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St. Lukes University Health Network SOP 405: Investigational Device ManagementVersion # 3.0 Page 1 of 8PURPOSE: To outline the management of investigational devices used in clinical trials in line
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Research and clinical trial are scientific studies conducted to investigate the efficacy and safety of new treatments, medications, or medical procedures.
Researchers, pharmaceutical companies, and medical institutions are required to file research and clinical trials with regulatory authorities.
Researchers must carefully document the study protocols, patient data, and outcomes of the research or clinical trial in a standardized format and submit it to the appropriate regulatory bodies.
The purpose of research and clinical trials is to gather scientific evidence on the safety and effectiveness of new treatments, medications, or procedures before they are approved for use in the general population.
Information that must be reported on research and clinical trials includes study protocols, patient demographics, treatment regimens, adverse events, and study outcomes.
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