FDA regulations allow for one emergency use of a test article in an institution without prospective IRB review, provided that such emergency use is reported to the IRB within five working days after such use. Information from these reports and monitoring activities will be used to identify protocol deviations and troubleshooting that may or may not require modification.
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Our target population includes patients and providers. Gupta specializes in cancer care with a specific expertise in treating lung, gynecological and gastrointestinal tumors.