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CMOS integrated lab-on-a-chip system for personalized biomedical diagnosis / / Hao Yu, Southern University of Science and Technology, China, Mei Yan, Consultant, China, Xiwei Huang, Hangzhou Dianzi University, China
| CMOS integrated lab-on-a-chip system for personalized biomedical diagnosis / / Hao Yu, Southern University of Science and Technology, China, Mei Yan, Consultant, China, Xiwei Huang, Hangzhou Dianzi University, China |
| Autore | Yu Hao <1976-> |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley / IEEE Press, , 2018 |
| Descrizione fisica | 1 online resource (289 pages) |
| Disciplina | 610.28/4 |
| Soggetto topico |
Medical instruments and apparatus - Research
Metal oxide semiconductors, Complementary |
| ISBN |
1-119-21833-0
1-119-21835-7 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Intro; Title Page; Copyright Page; Contents; Preface; Chapter 1 Introduction; 1.1 Personalized Biomedical Diagnosis; 1.1.1 Personalized Diagnosis; 1.1.2 Conventional Biomedical Diagnostic Instruments; 1.1.2.1 Optical Microscope; 1.1.2.2 Flow Cytometer; 1.1.2.3 DNA Sequencer; 1.2 CMOS Sensor-based Lab-on-a-Chip for System Miniaturization; 1.2.1 CMOS Sensor-based Lab-on-a-Chip; 1.2.2 CMOS Sensor; 1.2.2.1 CMOS Process Fundamentals; 1.2.2.2 CMOS Sensor Technology; 1.2.2.3 Multimodal CMOS Sensor; 1.2.3 Microfluidics; 1.2.3.1 Microfluidic Fundamentals; 1.2.3.2 Microfluidics Fabrication.
1.3 Objectives and Organization of this Book1.3.1 Objectives; 1.3.2 Organization; References; Chapter 2 CMOS Sensor Design; 2.1 Top Architecture; 2.2 Noise Overview; 2.2.1 Thermal Noise; 2.2.2 Flicker Noise; 2.2.3 Shot Noise; 2.2.4 MOSFET Noise Model; 2.3 Pixel Readout Circuit; 2.3.1 Source Follower; 2.3.2 Sub-threshold Gm Integrator; 2.3.3 CTIA; 2.4 Column Amplifier; 2.5 Column ADC; 2.5.1 Single-Slope ADC; 2.5.2 Sigma-Delta ADC; 2.6 Correlated Sampling; 2.6.1 Correlated Double Sampling; 2.6.2 Correlated Multiple Sampling; 2.7 Timing Control; 2.7.1 Row Timing Control. 2.7.2 Column Timing Control2.8 LVDS Interface; References; Chapter 3 CMOS Impedance Sensor; 3.1 Introduction; 3.2 CMOS Impedance Pixel; 3.3 Readout Circuit; 3.4 A 96 x 96 Electronic Impedance Sensing System; 3.4.1 Top Architecture; 3.4.2 System Implementation; 3.4.2.1 System Setup; 3.4.2.2 Sample Preparation; 3.4.3 Results; 3.4.3.1 Data Fitting for Single Cell Impedance Measurement; 3.4.3.2 Cell and Electrode Impedance Analysis; 3.4.3.3 EIS for Single-Cell Impedance Enumeration; References; Chapter 4 CMOS Terahertz Sensor; 4.1 Introduction; 4.2 CMOS THz Pixel. 4.2.1 Differential TL-SRR Resonator Design4.2.1.1 Stacked SRR Layout; 4.2.1.2 Comparison with Single-ended TL-SRR Resonator; 4.2.1.3 Comparison with Standing-Wave Resonator; 4.2.2 Differential TL-CSRR Resonator Design; 4.3 Readout Circuit; 4.3.1 Super-regenerative Amplification; 4.3.1.1 Equivalent Circuit of SRA; 4.3.1.2 Frequency Response of SRA; 4.3.1.3 Sensitivity of SRA; 4.3.2 Super-regenerative Receivers; 4.3.2.1 Quench-controlled Oscillation; 4.3.2.2 SRX Design by TL-CSRR; 4.3.2.3 SRX Design by TL-SRR; 4.4 A 135 GHz Imager; 4.4.1 135 GHz DTL-SRR-based Receiver. 4.4.2 System Implementation4.4.3 Results; 4.5 Plasmonic Sensor for Circulating Tumor Cell Detection; 4.5.1 Introduction of CTC Detection; 4.5.2 SRR-based Oscillator for CTC Detection; 4.5.3 Sensitivity of SRR-based Oscillator; References; Chapter 5 CMOS Ultrasound Sensor; 5.1 Introduction; 5.2 CMUT Pixel; 5.3 Readout Circuit; 5.4 A 320 × 320 CMUT-based Ultrasound Imaging System; 5.4.1 Top Architecture; 5.4.2 System Implementation; 5.4.2.1 Process Selection; 5.4.2.2 High Voltage Pulser; 5.4.2.3 Low-Noise Preamplifier and High Voltage Switch; 5.4.3 Results; 5.4.3.1 Simulation Results. |
| Record Nr. | UNINA-9910271024903321 |
Yu Hao <1976->
|
||
