Description
Book SynopsisConducting GCP-Compliant Clinical Research Wendy Bohaychuk and Graham Ball Good Clinical Research Practices, UK and Canada The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including:
- Standard operating procedures for investigators
- Standard operating procedures for sponsors and CROs
- GCP - an indexed reference
Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at
Table of ContentsThe 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.
