🗊 Презентация CSR

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CSR, слайд №1 CSR, слайд №2 CSR, слайд №3 CSR, слайд №4 CSR, слайд №5 CSR, слайд №6 CSR, слайд №7 CSR, слайд №8 CSR, слайд №9 CSR, слайд №10 CSR, слайд №11 CSR, слайд №12 CSR, слайд №13 CSR, слайд №14 CSR, слайд №15 CSR, слайд №16 CSR, слайд №17 CSR, слайд №18 CSR, слайд №19
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Слайды и текст этой презентации

Слайд 1


Before Presentation… This slide deck is based on Jain Chung’s presentation for the 1st CDM training course in 2008.
Описание слайда:
Before Presentation… This slide deck is based on Jain Chung’s presentation for the 1st CDM training course in 2008.

Слайд 2


CSR, слайд №2
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Слайд 3


ICH E9 Statistical Principles
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ICH E9 Statistical Principles

Слайд 4


ICH E3 Clinical Study Reports
Описание слайда:
ICH E3 Clinical Study Reports

Слайд 5


Process for Development Clinical Study Report
Описание слайда:
Process for Development Clinical Study Report

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Sample of CSR Report Body In the format of the Journal-Style scientific paper Background, Rationale and Objectives Materials And Methods Results 3.1...
Описание слайда:
Sample of CSR Report Body In the format of the Journal-Style scientific paper Background, Rationale and Objectives Materials And Methods Results 3.1 Study Population 3.2 Efficacy Results 3.3 Pharmacodynamic, Pharmacokinetic and PK/PD Modeling 3.4 Safety Analysis 4. Discussion 5. Conclusion 6. References Appendices

Слайд 7


Sample of CSR Report Body In the format of ICH E3 “Structure and Content of Clinical Study Reports” 1. Title page 2. Synopsis 3. Table of contents 4....
Описание слайда:
Sample of CSR Report Body In the format of ICH E3 “Structure and Content of Clinical Study Reports” 1. Title page 2. Synopsis 3. Table of contents 4. List of abbreviations 5. Ethics 6. Investigators and study administrative structure 7. Introduction 8. Study objectives 9. Investigational plan

Слайд 8


CSR Section 3 - Results 3.1 Study Population 3.1.1 Disposition of Patients 3.1.2 Patients Withdrawn Prematurely from treatment 3.1.3 Overall of...
Описание слайда:
CSR Section 3 - Results 3.1 Study Population 3.1.1 Disposition of Patients 3.1.2 Patients Withdrawn Prematurely from treatment 3.1.3 Overall of Analysis Populations 3.1.4 Protocol Violations 3.15 Demographic Data and Baseline Characteristics 3.1.6 Previous Concomitant Medications and Diseases

Слайд 9


CSR Section 3 - Results 3.2 Efficacy Results 3.2.1 Primary Efficacy Parameter 3.2.2 Secondary Efficacy Parameter (s) 3.1.3 Subgroup and Exploratory...
Описание слайда:
CSR Section 3 - Results 3.2 Efficacy Results 3.2.1 Primary Efficacy Parameter 3.2.2 Secondary Efficacy Parameter (s) 3.1.3 Subgroup and Exploratory Analyses 3.3 Pharmacodynamic, Pharmacokinetic and PK/PD Modeling

Слайд 10


CSR Section 3- Results 3.4 Safety Analysis 3.4.1 Extent of Exposure to Trial Medication 3.4.2 Overview of Safety 3.4.3 Adverse Events 3.4.3.1...
Описание слайда:
CSR Section 3- Results 3.4 Safety Analysis 3.4.1 Extent of Exposure to Trial Medication 3.4.2 Overview of Safety 3.4.3 Adverse Events 3.4.3.1 Overview Adverse Events 3.4.3.2 Deaths 3.4.3.3 Serious Adverse Events 3.4.3.4 Adverse Events and Laboratory abnormalities Leading to Withdrawal from treatment 3.4.3.5 Dose Modifications for Safety Reasons

