ASHP guidelines on the pharmacist's role in clinical drug research and future directions for pharmacists in clinical drug research are described. Health-system pharmacists have a responsibility to the patient and to the institution to ensure that clinical research systems are sound, that patients are protected, and that research is conducted in a safe, effective way. ASHP guidelines list minimum standards that are essential for improving performance. The ASHP Guidelines on Clinical Drug Research, approved in November 1997, update information previously found in the ASHP Guidelines for the Use of Investigational Drugs in Organized Health-Care Settings, approved in 1990, but have an expanded focus. Additions include recognition of relevant business practices, implications of technology, and the expansion of clinical research beyond the academic health center. At a minimum, all pharmacists involved in clinical research should handle the record keeping for drug accountability, provide drug information to patients and to other health care providers, ensure the appropriate care of patients at sites not involved in the study, and provide accountability at nonpharmacy locations. Managing and coordinating clinical drug research is an area of growth that represents a great opportunity for clinical drug research. By providing baseline and higher-level pharmaceutical services for clinical research projects, pharmacists can help to ensure data accuracy and completeness and patient safety.
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