Michael H. Gold, MD
Creating a clinical trials center takes time, commitment, and personnel. When considering conducting research, there are many terms that you should know including Form 1572 (a signed commitment by the investigator between their research site and the sponsor), IRB (Institutional Review Board), IC (Informed Consent), GCP (Good Clinical Practice), SOP (Standard Operating Procedures), etc. When conducting clinical trials, you should have an ethical eye, protect your subjects, have a well-designed plan, select qualified study staff, and document appropriately. The biggest component of research is the FDA. They monitor offices and can perform audit visits if needed. At these visits, they are allowed to look at every aspect of the office.
Performing research requires multiple people including the sponsor, the CRA, a monitor, and the investigator which includes the principal investigator, sub-investigators, and coordinators. If you want to start doing research, it is essential to talk to many other people in the field and to speak with your medical reps. The reps have access to their district manager and/or the companies’ medical science liaison who can help you get started and provide more information. At the beginning, expect to get Phase III trials that are conducted among numerous clinical sites or long term safety studies. After showing that you can handle studies like these, then you may get Phase II studies or even botox/filler studies. If you decide to get involved in research, you need to be ready, get proper staff to help you, get organized in your office, and have extra room for storage for the clinical trial materials and collected data.