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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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What is research and clinical trial?
Research and clinical trial are scientific studies conducted to investigate the efficacy and safety of new treatments, medications, or medical procedures.
Who is required to file research and clinical trial?
Researchers, pharmaceutical companies, and medical institutions are required to file research and clinical trials with regulatory authorities.
How to fill out research and clinical trial?
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.
What is the purpose of research and clinical trial?
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.
What information must be reported on research and clinical trial?
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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