| Hoboken, New Jersey : , : Wiley / IEEE Press, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
CMOS integrated lab-on-a-chip system for personalized biomedical diagnosis / / Hao Yu, Southern University of Science and Technology, China, Mei Yan, Consultant, China, Xiwei Huang, Hangzhou Dianzi University, China
| CMOS integrated lab-on-a-chip system for personalized biomedical diagnosis / / Hao Yu, Southern University of Science and Technology, China, Mei Yan, Consultant, China, Xiwei Huang, Hangzhou Dianzi University, China |
| Autore | Yu Hao <1976-> |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley / IEEE Press, , 2018 |
| Descrizione fisica | 1 online resource (289 pages) |
| Disciplina | 610.28/4 |
| Soggetto topico |
Medical instruments and apparatus - Research
Metal oxide semiconductors, Complementary |
| ISBN |
1-119-21833-0
1-119-21835-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Intro; Title Page; Copyright Page; Contents; Preface; Chapter 1 Introduction; 1.1 Personalized Biomedical Diagnosis; 1.1.1 Personalized Diagnosis; 1.1.2 Conventional Biomedical Diagnostic Instruments; 1.1.2.1 Optical Microscope; 1.1.2.2 Flow Cytometer; 1.1.2.3 DNA Sequencer; 1.2 CMOS Sensor-based Lab-on-a-Chip for System Miniaturization; 1.2.1 CMOS Sensor-based Lab-on-a-Chip; 1.2.2 CMOS Sensor; 1.2.2.1 CMOS Process Fundamentals; 1.2.2.2 CMOS Sensor Technology; 1.2.2.3 Multimodal CMOS Sensor; 1.2.3 Microfluidics; 1.2.3.1 Microfluidic Fundamentals; 1.2.3.2 Microfluidics Fabrication.
1.3 Objectives and Organization of this Book1.3.1 Objectives; 1.3.2 Organization; References; Chapter 2 CMOS Sensor Design; 2.1 Top Architecture; 2.2 Noise Overview; 2.2.1 Thermal Noise; 2.2.2 Flicker Noise; 2.2.3 Shot Noise; 2.2.4 MOSFET Noise Model; 2.3 Pixel Readout Circuit; 2.3.1 Source Follower; 2.3.2 Sub-threshold Gm Integrator; 2.3.3 CTIA; 2.4 Column Amplifier; 2.5 Column ADC; 2.5.1 Single-Slope ADC; 2.5.2 Sigma-Delta ADC; 2.6 Correlated Sampling; 2.6.1 Correlated Double Sampling; 2.6.2 Correlated Multiple Sampling; 2.7 Timing Control; 2.7.1 Row Timing Control. 2.7.2 Column Timing Control2.8 LVDS Interface; References; Chapter 3 CMOS Impedance Sensor; 3.1 Introduction; 3.2 CMOS Impedance Pixel; 3.3 Readout Circuit; 3.4 A 96 x 96 Electronic Impedance Sensing System; 3.4.1 Top Architecture; 3.4.2 System Implementation; 3.4.2.1 System Setup; 3.4.2.2 Sample Preparation; 3.4.3 Results; 3.4.3.1 Data Fitting for Single Cell Impedance Measurement; 3.4.3.2 Cell and Electrode Impedance Analysis; 3.4.3.3 EIS for Single-Cell Impedance Enumeration; References; Chapter 4 CMOS Terahertz Sensor; 4.1 Introduction; 4.2 CMOS THz Pixel. 4.2.1 Differential TL-SRR Resonator Design4.2.1.1 Stacked SRR Layout; 4.2.1.2 Comparison with Single-ended TL-SRR Resonator; 4.2.1.3 Comparison with Standing-Wave Resonator; 4.2.2 Differential TL-CSRR Resonator Design; 4.3 Readout Circuit; 4.3.1 Super-regenerative Amplification; 4.3.1.1 Equivalent Circuit of SRA; 4.3.1.2 Frequency Response of SRA; 4.3.1.3 Sensitivity of SRA; 4.3.2 Super-regenerative Receivers; 4.3.2.1 Quench-controlled Oscillation; 4.3.2.2 SRX Design by TL-CSRR; 4.3.2.3 SRX Design by TL-SRR; 4.4 A 135 GHz Imager; 4.4.1 135 GHz DTL-SRR-based Receiver. 4.4.2 System Implementation4.4.3 Results; 4.5 Plasmonic Sensor for Circulating Tumor Cell Detection; 4.5.1 Introduction of CTC Detection; 4.5.2 SRR-based Oscillator for CTC Detection; 4.5.3 Sensitivity of SRR-based Oscillator; References; Chapter 5 CMOS Ultrasound Sensor; 5.1 Introduction; 5.2 CMUT Pixel; 5.3 Readout Circuit; 5.4 A 320 × 320 CMUT-based Ultrasound Imaging System; 5.4.1 Top Architecture; 5.4.2 System Implementation; 5.4.2.1 Process Selection; 5.4.2.2 High Voltage Pulser; 5.4.2.3 Low-Noise Preamplifier and High Voltage Switch; 5.4.3 Results; 5.4.3.1 Simulation Results. |
| Record Nr. | UNINA-9910830993303321 |
|
Yu Hao <1976->
|
||
| Hoboken, New Jersey : , : Wiley / IEEE Press, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The design and management of medical device clinical trials [[electronic resource] ] : strategies and challenges / / Salah Abdel-aleem
| The design and management of medical device clinical trials [[electronic resource] ] : strategies and challenges / / Salah Abdel-aleem |
| Autore | Abdel-aleem Salah |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2010 |
| Descrizione fisica | 1 online resource (269 p.) |
| Disciplina |
610.28
610.28/4072 |
| Soggetto topico |
Clinical trials
Medical instruments and apparatus - Research |
| ISBN |
1-283-27396-9
9786613273963 1-118-12545-2 1-118-16461-X 1-118-16462-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
The Design and Management of Medical Device Clinical Trials: Strategies and Challenges; Contents; List of Abbreviations; Preface; Acknowledgments; 1. Challenges to the Design of Clinical Study; Development of Clinical SOPs; Selection of Study Patients, Investigators, and Study Sites; Definition of Enrolled Subjects in a Clinical Study; Definition of the Investigational Device System; Research Contract Challenges; Review of Literature; Challenges to the Design of the Study Protocol, Statistical Analysis Plan (SAP), and Selection of Study Endpoints; Masking or Blinding
Primary and Secondary OutcomesSelection of Study Endpoints; Differences between the Primary Endpoint in FDA and CE Mark Studies; SAP and Study Endpoints; Components of the SAP for Clinical Trials; Roles and Responsibilities of the Clinical Personnel in Completing the Study Protocol; Changing the Primary Outcome during the Conduct of the Study; Definition of Primary and Secondary Endpoints; Combined ""Composite"" Endpoints; Surrogate Endpoints; Reducing the Study's Sample Size; Statistical Terms to Define Endpoint Measurements; Reporting Results of Clinical Trials Superiority and Equivalence TrialsSubgroup Analysis; Challenges to ICF; Risk/Benefit Analysis; 2. Challenges to Managing the Study; Enhancing Patient Enrollment by Relaxation of Study Criteria; Compliance with the Study Protocol; Challenges Associated with Data Accuracy and Completeness; Data Analysis; Data Integrity; Criteria for Using Meta-Analysis Studies; Who Should have Access to Clinical Trial Records; Managing Study Data and Quality Assurance; Missing Data Analysis; Examination of Data across Study Sites; Challenges to Adverse Event Reporting; Adverse Event Coding Systems Protocol Deviation ReportAdverse Event Reporting in Final Study Clinical Report; Difference between the US and EU Definitions and Reporting of Adverse Events; Adverse Event Reporting Challenges; Minimization of Bias in Clinical Trials; 3. Selection of Historic Controls; Types of Control Group in Medical Device Clinical Trials; Purpose of Control Group; Use of Placebo Control; Advantages of Randomized Control Clinical Trials; Disadvantages of Randomized Control Clinical Trials; Commonly Used Pivotal Designs; Definition of Historic Control; Objective Performance Criteria (OPC) Examples of Clinical Studies with Historic ControlsLACI Clinical Study; Left Ventricular Assist Devices; Summary of Clinical Studies; Summary of Recommendations for Historic Control; 4. Fraud and Misconduct in Clinical Trials; Fraud and Misconduct in Clinical Trials; Warning Signs of Fraud; Tips for Detecting Serious Misconduct; False Claims Act; Fraud Prevention; Policy on Handling Complaints of Misconduct; Reporting Research Misconduct; Bioresearch Monitoring Information System (BMIS); 5. Challenges to the Regulation of Medical Device; Determination of 510(K) Devices 510(K) ""Substantial Equivalence Decision Making Process"" |
| Record Nr. | UNINA-9910139590703321 |
|
Abdel-aleem Salah
|
||
| Hoboken, N.J., : Wiley, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The design and management of medical device clinical trials [[electronic resource] ] : strategies and challenges / / Salah Abdel-aleem
| The design and management of medical device clinical trials [[electronic resource] ] : strategies and challenges / / Salah Abdel-aleem |
| Autore | Abdel-aleem Salah |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2010 |
| Descrizione fisica | 1 online resource (269 p.) |
| Disciplina |
610.28
610.28/4072 |
| Soggetto topico |
Clinical trials
Medical instruments and apparatus - Research |
| ISBN |
1-283-27396-9
9786613273963 1-118-12545-2 1-118-16461-X 1-118-16462-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
The Design and Management of Medical Device Clinical Trials: Strategies and Challenges; Contents; List of Abbreviations; Preface; Acknowledgments; 1. Challenges to the Design of Clinical Study; Development of Clinical SOPs; Selection of Study Patients, Investigators, and Study Sites; Definition of Enrolled Subjects in a Clinical Study; Definition of the Investigational Device System; Research Contract Challenges; Review of Literature; Challenges to the Design of the Study Protocol, Statistical Analysis Plan (SAP), and Selection of Study Endpoints; Masking or Blinding
Primary and Secondary OutcomesSelection of Study Endpoints; Differences between the Primary Endpoint in FDA and CE Mark Studies; SAP and Study Endpoints; Components of the SAP for Clinical Trials; Roles and Responsibilities of the Clinical Personnel in Completing the Study Protocol; Changing the Primary Outcome during the Conduct of the Study; Definition of Primary and Secondary Endpoints; Combined ""Composite"" Endpoints; Surrogate Endpoints; Reducing the Study's Sample Size; Statistical Terms to Define Endpoint Measurements; Reporting Results of Clinical Trials Superiority and Equivalence TrialsSubgroup Analysis; Challenges to ICF; Risk/Benefit Analysis; 2. Challenges to Managing the Study; Enhancing Patient Enrollment by Relaxation of Study Criteria; Compliance with the Study Protocol; Challenges Associated with Data Accuracy and Completeness; Data Analysis; Data Integrity; Criteria for Using Meta-Analysis Studies; Who Should have Access to Clinical Trial Records; Managing Study Data and Quality Assurance; Missing Data Analysis; Examination of Data across Study Sites; Challenges to Adverse Event Reporting; Adverse Event Coding Systems Protocol Deviation ReportAdverse Event Reporting in Final Study Clinical Report; Difference between the US and EU Definitions and Reporting of Adverse Events; Adverse Event Reporting Challenges; Minimization of Bias in Clinical Trials; 3. Selection of Historic Controls; Types of Control Group in Medical Device Clinical Trials; Purpose of Control Group; Use of Placebo Control; Advantages of Randomized Control Clinical Trials; Disadvantages of Randomized Control Clinical Trials; Commonly Used Pivotal Designs; Definition of Historic Control; Objective Performance Criteria (OPC) Examples of Clinical Studies with Historic ControlsLACI Clinical Study; Left Ventricular Assist Devices; Summary of Clinical Studies; Summary of Recommendations for Historic Control; 4. Fraud and Misconduct in Clinical Trials; Fraud and Misconduct in Clinical Trials; Warning Signs of Fraud; Tips for Detecting Serious Misconduct; False Claims Act; Fraud Prevention; Policy on Handling Complaints of Misconduct; Reporting Research Misconduct; Bioresearch Monitoring Information System (BMIS); 5. Challenges to the Regulation of Medical Device; Determination of 510(K) Devices 510(K) ""Substantial Equivalence Decision Making Process"" |
| Record Nr. | UNINA-9910814185203321 |
|
Abdel-aleem Salah
|
||
| Hoboken, N.J., : Wiley, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Design, execution, and management of medical device clinical trials [[electronic resource] /] / Salah Abdel-aleem
| Design, execution, and management of medical device clinical trials [[electronic resource] /] / Salah Abdel-aleem |
| Autore | Abdel-aleem Salah |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2009 |
| Descrizione fisica | 1 online resource (296 p.) |
| Disciplina | 610.28/4 |
| Soggetto topico |
Medical instruments and apparatus - Research
Clinical trials |
| ISBN |
1-282-27905-X
9786612279058 0-470-47591-9 0-470-47590-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
DESIGN, EXECUTION, AND MANAGEMENT OF MEDICAL DEVICE CLINICAL TRIALS; CONTENTS; List of Abbreviations; Preface; Acknowledgments; 1 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
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 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) 3 Qualification/Selection of Study Investigators and Study Monitoring Visits Qualification and Selection of Investigators; Monitoring Visits; Monitoring Reports; Interim Monitoring Visit Report Template; 4 Adverse Events Definitions 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 Classification of Adverse Events; Special Requirement for Reporting Certain Adverse Events; Case Example; Mandatory Device Reporting for FDA-Approved Devices; 5 Statistical Analysis Plan (SAP) and Biostatistics in Clinical Research; Statistical Analysis Plan (SAP); Selection of Study Endpoints; Biostatistics in Clinical Research; 6 Final Clinical Study Report; Final Clinical Report's Outline; Discussion of Sections in the Final Clinical Report; 7 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 (Bioresearch Monitoring); Code of Federal Regulations of Medical Devices; 8 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 |
| Record Nr. | UNINA-9910139803003321 |
|
Abdel-aleem Salah
|
||
| Hoboken, N.J., : John Wiley & Sons, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Design, execution, and management of medical device clinical trials [[electronic resource] /] / Salah Abdel-aleem
| Design, execution, and management of medical device clinical trials [[electronic resource] /] / Salah Abdel-aleem |
| Autore | Abdel-aleem Salah |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2009 |
| Descrizione fisica | 1 online resource (296 p.) |
| Disciplina | 610.28/4 |
| Soggetto topico |
Medical instruments and apparatus - Research
Clinical trials |
| ISBN |
1-282-27905-X
9786612279058 0-470-47591-9 0-470-47590-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
DESIGN, EXECUTION, AND MANAGEMENT OF MEDICAL DEVICE CLINICAL TRIALS; CONTENTS; List of Abbreviations; Preface; Acknowledgments; 1 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
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 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) 3 Qualification/Selection of Study Investigators and Study Monitoring Visits Qualification and Selection of Investigators; Monitoring Visits; Monitoring Reports; Interim Monitoring Visit Report Template; 4 Adverse Events Definitions 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 Classification of Adverse Events; Special Requirement for Reporting Certain Adverse Events; Case Example; Mandatory Device Reporting for FDA-Approved Devices; 5 Statistical Analysis Plan (SAP) and Biostatistics in Clinical Research; Statistical Analysis Plan (SAP); Selection of Study Endpoints; Biostatistics in Clinical Research; 6 Final Clinical Study Report; Final Clinical Report's Outline; Discussion of Sections in the Final Clinical Report; 7 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 (Bioresearch Monitoring); Code of Federal Regulations of Medical Devices; 8 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 |
| Record Nr. | UNINA-9910827440103321 |
|
Abdel-aleem Salah
|
||
| Hoboken, N.J., : John Wiley & Sons, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
