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CONSENT FOR EMERGENCY USE OF AN INVESTIGATIONAL PRODUCT Information about this template: This template is provided as a sample to assist care providers in the development of a compliant consent form
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How to fill out emergency use consent template

01
To fill out an emergency use consent template, follow these steps:
02
Start by entering the date of the consent at the top of the template.
03
Provide the name and contact details of the individual giving consent.
04
Include a brief statement explaining the purpose of the document and the nature of emergency use.
05
Clearly state that the individual understands the risks and benefits of the emergency use and voluntarily gives their consent.
06
Have the individual sign and date the document.
07
If applicable, include an additional section for witness signatures and contact information.
08
Keep a copy of the filled-out consent template for record-keeping purposes.

Who needs emergency use consent template?

01
The emergency use consent template is needed by healthcare providers, researchers, or institutions that administer or conduct emergency use treatments, interventions, or experimental procedures on individuals.
02
It is also required for individuals who are planning to participate in or receive emergency use treatments or interventions, ensuring that they are fully informed and provide their consent willingly.
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The emergency use consent template is a standardized document that is used to obtain informed consent from individuals participating in clinical trials or receiving unapproved medical treatments during emergency situations.
Researchers, clinical trial sponsors, or healthcare institutions conducting an emergency use of investigational drugs or devices are required to file the emergency use consent template.
To fill out the emergency use consent template, the individual or organization must provide detailed information about the study, potential risks, benefits, and alternatives to the treatment, ensuring clarity and comprehensiveness in language.
The purpose of the emergency use consent template is to ensure that individuals are adequately informed about the treatment options and the nature of the emergency use, ultimately protecting patient rights and promoting ethical standards in medical care.
The information that must be reported includes the nature of the treatment, potential risks, benefits, alternatives, and any relevant information about the investigational product or procedure.
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