One of the biggest issues that the Food and Drug Administration (FDA) has been focused on lately has been the lack of Principal Investigator (PI) oversight in the clinical trials that they manage. In this video I suggest some ways that we in the industry can improve PI oversight.
This is some very simple but practical advice for my research sites out there: do not put your contract and budgets in the regulatory binder. Instead provide a note to file that explains where these documents will be kept.
Many people often confuse or use the acronyms IND and NDA interchangeably. In this video I explain the differences in meaning between an IND and an NDA in clinical research.