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Question 1 of 3
1. Question
Prior notification regarding the emergency use should be made to the IRB if possible, and subsequent notification to the IRB must be made within 7 days of use.
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Question 2 of 3
2. Question
Test Article Consent Process: If it is the Investigator’s opinion that immediate use of the test article is necessary to save the patient’s life and time does not permit seeking the opinion of a physician not otherwise involved, the Investigator should make the appropriate determinations and proceed with the use.
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Question 3 of 3
3. Question
Within 30 days of the first emergency use of a test article, the Investigator does not have to submit a new protocol to the IRB for review and approval.
