Developing A World Class Clinical Trial Site, Edition 2 - Paperback

by P. K. Julka (Author)

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.

Author Biography

With over three decades of cancer treatment and research and a variety of major breakthroughs to his credit, Dr. P. K. Julka, Professor of Radiotherapy and Oncology and Dean (Academics) at All India Institute of Medical Sciences has treated cancer patients from all segments of the society. He has been felicitated with 'Padma Shri' in the year 2013 (the fourth highest civilian award in the Republic of India) for his outstanding contribution to the field of Medicine. Dr. Julka indisputably stands as the pioneers of cancer treatment in India and to his credit is India's first Peripheral blood stem cell transplant following high dose chemotherapy in Metastatic Breast Cancer. Due to his strong interest towards cancer research, he has participated as Principal Investigator in various National and International clinical trials. He has authored chapters on cancer treatment for various books and published more than 200 research papers in Scientific/Medical Journals of repute. He works closely with Govt. of India and has been appointed by Ministry of Health and Family Welfare to inspect cancer centers across the country under the National Cancer Control Programme. Besides this he is the Head of Delhi Cancer Registry, nominated member for the Academic Council of Guru Gobind Singh Indraprastha University (GGSIPU), Chairman of imaging and radiotherapy for Bureau of Indian Standards (BIS) and Fellow (FAMS) of the National Academy of Medical Sciences. Bestowed with the prestigious 'OISCA Foundation Award' (UN Award, 2001) for Cancer Research and Treatment, he has also received Indian Medical Association (IMA) Gold Medal for Preventive Oncology, P K Haldar Oration, WHO Fellowship and several other honours and awards. His citation has been included in the book 'Man of Achievement'. Revered by a large number of media houses and publications, he also educates the general public on cancer awareness, early screening and management through apt use of mass media such as newspapers, magazines and electronic media. He can be reached at drjulka@rediffmail.com