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Adverse Reaction (AR)

Written by Chad Henderson on .

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Any health problem that happens during the study that is caused by the study intervention.

Adverse Reaction (FDA, IND): An Adverse Event (AE) caused by a drug. Adverse reactions are a subset of all suspected adverse reactions where there is reason to conclude that the drug caused the event. FDA: 21 CFR 312.32, IND Safety Reporting; FDA: Safety Reporting Requirements for INDs and BA/BE Studies
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