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Research & Investigational Drugs P 1 of 6 VAM HCS HUMAN RESEARCH PROTECTION STANDARD OPERATING PROCEDURE SOP# HIP 05.01 Origin Version3.0 New Version # 3.1 Version Author Changes 3.1 Jessica Mendoza
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What is research and investigational drugs?
Research and investigational drugs refer to products that are being studied in clinical trials for potential medical uses.
Who is required to file research and investigational drugs?
The sponsors of clinical trials are required to file research and investigational drugs with regulatory agencies.
How to fill out research and investigational drugs?
Research and investigational drugs are typically filled out using a specific form provided by the regulatory agency overseeing the clinical trial.
What is the purpose of research and investigational drugs?
The purpose of research and investigational drugs is to gather data on the safety and effectiveness of the drug being studied.
What information must be reported on research and investigational drugs?
Information such as the study protocol, adverse events, patient demographics, and study results must be reported on research and investigational drugs.
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