SOCRA FDA timelines TEST - with 100% Correct Answers
If immediate use of the test article (exception) is used to preserve the life of a subject and time is not sufficient to obtain IC, within X an independent physician should review the use of the article - ANSWER 5 days If an article is used in an exempt way, this should be reported to the IRB in X after the use of the article - ANSWER 5 days Emergency use of a test article must be reported to the IRB in X time. Any subsequent use is subject to IRB review - ANSWER 5 days
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- 24 mei 2024
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- 2023/2024
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