ABSTRACT

It is the responsibility of the research monitor to manage numerous trials at various centers, as well as keep everyone on schedule. In this completely revised edition, topics covered include designing case report forms, interacting with clinicians and other health professionals, and discovering employment options and career paths within the indust

chapter 1|14 pages

Overview of the Clinical Research Process

chapter 5|20 pages

Data Management

chapter 6|12 pages

The Study Investigational Agent

chapter 7|8 pages

Selecting the Investigational Site

chapter 8|10 pages

Prestudy Sponsor Activities

chapter 9|10 pages

Study Initiation

chapter 10|14 pages

Adverse Event Monitoring

chapter 11|8 pages

Management of the Clinical Research Site

chapter 13|16 pages

Study Termination

chapter 14|14 pages

Audits Organizations Authorized to

chapter 15|8 pages

Traveling

chapter 16|12 pages

Independent Consulting

chapter |76 pages

Appendices

chapter |138 pages

B: FDA Information Sheets

chapter |8 pages

E: Algorithms

chapter |24 pages

Glossary of Terms

chapter |4 pages

Abbreviations