临床试验启动会议纪要

Initiation Meeting Minutes Subject:

临床试验启动会主题

Date：

日期

Venue:

地点

Participa

nts:

见会议签到表Meeting Attendance Record 出席人员

Prepared

by:

记录员

启动会主要内容记录

（请根据试验项目要求进行记录，可附页）

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

会议签到表Meeting Attendance Record

方案签字页（签名样张）

I have thoroughly read and reviewed the study protocol. Having read and understood the requirements and conditions of the study protocol. I agree to conduct or instruct this project and follow the time schedule indicated in protocol. I understand that it is protocol violation if revise the protocol without approval from Ethic committee.

我已完全阅读了研究方案，并明白了方案的要求。我同意遵循方案及时间规程来执导该项临床研究。我亦知道没有伦理委员会的批准就修改方案是违反方案的。

I agree to perform the clinical study according to the Chinese Good

Clinical Practice principles and regulatory authority requirements for source document verification and auditing/inspection of the study.

我同意按中国GCP原则进行临床试验，并接受法规部门对原始资料的核查和对临床试验的稽查/视察。

I agree to use the study material, including medication, only as specified in the protocol.

我同意只应用方案所规定的试验用品包括研究药物。

Signature of Investigator and Study Group 研究小组签字

姓名正楷Printed Name 日期

Date

签名

Signature

任务分配及授权表

Study Center Task Authorization Form

主要研究者签名Investigator’s

Signature:日期Date: