Clinical Trials

This volume provides an introduction to the process of clinical drug development. It demystifies the way new medicines are discovered, tested and regulated. This book is intended for those who wich to understand the background of clinical trials from a pharmaceutical company perspective, and is suitable for clinical trials supplies technicians and pharmacists, data management staff, information officers, medical secretaries and all support staff. This second edition is updated and includes information on the practical implications of recent EC legislation.

1: Drug Development; 2: Regulation of Drug Research; 3: Good Clinical Practice; 4: Clinical Investigators; 5: Trial Design and Protocols; 6: Case Record Forms; 7: Trial Supplies; 8: Clinical Research Associates; 9: Monitoring and Adverse Events; 10: Analysis and Reports; 11: Standard Operating Procedures (SOPs), Audits and Archives