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Use of an Investigational Device in Human Subjects
Research
Content Applies To
Mayo Clinic Human Research Protection Program
Research for which the Mayo Clinic IRB is the IRB of RecordPurpose
The
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What is use of an investigational?
Use of an investigational refers to the use of a drug, device, or biological product that is being studied in a clinical trial or research study.
Who is required to file use of an investigational?
Investigators or sponsors who are conducting a clinical trial or research study are required to file use of an investigational.
How to fill out use of an investigational?
Use of an investigational can be filled out by submitting the necessary forms and documentation to the relevant regulatory authorities.
What is the purpose of use of an investigational?
The purpose of use of an investigational is to ensure that the use of investigational products is conducted in a safe and ethical manner.
What information must be reported on use of an investigational?
Information such as the identity of the investigational product, the study protocol, and the informed consent process must be reported on use of an investigational.
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