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9 Steps Guide on How to Write a Clinical Trial Protocol?

9 Steps Guide on How to Write a Clinical Trial Protocol?


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About the Book

This book "9 Steps Guide On How To Write A Clinical Trial Protocol" is specially designed for the Clinical Trial investigators, Physicians, Sponsors, healthcare students and other clinical research professionals, who are involved or keen to explore clinical research in future to develop skills to write protocol for clinical studies. The books covers the topics Essential Clinical Trial Documents, Protocol Structure, Type of Research Studies, Trial Design Consideration, Ethical Consideration, Elementary Statistics, Randomization and its type, Blinding, Sample Sizing etc.The book is designed and written in a manner so that a reader can understand overall protocol writing and the essential element involved in it. We hope that the book would guide the readers to understand the overall process of protocol writing and impart essential skills involved in it.

About the Author :
Dr K Ashish has more than 5 years of experience in clinical research. He holds a PhD degree in Biotechnology and a MBA in Marketing. He worked through various disciplines of clinical research in both drug and device industry. He has personally conducted and supervised various clinical trials in the area of infectious disease oncology and cardiology from phase II-IV. His research interest is in the area of public health and biotech research and better clinical trial management. He is also Member Secretary for Public Health care Society. He has received several reward and recognitions during his career and has several publications. He has presented his work in international conference and rewarded for that. He is very keen in providing and developing clinical research education material and authored books like "20 golden checklist for clinical researcher" and "clinical research - from discovery to development." Beside this he is trainer and mentor to several organizations. Gaurav Goel has highly focused experience of over 5 years in clinical trial monitoring, project management, safety reporting, regulatory documentation, market analysis, medical writing and site management in the field of clinical research. He has personally supervised and conducted over 10 clinical trials (Phase I/II/III/IV). He has been trained at University of Oxford, U.K on 'How to do research on therapeutic interventions: Protocol Preparation'. He is the president of a non for profit society called "Public Healthcare Society (PHS)" and has been a guest faculty and editor for various classroom clinical research training program(s) and educative magazines.


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Product Details
  • ISBN-13: 9788192853741
  • Publisher: O2 Publications
  • Publisher Imprint: O2 Publications
  • Height: 216 mm
  • No of Pages: 174
  • Spine Width: 9 mm
  • Width: 140 mm
  • ISBN-10: 8192853748
  • Publisher Date: 01 Jun 2014
  • Binding: Paperback
  • Language: English
  • Returnable: N
  • Weight: 209 gr


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