Clinical trial noncompliance has always been an industry concern. According to the FDA, the most common compliance deficiencies during inspections include inadequate investigator oversight, protocol deviations, poor record keeping, insufficient investigational product accountability, and issues with subject protection and consenting1.
Clinical trial noncompliance has always been an industry concern. According to the FDA, the most common compliance deficiencies during inspections include inadequate investigator oversight, protocol deviations, poor record keeping, insufficient investigational product accountability, and issues with subject protection and consenting1. Unfortunately, many study sites consistently face these challenges, and are still charged with 483s. William (Bill) Tobia, M.S., M.B.A., recently developed the “No 483 for Me” app as a preventative measure to help study sites avoid common noncompliance practices during clinical trial conduct. You can download the No 483 for Me app here. Bill is Lead Clinical Instructor for US Monitoring at GlaxoSmithKline Pharmaceuticals, and also holds adjunct faculty positions with Boston University School of Medicine, Drexel University College of Medicine, Rutgers University School of Health Related Professions, and Massachusetts College of Pharmacy and Health Sciences.
Disclosure – The referenced app was designed and developed by Bill Tobia independently from his academic and corporate employers.
Moe Alsumidaie: What triggered you to develop the No 483 for Me app?
Bill Tobia: My background is a combination of industry and academia. The genesis of this app started after I published my first book in 2013, “Your Career Guide to Clinical Research”. Both the book and the app were inspired by interactions with my students in the classroom. I teach students in the disciplines of clinical research and regulatory affairs, many of whom are already working in the field, trying to enhance their knowledge. During my lectures, students ask me for information and real world experiences that I have, as a result of my being in the industry for more than 46 years. I love helping students learn and apply the information from the classroom to their industry employment, but I found myself repeating the same information from one class to the next. So, I wrote the book as a reference for them to use during and after their academic classes. The positive response to the book gave me the incentive to create the No 483 for Me app.
MA: What role in clinical research is this app targeting?
BT: The app is targeting clinical research site staff, so that would be either a clinical research coordinator, PI, research nurse, pharmacist or anyone else involved in the conduct of a clinical trial.
MA: What are the benefits for research staff?
BT: All of us involved in clinical research oftentimes find ourselves going to the FDA website to look up 21 CFR regulations. But once we get there, we find it difficult to quickly find the information that we need. What I am trying to do, by way of the No 483 for Me app, is to concentrate on simplicity and ease of use. So, rather than forcing someone to go to the FDA website, use the search field, and click on the classification number, what they can do on the app is simply identify the area where they are having issues, and click on it to access the specific section of the regulations. The home screen of the app reflects the common areas of noncompliance that clinical research sites routinely face, each of which with a clickable link.
To elaborate, if I were staff at a research site, and I wanted to know what to watch out for with respect to “training” noncompliance, it would be easy for me to click on the “training” icon in the app. This then brings me to two choices: one of which is a clickable link that takes me directly to the section in 21 CFR that references training. The other component includes commonly found issues, things that FDA BIMO inspectors have found where site staff are out of compliance.
MA: Can you elaborate on the No 483 for Me app functionality?
BT: In addition to the above mentioned functionality, the app also features an interesting self-assessment called “Whiz Quiz” that users will receive by push notification. Each “Whiz Quiz” contains a single brief question with multiple choice answers. As research staff answer the “Whiz Quiz” they will get a response indicating what the correct answer is. The next release of the app will provide motivational bonus points for correct answers – after all, “recruiting” in clinical research is not the only area where we are competitive!