Compliance In Focus

Writing great monitoring reports is not just about writing the report. It requires an in depth knowledge of the job, the study protocol, the site, their practices, the sponsor’s procedures, the monitoring plan, the report template, and of course, the regulations. Attention to visit preparation, clear notetaking during the visit, and prompt, clear report writing pays off in delivering a high-quality document. It is a difficult skill to master, but one that is rewarding, especially when faced with a regulatory inspection.

Writing monitoring reports is an important responsibility. A well-written monitoring report tells the story of your clinical trial to the FDA and helps facilitate inspections. However, this important task doesn’t often get the attention it deserves. Between scheduling visits, traveling and conducting the visits, it can fall down on a monitor’s priority list.