.00 Weight 1.00 Z -0.60 Death rate Value 0.29 Weight 0.00 Z 1.59 Enrollment per month Value 1.63 Weight 1.00 Z -0.52 Grade3 rate Value 0.57 Weight 0.00 Z 0.13 Lab flag density Value 21.62 Weight 1.00 Z 1.74 Major deviation rate Value 0.05 Weight 2.00 Z -0.18 Minor deviation rate Value 0.38 Weight 0.00 Z 0.76 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 1.00 Weight 0.00 Z -0.35 Sae rate Value 0.38 Weight 2.00 Z 0.43 Visit window compliance Value 1.00 Weight 1.50 Z 1.84 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	21	0.31	SITE015 (POL)	ecdf60b8-23eb-4471-b76e-4160036700ae

Outliers

Composite	Drivers	Risk score	Site	Site id	Trigger
1.17	withdrawal rate 11% vs study mean 2%, z=3.01 SAE rate 0.68 vs study mean 0.31, z=2.29 enrollment per open month 1.46 vs study mean 1.71, z=-1.64	0.44	SITE006 (GBR)	04ef3bb0-3f20-44e7-a597-df5918e0d1d1	single KRI \|z\| 3.01 ≥ 2.5
0.98	lab flags per patient 24.05 vs study mean 16.95, z=2.64	0.39	SITE009 (AUS)	02237f20-8790-4fd0-b21a-43bb77345d68	single KRI \|z\| 2.64 ≥ 2.5

Remote adequate

SITE001 (USA)
SITE002 (USA)
SITE003 (CAN)
SITE004 (DEU)
SITE005 (FRA)
SITE007 (JPN)
SITE008 (KOR)
SITE010 (ESP)
SITE011 (ITA)
SITE012 (BRA)
SITE013 (USA)
SITE014 (NLD)
SITE015 (POL)

Study stats

Aged query rate

Mean: 0.01
Median: 0.00
N: 15
Scored: yes
Sd: 0.02

Death rate

Mean: 0.15
Median: 0.14
N: 15
Scored: yes
Sd: 0.09

Enrollment per month

Mean: 1.71
Median: 1.70
N: 15
Scored: yes
Sd: 0.15

Grade3 rate

Mean: 0.55
Median: 0.57
N: 15
Scored: yes
Sd: 0.20

Lab flag density

Mean: 16.95
Median: 16.47
N: 15
Scored: yes
Sd: 2.69

Major deviation rate

Mean: 0.05
Median: 0.05
N: 15
Scored: yes
Sd: 0.03

Minor deviation rate

Mean: 0.27
Median: 0.26
N: 15
Scored: yes
Sd: 0.15

Missed visit rate

Mean: 0.00
Median: 0.00
N: 15
Scored: yes
Sd: 0.00

Open findings

Mean: 1.27
Median: 1.00
N: 15
Scored: yes
Sd: 0.77

Sae rate

Mean: 0.31
Median: 0.32
N: 15
Scored: yes
Sd: 0.16

Visit window compliance

Mean: 0.97
Median: 0.97
N: 15
Scored: yes
Sd: 0.01

Withdrawal rate

Mean: 0.02
Median: 0.00
N: 15
Scored: yes
Sd: 0.03

Thresholds

Composite: 1.50
Composite effective: 1.50
Default visit window days: 7
Min patients for csm: 3
Min sites for csm: 3
Query aging sla days: 14
Single kri min peers: 8
Single kri z: 2.50
Visit lead days: 14

Visits already pending

SITE006 (GBR)
SITE009 (AUS)

Visits proposed

none

Weights

Aged query rate: 1.00
Enrollment per month: 1.00
Lab flag density: 1.00
Major deviation rate: 2.00
Missed visit rate: 1.50
Sae rate: 2.00
Visit window compliance: 1.50
Withdrawal rate: 1.00

Open study

2026-09-19 08:58 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

4.0 s

Centralized statistical monitoring flagged 2 of 15 sites out of 317 patients, using 11 KRIs z-scored against the study population, per the TransCelerate RBM KRI set. SITE006 (GBR) triggered the single-KRI rule (|z| ≥ 2.5) with withdrawal rate 11% vs study mean 2% (z=3.01), SAE rate 0.68 vs mean 0.31 (z=2.29), and enrollment per open month 1.46 vs mean 1.71 (z=-1.64); composite 1.23, risk_score 0.459. SITE009 (AUS) triggered on lab flags per patient 24.05 vs mean 16.95 (z=2.64); composite 1.017, risk_score 0.399. Neither reached the composite threshold of 1.5. On-site visits have been proposed for these two sites (scheduled 2026-10-03), pending CRA confirmation; the remaining 13 sites remain adequate for remote/centralized monitoring. A human reviewer is asked to decide whether to confirm the proposed on-site visits for SITE006 and SITE009.

