临床试验启动会议纪要.doc

临床试验启动会议纪要 Initiation Meeting Minutes Subject: 主题 临床试验启动会 Date： 日期 Venue: 地点 Participants: 出席人员 见 会议签到表Meeting Attendance Record Prepared by: 记录员 下列文件在启动会时是否获得List below all documents that have been collected at the initiation meeting Yes No 临床试验批件Clinical Trial Permission (from SFDA) 伦理批件EC Approval Letter 合同Contract 如“否”，请说明 If “No”, please comment: 确认试验物品是否到达中心Confirmation of study materials and supplies at site Yes No 研究者文件夹Investigator’ Study File 试验基本文件Protocol, CRF, ICF, Source document, Subject diary 研究药物包括签收单Study drug, including receipt 试验所需设备或材料Study Supplies / materials 应急信件或盲底Emergency Envelop and/or Randomization List 如“否”，请说明 If “No”, please comment: 会中讨论Discussed in the Meeting Yes No 受试者入组Subjects Recruitment 本中心计划入组数Site Planned Subject Recruitment No.: 预期入组期限Expected Recruitment Duration: 如“否”，请说明 If “No”, please comment: 研究程序Study Procedure 研究时间Study Timeline 研究方案Signed Protocol Version/Date: 伦理批准的知情同意书ICF Approved by EC Version/Date: 病例报告表CRF Version/Date: 原始病历Source document Version/Date: 受试者日记Subject Diary Version/Date: 受试者评估程序Subject Assessment Procedure 样本处理和保存Biology Sample Handling and Storage 中心实验室程序Central Lab Procedure (if applicable) 受试者退出Subject Withdrawal 应急信封/随机程序Emergency Envelop/ Randomization Procedure 如“否”，请说明 If “No”, please comment: 药物管理Study Drug Management 药物储存Drug Storage 药物接收、发放和计数Drug Receipt, Dispensing and Accountability 药物归还/销毁Drug Return / Destruction 紧急破盲程序Emergency Unblinding Procedure 如“否”，请说明 If “No”, please comment: 安全性问题Safety Issues 不良事件记录Adverse Event Recording 严重不良事件的记录、报告和跟踪SAE Recording, Reporting and Follow-up 发生怀孕的报告程序Procedures in case of Pregnancy 如“否”，请说明 If “No”, please comment: 数据记录Data Recording CRF的填写和更改CRF Completion Correction 差异报告处理Discrepancy Report handling 如“否”，请说明 If “No”, please comment: 试验文档Study Documents 研究者文件夹以及存档Investigator’s Study File Ar