不断升级的监管要求对临床研究开展的影响。
The impact of escalating regulatory requirements on the conduct of clinical research.
作者信息
Gordon B G, Kessinger A, Mann S L, Prentice E D
机构信息
Department of Pediatrics, University of Nebraska Medical Center, Omaha, NE 68198-7680, USA.
出版信息
Cytotherapy. 2003;5(4):309-13. doi: 10.1080/14653240310002225.
PMID:12944237
Abstract
A discussion of the impact of escalating regulatory requirements is provided, from the point of view of the administration of the institutional review board of an academic institution, and from clinical investigators who conduct studies at that same institution. Current and anticipated future issues are discussed.
摘要
从学术机构机构审查委员会的管理角度以及在同一机构开展研究的临床研究人员的角度，对不断升级的监管要求的影响进行了讨论。还讨论了当前和预期未来的问题。
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