Evidence

As of: 2026-09-19
Deterministic summary: Centralized statistical monitoring across 15 site(s), 317 patient(s), 11 KRI(s) z-scored as of 2026-09-19. 2 outlier site(s): SITE006 (GBR): withdrawal rate 11% vs study mean 2%, z=3.01, SAE rate 0.68 vs study mean 0.31, z=2.29, enrollment per open month 1.46 vs study mean 1.71, z=-1.64 (trigger: single KRI |z| 3.01 ≥ 2.5; risk 0.459). SITE009 (AUS): lab flags per patient 24.05 vs study mean 16.95, z=2.64 (trigger: single KRI |z| 2.64 ≥ 2.5; risk 0.399). On-site visit(s) proposed for 2 site(s), pending CRA confirmation. Remaining 13 site(s): remote/centralized monitoring adequate.
Method: Each KRI z-scored across the study's sites (population sd; skipped when fewer than 3 sites or sd = 0). Composite = weighted mean of |z|. risk_score = 1 - exp(-composite/2): a heuristic 0–1 scale, not a calibrated probability. Deviations in either direction count — under-reporting is a signal too.
Patients: 317
Planned visits: 52
Review opened: yes
Sites: 15

Benchmarks

Barnes et al. 2021 (ACRO) RBQM model: initial + ongoing risk assessment, QTLs, KRIs, centralized statistical monitoring, remote monitoring, reduced SDV; 93% remote visits in 2020 with no loss of protocol-deviation detection.
Amatya & Edgerton 2021 (JSCDM): data-review SLA of 14 days — queries open longer are the aging KRI.
TransCelerate RBM KRI set: SAE rate, deviation rate, query aging, visit-window compliance, enrollment rate, withdrawal rate.

