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Bohaychuk, Wendy

Conducting GCP- Compliant Clinical Research

A Practical Guide

€ 335.95

New drugs under development, subject to clinical trials, must adhere to good clinical practice guidelines to ensure licensing. A how to book for newcomers and experienced researchers, this is a practical, working reference, with a checklist for designing standard operating procedures, that keeps clinical research GCP compliant.


Taal / Language : English

Inhoudsopgave:
Abbreviations ix
Introduction xi
The Current Rules for Conducting Clinical Research
1(24)
The Basic Tenets of GCP
2(2)
General Systems and Procedures for Implementation of GCP
3(1)
The General Regulatory Framework for GCP
4(1)
Standard Operating Procedures
5(5)
Suggestions for the Format and Contents of SOPs
8(1)
Topics for SOPs for Sponsors/CROs
Topics for SOPs for Investigators
9(1)
Clinical Research Auditing
10(5)
Types of Audits which may be Undertaken to Assess GCP Compliance
12(2)
Activities During Investigator Site Audits
14(1)
Regulatory Inspections
15(2)
Conduct During Regulatory Inspections of Study Sites
17(1)
Fraud. The Ultimate Non-Compliance in GCP
17(8)
Possible Indications of Fraud
18(1)
Case Study One
19(6)
Setting Up Clinical Studies
25(40)
Protocols
26(3)
CRFs and Other Data Collection Forms
29(4)
Information to be Collected in CRFs
31(1)
Basic Design Features of CRFs
32(1)
Investigator Brochures
33(3)
Regulatory Requirements
36(1)
Items to be Submitted to Regulatory Authorities
36(1)
Selection of Investigators and Study Sites
37(5)
Items to Consider at Pre-Study Assessment Visits
40(2)
Additional Considerations for Assessment of Phase I Facilities
42(1)
Qualifications of Clinical Research Personnel
42(2)
Study Agreements
44(6)
Investigator Responsibilities
47(2)
Sponsor/CRO Responsibilities
49(1)
Items in Financial Agreements
50(1)
Selection of CROs
50(2)
Items to Review in Selecting CROs
51(1)
Contracts with CROs
52(1)
Selecting Clinical Laboratories
52(2)
Selecting Clinical Laboratories
53(1)
Initiation Visits
54(11)
Items to be Addressed at Study Initiation Visits
56(1)
Items to be Provided to the Study Site Before the Study Begins
56(1)
Case Study Two
57(8)
Ethical Considerations
65(32)
Ethics Committee/IRB Review and Approval
66(9)
Review by Ethics Committees/IRBs Before Clinical Studies Begin
72(2)
Review by Ethnics Committees/IRBs During and After Clinical Studies
74(1)
Documentation of Safe Ethics Committee/IRB Approval
75(6)
Documentation of Ethics Committee/IRB Review and Approval
79(1)
Membership of Ethic Committees/IRBs
79(1)
Working Procedures of Ethics Committees/IRBs
80(1)
Conduct of Informed Consent
81(5)
Principles for the Conduct of Informed Consent
85(1)
Information to be Provided to Study Subjects in Clinical Studies
86(11)
Items for Informed Consent
88(3)
Case Study Three
91(6)
Monitoring and Safety Reporting
97(30)
Monitoring
98(7)
The Major Objectives of Monitoring Visits
102(2)
Management of CROs and Clinical Laboratories During Studies
104(1)
Protocol Violations and Protocol Amendments
105(4)
Contents of Protocol Amendments
109(1)
Reporting and Recording Safety Events
109(18)
Adverse Event Terminology
115(2)
Items of Information to Include on AE Pages in CRFs
117(1)
Case Study Four
117(10)
Collecting Data with Integrity
127(32)
The Differences Between Source Documents and CRFs
128(2)
Access to Source Documents
130(3)
Source Data Verification
133(8)
Initial Monitor Review and Retrieval of CRFs at the Investigator Site
138(1)
Extent of Source Data Verification
139(2)
Date Queries
141(4)
Initial Internal CRF Review
144(1)
General Internal Date Processing
145(1)
General Statistical Procedures
146(13)
Case Study Five
148(11)
Managing Study Medications/Devices
159(30)
Preparation of Study Medications/Devices
160(4)
General Labelling/Requirements
163(1)
Shipment of Study Medications/Devices
164(4)
Control of Study Medications/Devices at Study Sites
168(4)
Study Medications/Devices Inventory
171(1)
Study Medications/Devices Dispensing Records
171(1)
Overall Accountability of Study Medications/Devices
172(5)
Items to Consider for Re-allocation of Study Medications/Devices
177(1)
Randomisation and Blinding
177(5)
Information to Consider in Requests for Randomisation Schedules
181(1)
Management of Clinical Laboratory Samples
182(7)
Study Site Personnel Briefing for Management of Clinical Laboratory Samples
183(1)
Biological Sample Analysis Request Forms
184(1)
Case Study Six
184(5)
Final Stages in Clinical Studies
189(13)
Closure of Clinical Studies
190(3)
Procedures at Study Closure Visits
192(1)
Final Clinical Reports
193(1)
Archiving
194(8)
Typical Documents in Sponsor/CRO Archives
195(1)
Typical Document in Investigator Archives
196(1)
Case Study 7
197(5)
Reading List 202(5)
Index 207
Extra informatie: 
Hardback
226 pagina's
Januari 1999
486 gram
248 x 159 x 19 mm
Wiley-Blackwell us

Levertijd: 5 tot 11 werkdagen



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