Clinical Research Law and Ethics Volume 1: Human Research and a Complete Practical Guide to Regulatory Compliance

Clinical Research and Law Ethics: Human Research and a Complete Practical Guide To Regulatory Compliance: This book teaches you all you need to know about clinical research and its practical guide. The book is detailed with interesting topics in clinical research, law, and ethics and a complete practical guide for human research, and a detailed monitoring and practical guide in clinical trial research from scratch to finish with great emphasis on life 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 activities from site selection visit, initiation visit, interim visit and close out 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 is a masterpiece that comes in as a practical and theoretical workbook with detailed regulatory laws and ethics for clinical research associates, principal investigators, sub-investigators, clinical trial coordinators, clinical trial physicians, medical doctors in clinical trials, medical students, clinical trial students and inhouse clinical trial associates on training, pharmacist, clinical trial assistance and those aspiring to go into clinical research.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 laws and ethics/ compliance and the preparation, research design, protocol design, case report form designs, biostatistics/data management from scratch to finish.There are so many advanced important topics in this book that covers everything you need to learn or know about clinical research, its regulatory laws, and ethics, such as Pharmaceutical companies and CROs, and various sponsors in clinical research, clinical research design, protocol design, case report form design, recruitment process, the four phases of clinical trials, clinical trial preparation, study design, study startup, essential documents, and common technical documents, clinical research laws and ethics in clinical research, roles and responsibilities of clinical research personnel, compliance and audit in clinical research, how to write a clinical trial monitoring report, therapeutic areas in clinical research, data management and biostatistics, scenario practical sections, scenario practical practice section with questions and answers.This is a must-read book that covers everything you need to know about clinical research laws and ethics and the conduct of clinical research from scratch to finish. I strongly suggest that you buy this book because I know it will be useful to you and I recommend that you buy a copy for yourself and as a gift for your friends and work colleagues.In this book, you are also going to learn the following, Pharmaceutical Companies, CROs, and Academic sponsorsClinical Research Design, Protocol Design, CRF Design, and Recruitment Process.Four Phases of Clinical ResearchClinical Trial Preparation, Study Design, and Study Start-Up.Essential Documents and Common Technical DocumentsClinical Research Laws/Ethics in Clinical ResearchRoles and Responsibilities of Clinical Research PersonnelCompliance and Audit in Clinical ResearchHow to write Clinical Trial Monitoring Report.Therapeutic Areas in Clinical ResearchData Management and Biostatistics.Basics of Medical WritingScenario Practical SectionScenario practical Questions and Answers. Read more