A comprehensive guide for physicians conducting clinical research, this second edition addresses a broader research perspective. It includes information on the implications of the ICH Guidelines, current FDA regulations, and an Internet address directory. Everything the clinical trial manager, planner, monitor, and investigator need to know about t

chapter 1|14 pages

Overview and Elements of Clinical Research

chapter 2|14 pages

The Physician as Investigator

chapter 3|8 pages

Professional Interactions

chapter 5|18 pages

Investigational Agent Management

chapter 6|10 pages

Designing a Study and Protocol Development

chapter 7|16 pages

The Informed Consent Process

chapter 8|26 pages

Conducting the Study

chapter 9|20 pages

Monitoring of Clinical Trials

chapter 10|12 pages

Interactions with the Study Subject

chapter 11|12 pages

Adverse Events and Drug Safety

chapter 12|10 pages

Data Management

chapter 13|8 pages

The Study Results

chapter 14|10 pages

Audits of Clinical Research Sites

chapter |76 pages

A: FDA Regulations

chapter |138 pages

B: FDA Information Sheets

chapter |24 pages

Glossary of Terms

chapter |4 pages