ABSTRACT
The term investigational agent refers to the study medication, study drug, or experimental device to be studied in a research protocol. The use of investigational agents in clinical trials is strictly stipulated by Food and Drug Administration (FDA) regulations. It is imperative that the agent can be accounted for at every step of the clinical trial process-from the sponsor's shipment to the site to its use by the subject or destruction by the sponsor. This chapter will focus primarily on investigational drug substances, although the same general principles apply to devices.