Kri table

Composite	Drivers	In peer comparison	Kris	Outlier	Patients	Risk score	Site	Site id
0.36	sae_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.14 Weight 0.00 Z -0.07 Enrollment per month Value 1.76 Weight 1.00 Z 0.34 Grade3 rate Value 0.43 Weight 0.00 Z -0.58 Lab flag density Value 17.38 Weight 1.00 Z 0.16 Major deviation rate Value 0.05 Weight 2.00 Z -0.18 Minor deviation rate Value 0.33 Weight 0.00 Z 0.44 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 1.00 Weight 0.00 Z -0.35 Sae rate Value 0.43 Weight 2.00 Z 0.72 Visit window compliance Value 0.97 Weight 1.50 Z -0.02 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	21	0.17	SITE001 (USA)	41c36a32-fc47-4d50-b051-7b1fc3aba362
0.57	sae_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.00 Weight 0.00 Z -1.74 Enrollment per month Value 1.80 Weight 1.00 Z 0.63 Grade3 rate Value 0.23 Weight 0.00 Z -1.58 Lab flag density Value 18.09 Weight 1.00 Z 0.43 Major deviation rate Value 0.05 Weight 2.00 Z -0.24 Minor deviation rate Value 0.41 Weight 0.00 Z 0.94 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 2.00 Weight 0.00 Z 0.95 Sae rate Value 0.14 Weight 2.00 Z -1.08 Visit window compliance Value 0.96 Weight 1.50 Z -0.50 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	22	0.25	SITE002 (USA)	8a690aec-cb7a-4afc-be29-7b7ada67ff8f
0.54	sae_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.09 Weight 0.00 Z -0.68 Enrollment per month Value 1.72 Weight 1.00 Z 0.08 Grade3 rate Value 0.36 Weight 0.00 Z -0.90 Lab flag density Value 17.36 Weight 1.00 Z 0.16 Major deviation rate Value 0.05 Weight 2.00 Z -0.24 Minor deviation rate Value 0.23 Weight 0.00 Z -0.27 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 2.00 Weight 0.00 Z 0.95 Sae rate Value 0.09 Weight 2.00 Z -1.36 Visit window compliance Value 0.98 Weight 1.50 Z 0.46 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	22	0.24	SITE003 (CAN)	6a85d978-a1b2-4f02-9ac0-7b4b2451fbe0
0.27	withdrawal_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.14 Weight 0.00 Z -0.07 Enrollment per month Value 1.70 Weight 1.00 Z -0.06 Grade3 rate Value 0.62 Weight 0.00 Z 0.37 Lab flag density Value 15.90 Weight 1.00 Z -0.39 Major deviation rate Value 0.05 Weight 2.00 Z -0.18 Minor deviation rate Value 0.00 Weight 0.00 Z -1.78 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 1.00 Weight 0.00 Z -0.35 Sae rate Value 0.33 Weight 2.00 Z 0.13 Visit window compliance Value 0.97 Weight 1.50 Z 0.24 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	21	0.13	SITE004 (DEU)	57d3f212-59b6-4da2-9c5e-c0dc0574edea
0.81	major_deviation_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.19 Weight 0.00 Z 0.48 Enrollment per month Value 1.61 Weight 1.00 Z -0.63 Grade3 rate Value 0.67 Weight 0.00 Z 0.60 Lab flag density Value 16.81 Weight 1.00 Z -0.05 Major deviation rate Value 0.00 Weight 2.00 Z -1.58 Minor deviation rate Value 0.19 Weight 0.00 Z -0.51 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 0.00 Weight 0.00 Z -1.64 Sae rate Value 0.38 Weight 2.00 Z 0.43 Visit window compliance Value 0.95 Weight 1.50 Z -1.08 Withdrawal rate Value 0.05 Weight 1.00 Z 1.07	no	21	0.33	SITE005 (FRA)	b6661047-7201-40ac-aee9-8576a2852400
1.23	withdrawal_rate sae_rate enrollment_per_month	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.37 Weight 0.00 Z 2.55 Enrollment per month Value 1.46 Weight 1.00 Z -1.64 Grade3 rate Value 1.00 Weight 0.00 Z 2.25 Lab flag density Value 13.42 Weight 1.00 Z -1.31 Major deviation rate Value 0.05 Weight 2.00 Z -0.03 Minor deviation rate Value 0.26 Weight 0.00 Z -0.03 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 1.00 Weight 0.00 Z -0.35 Sae rate Value 0.68 Weight 2.00 Z 2.29 Visit window compliance Value 0.96 Weight 1.50 Z -0.63 Withdrawal rate Value 0.11 Weight 1.00 Z 3.01	yes	19	0.46	SITE006 (GBR)	04ef3bb0-3f20-44e7-a597-df5918e0d1d1
0.58	enrollment_per_month	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.11 Weight 0.00 Z -0.51 Enrollment per month Value 1.48 Weight 1.00 Z -1.47 Grade3 rate Value 0.79 Weight 0.00 Z 1.21 Lab flag density Value 16.00 Weight 1.00 Z -0.35 Major deviation rate Value 0.05 Weight 2.00 Z -0.03 Minor deviation rate Value 0.05 Weight 0.00 Z -1.43 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 1.00 Weight 0.00 Z -0.35 Sae rate Value 0.37 Weight 2.00 Z 0.35 Visit window compliance Value 0.99 Weight 1.50 Z 1.30 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	19	0.25	SITE007 (JPN)	43501c4e-f296-4706-87b8-1f842849e42d
0.72	major_deviation_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.11 Weight 0.00 Z -0.51 Enrollment per month Value 1.55 Weight 1.00 Z -0.99 Grade3 rate Value 0.58 Weight 0.00 Z 0.17 Lab flag density Value 16.47 Weight 1.00 Z -0.18 Major deviation rate Value 0.00 Weight 2.00 Z -1.58 Minor deviation rate Value 0.63 Weight 0.00 Z 2.42 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 0.00 Weight 0.00 Z -1.64 Sae rate Value 0.26 Weight 2.00 Z -0.30 Visit window compliance Value 0.98 Weight 1.50 Z 0.66 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	19	0.30	SITE008 (KOR)	153ca95d-26c6-4b48-a1a5-caccd6cd02d0
