Dr P. K. Julka

Developing a World Class Clinical Trial Site, Edition 2 Dr P. K. Julka

Developing a World Class Clinical Trial Site is aimed at providing a step-by-step guide on how to create a successful clinical trial site with inbuilt tips on every aspect of the development process. It offers insight on becoming a successful clinical trial investigator, providing a comprehensive understanding of the new drug discovery and development process along with: guidance on how to get involved in a clinical trial; constitution of the study team at a site; infrastructure development; study initiation, conduct, and closeout; safety reporting; informed consent process; investigational product accountability and management; maintenance of source document; completion of case report forms; HIPAA privacy rules; clinical trial monitoring; and regulatory inspections. The book could serve as an effective learning resource for the clinicians who wish to become researchers.