What is a "clinical study report" (CSR)?

A clinical study report (CSR) is a comprehensive document that provides detailed information about a clinical trial's methodology and findings. It presents an organized and systematic account of various aspects of the study, including the rationale for the trial, the study design, participant characteristics, methodologies used, results, and interpretations. The CSR is crucial for regulatory submissions, as it documents the efficacy and safety of the treatment under investigation and serves as a basis for decision-making by regulatory authorities.

Option B highlights the core purpose of a CSR, which is to communicate the clinical trial's scientific outcomes in a thorough manner. This documentation is essential not only for meeting regulatory requirements but also for contributing to the body of scientific knowledge in clinical research.

In contrast, the other options significantly deviate from the primary role of a CSR. A summary of participant feedback is more likely to form part of qualitative assessments but does not capture the comprehensive data and results required in a CSR. A cost analysis would focus on the financial aspects of the trial rather than the clinical data itself, and a promotional brochure would be directed towards marketing the trial rather than providing a thorough report on its findings. Thus, option B accurately represents the function and content of a clinical study report.