Investigators usually have little formal introduction to clinical research methodologies, and thus rely heavily on guidance from the coordinators they hire and the monitors they encounter. Unfortunately, coordinators, monitors, and physicians often have similar levels of research education and training. So it is not uncommon for those engaged in research to guide each other through the complex process and the maze of regulatory requirements. Traditionally, some CROs and most pharmaceutical companies have provided training programs to teach the basics of drug development to their newest monitors and in-house study coordinators. These courses tend to last two to five days and only cover the most important procedures and regulatory aspects intrinsic to the research process.
Intensive training is terribly expensive and, as a result, most companies provide very little.
Therefore, monitors initially gain experience by traveling with experienced monitors, as finances permit. However, there is usually great pressure on supervisors to limit the number of such training trips. In-house coordinators often receive less job instruction than monitors, because it is assumed that they will have ample opportunity to ask peers for assistance as questions arise. To be sure, the FDA's regulations governing the introduction of new medications into human subjects can readily be obtained and are easily comprehensible. But there are more issues involved in clinical research than the regulations address.