One way to remember the difference between an academic and private research site is that private research sites do not develop their own protocols. Private research sites obtain their protocols from sponsors.
Having source documents in multiple locations is not a common practice however, is allowed by most sponsors. One major caveat is that both locations must be mentioned on the form FDA 1572.
The negotiation process must be able to account for all services and procedures that occur during the course of the study. Because of how challenging this process can be, many items can easily be overlooked.
The Institutional Review Board (IRB) will always focus on subject safety. This video describes the requisites for a successful IRB approval process.
Many people are interested in the various functions of a typical Clinical Research Associate (CRA). Some of the responsibilities of a CRA revolve around monitoring patient safety, Investigational Product (IP) accountability, and interacting with study staff at different research sites.
In this video I discuss clinical research participant retention and recruitment. Factors such as transportation, appointment reminders, and studies that are concerned with a subject’s well being.