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A human trial, of any kind (IRB Approval: UCSF faculty, staff or students…
A human trial, of any kind
IRB Approval: UCSF faculty, staff or students conducting human subjects research require IRB approval before initiating the study. The site of the study and the source of funding do no matter. UCSF Does My Research Require IRB REview?
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Have you reviewed IRB guidance about your type of research? There are special considerations for different types of research projects --> Devices New Study
Investigational Devices
A medical device is considered investigational if: The device is not approved for marketing in the US
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There are two types of clinical studies involving medical devices that require an Investigational Device Exemption (IDE) be obtained by from the FDA in addition to IRB approval before a research study may commence. (1) A clinical study involving an unapproved device that poses significant risk to subjects
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Investigational Device Exemption (IDE): Investigator-initiated IDE, for clinical investigation
Prepare the Initial IDE Submission:(1) Report of Prior Investigations, published or unpublished reports of all prior clinical, animal and laboratory testing of the device (2) Investigational Plan, a complete written study protocol(3) Manufacturing Information: A description of the methods, facilities, and controls used for the manufacture, processing, storage and installation of the device. (4) The IDE Sponsor-Investigator writes the IDE Application including the Investigators Certification of Financial Interest) and the IDE Cover Letter
Develop the IDE Study Protocol. The IDE Protocol is the basis for both the IRB Application and initial IDE submission.(1) Review the protocol template.(2) Start with a protocol synopsis (pg 7 & 8 of template). The protocol synopsis will be valuable if you are planning a pre-IDE meeting.(3) Compile a reference list. Include all published articles and unpublished reports or manuscripts cited. Collect a copy of each article or report listed.
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