CSR, or Clinical Study Report, is a comprehensive document prepared by the sponsor upon the completion of a clinical trial. It provides detailed and extensive information about the plan, methods, conduct, and results of the study, ensuring transparency and clarity in how the research was carried out.
The Clinical Study Report is a critical component of the regulatory submission for obtaining marketing authorization for new medicines. It serves as a key source of information for regulatory authorities to assess the benefit-risk profile of the investigational product and make informed decisions regarding its approval.
CSR ensures that the clinical trial’s results and findings are accurately and transparently communicated, helping to advance scientific knowledge, support evidence-based medicine, and protect the safety and well-being of patients.
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