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
Natasha Martien, MBA, CCRP, SSBBP, CRCP, is a Human Subjects Research regulatory expert with 25 years of clinical research and healthcare management experience at institutes including Johns Hopkins Hospital, The Center for Cardiac and Vascular Research, and Scripps Clinic and Research Foundation. Martien has performed every operational role in clinical research at sites, including: training IRB members, Investigators and Research Coordinators; regulatory management; working for Naan Office of Human Research Protections supporting an IRB; Research Coordination; writing and negotiating clinical trial agreements and budgets; financial management and billing; Coverage Analysis; CTMS acquisition; data analysis; credentialing; Quality Assurance; writing consent forms and study materials; compliance; advertising and recruiting; and the creation of a Clinical Trials Office. Martien has conducted and managed Investigator Initiated, Industry and Grant funded studies in 24 medical disciplines and for all study types, such as INDs, IDEs, biologics, stem cells, behavioral, pilot, observational, chart reviews and clinical trial Phases I through IV.