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Tables of Contents for A Guide to Clinical Drug Research
Chapter/Section Title
Page #
Page Count
Contents
v
Foreword to the first edition
vii
Editor's notes to the second edition
ix
Glossary of commonly used terms
xi
List of contributors
xv
Clinical research: From idea to publication
1
12
Facilities and Equipment
13
6
What does the investigator need to know about the drug? - the Clinical Investigator's Brochure
19
28
The first administration of a new active substance to humans
47
18
Planning and coordinating the study
65
8
The study protocol
73
14
Study Design
87
12
Data management and statistical analysis
99
14
Ethical considerations
113
14
Aspects of study conduct
127
18
Good clinical practice
145
14
Communicating Clinical Research
159
20
The Clinical Study Report
179
8
Clinical research in a developing country
187
16
Index
203