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Презентация на тему CSR

Study Start UpConductClose outData Key InAnyQuery?QA staffQuality ControlDatabase QualityControl ReportYesNoDM send Query ReportSite RespondQueriesUpdate DatabaseDM Flow
Before Presentation…This slide deck is based on Jain Chung’s presentation for the Study Start UpConductClose outData Key InAnyQuery?QA staffQuality ControlDatabase QualityControl ReportYesNoDM send Query ReportSite RespondQueriesUpdate DatabaseDM Flow ICH E9 Statistical Principles ICH E3 Clinical Study Reports Process for Development Clinical Study ReportFinalized ProtocolSAP(A)Finalize CSR Structure and identify tables Sample of CSR Report Body In the format of the Journal-Style scientific Sample of CSR Report Body  In the format of ICH E3 CSR Section 3 - Results3.1 Study Population    3.1.1 Disposition CSR Section 3 - Results3.2 Efficacy Results   3.2.1 Primary Efficacy CSR Section 3- Results3.4 Safety Analysis    3.4.1  Extent CSR Section 3 - Results      3.4.4 Other CSR Sections: 4, 5, and 6 4. Discussion 5. Conclusion 6. References  Appendices Review CSR, final TLFs ValidationConsistencyInterpretationsDiscussions CSR Section 1: Background, Rationale and Objectives     1.1 CSR Section 2 - Materials and Methods2.1  Overall Study Design ICH E3 Structure and Content of  Clinical Study Reports1. Title page2. ICH E3 Structure and Content of  Clinical Study Reports (cont.)9. Investigational ICH E3 Structure and Content of  Clinical Study Reports (cont.)10 Study ReferencesICH Guidelines www.ich.org E9 Statistical Principles for Clinical TrialsE3 Structure and Content
Слайды презентации

Слайд 2 Study Start Up
Conduct
Close out







Data
Key In
Any
Query?
QA staff
Quality Control
Database

Study Start UpConductClose outData Key InAnyQuery?QA staffQuality ControlDatabase QualityControl ReportYesNoDM send Query ReportSite RespondQueriesUpdate DatabaseDM Flow

Quality
Control Report
Yes
No
DM send
Query Report
Site Respond
Queries
Update
Database


DM Flow


Слайд 3 ICH E9 Statistical Principles

ICH E9 Statistical Principles

Слайд 4 ICH E3 Clinical Study Reports

ICH E3 Clinical Study Reports

Слайд 5 Process for Development Clinical Study Report
Finalized Protocol
SAP(A)
Finalize CSR

Process for Development Clinical Study ReportFinalized ProtocolSAP(A)Finalize CSR Structure and identify

Structure and identify tables required
Review SAP
Starting CSR Section 1

& 2

Database Lock

Stat Outputs Available

Starting Section 3,4,5

SAP TLFs

Program Development

Program Validation

SAP

Outputs Review

CSR DRAFT

SAP(B)

Prelock Run(s)

CS:

ST

PGM

DM

ST & PGM


Слайд 6 Sample of CSR Report Body In the format of

Sample of CSR Report Body In the format of the Journal-Style

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

Sample of CSR Report Body In the format of ICH E3

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

10. Study patients
11. Efficacy evaluation
12. Safety evaluation
13. Discussion and overall conclusions
14. Tables, figures and graphs referred to but not included in the text
15. Reference list
16. Appendices


Слайд 8 CSR Section 3 - Results
3.1 Study Population

CSR Section 3 - Results3.1 Study Population  3.1.1 Disposition of

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

CSR Section 3 - Results3.2 Efficacy Results  3.2.1 Primary Efficacy

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

CSR Section 3- Results3.4 Safety Analysis  3.4.1 Extent of Exposure

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

CSR Section 3 - Results   3.4.4  Laboratory Parameters

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.

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

Discussion
5. Conclusion
6. References
Appendices


Слайд 13 Review CSR, final TLFs
Validation
Consistency
Interpretations
Discussions

Review CSR, final TLFs ValidationConsistencyInterpretationsDiscussions

Слайд 14 CSR Section 1: Background, Rationale and Objectives

CSR Section 1: Background, Rationale and Objectives   1.1 Background

1.1 Background
1.2 Rationale

1.3 Objective


Слайд 15 CSR Section 2 - Materials and Methods
2.1

CSR Section 2 - Materials and Methods2.1 Overall Study Design

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

2.3 Compliance with Good Clinical Practice
2.3.1 Ethics
2.3.2 Audits
2.3.3 Data Quality Assurance
2.4 Trial Medication
2.4.1 Rationale for Dosage Selection
2.4.2 Formulation and Packaging
2.4.3 Assignment to Treatment Group/Sequence
2.4.4 Blinding
2.4.5 Drug Administration
2.4.6 Dose Modification
2.4.7 Dose Accountability and Compliance


Слайд 16 ICH E3 Structure and Content of Clinical Study

ICH E3 Structure and Content of Clinical Study Reports1. Title page2.

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

10. Study patients
11. Efficacy evaluation
12. Safety evaluation
13. Discussion and overall conclusions
14. Tables, figures and graphs referred to but not included in the text
15. Reference list
16. Appendices



* Details for Sections 9 – 12 on next slides


Слайд 17 ICH E3 Structure and Content of Clinical Study

ICH E3 Structure and Content of Clinical Study Reports (cont.)9. Investigational

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


9.4 Treatments (cont.)
9.4.5 Selection and Timing of Dose for each Patient
9.4.6 Blinding
9.4.7 Prior and Concomitant Therapy
9.4.8 Treatment Compliance
9.5 Efficacy and safety variables
9.5.1 Efficacy and Safety Measurements Assessed and Flow Chart
9.5.2 Appropriateness of Measurements
9.5.3 Primary Efficacy Variable(s)
9.5.4 Drug Concentration Measurements
9.6 Data quality assurance
9.7 Statistical methods planned in the protocol & determination of sample size
9.8 Changes in the conduct of the study or planned analyses


Слайд 18 ICH E3 Structure and Content of Clinical Study

ICH E3 Structure and Content of Clinical Study Reports (cont.)10 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


12. Safety evaluation
12.1 Extent of exposure
12.2 Adverse events (AEs)
12.3 Deaths, other SAEs, and other significant adverse events
12.4 Clinical laboratory evaluation
12.5 Vital signs, physical findings and other observations related to safety
12.6 Safety conclusions


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