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[资源] 临床研究监督—种基于风险进行临床监察的策略（FDA英/汉2011.8）

Guidance for Industry
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
行业指南
临床研究监督——一种基于风险进行临床监察的策略

DRAFT GUIDANCE
指南草案

This guidance document is being distributed for comment purposes only.
本指南文件仅用于征求社会意见用
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
关于本指南草案的评论和建议请在本指南登于联邦公报后90日内提交至美国食品药品管理局卷宗管理处（HFA-305），地址：5630 Fishers Lane, rm. 1061, Rockville, MD 20852。电子方式的评论请在http://www.regulations.gov网站提交。所有评论都以登于联邦公报上的可用声明卷宗号作为识别标记。

For questions regarding this draft document contact (CDER) Ann Meeker O’Connell at 301-796-3150, (CBER) Office of Communication, Outreach and Development at 800-835-4709 or 301-827-1800, or (CDRH) Chrissy Cochran at 301-796-5490.
如对本指南草案有疑问，请联系药品评价和研究中心（CDER）Edwin Melendez，电话：301-796-3284； CDER对外信息、外联与发展办公室，电话： 800-835-4709 或 301-827-1800；或医疗器械和辐射健康中心（CDRH）Chrissy Cochran，电话：301-796-5490。

U.S. Department of Health and Human Services
美国卫生与公众服务部
Food and Drug Administration
美国食品药品管理局
Center for Drug Evaluation and Research (CDER)
药品评价和研究中心(CDER)
Center for Biologics Evaluation and Research (CBER)
生物制品评价和研究中心（CBER）
Center for Devices and Radiological Health (CDRH)
医疗器械和辐射健康中心（CDRH）
August 2011
2011年8月
Procedural
程序性指南
TABLE OF CONTENTS
目录

I. INTRODUCTION...............................................................1
简介
II. BACKGROUND................................................................1
背景
A. Current Monitoring Practices..............................................3
目前的临床监察实践
B. Other FDA Guidance on Monitoring...................................4
FDA发布的其它有关临床监察的指南文件
C. Rationale for Facilitating Risk-Based Monitoring…… ...4
促进基于风险基础的临床监察的理由
D. Steps FDA is Taking to Facilitate Wider Use of Alternative Monitoring Approaches..5
FDA目前采取的促进替代监察方法更多使用的措施
III. FACTORS THAT INFLUENCE STUDY QUALITY AND INTEGRITY.................6
影响临床试验质量和完整性的因素
IV. GENERAL MONITORING RECOMMENDATIONS................................................7
有关临床监察的一般建议
A. Types of Monitoring........................................................................................................7
临床监察类型
1. On-Site Monitoring..........................................................................................................................7
现场监察
2. Centralized Monitoring....................................................................................................................7
集中监察
B. Identify Critical Data and Processes to be Monitored................................................................9
需进行监察的关键数据和程序的确定
C. Factors to Consider when Developing a Monitoring Plan...........................................10
监察计划建立时应考虑的因素
D. Monitoring Plan...........................................................................................................................11
临床试验监察计划
1. Description of Monitoring Approaches.........................................................................................11
监察方法的描述
2. Communication of Monitoring Results..........................................................................................12
关于监察结果的沟通
3. Management of Noncompliance....................................................................................................12
非依从行为的管理
4. Training and Study-Specific Information.......................................................................................13
培训及试验特定信息
5. Monitoring Plan Amendments.......................................................................................................13
监察计划修正
V. DOCUMENTING MONITORING ACTIVITIES......................................................14
监察活动记录
VI. ADDITIONAL STRATEGIES TO ENSURE STUDY QUALITY............................14
保证试验质量的其它策略
A. Clinical Investigator Training and Communication.................................................................14
临床研究者培训与交流
B. Delegation of Monitoring Responsibilities to a CRO................................................................15
将监察责任委托给CRO公司[ Last edited by lwjxz on 2011-9-24 at 15:26 ]

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