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.
Monitoring reports shouldn’t be an afterthought. Not only are they required by ISO and ICH regulations on Good Clinical Practice, they are also an extremely useful way to demonstrate site performance and sponsor oversight during an FDA inspection.
IMARC’s latest resource is designed to provide guidance to monitors writing reports as well as those who review them.
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.