Clinical research and the development of new devices: considerations for nurses.
New investigational drugs and devices are commonly used in critically ill patients. The development of new drugs and the role of the critical care nurse caring for subjects in clinical trials are crucial to the success of the research process. The purpose of this article is to discuss the Food and Drug Administration's regulatory approval process for significant risk investigational devices.
Lanter
Jennifer
J
Access and Revenue Cycle Department, Ohio State University Medical Center, Columbus, OH 43218-3102, USA. Jennifer.lanter@osumc.edu
D001291:Attitude of Health Personnel; D002986:Clinical Trials as Topic / Q000451:nursing*; D003422:Critical Care / Q000379:methods; D018795:Device Approval; D004868:Equipment Failure; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000009:adverse effects / Q000145:classification / Q000592:standards*; D006801:Humans; D017146:Models, Organizational; D024802:Nurse's Role; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration