Clinical Study Report: Types and Major Components

A Clinical Study Report (CSR) is a technical document written based on a clinical trial study. It describes in detail the methods, key findings, and results of clinical trials.  It helps facilitate the evaluation of the therapeutic effectiveness of a drug or medical treatment.

Types of Clinical Study Report includes:

1. Full CSR: It gives a detailed clinical and statistical description with efficacy and safety data.
2. Supplementary CSR: is for planned but not primary analyses, that is, unexplained exploratory or cross-study analyses. It includes Introduction to the study, objective, method, results, discussion, and conclusions.
3. Abbreviated CSR: this CSR includes methods and efficacy sections in abbreviation with comprehensive safety sections.
4. Synopsis CSR: This CSR provides complete safety information that helps reviewers evaluate study results effectively.

Significant components of CSR:

1. CSR Title Page: Includes study type, short study title, study number, RA identifier number, sponsor, responsible medical officer, study center, test product, indications, etc.
2. Synopsis: includes study sponsor, study period, background and rationale of study, objective and endpoints, methodology and statistical methods used, no. of subjects included, a summary of results, safety results, and an overall conclusion.
3. Table of contents
4. List abbreviations and definitions of terms.
5. Ethics: this emphasizes the ethical conduct of the study, subject information consent form, and compliance with the guidelines of the independent ethics committee (IEC).
6. Investigators and administrative structure of the study
7. Introduction including the background of a clinical study and rationale
8. Study Objectives and endpoints
9. Investigational Plans: Overall study design, discussion of study design, selection of study population, treatments, study assessments, and procedure, data quality assurance, statistical analysis, changes in the conduct of the study, or planned analyses.
10. Study Subjects: disposition of subjects, protocol deviation, demographic and other baseline characteristics, concomitant medication, therapies and procedures, and measurement of treatment compliance.
11. Efficacy and safety data: includes Pharmacokinetic and immunogenetic results, and handling of missing, used, and discrepant data.
12. Safety Evaluation: the extent of exposure, adverse events, clinical laboratory evaluations, other safety evaluations, and safety results summary.
13. Discussion and overall study conclusion: including discussion and overall conclusion.
14. Tables and figures include disposition and demographic data, pharmacokinetic data, and safety data.
15. Reference listing
16. Appendices: for study information, subject data listing, case report forms, and individual subject data listing.

If you want help with any kind of medical writing services requirements then send us the details of your medical writing project today and we’ll get back to you right away.

Authored by Prerna Kumari, Medical Writer.