Procedure
- Submits a copy of the sponsor’s protocol and sponsor-provided device description for all protocols using investigational or commercially available devices or test articles being used in an investigational manner.
- Designates personnel who may use the device and ensure they have the appropriate training or qualifications to use the device safely on the IRB Personnel eForm.
- Designates where the study device or test article will be shipped to and stored.
- Describes the procedures for release of devices (e.g., written physician order) and maintenance of inventory.
- Provides information on whether the device will be at no cost or billed to the participant or the participant’s insurance.
- Completes and submits information about the device on FOR200 IRB application eForm.
- Maintains records for a period of no less than 2 years after FDA approval or longer, if required by the sponsor, in accordance with FDA regulations.
Reviewing Staff:
- Reviews the IRB application eForm and verifies it provides a complete description of the procedures related to the use and inventory of the investigational device or test article.
- Requests additional information, if necessary.
- Issues approval when all required information has been received by the OIRB.
- Reviews the IRB application eForm to ensure that the investigator or designated personnel are qualified to use investigational devices or test articles. Determines that storage, control, and dispensing of the investigational device is appropriate so that it only will be used by authorized investigators and on participants.
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