Monitoring visit reports, drafted from the CRA’s notes and checked against the monitoring plan before the manager signs
Every monitoring visit becomes a cited, checked report in under an hour, signed on time.
See one case, screen by screen ↓A CRA leaves the site at half past four with a day of notes: consent forms checked, eligibility verified, SDV on eight participants, an SAE reviewed, drug accountability reconciled, a delegation log updated. Then the report has to be written in the sponsor template, every checklist answer stated, every open action from the last visit followed up, and the numbers squared with CTMS, EDC and IRT — on top of the next visit.
The trial manager signs what arrives. The risk is not in what the notes say; it is in what they leave out. An action item from two visits ago that nobody discussed. Consent on a superseded ICF version written up as a reminder, not escalated under the monitoring plan. “No new SAEs” in a report when the safety database shows one. These are the lines an inspector reads.
Estimated split of CRA hours for one interim monitoring visit report, by hand and with the solution.
Six specialist agents read, match, carry forward, write, review and draft the site letter; the CRA and trial manager confirm and sign.
Sam Patel monitors IMV 6 at Site 114, Riverside Dermatology Research in Austin, for the Phase 3 atopic dermatitis study VLT-302. Here is the report’s path, screen by screen, in the working solution.
Lena opens the visit clock board: 3 studies, 4 CRAs, 12 sites. Four reports are waiting for her, already checked by the reviewer agent; two sets of visit notes arrived and are one click from a draft; one report is past its clock: returned to Dana, and now on day 11 of 10. Three escalations wait for her decision.
“Visit clock board · visit day → report signed, 10 working days”
That evening, Sam dictates his notes — 6 min 12 s, transcribed into eight paragraphs. All 23 consent forms checked, except 114-019 signed version 3.0 on September 9, after version 4.0 was in use. SDV on eight participants, weeks 12 to 24, with three discrepancies queried in the EDC. The draft opens next to the notes, in the sponsor template, with a citation on every sentence.
“Written by agents from 4 sources · every sentence cited”
The notes reader pulls the facts from eight paragraphs. The checklist matcher maps ten checklist items to statements; the carry-forward tracker checks three actions from the last report; the site data check reads CTMS, EDC and IRT. The report writer fills twelve sections and the report reviewer checks them against the VLT-302 monitoring plan. Sam spends 14 minutes confirming the draft before it goes to Lena.
“Notes to checked draft in 39.6 s. Sam spent 14 minutes confirming it.”
The reviewer compares the draft with every source. The safety section says “No new SAEs” — but paragraph 5 of Sam’s notes and the safety database both show one for 114-011: pneumonia requiring hospitalisation, onset September 18, reported September 19. Consent on the superseded ICF is written as a reminder, when monitoring plan §7.2 makes it an important protocol deviation to escalate within 2 working days.
“A safety statement that contradicts the source cannot be signed.”
The last report, IMV 5 on August 27, left AI-114-031 open: assess the August 14 fridge temperature excursion — 9.1 °C for 46 minutes — and confirm quarantine of the affected kits, due September 15. It appears in neither the notes nor the draft. The checklist answer for previous action items is Partial. It is now 41 days open.
“Every report must follow up actions not resolved in previous reports.”
Lena presses Sign report. It does not open. Three must-fix findings are listed — the consent escalation, the dropped action and the SAE statement — and signing opens only when each one is fixed, or dismissed with a reason that goes on the record.
“The monitoring plan does not allow a report to be signed with a missing escalation, a dropped action or a safety statement that contradicts the source.”
Each finding carries suggested text and its evidence. Applying the consent fix makes three changes: the informed consent sentence now records the deviation and the re-consent on version 4.0 at the week 28 visit on October 14; the escalation section records it under §7.2; and a new action, AI-114-037, asks Dr. Whitford to re-consent 114-019 and file a note to file with both versions. The changed text is highlighted in the report.
“Fixed — 3 changes made to the report”
With the three must-fix findings fixed, signing opens: 3 of 5 findings resolved, 5 open actions, 1 escalation. Lena signs with her password and the meaning “I have reviewed and approve this monitoring report”. The two minor findings left — the randomised count and the wording about the PI — are recorded as accepted as written by her. Signed October 7, day 4 of its 10-day clock.
The letter writer drafts the letter to Dr. Alan Whitford: thanks to the team, what was reviewed, and the open actions with owners and due dates — the queries older than 30 days, the lab normal ranges, the PI oversight call on October 8, the re-consent of 114-019, the fridge excursion assessment. Internal assessments and escalations stay out of it. Lena presses Send follow-up letter; the report and the letter are filed to the TMF.
Site-facing actions only — no internal assessments, and only after signature.
The reviewer raised the consent issue as an escalation on Lena’s home screen. She chooses what happens — re-consent and request a root cause and CAPA from the site, re-consent only as a single occurrence, or notify Quality of a possible serious breach — and adds a comment for the record. The decision is written to the report’s activity trail.
