This chapter focuses on general adminstrative aspects of both Phase III and Phase IV clinical drug protocols. In the development of any given pharmacologic agent, Phase III precedes registration of a new drug application (NDA) with the Food and Drug Administration (FDA). Successful completion of Phase III clinical trials is accompanied by FDA support of the NDA, and emanating from this are Phase IV clinical trials. Controlled, as well as uncontrolled, clinical trials are employed in the Phase III stage of drug development. The patient’s initials, date of entry into the screening or pretreatment phase, the date on which the study drug is administered, study drug lot number or allocation number, and the patient’s date of completion or date patient is aborted are facts essential to a comprehensive patient roster. The accurate recording of all adverse clinical and laboratory events is paramount in all phases of drug development.