How to Write a Useful Clinical Monitoring Report

Documentation is among the least glamorous and most burdensome aspects of compliance. For regulators, nothing happened if it wasn’t documented. Some companies err on the side of caution by requiring too much documentation without focusing on the documentation’s purpose. However, it’s also important to not neglect documentation when it is needed. One place where this balance is particularly important is in site clinical monitoring.

Site monitoring reports serve a regulatory purpose by proving the site monitoring happened. Their usefulness extends beyond simply checking a box on the compliance checklist. A well-written report shouldn’t be an afterthought but should be an integral part of the site visit. The report and visit are essential parts of proper clinical trial management.

#1: Clinical Monitoring Report Preparation

Site monitoring has a purpose. Keep that purpose in mind as you prepare. There are requirements in the study protocol that must be met, some of which pertain to what information needs to be included in the report. Depending on how or if the clinical trial is using centralized or remote monitoring, some of the information for the report can be collected before the monitor is even on-site. If those methods are used, reviewing documentation and data can be done beforehand. Remote access to that information is also useful when it comes to writing the report after the visit.

An important component of preparing is to look at past clinical monitoring reports and audit reports, if any have been conducted. If a previous site interim visit reported a problem, that requires follow-up during the next visit. Time on-site is limited, so these issues should be prioritized. A risk-based approach to monitoring will also indicate certain areas that require precedent.

#2: Note Taking

Taking notes takes time, but it’s worth it in situations where you couldn’t possibly remember everything. The monitoring report template should be open throughout the visit, both to keep you on track and to give you a place to write notes. Everyone has their own system of taking notes, but your focus should be on the areas most important to regulators — patient safety and data quality. This is the whole reason for doing the site monitoring, so take notes that demonstrate adherence to protocol, good clinical practices (GCP), and regulations. Or notes on how the site is not adhering to those requirements.

#3: Monitoring Follow-Up

Your clinical monitoring visit and the ensuing report aren’t isolated incidents. They will be shaped by previous visits and affect future ones. Hopefully, issues from the past site monitoring reports that you reviewed while preparing for the visit have been resolved. If not, include it in your notes and the final report. Any corrective action the site has implemented should prevent recurrence. The site and monitor should work together to find solutions that will bring the site into compliance. Your report should also include any items that will need follow-up during the next visit.

Besides follow-up for a single site, monitors should also be aware of how any issues might reflect a trend across the whole study. If multiple sites are having the same issue, it might have more to do with the study protocol than the sites themselves.

#4: Write Your Clinical Monitoring Report ASAP

Taking great notes is critical, but the best time to write the report is when it’s fresh on your mind. There might be details that didn’t make it into your notes that would soon be forgotten. Or you might look back at your notes later and realize something that made sense in the moment no longer does. It’s important to write the report quickly because human memory is fallible. Going along with that, if multiple site visits are scheduled for the same day, there’s danger in remembering something from one site as pertaining to another. At the very least, the report for one site should be written before visiting the next.

#5: Be Clear and Concise in Your Report

A site monitoring report shouldn’t read like a doctoral thesis. But it also can’t be a collection of bullet points. There’s a balance that monitors have to achieve between having too much information and not enough. The report absolutely should include:

• The date of the visit.
• Name of people involved (from the site and sponsor).
• Summary of what was reviewed.
• Description of any issues or potential issues (e.g., nonconformance, problems with data, etc.)
• Description of any corrective action, who is responsible for that action, and when that action will be completed.

While there’s no wordcount requirement for a site monitoring report, the summary and descriptions do need to be detailed enough to verify the monitoring plan was followed.

Conclusion

Documenting what happens during a clinical monitoring visit is just as important as the visit itself. It’s essential for showing the site is compliant with regulations and the study protocol. It also demonstrates the improvements sites make when issues are discovered and who is responsible for them. Reports from previous visits serve as a starting point for the next visit and ensure follow-up items aren’t forgotten. Keeping all this in mind, the site monitoring report needs to be given forethought and attention to make it a useful document.