28/05/2023
The complete theoretical and practical guide for clinical research associates and those aspiring to enter into clinical research is a book that teaches you all you need to know about clinical research and its practical guide. The book is detailed with interesting topics in clinical research and monitoring of clinical research from scratch to finish with live practical scenarios and illustrations. This book is second to none and it is written bearing in mind what a clinical research associate should know and how he can successfully carry out his monitoring, from site selection visit, initiation visit interim visit, and closeout visit, and all the regulatory and ethical guidelines that can help a clinical research associate to monitor his or her site activities successfully according to the ethical and regulatory standard of ICH good clinical practice.
This book comes in as a practical and theoretical workbook for clinical research associates and those aspiring to go into clinical research because of the important topics covered in the text. I can assure you. that this is the right book for you as each chapter is packed with full captivating topics that will blow your mind and advance your knowledge in everything you need to know about clinical trial research from scratch to finish. This book will refresh your mind about your work in clinical research and what you have learned in the past with new topics added in the book that will interest you more. It is written with a complete theoretical and practical guide for clinical research associates, and it will teach all you need to know about the current FDA guidelines and the newest GCP guidelines for 2023, and other ethical guidelines that can help you monitor your clinical trials effectively.
This book is not only for clinical research associates but is also for those training as clinical research associates and students studying clinical research in Universities and Colleges / Training Institutes. There are so many advanced important topics in the book that covers everything you need to learn or know such as pharmaceutical companies and CROs, different phases of clinical trials, clinical trial preparation, essential documents and regulatory submission study start-up, pre-study visit, initiation visit, interim visit, and close visit., ethics in clinical research, regulatory affairs in clinical research, medical device trials, common technical documents, clinical study reports, pharmaceutical medicine, vendor management, Statistics, and Biostatistics, etc.
The book teaches you about protocol and protocol design, recruitment of patients, how to report a serious adverse event, and everything you need to know about site setup and clinical trial study reports. How to write your report after each site visit.
This is a must-read book that covers everything you need to know about clinical research and the conduct of clinical research. I strongly suggest that you purchase this book, and you can buy a copy for your friends and work colleagues too.
In this book, you are going to learn the following,
Pharmaceutical companies and CROs
Different Phases of clinical research
Clinical Trial Preparation
Essential documents and Regulatory submission
Study start-up
Pre-study visit
Initiation visit
Interim visit
Closeout visit
Ethics in clinical research
Regulatory affairs in clinical research
Medical Device Trial
Common Technical Document
Clinical Study Report
Pharmaceutical medicine
Statistics and Biostatistics
Protocol design, Case Report Form Design
Recruitment Proces.
The complete theoretical and practical guide for clinical research associates and those aspiring to enter into clinical research.
