دانلود کتاب Design, Execution, and Management of Medical Device Clinical Trials

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DESIGN, EXECUTION, AND MANAGEMENT OF MEDICAL DEVICE CLINICAL TRIALS......Page 5
CONTENTS......Page 9
List of Abbreviations......Page 13
Preface......Page 17
Acknowledgments......Page 23
1 An Overview of Clinical Study Tasks and Activities......Page 25
Key Clinical Study Tasks and Activities......Page 26
Discussion of Key Tasks and Activities......Page 27
Management of Key Clinical Tasks and Activities......Page 33
The Clinical Research Team......Page 34
2 Development of Clinical Protocols, Case Report Forms, Clinical Standard Operating Procedures, Informed Consent Form, Study Regulatory Binder, Study Research Agreement, and Other Clinical Materials......Page 39
Clinical Protocol......Page 41
Case Report Forms (CRFs)......Page 52
Example of the Case Report Form Template......Page 56
Informed Consent Form (ICF)......Page 59
Instructions for Use of Device......Page 62
Study Regulatory Binder......Page 63
Study Research Agreement......Page 64
Research Agreement Template......Page 67
Research Contract Challenges......Page 74
Clinical Forms and Certificates......Page 75
Clinical Standard Operating Procedures (SOPs)......Page 78
3 Qualification/Selection of Study Investigators and Study Monitoring Visits......Page 87
Qualification and Selection of Investigators......Page 88
Monitoring Visits......Page 91
Monitoring Reports......Page 97
Interim Monitoring Visit Report Template......Page 99
4 Adverse Events Definitions and Reporting Procedures......Page 105
Adverse Event Definitions......Page 107
Adverse Event Reporting Pathway......Page 108
Terms for Causality Assessment......Page 109
GAPS/Challenges in Adverse Event Reporting......Page 110
Differences between the United States and Europe in Reporting Adverse Events......Page 112
Serious Adverse Event Narratives......Page 113
Classification of Adverse Events......Page 114
Mandatory Device Reporting for FDA-Approved Devices......Page 116
5 Statistical Analysis Plan (SAP) and Biostatistics in Clinical Research......Page 117
Statistical Analysis Plan (SAP)......Page 118
Selection of Study Endpoints......Page 121
Biostatistics in Clinical Research......Page 125
6 Final Clinical Study Report......Page 137
Final Clinical Report’s Outline......Page 138
Discussion of Sections in the Final Clinical Report......Page 140
7 Medical Device Regulations, Combination Product, Study Committees, and FDA-Sponsor Meetings......Page 151
Medical Device Regulations......Page 153
Combination Products......Page 188
Study Committees......Page 192
FDA-Sponsor Meetings......Page 194
Registration of Clinical Trials......Page 198
Implementation of the HIPAA Privacy Rule in Clinical Research......Page 199
Institutional Review Boards (IRB)......Page 204
FDA’s Oversight of Clinical Trials (Bioresearch Monitoring)......Page 215
Code of Federal Regulations of Medical Devices......Page 218
8 Design Issues in Medical Devices Studies......Page 219
Assumptions and Parameters of Clinical Trial Design......Page 220
Clinical Trials’ Design Issues and Data Analysis Issues......Page 226
Use of Historic Controls as the Control Group in IDE Studies......Page 230
Summary of Recommendations When Using Historic Controls......Page 242
9 Investigator-Initiated Clinical Research......Page 245
Definition and Examples of Investigator-Initiated Clinical Research......Page 246
Development, Conduct, and Management of Investigator-Initiated Clinical Research......Page 248
Regulation of Investigator-Initiated Clinical Research......Page 249
Required Infrastructure for Investigator-Initiated Clinical Research......Page 250
Clinical Research Sponsored by NIH......Page 251
10 Ethical Conduct for Human Research......Page 253
The Nuremberg Code (1947)......Page 254
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974)......Page 255
Special Ethical Concerns in Clinical Research on Use of Placebo......Page 256
Glossary of Clinical Trial and Statistical Terms......Page 259
References......Page 273
Index......Page 279