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The Sourcebook for Clinical Research

A Practical Guide for Study Conduct

The Sourcebook for Clinical Research - Martien, Natasha; Nelligan, Jeff - ISBN: 9780128162422
Prijs: € 96,95
Levertijd: 12 tot 15 werkdagen
Bindwijze: Boek, Paperback (08-08-2018)
Genre: Farmacie, farmacotherapie
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Beschrijving

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 process
  • Provides 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

Details

Titel: The Sourcebook for Clinical Research
auteur: Martien, Natasha; Nelligan, Jeff
Mediatype: Boek
Bindwijze: Paperback
Taal: Engels
Aantal pagina's: 274
Uitgever: Elsevier Science
Plaats van publicatie: 03
Publicatiedatum: 2018-08-08
NUR: Farmacie, farmacotherapie
Afmetingen: 235 x 191
ISBN/ISBN13: 9780128162422
Intern nummer: 42412461

Biografie (woord)

Jeff Nelligan, J.D., is a Washington, D.C.-based executive with extensive healthcare oversight, regulatory, and finance experience in three Federal Cabinet Agencies and in the Legislative branch, including: as a Director at the Centers for Medicare and Medicaid Services (CMS) within the U.S. Department of Health and Human Services; as a Managing Director at the U.S. Government Accountability Office (GAO); and, as a senior staffer for three Members of Congress in the U.S. Senate and the U.S. House of Representatives. He is a graduate of Williams College and Georgetown University Law Center.

Extra informatie

Presents a step-by-step manual that guides clinical research personnel through the clinical trial process, including both basic and advanced topics

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