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The Sourcebook for Clinical Research
A Practical Guide for Study Conduct
Presents a step-by-step manual that guides clinical research personnel through the clinical trial process, including both basic and advanced topics
Natasha Martien (Author), Jeff Nelligan (Author)
9780128162422, Elsevier Science
Paperback, published 8 August 2018
274 pages
23.4 x 19 x 1.8 cm, 0.61 kg
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.
1. Foundational Elements and Regulatory Requirements2. Preparation Before a Clinical Trial Begins3. Recruiting Clinical Research Subjects4. Clinical Trial Conduct—A Daily Perspective5. Organizations With Oversight Responsibility in Clinical Research6. Exceptional Circumstances in Clinical Research7. Education and Certification in Clinical Research8. The Newest Changes in Clinical Research9. After the Study Has Ended