1.02	lab_flag_density	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.05 Weight 0.00 Z -1.15 Enrollment per month Value 1.66 Weight 1.00 Z -0.31 Grade3 rate Value 0.30 Weight 0.00 Z -1.22 Lab flag density Value 24.05 Weight 1.00 Z 2.64 Major deviation rate Value 0.10 Weight 2.00 Z 1.37 Minor deviation rate Value 0.20 Weight 0.00 Z -0.45 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 2.00 Weight 0.00 Z 0.95 Sae rate Value 0.10 Weight 2.00 Z -1.30 Visit window compliance Value 0.98 Weight 1.50 Z 0.40 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	yes	20	0.40	SITE009 (AUS)	02237f20-8790-4fd0-b21a-43bb77345d68
0.87	major_deviation_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.15 Weight 0.00 Z 0.01 Enrollment per month Value 1.78 Weight 1.00 Z 0.50 Grade3 rate Value 0.40 Weight 0.00 Z -0.72 Lab flag density Value 14.45 Weight 1.00 Z -0.93 Major deviation rate Value 0.10 Weight 2.00 Z 1.37 Minor deviation rate Value 0.35 Weight 0.00 Z 0.55 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 2.00 Weight 0.00 Z 0.95 Sae rate Value 0.15 Weight 2.00 Z -1.00 Visit window compliance Value 0.96 Weight 1.50 Z -0.87 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	20	0.35	SITE010 (ESP)	f186499d-e4f9-4087-bf86-8f859f5ca742
0.75	enrollment_per_month	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.13 Weight 0.00 Z -0.28 Enrollment per month Value 1.90 Weight 1.00 Z 1.27 Grade3 rate Value 0.42 Weight 0.00 Z -0.64 Lab flag density Value 17.54 Weight 1.00 Z 0.22 Major deviation rate Value 0.08 Weight 2.00 Z 0.88 Minor deviation rate Value 0.25 Weight 0.00 Z -0.12 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 2.00 Weight 0.00 Z 0.95 Sae rate Value 0.21 Weight 2.00 Z -0.64 Visit window compliance Value 0.98 Weight 1.50 Z 0.88 Withdrawal rate Value 0.04 Weight 1.00 Z 0.87	no	24	0.31	SITE011 (ITA)	4d6aa2db-c00e-41d7-84fd-45c11af9b683
0.94	enrollment_per_month missed_visit_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.19 Weight 0.00 Z 0.50 Enrollment per month Value 2.05 Weight 1.00 Z 2.28 Grade3 rate Value 0.62 Weight 0.00 Z 0.35 Lab flag density Value 15.58 Weight 1.00 Z -0.51 Major deviation rate Value 0.08 Weight 2.00 Z 0.69 Minor deviation rate Value 0.27 Weight 0.00 Z 0.01 Missed visit rate Value 0.00 Weight 1.50 Z 1.56 Open findings Value 2.00 Weight 0.00 Z 0.95 Sae rate Value 0.27 Weight 2.00 Z -0.26 Visit window compliance Value 0.95 Weight 1.50 Z -1.22 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	26	0.38	SITE012 (BRA)	cccce890-9716-475d-b932-9cd0a8f91415
1.32	missed_visit_rate major_deviation_rate sae_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.13 Weight 0.00 Z -0.22 Enrollment per month Value 1.83 Weight 1.00 Z 0.84 Grade3 rate Value 0.78 Weight 0.00 Z 1.18 Lab flag density Value 13.83 Weight 1.00 Z -1.16 Major deviation rate Value 0.00 Weight 2.00 Z -1.58 Minor deviation rate Value 0.35 Weight 0.00 Z 0.54 Missed visit rate Value 0.01 Weight 1.50 Z 2.16 Open findings Value 0.00 Weight 0.00 Z -1.64 Sae rate Value 0.56 Weight 2.00 Z 1.56 Visit window compliance Value 0.98 Weight 1.50 Z 0.53 Withdrawal rate Value 0.04 Weight 1.00 Z 0.93	no	23	0.48	SITE013 (USA)	a997faca-aa8b-45f9-9831-20fd3de47882
1.07	missed_visit_rate visit_window_compliance major_deviation_rate	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.16 Weight 0.00 Z 0.10 Enrollment per month Value 1.66 Weight 1.00 Z -0.32 Grade3 rate Value 0.42 Weight 0.00 Z -0.62 Lab flag density Value 15.68 Weight 1.00 Z -0.47 Major deviation rate Value 0.11 Weight 2.00 Z 1.52 Minor deviation rate Value 0.11 Weight 0.00 Z -1.08 Missed visit rate Value 0.01 Weight 1.50 Z 2.23 Open findings Value 2.00 Weight 0.00 Z 0.95 Sae rate Value 0.32 Weight 2.00 Z 0.03 Visit window compliance Value 0.94 Weight 1.50 Z -1.98 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	19	0.42	SITE014 (NLD)	d2d661bb-ff20-4ba4-beab-ba501fb96fd0
0.75	visit_window_compliance lab_flag_density	yes	Aged query rate Value 0.00 Weight 1.00 Z — Death rate Value 0.29 Weight 0.00 Z 1.59 Enrollment per month Value 1.63 Weight 1.00 Z -0.52 Grade3 rate Value 0.57 Weight 0.00 Z 0.13 Lab flag density Value 21.62 Weight 1.00 Z 1.74 Major deviation rate Value 0.05 Weight 2.00 Z -0.18 Minor deviation rate Value 0.38 Weight 0.00 Z 0.76 Missed visit rate Value 0.00 Weight 1.50 Z -0.50 Open findings Value 1.00 Weight 0.00 Z -0.35 Sae rate Value 0.38 Weight 2.00 Z 0.43 Visit window compliance Value 1.00 Weight 1.50 Z 1.84 Withdrawal rate Value 0.00 Weight 1.00 Z -0.54	no	21	0.31	SITE015 (POL)	ecdf60b8-23eb-4471-b76e-4160036700ae

