This handbook provides a comprehensive and practical guide covering the multidisciplinary aspects of clinical research. It provides practical advice and informed comment on the organisation, management and administration of clinical trials.

Table of Contents

The History of the Pharmaceutical Industry Drug Regulation in the 1990s Ethics Liability and Indemnity in Clinical Research Clinical Trial Design Phase I Studies and Pharmokinetics Post-Marketing Surveillance and Phase IV Studies The Protocol Design of Case Report Forms for Clinical Trials Clinical Trials Materials Investigator Selection and Monitoring Adverse Drug Reactions Adverse Drug Interactions Clinical Data Management Statistics Project Management in Drug Development Communication Audit of Clinical Studies

Author Biography

For the purposes of the contract, the signatories on behalf of the Association of Clinical Research in the Pharmaceutical Industry (ACRPI) should be: Dr Val Lyness (Chairman), and Dr Bryan Hurst (Treasurer)