CLINICAL STUDY REPORT. CSR

Author: Akhila Kardas , Drakshayani Dulla and Satish Kumar Vemavarapu

clinOXY Student ID: B16O13, B16OF15

Introduction:

Clinical Study Report is a comprehensive document which includes the methodology, results and conclusions of a clinical trial. It is a descriptive document of a single clinical trial accompanied by tables, listings and figures displaying all study data and results. It is a critical component in the process of evaluating and submitting the application of new medical treatments, interventions or drugs to the Regulatory Authorities.

The?International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use?(ICH E3) is a body that brings together the Regulatory Authorities and Pharmaceutical Industries of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. In 1995 it produced a tripartite harmonised ICH guideline on the format and content of a study report to be acceptable in all three ICH regions.?Recommended prerequisites and content for producing a report conformant to ICH guidelines have been outlined by SE Caldwell.

Contents of a Clinical Study Report:

1. Title Page

The Title page includes the study title, protocol number, study phase, study initiation and completion date along with contact details for the sponsor and principal investigator.

2. Synopsis

Synopsis is a brief summary of the study objectives, methodology, results and conclusions. This section provides an overview and quick understanding of the study's key points.

3. Table of Contents

Table of contents section includes the page number, a list or other locating information of each section, including summary tables, figures and graphs.

4. List of Abbreviations and Definitions of Terms

A list of the abbreviations and lists and definitions of specialized or unusual terms or measurements units used in the report should be provided. Abbreviated terms should be spelled out and the abbreviation is indicated in parentheses at first appearance in the text.

5. Ethics

This section includes the confirmation that the study and any amendments were reviewed by an Independent Ethics Committee (IEC) or Institutional Review Board (IRB). It should be confirmed that the study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki. It also includes the information on how and when the Informed consent was obtained in relation to patient enrollment.

6. Investigators and Study Administrative Structure

The administrative structure including principal investigator, coordinating investigator, steering committee, administration, monitoring and evaluation committees, institutions, statistician, central laboratory facilities, contract research organization (C.R.O.), clinical trial supply management of the study should be described briefly in the body of the report.

7. Introduction

The Introduction section contains a brief summary of the study in the context of the development of the investigational product relating the critical features of the study (e.g. Aim, target population, duration, and treatment). The guidelines that were followed in the development of the protocol or any other agreements between the sponsor/company and regulatory authorities that are relevant to the study are described.

8. Study Objectives

Study objective is a statement describing the overall purpose of the study.

9. Investigational Plan

Investigational plan describes the overall study design and plan description including the choice of controlled groups, selection of study population, treatment, efficacy and safety variables, data quality assurance, statistical methods planned in the protocol and determination of sample size.

10. Study Patients

Study patients section provides a clear accounting of all patients who entered the study, the number of patients randomized, the patients who entered and completed each phase of the study, reasons for all post-randomization discontinuations. It also includes any deviations related to study inclusion or exclusion criteria, conduct of trial, patient’s management or assessment.

11. Efficacy Evaluation

Efficacy evaluation section includes the group data for the critical demographic and baseline characteristics of the patients, measurements of compliance of individual patients with the treatment regimen, efficacy results and tabulations of individual patient data.

12. Safety Evaluation

Safety evaluation section includes the analysis of safety-related data in three levels:-

• Extent of exposure – Duration, Dose and drug concentration.
• Adverse events – Brief summary of adverse events, listing of adverse events by patients.
• Deaths or other Serious Adverse Events.

13. Discussion and Overall Conclusions

Discussion and overall conclusions section includes the efficacy and safety results of the study and the relationship of risk and benefit. It also includes any new or unexpected findings. ?

14. Tables, Figures and Graphs referred to but included in the text

Tables, Figures and Graphs help us understand and summaries the important results, demographics, efficacy and safety data, Adverse event data and list of deaths or other Serious adverse events.

15. Reference List

Reference list includes the list of articles from literature to the evaluation of the study. The references should be mentioned in accordance with the internationally accepted standards of 1979 Vancouver declaration.

16. Appendices

Appendices section includes a list of all appendices available for the study report.

Conclusion:-

The Clinical Study Report (CSR) is the document that provides clear information of the critical design features, study plan, methods and conduct of the study, individual patient data and details of the analytical methods.

CSR’s are required by the regulatory authorities to provide approval for new drugs, devices or treatments.

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References:-

1. https://en.wikipedia.org/wiki/Clinical_study_report

2. https://pubmed.ncbi.nlm.nih.gov/30222433/

3. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-3-structure-and-content-clinical-study-reports-step-5_en.pdf.