Otsuka Pharmaceutical Development and Commercialization, Inc., Princeton, New Jersey, USA.
Clin Cancer Res. 2010 Mar 15;16(6):1756-63. doi: 10.1158/1078-0432.CCR-09-3267. Epub 2010 Mar 9.
Good Clinical Practice (GCP) provides an internationally accepted standard to ensure subject safety and data quality in clinical trials. Much of GCP parallels ethical considerations that have accumulated in successive versions of the World Medical Association's Declaration of Helsinki. This document advocates for preservation of rights, safety, and well-being of human study participants. By contrast, GCP data quality provisions follow from evolution in the United States drug regulatory system during the 1960s. Evidence of fraudulent or otherwise biased data-gathering ultimately led to U.S. Food and Drug Administration (FDA) data integrity regulations that were subsequently embraced as GCP principles in the Declaration of Helsinki. This manuscript summarizes GCP data quality provisions and describes practices that clinical site investigators can adopt to comply with these principles and to prevent adverse audit findings in the event of a regulatory inspection.
良好临床规范（Good Clinical Practice，GCP）为确保临床试验中的受试者安全和数据质量提供了国际认可的标准。GCP 的很大一部分内容与世界医学协会《赫尔辛基宣言》中不断积累的伦理考虑因素相吻合。该文件主张维护人类研究参与者的权利、安全和福祉。相比之下，GCP 数据质量规定源自 20 世纪 60 年代美国药物监管系统的发展。欺诈或其他有偏差的数据收集证据最终导致美国食品和药物管理局（FDA）的数据完整性法规，随后这些法规被《赫尔辛基宣言》采纳为 GCP 原则。本文总结了 GCP 数据质量规定，并描述了临床研究机构调查员可以采用的实践，以遵守这些原则，并在监管检查时防止出现不利的审核结果。
