Building quality in clinical trials with use of a quality systems approach.
There is an increasing focus on having quality systems in place during the planning stages of clinical trials. Such systems require the development and implementation of standards for each step. Although this is not imposing something totally new on clinical research, a systematic approach will produce a more reliable and useful end product--high-quality data obtained without compromising the protection of human subjects' rights and welfare. A suggested quality system with standards for each step is addressed in this article.
Kleppinger
Cynthia F
CF
Division of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Ball
Leslie K
LK
D035843:Biomedical Research / Q000592:standards*; D002986:Clinical Trials as Topic; D006801:Humans; D011785:Quality Assurance, Health Care / Q000379:methods* / Q000592:standards*; D012107:Research Design / Q000592:standards*