Get the free REQUEST FOR IRB REVIEW OF HUMANITARIAN USE DEVICE (HUD) CONTINUING REVIEW FORM
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This document is used to request IRB review for the continuation of a Humanitarian Use Device (HUD) study, including details about the device, healthcare providers, and patient information.
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How to fill out request for irb review
How to fill out REQUEST FOR IRB REVIEW OF HUMANITARIAN USE DEVICE (HUD) CONTINUING REVIEW FORM
01
Obtain the REQUEST FOR IRB REVIEW OF HUMANITARIAN USE DEVICE (HUD) CONTINUING REVIEW FORM from your institution's IRB website or office.
02
Fill out the project title and investigator information accurately.
03
Provide a detailed description of the humanitarian use device, including the intended use and patient population.
04
Indicate the number of patients treated with the device since the last review.
05
Include any adverse events or problems that have occurred during the use of the device.
06
Attach any relevant supporting documents, such as data collection forms, consent forms, and research updates.
07
Review the completed form for accuracy and completeness.
08
Submit the form to the IRB office according to your institution's guidelines.
Who needs REQUEST FOR IRB REVIEW OF HUMANITARIAN USE DEVICE (HUD) CONTINUING REVIEW FORM?
01
Researchers conducting studies involving a humanitarian use device.
02
Medical professionals using or overseeing the use of the device in a clinical setting.
03
Institutions seeking to ensure compliance with ethical standards regarding human subject research.
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People Also Ask about
What is the humanitarian device exemption?
Humanitarian Device Exemption (HDE): a marketing application for an HUD (Section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). An HDE is exempt from the effectiveness requirements of Sections 514 and 515 of the FD&C Act and is subject to certain profit and use restrictions.
What does an investigation to collect data on a new indication of a significant risk HUD require?
Which of the following statements is true regarding IRB approval of clinical use of a HUD in a healthcare facility? Since a HUD is a marketed device, the regulations do not require IRB approval for clinical use. The clinician obtains initial IRB approval and ensures continuing review approval by the IRB.
Which of the following statements is true regarding IRB approval of clinical use of a HUD?
The provisions for obtaining an HDE are: The device is designed to treat or diagnose a disease or condition that affects fewer than 8,000 individuals per year in the U.S. The device is not available otherwise, and there is no comparable device available to treat or diagnose the disease or condition; and.
What does an investigation to collect data on a new indication of significant risk HUD require?
An HDE is a type of Pre-Market Approval (PMA) that allows the FDA to grant an exemption from the effectiveness requirements of the PMA regulations. Devices approved with an HDE are referred to as a Humanitarian Use Devices (HUD).
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What is REQUEST FOR IRB REVIEW OF HUMANITARIAN USE DEVICE (HUD) CONTINUING REVIEW FORM?
The REQUEST FOR IRB REVIEW OF HUMANITARIAN USE DEVICE (HUD) CONTINUING REVIEW FORM is a document that must be submitted to an Institutional Review Board (IRB) for the ongoing review and oversight of a humanitarian use device that is being used in clinical settings. It ensures compliance with ethical standards and regulatory requirements.
Who is required to file REQUEST FOR IRB REVIEW OF HUMANITARIAN USE DEVICE (HUD) CONTINUING REVIEW FORM?
The form must be filed by the sponsor or principal investigator of the study involving the humanitarian use device. It is required for any ongoing clinical investigation where a HUD is being utilized.
How to fill out REQUEST FOR IRB REVIEW OF HUMANITARIAN USE DEVICE (HUD) CONTINUING REVIEW FORM?
To fill out the form, the investigator must provide detailed information regarding the ongoing use of the HUD, including patient outcomes, any adverse events, data on device performance, and updates on ongoing research activities. Accurate and thorough documentation is crucial for IRB review.
What is the purpose of REQUEST FOR IRB REVIEW OF HUMANITARIAN USE DEVICE (HUD) CONTINUING REVIEW FORM?
The purpose of the form is to facilitate the continuing review process of the HUD to ensure that it is being used ethically and safely in clinical settings. It helps the IRB assess whether the benefits to patients outweigh any potential risks associated with the device.
What information must be reported on REQUEST FOR IRB REVIEW OF HUMANITARIAN USE DEVICE (HUD) CONTINUING REVIEW FORM?
The form must include information such as patient enrollment numbers, adverse events or complications, data on device effectiveness, any modifications made to the device or protocol, and submission of any relevant literature related to the HUD.
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