The same report, seen by the CRA who writes it, the manager who signs it, and the people who follow up what it raises.
Six specialist agents read, match, carry forward, write, review and draft the site letter; the CRA and trial manager confirm and sign.
Turns the CRA’s dictation or typed notes into facts: participants, numbers, issues and promises made by the site, each with its paragraph reference.
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 every action raised at the site, and carries each unresolved one forward with its age and the visits it has been carried.
Writes the monitoring visit report in the sponsor template for the visit type, with a citation on every sentence to the notes, the checklist, the last report or the site data.
Checks the draft against the study’s monitoring plan and the site data: missing escalations, dropped carry-forward actions, inconsistencies with CTMS, EDC and IRT, missing statements and subjective wording — each with severity, evidence and 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.
The trial manager can ask about any visit report, finding, action item or escalation — or tell it what to change.
Which reports could miss the 10-day clock?
2 reports are at risk on the 10-day clock: MVR-26-0407 at Site 121 is on day 11, returned to Dana; MVR-26-0410 at Site 133 is on day 6 with 1 minor finding and is ready to sign. Also watch Site 114 and Site 314, both on day 4 with must-fix findings — signing is locked until those are fixed.
What did the reviewer find in the Site 114 report?
Five findings on MVR-26-0412, three of them must-fix: consent on superseded ICF v3.0 for 114-019 is not escalated; action AI-114-031 (fridge excursion) was dropped; “No new SAEs” contradicts 114-011. And two minor: randomised 22 versus 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 the trial manager within 2 working days, and the sponsor decides and records the action. 114-019 signed v3.0 on Sep 9; v4.0 was in use from Sep 1.
Escalate action items open more than 45 days
Done — the rule is now 45 days (was 60). 2 more actions cross it and are escalated: AI-309-008 at Site 309 Kestrel, Denver (56 days) and AI-210-014 at Site 210 San Marco, Milan (48 days). Settings and the action board are updated.
13 screens from the working solution, on its sample data. Pick one to see it large.
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 | Set in working days |
| Manager signs | 5 working days | Set in working days |
| Follow-up letter to the investigator | 2 days after signature | Set in working days |
| Escalate an action item open longer than | 60 days, or carried over two visits | 30 · 45 · 60 · 90 days |
| Escalation rules from the monitoring plan | Consent on a superseded ICF version · SAE reported after 24 hours · suspected serious breach | Each on or off |
| Reviewer checks on every draft | Site data · carry-forward · checklist statements · subjective wording | Each on or off |
| Report template | Sponsor template per visit type | IMV · SIV · COV · Remote |
| Signature meaning | I have reviewed and approve this monitoring report | Or: 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 · Context: ICH E6(R3) §3.11.4.6 and FDA guidance on risk-based monitoring (2013). People, companies and products 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 in the sponsor’s template. This one reads the notes, the visit checklist, the last report’s open actions and the site data, writes the report with a citation on every sentence, and has a reviewer agent check it against the monitoring plan before the trial manager signs.
The CRA dictates or types the notes. The notes reader turns them into facts with paragraph references, the checklist matcher maps every checklist answer to a statement, and the report writer fills each section of the template for the visit type — IMV, SIV, COV or remote. The CRA confirms the draft before it goes to the manager.
Yes. The carry-forward tracker reads every action not closed in previous reports for the site and carries it forward with its age. If an open action is missing from the draft, the reviewer raises it as a must-fix finding, and actions past the threshold or carried over two visits are escalated.
Missing escalations under the monitoring plan, dropped carry-forward actions, statements that disagree with CTMS, EDC or IRT, checklist items with no statement, and subjective wording about people. Each finding has a severity, its evidence and suggested text. It proposes fixes; it never signs.
Yes. The CRA confirms the draft, the trial manager fixes or dismisses each finding — a dismissal needs a reason — and signs with a password and a stated meaning. Escalations are decided by a named person, and every step is on the activity trail.
The letter is written only after the report is signed: the open actions with owners and due dates, the actions closed since the last visit, and the next visit date. Internal assessments and escalations are left out.
Yes. The days for the CRA to submit and the manager to sign, when the letter goes out, the action-item threshold, the escalation rules, the reviewer’s checks, the report templates and the signature meaning are all settings.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your monitoring plans, report and letter templates, and a sample of past visit notes and reports — and it goes live once every quality gate has passed.
A trial synopsis becomes a checked first-draft protocol in days, in your own approved language.
1-min filmTMF CheckEvery trial document is read, filed in the right place and checked, so the file is inspection-ready every day.
1-min filmCSR WriterResults sections and patient narratives are drafted within days of database lock, every number linked to its table.
1-min filmWe’ll run the Monitoring Visit Report Writer on a sample of your own visit notes and monitoring plan.