How to run an Interim Monitoring Visit

An interim monitoring visit is the routine, risk-based check that the site is running the study to protocol, GCP and the monitoring plan, and that the data are accurate and complete. It is the visit where most findings arise, because it is where the study's day-to-day reality meets the protocol's requirements.

The CRA should not treat the IMV as a tick-box exercise. The monitoring plan defines the sample size, the data points to verify and the risk indicators to follow. The visit should focus on the areas where a site is most likely to drift: informed consent, eligibility, safety reporting, protocol deviations, investigational product accountability and data quality. A smaller, well-targeted sample is more useful than a broad review that never gets finished.

The starting point is the previous visit report and the outstanding action log. The CRA should know which findings were closed, which are still open and which are overdue before arriving on site. The visit should test whether the site's corrective and preventive action actually changed practice, not just whether a form was signed.

The IMV also has a forward-looking purpose. It should tell the sponsor whether the site's risk level is changing and what needs attention before the next visit. A site that is improving should be recognised; a site that is drifting should be escalated early, with a clear description of the risk and the action required.

The document request should go out at least two weeks before the visit. The CRA should review the previous report and the action log before the visit, so that on-site time is spent testing the issues rather than discovering them.

• Previous visit report and follow-up letter.
• Outstanding action log with current status and owners.
• Subject screening and enrolment list, or an agreed de-identified extract.
• SAE log and the current safety reporting tracker.
• Protocol deviation log and any sponsor correspondence about deviations.
• Investigational product accountability records, including temperature logs.
• Current approved informed consent form and any re-consent versions.
• The monitoring plan and the SDV plan for the study.
• Query report or data clarification status.
• Any recent site correspondence that affects the monitoring scope.

• AE or SAE not reported within the protocol timeline. The most common cause is that the site did not recognise the event as serious. The CRA should check the event date, the site's awareness date and the sponsor receipt date, and record where the delay occurred.
• ICF signed after a study procedure. This is a critical finding when the procedure was study-specific. The CRA should establish the sequence from source, assess the impact on the participant and escalate immediately.
• Source data missing for a recorded CRF value. A CRF value without a source is not verifiable. The CRA should document the missing source and agree how the site will correct or support the entry.
• IP temperature excursion not documented or reported. A temperature log gap is not automatically an excursion, but it is a loss of evidence. The CRA should review the monitoring records and the site's response, and assess whether affected product was dispensed.
• Eligibility criteria not evidenced in source. The CRF may record that a criterion was met without the source to support it. The CRA should check the underlying records and document any participant whose eligibility cannot be confirmed.
• Delegation log not updated after a staff change. Staff changes are normal; an outdated delegation log is not. The CRA should confirm who did what and when, and whether training and delegation were in place before the task.
• Queries open beyond the agreed window. A large or ageing query backlog affects data quality and can signal a site capacity problem. The CRA should review the age and type of queries, not just the count.
• Prohibited concomitant medication missed. The CRA should check the medication review against the protocol's prohibited list and document the participant impact and any required reporting.

The IMV report should be explicit about the scope of the visit. What was reviewed, what was not reviewed, how many participants or data points were sampled and what the sample showed. The sponsor should be able to see the basis for every conclusion without reading the whole monitoring file.

1. What was verified and what was not, with the sample size?
2. Which findings are critical, major or minor, and what is the CAPA and due date?
3. Is the site's risk level changing?
4. What must the sponsor know before the next visit?

The follow-up letter should go to the site within the agreed window, typically ten working days. It should restate the findings, the agreed actions, the owners and the due dates, and distinguish between items that need a site response and items the CRA or sponsor will handle.

Every finding should be tracked to closure. A CAPA that has been agreed but not implemented is still open. The CRA should check the evidence of implementation at the next contact, not just accept an assurance that the action was completed.

Critical findings should be escalated immediately rather than waiting for the report. The sponsor may need to take action to protect participants or data, and the site may need support to correct the issue quickly.

The report and follow-up letter should be filed in the trial master file and the investigator site file according to the sponsor's document plan. The next visit plan should be based on the risk profile found at this visit, not on a fixed calendar alone.