Principles of good clinical practice:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
London [u.a.]
Pharmaceutical Press
2010
|
| Ausgabe: | 1. publ. |
| Schriftenreihe: | Pharmacy business administration series
|
| Schlagworte: | |
| Online-Zugang: | Inhaltstext Inhaltsverzeichnis |
| Beschreibung: | XVI, 256 S. graph. Darst. |
| ISBN: | 9783769247848 9780853697909 |
Internformat
MARC
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| 245 | 1 | 0 | |a Principles of good clinical practice |c ed. by Michael J. McGraw ... |
| 250 | |a 1. publ. | ||
| 264 | 1 | |a London [u.a.] |b Pharmaceutical Press |c 2010 | |
| 300 | |a XVI, 256 S. |b graph. Darst. | ||
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Datensatz im Suchindex
| _version_ | 1805095827313524736 |
|---|---|
| adam_text |
Preface
ix
About the editors
χ
Contributors
xii
Abbreviations
xiv
1
Introduction to Good Clinical Practice
1
Sean W. Develin
2
Regulatory requirements
15
Catherine Burgess,
Marie-Laure Papi,
Kristel Van
de Voorde,
and Guy
Nys
Introduction
15
International Conference on
Harmonisation
requirements
15
The United States (US) regulatory framework
17
The European Union regulatory framework
27
Summary
37
3
Informed consent
41
Steven P. Steinbrueck, Barbara S. Davis, and Elizabeth E.
Bodi
Background
42
Regulations and guidelines
44
introduction to form and process
44
Liability, understanding, therapeutic misconception
51
Developing a 'gold standard1
54
Leadership
57
Additional topics
57
Summary
60
4
Investigator responsibilities
63
Jesse Goldman, Michaei J. McGraw, and Adam N, George
Qualifications
64
Assessment of the research
65
I Contents
Communication with the Institutional Review Board
or Independent Ethics Committee 67
Communication with sponsor 68
Protecting safety, rights, and welfare of subjects
68
Investigational product
' '
Safety reporting
73
Assessment of causality
73
Documentation and record retention
74
Financial disclosure
75
Inspections by health authorities
75
Summary
75
5
Sponsor responsibilities
77
Donna W. Dorozinsky
Quality
77
Medical expertise
78
Study design
79
Data management
80
Record keeping
81
Safety reporting
83
Investigator selection
86
Investigational product
86
Registration of clinical trials
88
Reporting of clinical trial results
88
Summary
89
6
Clinical trial design
91
Steven
Gelone
and Patrick Scoble
Introduction
91
What is clinical research?
91
Historical perspective on clinical research
92
Why is clinical research needed?
92
The phases of drug development
93
Where does clinical research begin?
95
Critical concepts in clinical research
95
Approaches to the design of clinical research studies
95
Bias in clinical research
98
Type I error, Type II error, and sample size
100
Equivalency/non-inferiority versus superiority in clinical trials
102
Clinical equipoise in controlled clinical trials
104
Comparison of placebo versus the best-available control group
in controlled clinical studies
105
Challenges in conducting clinical research
105
The interpretation and integration of clinical research into clinical practice
106
Contents
I
vii
7
Site monitoring
109
Vickie
T.
Payne
Selection and qualifications of the monitor
109
The evaluation visit
110
The initiation visit
112
The monitoring visit
114
The close-out visit
117
Summary
119
8
Institutional Review Boards and Independent
Ethics Committees
121
Michael R. Jacobs
Composition, procedures, and function
122
Protection of human subjects
125
Review of the protocol, Investigator's Brochure, and informed consent
128
Qualifications of the investigator and investigative team
138
Risk-benefit analysis
. 139
Continuing review
144
Final thoughts
145
9
Pharmacovigilance
149
Stephen Klincewicz, Yuung Yuung Yap, and Adrian Thomas
Introduction
149
Adverse events
150
Reporting guidelines and timeline
153
Signal detection
159
Databases
161
Conclusion
163
10
Clinical trial registration and reporting
167
Barbara Godlew, Shawn
Pelletier,
and Maureen Strange
Introduction and history
167
Clinical trial registration
170
Clinical trial results databases
175
Legislation and regulatory requirements
177
Clinical trial disclosure implications for future therapeutic development
178
Summary
180
11
Quality assurance
183
Peter Smith
Introduction
183
Defining quality
184
Auditing: purpose of auditing
185
The audit plan
186
viii
I Contents
Conduct of the audit
188
Types of audit
188
Summary
200
12
Future implications of Good Clinical Practice
203
Thomas Jacobsen
Globalization of clinical research
203
Genomics
205
Gene transfer
207
Stem cell research
208
Nanotechnology
210
Conclusion
212
Appendix
1
The Nuremberg Code
215
Appendix
2
World Medical Association Declaration of Helsinki:
Ethical Principles for Medical Research Involving Human Subjects
217
Appendix
3
The Belmont Report: Ethical Principles and Guidelines
for the Protection of Human Subjects of Research
223
Glossary
235
Index
245 |
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| discipline | Chemie / Pharmazie Medizin |
| edition | 1. publ. |
| format | Book |
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| id | DE-604.BV037337222 |
| illustrated | Illustrated |
| indexdate | 2024-07-20T11:05:28Z |
| institution | BVB |
| isbn | 9783769247848 9780853697909 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-022491009 |
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| physical | XVI, 256 S. graph. Darst. |
| publishDate | 2010 |
| publishDateSearch | 2010 |
| publishDateSort | 2010 |
| publisher | Pharmaceutical Press |
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| series2 | Pharmacy business administration series |
| spelling | Principles of good clinical practice ed. by Michael J. McGraw ... 1. publ. London [u.a.] Pharmaceutical Press 2010 XVI, 256 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Pharmacy business administration series GCP-Regeln (DE-588)4281617-8 gnd rswk-swf GCP-Regeln (DE-588)4281617-8 s DE-604 McGraw, Michael J. Sonstige oth text/html http://deposit.dnb.de/cgi-bin/dokserv?id=3515666&prov=M&dok_var=1&dok_ext=htm Inhaltstext Digitalisierung UB Regensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=022491009&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Principles of good clinical practice GCP-Regeln (DE-588)4281617-8 gnd |
| subject_GND | (DE-588)4281617-8 |
| title | Principles of good clinical practice |
| title_auth | Principles of good clinical practice |
| title_exact_search | Principles of good clinical practice |
| title_full | Principles of good clinical practice ed. by Michael J. McGraw ... |
| title_fullStr | Principles of good clinical practice ed. by Michael J. McGraw ... |
| title_full_unstemmed | Principles of good clinical practice ed. by Michael J. McGraw ... |
| title_short | Principles of good clinical practice |
| title_sort | principles of good clinical practice |
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