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 | ||
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