The monitoring visit report is the written record of what a monitor checked at a site, what was wrong and what will be done about it. Here are its sections, a findings table you can copy, and how SDV and query data in Capture feed it.
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Visit details
Activities performed
SDV on 12 subjects
Findings and deviations
2 major, 4 minor
Action items
Conclusion and sign-off
Key points
What it is
Monitoring exists to confirm that participants' rights and safety are protected, that the data are accurate and verifiable from source, and that the trial follows the protocol, GCP and regulations. The visit report is the evidence that this happened. ICH E6(R2) section 5.18.6 sets its content; E6(R3), adopted in 2025, keeps written reporting and adds more emphasis on risk-proportionate and central monitoring, so check which numbering your sponsor follows.
A common weakness is the report that lists tasks done but not conclusions. "SDV performed" tells a reader nothing; "SDV performed on 12 subjects, 94 percent of verified fields matched source, three transcription errors corrected through queries" can be acted on. Aim for the second kind, and write the conclusion as a statement about site readiness or concern, not a summary of the schedule.
Reports differ by visit type: site selection, initiation, interim monitoring and close-out visits each stress different sections. The template below is written for the interim visit, which is the one you will write most often, and notes where other visit types differ. The link between findings and the protocol deviation log matters: a finding that is a deviation should appear in both with the same classification.
Use a three-level scheme defined in the monitoring plan, for example critical (affects participant safety, rights or data integrity of a key endpoint), major (could affect these if repeated) and minor (isolated, low impact). The classification drives the response time, so define it once and apply it the same way at every site. Safety findings, such as an unreported SAE, are reported to the sponsor immediately and do not wait for the written report.
Under risk-based monitoring, not every field is verified at every visit. The report should state which data were in scope, why, and the verification rate, so a reader can see that the plan was followed.
SDV complete
78%
Open queries
9
Open deviations
3
Template
| # | Section | What to include |
|---|---|---|
| 1 | Visit details | Study, site, visit type and number, date and duration, monitor, report date, protocol version in force. |
| 2 | People contacted | Investigator and staff seen, with roles, plus anyone contacted by phone before or after. |
| 3 | Activities performed | What was reviewed: consent, eligibility, source against eCRF, safety reporting, product accountability, ISF, facilities. Scope and sample size. |
| 4 | Status since last visit | Enrolment against target, completed visits, withdrawals, and progress on previous action items. |
| 5 | Findings and deviations | Each finding with facts, classification, and whether it is a protocol deviation. |
| 6 | Action items | Action, owner, due date, and the evidence that will close it. |
| 7 | Conclusion | Overall assessment of site compliance and data quality, and whether the visit frequency should change. |
| 8 | Sign-off and distribution | Monitor signature, reviewer, sponsor review date, follow-up letter sent to the investigator. |
Findings table
Copy this layout into section 5 and 6. The rows use invented demo findings.
| Ref | Finding (fact) | Class | Deviation? | Action and owner | Due |
|---|---|---|---|---|---|
| F-01 | Consent version 2 signed by two participants after version 3 approval | Major | Yes | Reconsent per ethics guidance; investigator; update deviation log | 14 days |
| F-02 | Delegation log missing one coordinator's signature date | Minor | No | Complete and date correctly with note to file; investigator | 7 days |
| F-03 | Three systolic blood pressure values transcribed with a digit error | Minor | No | Correct through queries; site coordinator | 5 days |
| F-04 | Product temperature log has a 2-day gap | Major | Yes | Assess product impact with sponsor; pharmacist | 3 days |
Findings must be traceable to source. Reference the participant number and document, but keep participant names out of the report.
Where the report data comes from
Capture holds the data that sections 3, 4 and 5 describe. Source data verification can be set per field, so the monitor knows exactly which fields are in scope, and SDV status is tracked per form. Queries raised during review are visible with their status, and the monitoring dashboard shows enrolment and site-level status, so the report quotes the same numbers the sponsor sees. The report itself is a document you write and file, since Capture does not generate it.
Changed by Data manager · reason: critical safety value added
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How to use it
Before the visit, note SDV status, open queries and enrolment, and list open items from the previous report.
Record what you reviewed and the sample, with participant numbers, so every finding can be traced.
State what you saw without judgement, then classify. Avoid vague words such as "some" and "generally".
Each action has an owner, a due date and a defined closing evidence.
Make sure every finding that is a protocol deviation is also logged, with the same severity.
Issue the findings and actions to the investigator within the timeline in the monitoring plan and file both documents.
Open the report with the previous actions and record each as closed or still open.
Before sign-off
Date, site, monitor, people contacted, what was reviewed, findings, conclusions, actions.
Using the scheme in the monitoring plan, applied the same way as at other sites.
Any SAE or participant-safety concern was reported at once, not left to the report.
Which data were verified, why, and the verification rate.
Owner, due date and evidence for each. Link to the protocol deviation tracking record where relevant.
The report in the sponsor's file and the follow-up letter in the investigator site file.
The monitor submits a written report to the sponsor after each site visit or trial-related communication. It includes the date, site, monitor name, the people contacted, a summary of what was reviewed, significant findings, deviations and deficiencies, conclusions, and actions taken or recommended to secure compliance.
The sponsor reviews it and documents the review and follow-up, in line with the monitoring plan. The investigator receives a follow-up letter with findings and actions.
Within the timeline set in the monitoring plan, commonly days rather than weeks after the visit. Delays weaken the traceability of findings.
Not always. A finding is anything the monitor identifies as non-compliant or deficient. A deviation is a departure from the protocol. Deviations should be in both the report and the deviation log with the same classification.
No. The report is a document you write. Capture supplies the data that goes into it: SDV status set per field, query status and the monitoring dashboard.
Not every field is verified at every visit, so the report should say which data were in scope, why, and the verification rate. Central review findings can also trigger a visit and should be referenced.
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