The Sourcebook for Clinical Research - Martien, Natasha; Nelligan, Jeff
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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…mehr

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Produktbeschreibung
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.
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Autorenporträt
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.