Aims to describe the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Numerous real-life stories and detailed case studies at the end of each chapter make this book useful for the more experienced, highlighting what can go wrong in a clinical study.

The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies.

The Current Roles for Conducting Clinical Research.
Setting up Clinical Studies.
Ethical Considerations.
Monitoring and Safety Reporting.
Collecting Data with Integrity.
Managing Study Medications/Devices.
Final Stages in Clinical Studies.