Clinical Research Regulations
flashcards
Decks in class (18)
# Cards
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The Nuremberg Code (Oct 1946 - April 1949) - C14
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The Belmont Report 1979- C37
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The Declaration of Helsinki 1964 - C17
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45 CFR 46 (Protection of Human Subjects - Common Rule) - C51
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21 CFR 11 (Electronic records)9
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21 CFR 50 (Protection of Human Subjects, ICF)1
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21 CFR 54 (Financial Disclosure)5
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21 CFR 56 (IRB) - C29
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21 CFR 312 (IND)1
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21 CFR 812 (IDE)1
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ICH GCP Rev21
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ICH GCP Rev3 (on exam from 1/1/2026)1
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ICH E2A (Clinical Data Safety Management, AEs)7
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FDA forms7
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Audits and inspections of clinical trials6
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Definitions13
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Timelines29
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FDA vs ICH0
