Cheryl Elaine Kelly - Comment

While lines 464 -469 seem to address monitor training it does not speak to qualifications or training necessary for a particular type of trial. Several references are made regarding investigator experience and knowledge level as appropriate for a particular study , but the same is never addressed for monitors who actually perform both onsite and remote monitoring. The level of expertise in relation to a particular trial of a monitor has direct bearing on the quality of data reported, esp. in the area of adverse events, which bears directly on human subject safety and effeciency of the study. I have had monitors come to verify data on intricate neurosugical clinical studies whose back ground and most recent job was in Human Resources. If monitors are coming to monitor clinical studies, they should at least have some sort of clinical background or training. The data management people should work with the data, but when it comes to deciding what gets reported to them for data inclusion and what does not and what emphaisis it has comes from the monitor. How accurate can that be if the monitor does not even know the terminology of the area to be monitored? How time consuming for the investigative site if for every explaination there needs to be an anatomy and physiology lesson preceeding it. I am not suggesting that each monitor be an expert in his/her field, but posess at least a general working knowledge of the subject matter, ie nurses, respiratory therapists, etc., for clinical trials. Someone who understands drug interactions, basic knowledge of how the body functions, etc. Sponsors should tailor monitor expertise and background to the nature of the study. Someone with a clinical background should be sent to monitor a clinical study as a safe guard to subjects both in the trials and those that will later use the products as the general public.