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[推荐入门级书籍]conducting GCP-compliant clinical trials

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发表于 2009-6-23 21:51 | 显示全部楼层 |阅读模式
Abbreviations
Introduction

1. The Current Rules for Conducting Clinical Research 1
The Basic T1.h1e 2 T GenCePts of

Checklist 1.1-1. General Systems and Procedures
for Implementation of GCP
The General Regulatory Framework for GCP
Standard Operating Procedures
Checklist 1.3-1. Suggestions for the Format and
Contents of SOPs
Checklist 1.3-2. Topics for SOPs for
Sponsors/CROs
Checklist 1.3-3. Topics for SOPs for Investigators
Clinical Research Auditing
Checklist 1.4-1. Types of Audits which may be
Undertaken to Assess GCP Compliance
Checklist 1.4-2. Activities During Investigator
Site Audits
Regulatory Inspections
Checklist 1.5-1. Conduct During Regulatory
Inspections of Study Sites
Fraud. The Ultimate Non-Compliance in GCP
Checklist 1.6-1. Possible Indications of Fraud
CASE STUDY ONE
2. Setting Up Clinical Studies
2.1 Protocols

Conducting GCP-Compliant Clinical Research. W. Bohaychuk and G. Ball
Copyright © 1999 John Wiley & Sons, Ltd
ISBNs: 0-471-98824-3 (Hardback); 0-470-84626-7 (Electronic)
vi Contents
CRFs and Other Data Collection Forms
Checklist 2.2-1. Information to be Collected
in CRFs
Checklist 2.2-2. Basic Design Features of CRFs
Investigator Brochures
Regulatory Requirements
Checklist 2.4-1. Items to be Submitted to
Regulatory Authorities
Selection of Investigators and Study Sites
Checklist 2.5-1. Items to Consider at Pre-Study
Assessment Visits
Checklist 2.5-2. Additional Considerations for
Assessment of Phase I Facilities
Qualifications of Clinical Research Personnel
Study Agreements
Checklist 2.7-1. Investigator Responsibilities
Checklist 2.7-2. Sponsor/CRO Responsibilities
Checklist 2.7-3. Items in Financial Agreements
Selection of CROs
Checklist 2.8-1. Items to Review in Selecting
CROs
Checklist 2.8-2. Contracts with CROs
Selecting Clinical Laboratories
Checklist 2.9-1. Selecting Clinical Laboratories
Initiation Visits

Checklist 2.10-1. Items to be Addressed at Study
56
Checklist 2.10-2. Items to be Provided to the
Study Site Before the Study Begins 56
CASE STUDY TWO 57
3. Ethical Considerations
3.1 Ethics Committee/IRB Review and Approval
Checklist 3.1-1. Review by Ethics
Committees/IRBs Before Clinical Studies Begin
Checklist 3.1-2. Review by Ethics
Committees/IRBs During and After Clinical
Studies
Committee/IRB Approval
3.2 Documentation of Safe Ethics

