Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

What is the main purpose of a Clinical Study Report (CSR)?

1. To create a marketing strategy for the drug

2. To summarize study methods, results, and conclusions

3. To recruit new subjects for trials

4. To revise study hypotheses during the trial

The correct answer is: To summarize study methods, results, and conclusions

The main purpose of a Clinical Study Report (CSR) is to provide a comprehensive summary of the study methodologies, results, and conclusions. This document serves as a vital record of the trial, encapsulating the objectives, design, conduct, and results in a structured manner. It is essential for regulatory submissions, as it allows regulatory authorities to understand the implications of the study findings, evaluate the effectiveness and safety of the investigated drug or intervention, and aid in decision-making processes regarding market approval. By standardizing the reporting of clinical trial data, the CSR also supports transparency in clinical research, helps maintain the integrity of the scientific process, and facilitates peer review and publication in scientific journals. The structure and thoroughness of the CSR are vital for presenting complex clinical results in an accessible manner, thus acting as a critical tool in the continuum of clinical research from trial execution to public knowledge.