Catalogue


Design, execution, and management of medical device clinical trials /
Salah Abdel-aleem.
imprint
Hoboken, N.J. : John Wiley & Sons, c2009.
description
xxi, 272 p.
ISBN
0470474262 (cloth), 9780470474266 (cloth)
format(s)
Book
Holdings
More Details
imprint
Hoboken, N.J. : John Wiley & Sons, c2009.
isbn
0470474262 (cloth)
9780470474266 (cloth)
contents note
An overview of clinical study tasks and activities -- Development of the clinical protocol case report forms, clinical standard operating procedures, informed consent form, study regulatory binder, study research agreement, and other clinical materials -- Qualification/selection of investigators and study monitoring visits -- Adverse events definitions & reporting procedures -- Statistical analysis plan (SAP) and biostastics in clinical research -- Final clinical study report -- Medical device regulations, combination product, study committees, and FDA-sponsor meetings -- Design issues in medical device studies -- Investigator initiated clinical research -- Ethical conduct for human research -- Glossary of clinical trial and statistical terms.
catalogue key
6931658
 
Includes bibliographical references and index.
A Look Inside
About the Author
Author Affiliation
Salah M. Abdel-Aleem, PhD, is Senior Manager of Clinical Operations at Proteus Biomedical, Inc., a medical device and pharmaceutical company that develops therapies for cardiovascular and diabetic diseases. Dr. Abdel-aleem has over twenty years of clinical research experience in various academic and corporate settings.
Summaries
Bowker Data Service Summary
This work provides professionals with both an in-depth and broad range of knowledge of clinical research tasks and activities and allows them to execute these tasks and activities successfully. It allows readers to form an integrated picture of every aspect of the clinical trial.
Long Description
An essential introduction to conducting the various stages of medical device clinical trialsClinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities.Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes:Qualification and selection of investigatorsStudy monitoring visitsDefinitions and reporting procedures for adverse eventsThe use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpointsThe roles and responsibilities of all members of a clinical research teamThe book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic.Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.
Main Description
An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.
Main Description
An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the authors and other researchers previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.
Main Description
Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples complied from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices. Book jacket.
Main Description
Design, Execution, and Management of Medical Device Clinical Trials provides practical examples, ranging from the development of clinical protocol and the selection of clinical sites and ending with the completion of the final clinical report study. In addition, this book explores the role of every member of the clinical research team, including all responsibilities associated with their function. This text provides professionals with both an in-depth and broad range of knowledge of clinical research tasks and activities, and allows readers to execute these tasks and activities successfully.
Main Description
Design, Execution, and Management of Medical Device Clinical TrialsSalah m. Abdel-AleemAn essential introduction to conducting the various stages of medical device clinical trialsClinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities.Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes:Qualification and selection of investigatorsStudy monitoring visitsDefinitions and reporting procedures for adverse eventsThe use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpointsThe roles and responsibilities of all members of a clinical research teamThe book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic.Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.
Main Description
Throughout this book, practical examples compiled from the author's previous clinical trial experiences are discussed in a sequential manner as they occurred in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical report study. This approach allows readers to have an integrated picture of every aspect of the clinical trial. In addition, the role of every member of the clinical research team, including all responsibilities associated with their function, is outlined. This book provides professionals with both an in-depth and broad range of knowledge of clinical research tasks and activities and allows readers to execute these tasks and activities successfully. Chapter coverage includes an overview of clinical study tasks and activities; development of the clinical protocol and other clinical materials, qualification and selection of investigators and study monitoring visits; adverse events definitions and reporting procedures; Statistical Analysis Plan (SAP) and biostatistics in clinical research; final clinical study report; medical device regulations; design issues in medical device studies; investigator initiated clinical studies; and ethical conduct for human research.
Table of Contents
List of Abbreviations
Preface
Acknowledgments
An Overview of Clinical Study Tasks and Activities
Key Clinical Study Tasks and Activities
Discussion of Key Tasks and Activities
Management of Key Clinical Tasks and Activities
Example of the Spread Sheet for Managing Clinical Study Activities
The Clinical Research Team
Development of Clinical Protocols, Case Report Forms, Clinical Standard Operating Procedures, Informed Consent Form, Study Regulatory Binder, Study Research Agreement, and Other Clinical Materials
Clinical Protocol
Case Report Forms (CRFs)
Example of the Case Report Form Template
Informed Consent Form (ICF)
Instructions for Use of Device
Study Regulatory Binder
Study Research Agreement
Research Agreement Template
Research Contract Challenges
Clinical Forms and Certificates
Clinical Standard Operating Procedures (SOPs)
Qualifi cation/Selection of Study Investigators and Study Monitoring Visits
Qualifi cation and Selection of Investigators
Monitoring Visits
Monitoring Reports
Interim Monitoring Visit Report Template
Adverse Events Defi nitions and Reporting Procedures
Adverse Event Definitions
Policies, Regulations, and Guidelines Regarding Adverse Event Reporting
Adverse Event Reporting Pathway
Terms for Causality Assessment
GAPS/Challenges in Adverse Event Reporting
Adverse Event Reporting Time Periods (21 CFR 803)
Differences between the United States and Europe in Reporting Adverse Events
Serious Adverse Event Narratives
Classifi cation of Adverse Events
Special Requirement for Reporting Certain Adverse Events
Case Example
Mandatory Device Reporting for FDA-Approved Devices
Statistical Analysis Plan (SAP) and Biostatistics in Clinical Research
Statistical Analysis Plan (SAP)
Selection of Study Endpoints
Biostatistics in Clinical Research
Final Clinical Study Report
Final Clinical Report's Outline
Discussion of Sections in the Final Clinical Report
Medical Device Regulations, Combination Product, Study Committees, and FDA-Sponsor Meetings
Medical Device Regulations
Combination Products
Study Committees
FDA-Sponsor Meetings
Registration of Clinical Trials
Implementation of the HIPAA Privacy Rule in Clinical Research
Institutional Review Boards (IRB)
FDA's Oversight of Clinical Trials
Code of Federal Regulations of Medical Devices
Design Issues in Medical Devices Studies
Design of the Clinical Trial
Assumptions and Parameters of Clinical Trial Design
Clinical Trials' Design Issues and Data Analysis Issues
Use of Historic Controls as the Control Group in IDE Studies
Summary of Recommendations When Using Historic Controls
Investigator-Initiated Clinical Research
Defi nition and Examples of Investigator-Initiated Clinical Research
Development, Conduct, and Management of Investigator-Initiated Clinical Research
Regulation of Investigator-Initiated Clinical Research
Required Infrastructure for Investigator-Initiated Clinical Research
Clinical Research Sponsored by NIH
Ethical Conduct for Human Research
The Nuremberg Code (1947)
World Medical Association-Declaration of Helsinki (1964-Present)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974)
The Belmont Report (1978)
Special Ethical Concerns in Clinical Research on Use of Placebo
Glossary of Clinical Trial and Statistical Terms
References
Index
Table of Contents provided by Publisher. All Rights Reserved.

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