Overview

This book is intended to provide a fundamental knowledge on Clinical Research and Good Clinical Practice (GCP) Guidelines with a crisp description on important topics such as Introduction to Clinical Research; Evolution of Ethical Research Principles, Regulations and Guidelines; Essential Clinical Trial Documents; Clinical Study Process; Ethics Review Board (ERB); Roles and Responsibilities of Investigator; Roles and Responsibilities of Sponsor; Informed Consent Process; Serious Adverse Event (SAE), Maintenance of Source Document, IND/NDA/ANDA/AADA and List/Location of Essential Trial Documents Before, During and After Completion/Termination of the Trial.

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Sanjay Gupta is a well known clinical research expert having more than 15 years of extensive clinical research experience. He has personally conducted and supervised over 100 clinical trials (Global registration trials, Exploratory Phase-II trials, Phase-I trials, Investigators initiated trials etc.) across a wide range of therapeutic areas including Oncology, Endocrinology, Psychiatry, Critical Care, Infectious Diseases, Andrology, Ophthalmology etc. He has authored 9 books and his books All You Need to Know about Clinical Research and The Big Book of Clinical Research have been widely acclaimed by key stakeholders. He has presented his research work in various International Journals and Conferences including American Society of Clinical Oncology (ASCO), Seminars in Oncology, British Journal of Cancer (BJC), Gastric and Breast Cancer (GBC) and British Journal of Radiology (BJR). He is the founder member of Society for the Promotion of Ethical Clinical Trials (SPECT), Network Coordinator for a cancer research network set-up by University of Oxford, London (INDOX Network) and Advisory Board Member for International Journal of Pharmaceutical Sciences and Nanotechnology. He has been instrumental in taking various clinical research training initiatives by virtue of developing specialized training programs.

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