{"product_id":"design-execution-and-management-of-medical-device-clinical-trials-isbn-9780470474266","title":"Design, Execution, and Management of Medical Device Clinical Trials","description":"An essential introduction to conducting the various stages of medical device clinical trials  \u003cp\u003eClinical 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.\u003c\/p\u003e \u003cp\u003eThroughout 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:\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eQualification and selection of investigators\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eStudy monitoring visits\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eDefinitions and reporting procedures for adverse events\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eThe use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eThe roles and responsibilities of all members of a clinical research team\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eThe 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.\u003c\/p\u003e \u003cp\u003eDesign, 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.\u003c\/p\u003e \u003cp\u003eList of Abbreviations xi\u003c\/p\u003e \u003cp\u003ePreface xv\u003c\/p\u003e \u003cp\u003eAcknowledgments xxi\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 An Overview of Clinical Study Tasks and Activities 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eKey Clinical Study Tasks and Activities 2\u003c\/p\u003e \u003cp\u003eDiscussion of Key Tasks and Activities 3\u003c\/p\u003e \u003cp\u003eManagement of Key Clinical Tasks and Activities 9\u003c\/p\u003e \u003cp\u003eExample of the Spread Sheet for Managing Clinical Study Activities 10\u003c\/p\u003e \u003cp\u003eThe Clinical Research Team 10\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Development of Clinical Protocols, Case Report Forms, Clinical Standard Operating Procedures, Informed Consent Form, Study Regulatory Binder, Study Research Agreement, and Other Clinical Materials 15\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eClinical Protocol 17\u003c\/p\u003e \u003cp\u003eCase Report Forms (CRFs) 28\u003c\/p\u003e \u003cp\u003eExample of the Case Report Form Template 32\u003c\/p\u003e \u003cp\u003eInformed Consent Form (ICF) 35\u003c\/p\u003e \u003cp\u003eInstructions for Use of Device 38\u003c\/p\u003e \u003cp\u003eStudy Regulatory Binder 39\u003c\/p\u003e \u003cp\u003eStudy Research Agreement 40\u003c\/p\u003e \u003cp\u003eResearch Agreement Template 43\u003c\/p\u003e \u003cp\u003eResearch Contract Challenges 50\u003c\/p\u003e \u003cp\u003eClinical Forms and Certificates 51\u003c\/p\u003e \u003cp\u003eClinical Standard Operating Procedures (SOPs) 54\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Qualification\/Selection of Study Investigators and Study Monitoring Visits 63\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eQualification and Selection of Investigators 64\u003c\/p\u003e \u003cp\u003eMonitoring Visits 67\u003c\/p\u003e \u003cp\u003eMonitoring Reports 73\u003c\/p\u003e \u003cp\u003eInterim Monitoring Visit Report Template 75\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Adverse Events Definitions and Reporting Procedures 81\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAdverse Event Definitions 83\u003c\/p\u003e \u003cp\u003ePolicies, Regulations, and Guidelines Regarding Adverse Event Reporting 84\u003c\/p\u003e \u003cp\u003eAdverse Event Reporting Pathway 84\u003c\/p\u003e \u003cp\u003eTerms for Causality Assessment 85\u003c\/p\u003e \u003cp\u003eGAPS\/Challenges in Adverse Event Reporting 86\u003c\/p\u003e \u003cp\u003eAdverse Event Reporting Time Periods (21 CFR 803) 88\u003c\/p\u003e \u003cp\u003eDifferences between the United States and Europe in Reporting Adverse Events 88\u003c\/p\u003e \u003cp\u003eSerious Adverse Event Narratives 89\u003c\/p\u003e \u003cp\u003eClassification of Adverse Events 90\u003c\/p\u003e \u003cp\u003eSpecial Requirement for Reporting Certain Adverse Events 92\u003c\/p\u003e \u003cp\u003eCase Example 92\u003c\/p\u003e \u003cp\u003eMandatory Device Reporting for FDA-Approved Devices 92\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Statistical Analysis Plan (SAP) and Biostatistics in Clinical Research 93\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eStatistical Analysis Plan (SAP) 94\u003c\/p\u003e \u003cp\u003eSelection of Study Endpoints 97\u003c\/p\u003e \u003cp\u003eBiostatistics in Clinical Research 101\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Final Clinical Study Report 113\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eFinal Clinical Report’s Outline 114\u003c\/p\u003e \u003cp\u003eDiscussion of Sections in the Final Clinical Report 116\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Medical Device Regulations Combination Product, Study Committees, and FDA-Sponsor Meetings 127\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eMedical Device Regulations 129\u003c\/p\u003e \u003cp\u003eCombination Products 164\u003c\/p\u003e \u003cp\u003eStudy Committees 168\u003c\/p\u003e \u003cp\u003eFDA-Sponsor Meetings 170\u003c\/p\u003e \u003cp\u003eRegistration of Clinical Trials 174\u003c\/p\u003e \u003cp\u003eImplementation of the HIPAA Privacy Rule in Clinical Research 175\u003c\/p\u003e \u003cp\u003eInstitutional Review Boards (IRB) 180\u003c\/p\u003e \u003cp\u003eFDA’s Oversight of Clinical Trials (Bioresearch Monitoring) 191\u003c\/p\u003e \u003cp\u003eCode of Federal Regulations of Medical Devices 194\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Design Issues in Medical Devices Studies 195\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDesign of the Clinical Trial 196\u003c\/p\u003e \u003cp\u003eAssumptions and Parameters of Clinical Trial Design 196\u003c\/p\u003e \u003cp\u003eClinical Trials’ Design Issues and Data Analysis Issues 202\u003c\/p\u003e \u003cp\u003eUse of Historic Controls as the Control Group in IDE Studies 206\u003c\/p\u003e \u003cp\u003eSummary of Recommendations When Using Historic Controls 218\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Investigator-Initiated Clinical Research 221\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDefinition and Examples of Investigator-Initiated Clinical Research 222\u003c\/p\u003e \u003cp\u003eDevelopment, Conduct, and Management of Investigator-Initiated Clinical Research 224\u003c\/p\u003e \u003cp\u003eRegulation of Investigator-Initiated Clinical Research 225\u003c\/p\u003e \u003cp\u003eRequired Infrastructure for Investigator-Initiated Clinical Research 226\u003c\/p\u003e \u003cp\u003eClinical Research Sponsored by NIH 227\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Ethical Conduct for Human Research 229\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe Nuremberg Code (1947) 230\u003c\/p\u003e \u003cp\u003eWorld Medical Association—Declaration of Helsinki (1964–Present) 231\u003c\/p\u003e \u003cp\u003eNational Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974) 231\u003c\/p\u003e \u003cp\u003eThe Belmont Report (1978) 232\u003c\/p\u003e \u003cp\u003eSpecial Ethical Concerns in Clinical Research on Use of Placebo 232\u003c\/p\u003e \u003cp\u003eGlossary of Clinical Trial and Statistical Terms 235\u003c\/p\u003e \u003cp\u003eReferences 249\u003c\/p\u003e \u003cp\u003eIndex 255\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eSALAH M. ABDEL-ALEEM, P\u003csmall\u003eH\u003c\/small\u003eD,\u003c\/b\u003e 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.   \u003c\/p\u003e\u003cp\u003e\u003cb\u003eAN ESSENTIAL INTRODUCTION TO CONDUCTING THE VARIOUS STAGES OF MEDICAL DEVICE CLINICAL TRIALS\u003c\/b\u003e \t \u003c\/p\u003e\u003cp\u003eClinical 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. \u003c\/p\u003e\u003cp\u003eThroughout 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: \u003c\/p\u003e\u003cul\u003e \u003cli\u003eQualification and selection of investigators\u003c\/li\u003e \u003cli\u003eStudy monitoring visits\u003c\/li\u003e \u003cli\u003eDefinitions and reporting procedures for adverse events\u003c\/li\u003e \u003cli\u003eThe use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints\u003c\/li\u003e \u003cli\u003eThe roles and responsibilities of all members of a clinical research team\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eThe 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. \u003c\/p\u003e\u003cp\u003eDesign, 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.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989042512101,"sku":"NP9780470474266","price":124.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780470474266.jpg?v=1761782554","url":"https:\/\/k12savings.com\/es\/products\/design-execution-and-management-of-medical-device-clinical-trials-isbn-9780470474266","provider":"K12savings","version":"1.0","type":"link"}