The Sourcebook for Clinical Research: A Practical Guide for Study Conduct 1st edition
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The Sourcebook for Clinical Research: A Practical Guide for Study Conduct 1st edition – Ebook Instant Download/Delivery ISBN(s): 9780128162422,9780128162439,0128162422,0128162430
Product details:
- ISBN 10:0128162430
- ISBN 13: 9780128162439
- Author: Natasha Martien, Jeff Nelligan
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.
Table contents:
Chapter 1 Foundational Elements and Regulatory Requirements
Chapter 2 Preparation Before a Clinical Trial Begins
Chapter 3 Recruiting Clinical Research Subjects
Chapter 5 Organizations With Oversight Responsibility in Clinical Research
Chapter 6 Exceptional Circumstances in Clinical Research
Chapter 7 Education and Certification in Clinical Research
Chapter 8 The Newest Changes in Clinical Research
Chapter 9 After the Study Has Ended
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