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Example Table of Contents for a Clinical Study Report
1. TITLE PAGE
2. SYNOPSIS
3. TABLE OF CONTENTS FOR THE INDIVIDUAL CLINICAL STUDY REPORT
4. LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS
5. ETHICS
5.1 Independent Ethics Committee (IEC) or Institutional Review Board (IRB)
5.2 Ethical Conduct of the Study
5.3 Patient Information and Consent
6. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE
7. INTRODUCTION
8. STUDY OBJECTIVES
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 Products(s)
9.4.3 Method of Assigning Patients to Treatment Groups
9.4.4 Selection of Doses in the Study
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 and Determination of Sample Size
9.7.1 Statistical and Analytical Plans
9.7.2 Determination of Sample Size
9.8 Changes in the Conduct of the Study or Planned Analyses
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
11.4.1 Analysis of Efficacy
11.4.2 Statistical/Analytical Issues
11.4.2.1 Adjustments for Covariates
11.4.2.2 Handling of Dropouts or Missing Data
11.4.2.3 Interim Analyses and Data Monitoring
11.4.2.4 Multicenter Studies
11.4.2.5 Multiple Comparisons/Multiplicity
11.4.2.6 Use of an “Efficacy Subset” of Patients
11.4.2.7 Active-Control Studies Intended to Show Equivalence
11.4.2.8 Examination of Subgroups
11.4.3 Tabulation of Individual Response Data
11.4.4 Drug Dose, Drug Concentration, and Relationships to Response
11.4.5 Drug-Drug and Drug-Disease Interactions
11.4.6 By-Patient Displays
11.4.7 Efficacy Conclusions
12. SAFETY EVALUATION
12.1 Extent of Exposure
12.2 Adverse Events
12.2.1 Brief Summary of Adverse Events
12.2.2 Display of Adverse Events
12.2.3 Analysis of Adverse Events
12.2.4 Listing of Adverse Events by Patient
12.3. Deaths, Other Serious Adverse Events, and Other Significant Adverse Events
12.3.1 Listing of Deaths, Other Serious Adverse Events, and Other Significant Adverse Events
12.3.1.1 Deaths
12.3.1.2 Other Serious Adverse Events
12.3.1.3 Other Significant Adverse Events
12.3.2 Narratives of Deaths, Other Serious Adverse Events, and Certain Other Significant Adverse Events
12.3.3 Analysis and Discussion of Deaths, Other Serious Adverse Events, and Other Significant Adverse Events
12.4 Clinical Laboratory Evaluation
12.4.1 Listing of Individual Laboratory Measurements by Patient (Appendix 16.2.8) and Each Abnormal Laboratory Value (see section 14.3.4)
12.4.2 Evaluation of Each Laboratory Parameter
12.4.2.1 Laboratory Values Over Time
12.4.2.2 Individual Patient Changes
12.4.2.3. Individual Clinically Significant Abnormalities
12.5. Vital Signs, Physical Findings, and Other Observations Related to Safety
12.6 Safety Conclusions
13. DISCUSSION AND OVERALL CONCLUSIONS
14. TABLES, FIGURES, AND GRAPHS REFERRED TO BUT NOT INCLUDED IN THE TEXT
14.1 Demographic Data Summary figures and tables.
14.2 Efficacy Data Summary figures and tables.
14.3 Safety Data Summary figures and tables.
14.3.1 Displays of Adverse Events
14.3.2 Listings of Deaths, Other Serious and Significant Adverse Events
14.3.3 Narratives of Deaths, Other Serious and Certain Other Significant Adverse Events
14.3.4 Abnormal Laboratory Value Listing (each patient)
15. REFERENCE LIST
16. APPENDICES
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