Design, Execution, and Management of Medical Device Clinical Trials
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Published By John Wiley & Sons, Inc.

9780470475911, 9780470474266

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Frontmatter

Design, Execution, and Management of Medical Device Clinical Trials ◽

10.1002/9780470475911.fmatter ◽

2009 ◽

pp. i-xxi

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Statistical Analysis Plan (SAP) and Biostatistics in Clinical Research

Design, Execution, and Management of Medical Device Clinical Trials ◽

10.1002/9780470475911.ch5 ◽

2009 ◽

pp. 93-112

Keyword(s):

Statistical Analysis ◽

Clinical Research ◽

Statistical Analysis Plan

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An Overview of Clinical Study Tasks and Activities

Design, Execution, and Management of Medical Device Clinical Trials ◽

10.1002/9780470475911.ch1 ◽

2009 ◽

pp. 1-13

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Investigator-Initiated Clinical Research

Design, Execution, and Management of Medical Device Clinical Trials ◽

10.1002/9780470475911.ch9 ◽

2009 ◽

pp. 221-227

Keyword(s):

Clinical Research

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Qualification/Selection of Study Investigators and Study Monitoring Visits

Design, Execution, and Management of Medical Device Clinical Trials ◽

10.1002/9780470475911.ch3 ◽

2009 ◽

pp. 63-80

Keyword(s):

Study Monitoring ◽

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Development of Clinical Protocols, Case Report Forms, Clinical Standard Operating Procedures, Informed Consent Form, Study Regulatory Binder, Study Research Agreement, and Other Clinical Materials

Design, Execution, and Management of Medical Device Clinical Trials ◽

10.1002/9780470475911.ch2 ◽

2009 ◽

pp. 15-62

Keyword(s):

Case Report ◽

Informed Consent ◽

Standard Operating Procedures ◽

Consent Form ◽

Clinical Protocols ◽

Study Research ◽

Informed Consent Form ◽

Standard Operating

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Design Issues in Medical Devices Studies

Design, Execution, and Management of Medical Device Clinical Trials ◽

10.1002/9780470475911.ch8 ◽

2009 ◽

pp. 195-219

Keyword(s):

Medical Devices ◽

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Final Clinical Study Report

Design, Execution, and Management of Medical Device Clinical Trials ◽

10.1002/9780470475911.ch6 ◽

2009 ◽

pp. 113-125

Keyword(s):

Clinical Study ◽

Clinical Study Report ◽

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Ethical Conduct for Human Research

Design, Execution, and Management of Medical Device Clinical Trials ◽

10.1002/9780470475911.ch10 ◽

2009 ◽

pp. 229-233

Keyword(s):

Ethical Conduct ◽

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Glossary of Clinical Trial and Statistical Terms

Design, Execution, and Management of Medical Device Clinical Trials ◽

10.1002/9780470475911.gloss ◽

2009 ◽

pp. 235-247

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