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A Practical Guide to Managing Clinical Trials
Taschenbuch von Joann Pfeiffer (u. a.)
Sprache: Englisch

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Beschreibung
A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application.

Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application.

Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Über den Autor

Dr. JoAnn Pfeiffer has extensive experience in site management, and is currently the Program Director of Arizona State University's (ASU) Clinical Research Management Program in the College of Nursing and Health Innovation.

Dr. Cris Wells has broad experience in overseeing basic and translational studies as well as clinical trials. She is currently the Senior Director of Health-Related Programs at ASU.

Inhaltsverzeichnis

Chapter 1: Rules, Roles and Responsibilities

Chapter 2: Products, Protocols, and Pre-trial Preparation

Chapter 3: Sponsor, Site and Study Start-up

Chapter 4: Enticement, Enrollment, and Engagement: The Informed Consent Process

Chapter 5: From Enrollment to Final Visit

Chapter 6: Collaborating for Compliance and Quality Data - Monitoring and Audits

Chapter 7: Building Budgets

Chapter 8: Contracts, Clauses and Closing the Deal

Chapter 9: US Clinical Trials - Additional Topics

Chapter 10: Clinical Research and India

Details
Erscheinungsjahr: 2020
Fachbereich: Wahrscheinlichkeitstheorie
Genre: Mathematik
Rubrik: Naturwissenschaften & Technik
Medium: Taschenbuch
ISBN-13: 9780367497828
ISBN-10: 0367497824
Sprache: Englisch
Ausstattung / Beilage: Paperback
Einband: Kartoniert / Broschiert
Autor: Pfeiffer, Joann
Wells, Cris
Hersteller: CRC Press
Maße: 234 x 156 x 15 mm
Von/Mit: Joann Pfeiffer (u. a.)
Erscheinungsdatum: 25.02.2020
Gewicht: 0,424 kg
Artikel-ID: 128403424
Über den Autor

Dr. JoAnn Pfeiffer has extensive experience in site management, and is currently the Program Director of Arizona State University's (ASU) Clinical Research Management Program in the College of Nursing and Health Innovation.

Dr. Cris Wells has broad experience in overseeing basic and translational studies as well as clinical trials. She is currently the Senior Director of Health-Related Programs at ASU.

Inhaltsverzeichnis

Chapter 1: Rules, Roles and Responsibilities

Chapter 2: Products, Protocols, and Pre-trial Preparation

Chapter 3: Sponsor, Site and Study Start-up

Chapter 4: Enticement, Enrollment, and Engagement: The Informed Consent Process

Chapter 5: From Enrollment to Final Visit

Chapter 6: Collaborating for Compliance and Quality Data - Monitoring and Audits

Chapter 7: Building Budgets

Chapter 8: Contracts, Clauses and Closing the Deal

Chapter 9: US Clinical Trials - Additional Topics

Chapter 10: Clinical Research and India

Details
Erscheinungsjahr: 2020
Fachbereich: Wahrscheinlichkeitstheorie
Genre: Mathematik
Rubrik: Naturwissenschaften & Technik
Medium: Taschenbuch
ISBN-13: 9780367497828
ISBN-10: 0367497824
Sprache: Englisch
Ausstattung / Beilage: Paperback
Einband: Kartoniert / Broschiert
Autor: Pfeiffer, Joann
Wells, Cris
Hersteller: CRC Press
Maße: 234 x 156 x 15 mm
Von/Mit: Joann Pfeiffer (u. a.)
Erscheinungsdatum: 25.02.2020
Gewicht: 0,424 kg
Artikel-ID: 128403424
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