Pharmaceutical Research Center

University Of Wisconsin-Madison, Madison WI

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY (See instructions): The Pharmaceutical Research Center (PRC) is responsible for the safe and ethical provision of investigational/study medications to research subjects enrolled in clinical drug trials within the University of Wisconsin Hospital and Clinics (UWHC) and the University of Wisconsin Carbone Cancer Center (UWCCC). The PRC service ensures that drug research protocols proceed optimally through UWHC's established medication use system and in accordance with all federal, state, institutional and sponsor regulations governing clinical research. While the PRC program supports all UW-Madison investigators conducting clinical drug research, its relationship with UWCCC is unique in its level of commitment, the breadth and depth of services provided and its expertise in handling biohazardous and gene therapy products. The PRC provides detailed protocol review and feasibility assessment within the confines of an academic medical center. It ensures full compliance with federal, state, sponsor and institutional requirements through activities such as; establishment of drug handling/distribution/preparation/destruction procedures; creation of investigational drug monographs for health care providers; education of healthcare staff regarding protocol procedures; creation of preprinted physician orders and prescriptions; drug inventory management and accountability; drug preparation and/or oversight; quality assurance audits; and protocol amendment management. It operates satellite pharmacy locations, optimizing ability to extend clinical research into the community. The services are continually refined and expanded to meet the evolving needs of UWCCC research faculty, research infrastructure and the research subject.