🗊Презентация CSR

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Вы можете ознакомиться и скачать презентацию на тему CSR. Доклад-сообщение содержит 19 слайдов. Презентации для любого класса можно скачать бесплатно. Если материал и наш сайт презентаций Mypresentation Вам понравились – поделитесь им с друзьями с помощью социальных кнопок и добавьте в закладки в своем браузере.

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.

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CSR, слайд №2
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ICH E9 Statistical Principles
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ICH E9 Statistical Principles

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

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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 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
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

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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
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 Analysis Populations 3.1.4 Protocol Violations 3.15 Demographic Data and Baseline Characteristics 3.1.6 Previous Concomitant Medications and Diseases
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

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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
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

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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
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

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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
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

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

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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
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

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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
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 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
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 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
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

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

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