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”, plea 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”, plea comment: | ||||||
会中讨论Discusd in the Meeting | Yes | No | ||||
1.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”, plea comment: | ||||||
2.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 Asssment 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”, plea comment: | ||||||
3.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”, plea comment: | ||||||
4.安全性问题Safety Issues | ||||||
–不良事件记录Adver 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 ca of Pregnancy | ||||||
如“否”，请说明 If “No”, plea comment: | ||||||||
5.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”, plea comment: | ||||||||
6.试验文档Study Documents | ||||||||
–研究者文件夹以及存档Investigator’s Study File & Archiving | ||||||||
如“否”，请说明 If “No”, plea comment: | ||||||||
7.任务分配及授权Task Authorization | ||||||||
–完成方案签字页Signature Sheet for Protocol | ||||||||
–完成任务授权表Task Authorization Form Task Authorization Form | ||||||||
如“否”，请说明 If “No”, plea comment: | ||||||||
附件：1、会议签到表 2、方案签字页（研究者签名样张） 3、任务授权表 | ||||||||
方案号 Protocol No.: | 方案名称 Study Title: | ||||||
会议名称 Meeting Name: | 启动会 | 会议地点 Meeting Venue: | |||||
会议时间 Meeting Time: | 申办者 Sponsor: | ||||||
参加人员签名 Name of Participants | 工作单位 Company / Hospital | 职称 Title | 联系电话 Tel | 传真 Fax | 电子邮箱 E-mail | ||
方案号 Protocol No: | 方案版本/日期 Protocol Version & date: | ||||||
研究题目 Study Title: | |||||||
中心编号 Study Center No: | 研究中心 Study Center: | ||||||
主要研究者 PI: | 监查员 Monitor: | ||||||
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