Developing a World Class Clinical Trial Site

  • ISBN 9788192227702
  • Author: P K Julka, Dr
  • Publ Date: 2011-08-05
  • Edition:
  • Binding: Paperback / softback

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The book is aimed at providing a comprehensive understanding of new drug discovery and development process along with guidance on how to get involved in a clinical trial; constitution of 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; regulatory inspections etc. The book would be of great benefit to the existing and new investigators/sites.
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