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Institutional Review BoardEmergency Use of Investigational Drug, Device, or BiologicWhen to use this Form should be used to notify the Institutional Review Board of the emergency use of an investigational
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How to fill out emergency use of investigational

01
Step 1: Read the emergency use guidance provided by the regulatory authority.
02
Step 2: Gather all necessary information and documentation about the investigational product.
03
Step 3: Complete the emergency use application form with accurate and detailed information.
04
Step 4: Submit the application form along with supporting documents to the regulatory authority.
05
Step 5: Await review and approval from the regulatory authority.
06
Step 6: If approved, follow the specified guidelines and protocols for the emergency use of the investigational product.
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Step 7: Monitor and report any adverse events or outcomes related to the emergency use.
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Step 8: Comply with any additional requirements or instructions given by the regulatory authority during the emergency use period.

Who needs emergency use of investigational?

01
Individuals who are facing a life-threatening condition and have exhausted all available treatment options.
02
Patients who are not eligible to participate in clinical trials but could potentially benefit from the investigational product.
03
Healthcare professionals who are authorized and qualified to administer investigational products during emergency situations.
04
Countries or regions facing public health emergencies where the use of investigational products can help mitigate the situation.

What is Emergency Use of Investigational Drug, Device, or Biologic Form?

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Emergency use of investigational refers to the use of a drug, biologic, or medical device that is still undergoing clinical trials, outside of the scope of the approved labeling.
The sponsor of the investigational product is required to file for emergency use of investigational.
To fill out emergency use of investigational, the sponsor must submit an application to the FDA requesting permission to use the investigational product in an emergency situation.
The purpose of emergency use of investigational is to provide access to potentially life-saving treatments for patients who have no other options available.
The emergency use of investigational report must include information on the patient, the product used, the reason for emergency use, and any adverse events that occur.
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