Clinical Study Report

A clinical study report (CSR) is a scientific document prepared by the pharmaceutical industry to get marketing permission for the trial drug, which is frequently designed in accordance with ICH E3 principles. This guarantees that the report is complete, precise, brief, and plain.

The clinical Case study report is a comprehensive report on a single study of any therapeutic, prophylactic, or diagnostic medication or treatment regimen done on patients. There are also clinical and statistical narratives, presentations, and analyses. Tables and graphical representations are also included. Appendices including protocol data, model case report forms, investigator information, detailed facts on the drug or experimental materials, linked publications, and patient data listings and demographics are also included. It also includes technical statistical data such as derivations—computations, analyses, computer output etc.

Abbreviated reports, including appropriate data regarding design, outcome, and exact details concerning safety aspects, may be admissible in some cases, according to regulatory authority rules. Full CSRs, Supplemental CSRs, Abbreviated CSRs, and Synoptic CSRs are the four forms of CSRs.

Because CSRs are rapidly becoming more available and accessible, it is being pushed to leverage this gold mine of data for systematic reviews.

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