中国药房2012,Vol.23Issue(37):3472-3473,2.DOI:10.6039/j.issn.1001-0408.2012.37.06
Ⅰ期临床试验过程中受试者的管理体会
Experience of Management about Subjects in Phase Ⅰ Clinical Trials
梁莉 1焦凯 1李丹 1乔华 1常威 1冯泽岸 2王婷1
作者信息
- 1. 兰州大学第一医院,兰州 730000
- 2. 兰州大学药学院,兰州 730000
- 折叠
摘要
Abstract
OBJECTIVE: To promote standardized management of subjects in phase I clinical trials. METHODS: The experience of the management of subjects in our hospital was summarized to explore the suitable management model. RESULTS & CONCLUSIONS: The management of subjects is standardized, the compliance of subjects is improved and the quality of clinical trail is ensured through designating the specific personnel to go into mutual respecting and understanding partnership with subjects with sound compliance and establish comfortable testing environment, adhering to informed completely of informed consent principle.关键词
Ⅰ期临床试验/受试者/管理Key words
Phase I clinical trials/ Subjects/ Management分类
医药卫生引用本文复制引用
梁莉,焦凯,李丹,乔华,常威,冯泽岸,王婷..Ⅰ期临床试验过程中受试者的管理体会[J].中国药房,2012,23(37):3472-3473,2.