Слайд 11


CSR Section 3 - Results 3.4.4 Laboratory Parameters 3.4.4.1 Mean (or Median) Change from Baseline 3.4.4.2 Shift from Baseline 3.4.5 Vital Signs 3.4.6...
Описание слайда:
CSR Section 3 - Results 3.4.4 Laboratory Parameters 3.4.4.1 Mean (or Median) Change from Baseline 3.4.4.2 Shift from Baseline 3.4.5 Vital Signs 3.4.6 ECGs

Слайд 12


Other CSR Sections: 4, 5, and 6 4. Discussion 5. Conclusion 6. References Appendices
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Other CSR Sections: 4, 5, and 6 4. Discussion 5. Conclusion 6. References Appendices

Слайд 13


Review CSR, final TLFs Validation Consistency Interpretations Discussions
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Review CSR, final TLFs Validation Consistency Interpretations Discussions

Слайд 14


CSR Section 1: Background, Rationale and Objectives 1.1 Background 1.2 Rationale 1.3 Objective
Описание слайда:
CSR Section 1: Background, Rationale and Objectives 1.1 Background 1.2 Rationale 1.3 Objective

Слайд 15


CSR Section 2 - Materials and Methods 2.1 Overall Study Design 2.1.1 Protocol Amendments 2.2 Study Population 2.2.1 Overview 2.2.2 Inclusion Criteria...
Описание слайда:
CSR Section 2 - Materials and Methods 2.1 Overall Study Design 2.1.1 Protocol Amendments 2.2 Study Population 2.2.1 Overview 2.2.2 Inclusion Criteria 2.2.3 Exclusion Criteria 2.2.4 Criteria for Withdrawal from Treatment or Study and Replacement Policy 2.2.5 Concomitant Medication, Treatments and Procedures

Слайд 16


ICH E3 Structure and Content of Clinical Study Reports 1. Title page 2. Synopsis 3. Table of contents 4. List of abbreviations 5. Ethics 6....
Описание слайда:
ICH E3 Structure and Content of Clinical Study Reports 1. Title page 2. Synopsis 3. Table of contents 4. List of abbreviations 5. Ethics 6. Investigators and study administrative structure 7. Introduction 8. Study objectives 9. Investigational plan

Слайд 17


ICH E3 Structure and Content of Clinical Study Reports (cont.) 9. Investigational plan 9.1 Overall study design and plan description 9.2 Discussion...
Описание слайда:
ICH E3 Structure and Content of Clinical Study Reports (cont.) 9. Investigational plan 9.1 Overall study design and plan description 9.2 Discussion of study design, including the choice of control groups 9.3 Selection of study population 9.3.1 Inclusion Criteria 9.3.2 Exclusion Criteria 9.3.3 Removal of Patients from Therapy or Assessment 9.4 Treatments 9.4.1 Treatments Administered 9.4.2 Identity of Investigational Product(s) 9.4.3 Method of Assigning Patients to Treatment Groups 9.4.4 Selection of Doses in the Study

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ICH E3 Structure and Content of Clinical Study Reports (cont.) 10 Study patients 10.1 Disposition of patients 10.2 Protocol deviations 11. Efficacy...
Описание слайда:
ICH E3 Structure and Content of Clinical Study Reports (cont.) 10 Study patients 10.1 Disposition of patients 10.2 Protocol deviations 11. Efficacy evaluation 11.1 Data sets analyzed 11.2 Demographic and other baseline characteristics 11.3 Measurements of treatment compliance 11.4 Efficacy results and tabulations of individual patient data

Слайд 19


References ICH Guidelines E9 Statistical Principles for Clinical Trials E3 Structure and Content of Clinical Study Reports
Описание слайда:
References ICH Guidelines E9 Statistical Principles for Clinical Trials E3 Structure and Content of Clinical Study Reports

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