A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic.Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research processProvides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately.Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject’s needs urgently and compliantly
✔ Author(s): Natasha Martien,Jeff Nelligan
✔ Title: The Sourcebook for Clinical Research: A Practical Guide for Study Conduct
✔ Rating : 4.3 out of 5 base on (19 reviews)
✔ ISBN-10: 0128162422
✔ Language: English
✔ Format ebook: PDF, EPUB, Kindle, Audio, HTML and MOBI
✔ Device compatibles: Android, iOS, PC and Amazon Kindle
Readers' opinions about The Sourcebook for Clinical Research by Natasha Martien
Byrdie Bartlett
Discover the poignant story of a family navigating life's ups and downs in this moving novel. The author's empathetic writing and well-drawn characters create a deeply emotional experience. Each chapter explores themes of love, loss, and resilience with sensitivity. The plot's twists and turns keep you engaged throughout. It's a heartwarming and thought-provoking read. Perfect for readers who enjoy stories about family dynamics.
Bets Leonard
Uncover the secrets of a haunted mansion in this chilling gothic novel. The author's atmospheric writing and suspenseful plot make for a captivating read. Each character's hidden motives and dark pasts add to the tension. The twists and surprises keep you guessing until the very end. It's a haunting and immersive story that you won't want to put down. Perfect for fans of gothic fiction.
Juliana Sellers
Delve into a richly detailed fantasy world where magic and mystery abound. The author's imaginative world-building and captivating plot draw you in from the start. Each character's journey is thrilling and their development is relatable. The narrative is filled with enchanting elements that keep you hooked. It's a story that sparks the imagination and transports you to another realm. Perfect for fans of epic fantasy.
The Music of What Happens, Cobra Kai: The Karate Kid Saga Continues – Johnny’s Story, Tom Henry’s Keyword Index Based on the 2020 NEC Code : Handbook Edition, Beginner Acoustic Fingerstyle Guitar: The Complete Guide to Playing Fingerstyle Acoustic Guitar (Learn How to Play Acoustic Guitar), Uniform Trust and Estate Statutes, 2020-2021 Edition (Selected Statutes), How To Program Any Synthesizer, Accounting Principles, 13e WileyPLUS NextGen Card with Loose-Leaf Print Companion Set, Autism and Me – Autism Book for Kids Ages 8-12: An Empowering Guide with 35 Exercises, Quizzes, and Activities!, SIE Exam Prep 2020-2021: SIE Study Guide with 375 Questions and Detailed Answer Explanations for the FINRA Securities Industry Essentials Exam (5 Full-Length Practice Tests), I Love That You’re My Bestie So I wrote A Book About It: A Special Personalized What I Love About My Best Friend Fill In The Blank Book for Birthday or Just Because,