SAMPLE
wrldOS
AI Visit Prep Report
Site readiness package — prepared for your upcoming monitoring visit · SAMPLE
~9h
Pre-visit review done for you (est.)
~$2,655
≈ modeled value (assumes $295/hr blended external review)
Return on this review. wrldOS prepped this visit in minutes — an estimated 9h your research team didn't spend, with the site's risk scored and deviation & essential-doc gaps surfaced before the monitor arrives. You walk in audit-ready and protect your standing with the sponsor. Modeled on this 6-document sample; sites reporting 21+ prep hours (Tufts CSDD · Applied Clinical Trials, 2026) model $6,200+ returned per visit.
1 · Executive summary
Composite risk is elevated by a cluster of operationally-linked signals at this site: a dosing event outside the protocol visit window, two queries aging beyond 30 days, a serious adverse event reported outside the 24-hour window, and an informed-consent form version that was not re-signed for two subjects. None are individually critical, but together they warrant focused source-data verification at the upcoming visit.
2 · Source data verification priorities
- high — Re-consent verification — confirm ICF v4.2 re-signature for the two affected subjects before any further study procedures.
- high — Dose modification source — verify the 03/02 dosing event against the protocol visit window and the dose-modification log.
- medium — RECIST 1.1 tumor assessments — reconcile target-lesion measurements against radiology source for the most recent two timepoints.
- medium — SAE source documents — confirm awareness date/time and the reporting timeline for the Grade 3 event.
- low — Concomitant medications — spot-check con-med log against visit notes for the prior cycle.
3 · Draft monitoring findings
- One subject was dosed on 03/02/2026, outside the protocol-defined visit window — confirm whether a deviation was logged and assess impact on the dosing schedule.
- Two open queries have aged beyond 30 days (one ALT lab value out of range at 5× ULN); answer both before the visit and attach the supporting source.
- A Grade 3 serious adverse event appears to have been reported ~31 hours after site awareness; verify the awareness timestamp against the 24-hour expedited-reporting requirement.
- Informed-consent form v4.2 was not re-signed for two subjects following the latest protocol amendment; re-consent should be confirmed before further procedures.
- Source documentation for one out-of-range laboratory value could not be located in the reviewed records; locate and file the missing source before the visit.
4 · Recommended action items
- Site Coordinator: Pull source for the 03/02 dosing event, the aging ALT query, and the SAE timeline so each is ready for verification at the visit.
- Site Coordinator: Complete re-consent (ICF v4.2) for the two affected subjects and file the signed forms before the visit.
- Principal Investigator: Review and sign off on the dose-modification rationale and the SAE narrative.
- Site Data Manager: Answer the two queries aging beyond 30 days and attach source for the out-of-range ALT value.
5 · Methodology & data handling
wrldOS operates on the site’s uploaded, de-identified trial documents. A deterministic redaction safeguard re-checks for residual structured identifiers (emails, phone numbers, MRN/SSN, dates, ZIP codes) server-side before any document text is processed by an AI model — raw files are never stored, and only the safeguard-checked text is analyzed. Findings are drafted by specialized AI agents and grounded in the supplied, de-identified documents. This package is advisory: it accelerates your site’s preparation for monitoring visits and inspections. It does not replace the sponsor’s validated systems, your team’s professional judgment, or required regulatory documentation, which remain the system of record.
6 · Audit trail
- 6/23/2026, 2:02:11 PM — 6 de-identified documents ingested; safeguard re-redaction pass completed (0 residual identifiers found).
- 6/23/2026, 2:02:19 PM — Protocol Agent extracted visit windows, key I/E criteria, and safety-reporting timing.
- 6/23/2026, 2:02:27 PM — Risk Agent scored composite site risk from query, deviation, and safety-timing signals.
- 6/23/2026, 2:02:33 PM — Monitoring Agent drafted SDV priorities and monitoring findings.
- 6/23/2026, 2:02:38 PM — Regulatory Agent flagged ICF version-control and SAE timeline gaps.
- 6/23/2026, 2:02:44 PM — Delivery Agent assembled the report, action items, and audit trail.
Now picture this for your next monitoring visit.
Upload your site's de-identified files and get your own readiness picture — risk scored, gaps surfaced, owners assigned — human-reviewed and delivered within 24 hours. First report $2,500.