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(b) (4) (b) (4) September 24, 2019Via Email (Fred.Hines@fda.hhs.gov and Steven.Casper@fda.hhs.gov) Fred Hines, D.V.M. (Consumer Safety Officer) Steven Casper, Ph.D. (Evaluation and Research Staff)
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Detailed study summaries are comprehensive documents that encapsulate the findings and methodologies of studies conducted, often used for regulatory compliance or research documentation.
Organizations or individuals conducting research or studies that fall under specific regulatory requirements are typically required to file detailed study summaries.
To fill out detailed study summaries, one must provide structured information including the study objectives, methodologies, results, and conclusions, following any provided guidelines or templates.
The purpose of detailed study summaries is to clearly communicate the results and methodologies of research, ensuring transparency and accountability, and aiding in compliance with regulatory standards.
Information that must be reported includes the title of the study, objectives, methods used, findings, conclusions, and any relevant data supporting the results.
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