Monitoring visit report automation: a cited, checked report in under an hour, every open action rolled forward
A cited, checked visit report in under an hour, every open action rolled forward.
See one case, screen by screen ↓Software that turns a CRA's visit notes into the monitoring visit report. Monitoring Visit Report Automation has six agents read the notes, the visit checklist, the last report and the site data from CTMS, EDC and IRT, write the report in the sponsor template with a citation on every sentence, and review it against the monitoring plan before the clinical trial manager signs.
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After every site visit the CRA has dictated or typed notes, the visit checklist, the open actions from the last report and the site's data in CTMS, EDC and IRT. Turning those into a monitoring visit report in the sponsor template, section by section, takes two to four hours — off site, after the visit, against the sponsor SOP's 10-working-day clock from visit day to signed report.
Then the clinical trial manager reads it line by line and often sends it back for what is missing: an important deviation recorded as a reminder instead of escalated, an action from the last visit silently dropped, a medication statement that contradicts the EDC, an opinion about the investigator that reads badly in an inspection. Monitoring reports are the first thing inspectors ask for, and unresolved monitoring findings are cited against the sponsor.
Estimated split for one interim monitoring visit report, written and reviewed by hand and with the solution.
Six agents read, roll forward, write and review in the margin; the CRA confirms and the trial manager signs.
Site 114, Riverside Dermatology Research in Austin, runs VLT-302 — Veltrimab, Phase 3, atopic dermatitis. Sam Patel did interim monitoring visit 6 on 1 October. Lena Ortiz, the clinical trial manager, signs it. Here is what happens, screen by screen, in the working solution.
Lena's queue holds 4 reports that need her, 2 with notes in and not yet drafted, and 2 with the CRA. MVR-26-0412 for Site 114 is due 15 October. The agents wrote it from Sam's notes, the visit checklist, the last report and the site data — every sentence carries a numbered citation — and the report reviewer has left five comments in the margin, each tied by a line to the sentence it questions.
“3 must-fix comments open · signing opens when they are fixed or dismissed with a reason”
Above section 01 sit the three actions from IMV 5 on 27 August. AI-114-028, the IRB approval of protocol amendment 3, was closed before this visit. AI-114-033, the evening-clinic coordinator on the delegation log, was closed at this visit. AI-114-031 — the IP fridge temperature excursion on 14 August, 9.1 °C for 46 minutes — is marked in red: not in this report.
The carry-forward tracker never closes an action without evidence.
Lena opens the comment: “AI-114-031 from IMV 5 — the fridge excursion — is still open. Why isn't it in this report?” The reviewer shows why: raised 27 August, due 15 September, in neither the notes nor the draft, and the checklist marks previous action items as Partial. The last report's actions open on the left, and a suggested sentence is ready.
“Every report must follow up actions not resolved in previous reports.”
One click makes two changes: a sentence in the investigational product section says the action was not discussed and remains open after 41 days, and the action goes into the action table, due 9 October. At the top, AI-114-031 now reads “Carried forward · open 41 d”.
Participant 114-019 signed ICF version 3.0 on 9 September, after version 4.0 was in use at the site from 1 September — an important deviation under monitoring plan §7.2, recorded in the draft only as a reminder. And “No rescue medication” contradicts both the notes and the EDC: 114-011 took oral prednisone for 7 days from 18 September for a flare — rescue therapy under protocol §6.4. Lena applies both fixes; the consent becomes an escalation and a re-consent action.
“A statement that contradicts the source cannot be signed.”
With the three must-fix comments resolved, signing opens: 3 of 5 findings resolved, 5 open actions, 1 escalation. The two minor comments — 22 randomised in the draft against 23 in IRT, and the opinion about the PI — are recorded as accepted as written by her. She signs with her password under the meaning “I have reviewed and approve this monitoring report”, on day 4.
Must-fix comments lock signing; a dismissal needs a reason on the record.
The letter writer drafts the letter to Dr. Alan Whitford: thanks to Dr. Nora Feld and Jess Moreno, the five open actions with owner and due date — the fridge excursion assessment by 9 October, the re-consent of 114-019 by 14 October — the action closed since the last visit, and the next visit on 29 October. Internal assessments and the escalation stay out of it. Lena presses Send follow-up letter; the report and letter are filed to the TMF.
The letter writer only runs after signature.
Omar visited Site 309, Kestrel Heart Institute in Denver, on 6 October — CRV-210, interim monitoring visit 3 — and dictated 4 min 39 s of notes, transcribed. His notes arrive with the 8-item checklist, the last report's 3 actions to roll forward and the site data from CTMS, EDC and IRT. Lena presses Write the report.
The notes reader reads 6 paragraphs, 9 participants and 34 facts. The checklist matcher matches 8 items and finds 2 partial or No; the carry-forward tracker finds 2 of last visit's 3 actions still open; the site data check compares enrolment, con meds and queries. The report writer fills 12 sections of the CRV-210 template while the screen follows, every sentence cited.
The report writer never writes a sentence without a source.
Three comments appear, two of them must-fix. AI-309-007 — re-consent 309-003 on ICF v3.1, raised at IMV 2 on 12 August — is still open after 56 days, yet the draft says every consent is on the current version. AI-309-008, the sub-investigator's CV and GCP certificate, is now carried over two visits and the draft does not escalate it. The September pharmacy temperature log was not reviewed, with no follow-up planned.
The same report, seen by the people who write it, sign it and decide what it escalates — what their week looked like, and what it looks like now.
Six agents read, roll forward, write and review in the margin; the CRA confirms and the trial manager signs.
Turns the CRA's dictation or typed notes into facts — participants, numbers, issues and promises made by the site — each with its paragraph reference, keeping the CRA's numbers exactly.
