受试者管理-PLOS.doc

Clinical Investigation Protocol Study on the Variability of Agomelatine? Clinical Trial Authorization NO. 2012L01023 Protocol NO.XY3-AGO1208A01 Principal Investigator: Guoping Yang Protocol Designer: Guoping Yang Leading Researchers: Guoping Yang, Qi Pei, Yan Wang, Ranran Zhang, Lu Huang, Hongyi Tan, Chengxian Guo, Zhe Yi Hu, Yu Xia Xiang, Hong Yuan Research Institution: the Third Xiangya Hospital, Central South University? Address, 138 Tong Zi Po Road, YueLu District, Changsha, Hunan, China Telephone, +86 0731Postcode 410013 version number： 1.0 Version Date： August 28, 2012  Catalogues Ethical Approval 4 Trial Protocol Abstract 6 缩略语对照表 12 1. 研究背景 14 1.1．药理毒理 14 1.2．药代动力学 15 1.3．不良反应和副作用 15 1.4．临床应用 15 2．试验目的 15 3．研究方案依据 15 4．试验负责人及主要研究人员简介 16 5．试验用药 16 6．受试者选择 16 6.1．筛选步骤 16 6.2． 入选标准 17 6.3．排除标准 17 6.4． 剔除标准： 18 7. 剂量及确定依据 19 8. 试验设计及方案描述 19 8.1．受试者例数 19 8.2．给药途径和给药方案 19 8.3试验设计 19 8.4．试验方法 21 8.5.试验前后体检及试验期间随访观察 22 8.6． 生物样品分析方法 22 9．数据处理与统计 22 9.1. 数据提供 22 9.2．药动学参数估算方法 22 10．统计分析 23 11. 安全性评价 23 11.1 医疗监护 23 11.2不良事件 24 11.3．严重不良事件 25 11.4．阿戈美拉汀片可能出现的不良反应及抢救措施 26 11.5．终止试验标准 26 12． 伦理要求 26 13 . 试验管理与质量控制 27 13.1．管理机构和实施GCP的情况 27 13.2．各方职责 27 13.3．方案修订 28 13.4．受试者管理 28 13.5．试验药物管理 28 13.6．给药依从性管理 29 13.7．受试者退出试验的管理 29 13.8．伴随治疗 29 13.9．数据记录与文件保留 29 13.10．个人资料的保密 30 13.11．质量控制 30 14．参考文献 30  Ethical Approval 1. Documents should be adhered Clinical trials must be undertaken to the demands in the standard operating procedure of Department of Clinical Study Phase I, the Third Xiangya Hospital of Central South University, and should be complied with the trial protocol which should be designed to follow the following documents: Declaration of Helsinki The Drug Administration Law of the PRC Drug Registration Regulation the Criterions for the Quality Control of Clinical Trial of Drugs Chemical drug preparations of human bioavailability and bioequivalence study technical guidelines 2. Institutional Review Board and the Ethics Co