Unfortunately, in the last couple of years, the clinical-medical research field has had a very bad image on the public. This is mostly due to the focus of the media on certain selective incidents during the researches. Tragedies such as the “deaths of an 18-year-old subject in a gene transfer study at the University of Pennsylvania and of a 24-year-old healthy volunteer in an asthma challenge study at The Johns Hopkins University” (Goebel et al. par. 1). And in fact, public perception of this kind of research is negative. This is a misunderstanding.
Since the situation is the following, we will evaluate whether or not the site requires assistance in preparing for the audit. The negative perception can create a feeling of “fear” inside the staff of a multicentre clinical trial like the one I have been monitoring for the past months. There are different sites testing the safety and efficacy of a new drug to treat diabetes and one of these sites has been notified that soon will have an inspection from the FDA. The first thing to do is to send a message to the staff not to have fear and not panic over the inspection. It is true that the public perception is negative but if the procedures and rules are followed strictly then nothing can go wrong. It is very important to have tranquility among the staff when the inspection comes.
Secondly, in order to achieve this tranquility, there must be an explanation to the staff of what is a 483 Control Form and what is its purpose. It might be the case where many staff members do not know the controlling procedures adequately and this can create serious misunderstandings.
A 483 Control Form is a report made by the FDA inspector after he has investigated and reviewed the sites. This form contains his opinions on the situation he found and an evaluation of the procedures of the research facility (Goebel et al. par. 4). This report is then reviewed by other members of the FDA and a follow-up letter is then published stating the official position of the FDA on the issue at hand. A particular point that must be explained to the staff is that this form is intended to teach and not to punish (Goebel et al. par. 6).
Then another step would be to make necessary preparations. First, the site has to check if it has all the necessary documentation available. Also, the staff must be informed that the inspection includes interviews with them by the inspectors. There is nothing to fear if the procedures if you have followed correctly the requirements of your work. So, the staff will be advised to be honest.
Two important points should be made here; that the staff must be advised to understand the questions and their context before responding, and that are not obliged to give personal information other than training and professional qualifications. Something they should not do is to guess, lie or deny what seems obvious. Another thing would be to advise them not to answer questions outside of their area of expertise or authority.
Basically, what is important in an audit control inspection is to be “transparent” and honest about your work. If all of the above is done correctly then the inspection would not find anything even questionable.
References
- Goebel, P. Whalen, M. Khin-Maung-Gyi, F. “What a Form 483 Really Means”. Applied Clinical Trials Online. 2001.
- Sall, B. “Auditing to Ensure Reliable Clinical Trials”. MD&DI Online. 1997.