Matches every visit checklist answer to a statement in the notes; Partial and No answers become statements the report must make.
Reads the open actions from the last report and the action register, carries every unresolved one forward with its age and the number of visits it has been carried, and proposes escalation when the threshold is crossed.
Writes the monitoring visit report in the sponsor template for the visit type, citing the notes, the checklist, the last report or the site data on every sentence.
Checks the draft against the monitoring plan and the site data — missing escalations, dropped carry-forward actions, inconsistencies with CTMS, EDC and IRT, missing statements and subjective wording — and leaves each finding in the margin with its evidence and a suggested text.
Writes the follow-up letter to the investigator from the signed report: open actions with owner and due date, actions closed since the last visit and the next visit.
Confirm, then sign. The agents propose; a named person decides.
Ask about any visit report, finding, action item or escalation — or say what to change. Answers point to the notes, the checklist, the last report or the site data.
What did the reviewer find in the Site 114 report?
Five margin comments on MVR-26-0412, three of them must-fix: consent on superseded ICF v3.0 for 114-019 is not escalated — v4.0 was in use from Sep 1; action AI-114-031 (fridge excursion) was dropped; and “No rescue medication” contradicts 114-011. The two minor ones: randomised 22 against 23 in IRT, and subjective wording about the PI.
Why is consent on an old version escalated?
Under the VLT-302 monitoring plan §7.2, consent on a superseded ICF version is an important protocol deviation: the participant was not given the current information. It must reach you within 2 working days. 114-019 signed v3.0 on Sep 9; v4.0 was in use from Sep 1.
Any prohibited medication?
One: 314-004 at Elm Street Heart Centre, Manchester — ibuprofen for 10 days from Sep 12, prohibited under protocol §6.3. The reviewer flagged that the draft did not escalate it; it is waiting for your decision.
How is the follow-up letter written?
After you sign, the letter writer builds the letter to the investigator from the signed report: the open actions with owners and dates, actions closed since the last visit, and the next visit date. Internal assessments and escalations stay out of it. You press Send follow-up letter; both documents are filed to TMF zone 05.
13 screens from the working solution, on its sample data. Pick one to see it large.
The clocks, escalation rules and the reviewer's checks are settings, and they take effect on every report.
| Setting | Default | Choose from |
|---|---|---|
| CRA submits the report | 5 working days from the visit | Step up or down, one working day at a time |
| Manager signs | 5 working days | Step up or down, one working day at a time |
| Follow-up letter to the investigator | 2 working days after signature | Step up or down, one working day at a time |
| Action item open too long | 60 days, or carried over two visits | 30 · 45 · 60 · 90 days |
| Escalation rules from the monitoring plan | Superseded ICF within 2 working days · prohibited or rescue medication the same day · suspected serious breach to Quality within 1 working day | Each rule on or off |
| Reviewer checks | Compare with site data · carry forward unresolved actions · a statement for every checklist item · flag subjective wording | Each check on or off — applies to the next draft |
| Report template | Northwind Bio · IMV v7 | IMV v7 · SIV v4 · COV v3 · Remote v2 |
| Signature meaning | I have reviewed and approve this monitoring report | I have reviewed and approve this monitoring report · I have reviewed this report; escalations recorded |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample study data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = published figures (Tufts CSDD CRA workload and utilization benchmarks, reported in Applied Clinical Trials — about 41% of CRA hours on site and about 36 hours a month on off-site monitoring work; ICH E6(R3) section 3.11.4 on monitoring). People, sites, studies and companies named on this page are fictional — characters and sample data in the working solution.
Software that turns a CRA's visit notes into the monitoring visit report. Monitoring Visit Report Automation has six agents read the notes, the visit checklist, the last report and the site data from CTMS, EDC and IRT, write the report in the sponsor template with a citation on every sentence, and review it against the monitoring plan before the clinical trial manager signs.
The carry-forward tracker puts every action from the previous report at the top of the new one, with its fate at this visit: closed before, closed at this visit, carried forward with its age, or not in this report. A missing one becomes a must-fix comment, and the nightly action watch escalates actions past the threshold or carried over two visits.
Missing escalations under the monitoring plan, dropped carry-forward actions, statements that contradict the site data in CTMS, EDC and IRT, checklist items without a statement, and subjective wording about people. Each comment sits in the margin next to the sentence, with the rule, the evidence and a suggested text.
No. The reviewer proposes fixes and never signs or applies one by itself. The clinical trial manager signs with a password under a stated meaning, and the follow-up letter is written only after signature, with no internal assessments or escalations in it.
Yes. The CRA confirms the draft; the clinical trial manager fixes or dismisses each comment with a reason, decides each escalation and signs. Must-fix comments lock signing until they are resolved, and every step is on the activity trail.
Yes. The report template per visit type, the CRA and manager clocks, the letter clock, the escalation rules from your monitoring plan, the reviewer's checks, the signature meaning and the TMF filing zone are all settings.
Yes. A CRA can add a dictation, typed notes or a checklist photo after the visit. The notes reader keeps the CRA's numbers exactly, records participant IDs only, and never infers a fact that is not in the notes.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your monitoring plans, report templates and a sample of past visit notes and reports — and it goes live once every quality gate has passed. We will walk you through it on your own reports first.
A checked first-draft protocol in days, in your approved language.
1-min demoeTMF Quality CheckAn inspection-ready trial master file every day, each site scored on what is due today.
1-min demoClinical Study Report AuthoringResults drafted within days of database lock, linked to tables.
1-min demoWe'll run Monitoring Visit Report Automation on a sample of your own visit notes and past reports.