Outliers

Composite	Drivers	Risk score	Site	Site id	Trigger
1.23	withdrawal rate 11% vs study mean 2%, z=3.01 SAE rate 0.68 vs study mean 0.31, z=2.29 enrollment per open month 1.46 vs study mean 1.71, z=-1.64	0.46	SITE006 (GBR)	04ef3bb0-3f20-44e7-a597-df5918e0d1d1	single KRI \|z\| 3.01 ≥ 2.5
1.02	lab flags per patient 24.05 vs study mean 16.95, z=2.64	0.40	SITE009 (AUS)	02237f20-8790-4fd0-b21a-43bb77345d68	single KRI \|z\| 2.64 ≥ 2.5

Remote adequate

SITE001 (USA)
SITE002 (USA)
SITE003 (CAN)
SITE004 (DEU)
SITE005 (FRA)
SITE007 (JPN)
SITE008 (KOR)
SITE010 (ESP)
SITE011 (ITA)
SITE012 (BRA)
SITE013 (USA)
SITE014 (NLD)
SITE015 (POL)

Study stats

Aged query rate

Mean: 0.00
Median: 0.00
N: 15
Scored: no
Sd: 0.00

Death rate

Mean: 0.15
Median: 0.14
N: 15
Scored: yes
Sd: 0.09

Enrollment per month

Mean: 1.71
Median: 1.70
N: 15
Scored: yes
Sd: 0.15

Grade3 rate

Mean: 0.55
Median: 0.57
N: 15
Scored: yes
Sd: 0.20

Lab flag density

Mean: 16.95
Median: 16.47
N: 15
Scored: yes
Sd: 2.69

Major deviation rate

Mean: 0.05
Median: 0.05
N: 15
Scored: yes
Sd: 0.03

Minor deviation rate

Mean: 0.27
Median: 0.26
N: 15
Scored: yes
Sd: 0.15

Missed visit rate

Mean: 0.00
Median: 0.00
N: 15
Scored: yes
Sd: 0.00

Open findings

Mean: 1.27
Median: 1.00
N: 15
Scored: yes
Sd: 0.77

Sae rate

Mean: 0.31
Median: 0.32
N: 15
Scored: yes
Sd: 0.16

Visit window compliance

Mean: 0.97
Median: 0.97
N: 15
Scored: yes
Sd: 0.01

Withdrawal rate

Mean: 0.02
Median: 0.00
N: 15
Scored: yes
Sd: 0.03

Thresholds

Composite: 1.50
Composite effective: 1.50
Default visit window days: 7
Min patients for csm: 3
Min sites for csm: 3
Query aging sla days: 14
Single kri min peers: 8
Single kri z: 2.50
Visit lead days: 14

Visits already pending

none

Visits proposed

Scheduled on	Site	Site id	Visit id
2026-10-03	SITE006 (GBR)	04ef3bb0-3f20-44e7-a597-df5918e0d1d1	f425a2a0-ae67-40b4-a81e-4f40b0255d33
2026-10-03	SITE009 (AUS)	02237f20-8790-4fd0-b21a-43bb77345d68	51ef5f45-1f8a-4e69-8e74-5c4a1acd9643

Weights

Aged query rate: 1.00
Enrollment per month: 1.00
Lab flag density: 1.00
Major deviation rate: 2.00
Missed visit rate: 1.50
Sae rate: 2.00
Visit window compliance: 1.50
Withdrawal rate: 1.00

Open study