Checklist 3.2-1. Documentation of Ethics
Committees/IRB Review and Approval
Checklist 3.2-2. Membership of Ethics
Committees/IRBs
Checklist 3.2-3. Working Procedures of Ethics
Committees/IRBs
Checklist 3.3-1. Principles for the Conduct
of Informed Consent
Subjects in Clinical Studies
Checklist 3.4-1. Items for Informed Consent
CASE STUDY THREE
3.3 Conduct of Informed Consent
3.4 Information to be Provided to Study
4. Monitoring and Safety Reporting
4.1 Monitoring
Checklist 4.1-1. The Major Objectives of
Monitoring Visits
Checklist 4.1-2. Management of CROs and
Clinical Laboratories During Studies
Checklist 4.2-1. Contents of Protocol
Amendments
Checklist 4.3-1. Adverse Event Terminology
Checklist 4.3-2. Items of Information to Include
on AE Pages in CRFs
CASE STUDY FOUR
4.2 Protocol Violations and Protocol Amendments
4.3 Reporting and Recording Safety Events
5. Collecting Data with Integrity
5.1 The Difference Between Source Documents
5.2 Access to Source Documents
5.3 Source Data Verification
and CRFs
Checklist 5.3-1. Initial Monitor Review and
Retrieval of CRFs at the Investigator Site
Checklist 5.3-2. Extent of Source Data
Verification
Checklist 5.4-1. Initial Internal CRF Review
5.4 Data Queries
viii Contents
5.5 General Internal Data Processing 145
5.6 General Statistical Procedures 6. Managing Study MedicationdDevices 159
Preparation of Study Medications/Devices 160
Checklist 6.1-1. General Labelling Requirements 163
Shipment of Study Medications/Devices 164
Control of Study Medications/Devices at
Study
Checklist 6.3-1. Study Medications/Devices
Inventory Checklist 6.3-2. Study Medications/Devices
Dispensing 171
Overall Accountability of Study
Medications/Devices Checklist 6.4-1. Items to Consider for
Re-allocation of Study Medications/Devices 177
Randomis1a7t7io Bnl iannddin g
Checklist 6.5-1. Information to Consider in
Requests for Randomisation Schedules 181
Management of Clinical Laboratory Samples 182
Checklist 6.6-1. Study Site Personnel Briefing
for Management of Clinical Laboratory Samples 183
Checklist 6.6-2. Biological Sample Analysis184
7. Final Stages in Clinical Studies
7.1 Closure of Clinical Studies
Checklist 7.1-1. Procedures at Study Closure
Visits
7.2 Final Clinical Reports
7.3 Archiving
Checklist 7.3-1. Typical Documents in
Sponsor/CRO Archives
Checklist 7.3-2. Typical Documents in
Investigator Archives
CASE STUDY 7
Reading List
Index

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谢谢LZ  发表于 2014-1-21 12:53
 楼主| 发表于 2009-6-24 10:51 | 显示全部楼层
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3Q~~~`  发表于 2014-1-21 12:54

评分

参与人数 2经验 +22 收起 理由
视野 + 2 很给力!
山雪 + 20 积极分享!

查看全部评分

发表于 2009-6-24 11:20 | 显示全部楼层
为了鼓励更多会员的积极参与,本内容的最后一个附件10设置回复可下载,需要下载的朋友请回复主题后才能下载全部内容
发表于 2009-6-24 11:48 | 显示全部楼层
菜鸟要学习,大虾多指教~~~
发表于 2009-6-25 13:35 | 显示全部楼层
我喜欢,谢谢哦
发表于 2009-6-25 15:43 | 显示全部楼层
菜鸟要学习,大虾多指教~~~
发表于 2009-6-25 15:44 | 显示全部楼层
山雪大哥,聪明,这样可以顶人气,好
发表于 2009-6-26 13:05 | 显示全部楼层
这个必须顶了,谢谢楼主分享
发表于 2009-6-26 15:57 | 显示全部楼层
好东西,不错,不过太多了,怕看不完哦
发表于 2009-6-27 15:22 | 显示全部楼层
下了前9个部分,都打不开啊
正期待呢
发表于 2009-6-27 15:23 | 显示全部楼层
下了前9个部分,都打不开啊
正期待呢
haibls 发表于 2009-6-27 15:22 [url=http://www.druggcp.net/bbs/images/common/back.gif
http://www.druggcp.net/bbs/images/common/back.gif[/quote[/url]]
打开啦 学习中……
发表于 2009-6-28 16:06 | 显示全部楼层
好东东~~~一定要看的~~
发表于 2009-6-28 17:32 | 显示全部楼层
好东西 谢谢分享
发表于 2009-6-29 23:35 | 显示全部楼层
希望学习!希望中~~~~~
发表于 2009-6-30 11:46 | 显示全部楼层
好东西啊,哈哈哈,感谢前辈了!!!!
发表于 2009-6-30 16:39 | 显示全部楼层
谢谢楼主的分享!!好东西
发表于 2009-7-2 13:04 | 显示全部楼层
下载了就吼一嗓子!!
发表于 2009-7-2 16:50 | 显示全部楼层
我想下来看看,谢谢楼主的分享
发表于 2009-7-3 22:53 | 显示全部楼层
英文的就不看了,我手里英文资料太多了,没时间看啊
发表于 2009-7-9 08:50 | 显示全部楼层
恩  以后多发点新人学习的东西
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