Clinical research: regulatory issues.
The regulatory issues faced by institutions performing clinical research are described. Many institutions do not have on staff an expert who understands the regulatory issues involved in managing investigational new drug research and who knows the institution's obligations under the federal rules. Because pharmacists understand the FDA regulations that apply to the management of drugs in clinical research, institutions are asking pharmacists to expand their role and manage clinical research offices. Many authorities govern various aspects of investigational drug research. FDA has published regulations for good clinical practice (GCP), and the International Conference on Harmonisation is developing an international standard for the proper management of clinical trials. The guidelines published by the Joint Commission on Accreditation of Healthcare Organizations aim to protect patients who are in the institution to receive health care and also participate in clinical trials. The Social Security Administration Acts specifically state that only items and services that are reasonable and necessary for the diagnosis and treatment of injury or disease can be billed to the government; research-related billings are excluded from coverage. Proper management of drug research is crucial to the success of a research program that is integrated with patient care.
Kentucky Center for Clinical Research and Investigator Services, University of Kentucky, Lexington 40536-0082, USA. dwermel@pop.uky.edu
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D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D017277:Drug Approval; D015507:Drugs, Investigational; D017408:Guidelines as Topic; D006801:Humans; D007591:Joint Commission on Accreditation of Healthcare Organizations; D008484:Medicaid; D006278:Medicare; D010607:Pharmacy Service, Hospital / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration
D015507:Drugs, Investigational