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Investigational Drugs/Biological Products Protocol: Principal Investigator: Person filling out Form: Date: Ext: Complete this form for each drug or biological agent that is part of the study: 1. Drug/agent
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What is Investigational Drugs/Biological Products Form?

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Investigational drugs/biological products are substances that are being researched for potential therapeutic purposes but have not yet been approved by regulatory authorities for use in the general population.
Research institutions, pharmaceutical companies, and other entities conducting clinical trials are required to file investigational drugs/biological products with regulatory authorities.
To fill out investigational drugs/biological products, the sponsor of the clinical trial must provide detailed information about the product, study protocol, safety data, and more to regulatory authorities.
The purpose of investigational drugs/biological products is to gather data on safety and efficacy to support regulatory approval for widespread use in the population.
Information such as study protocol, adverse events, safety data, product manufacturing details, and more must be reported on investigational drugs/biological products.
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