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IRB approval of research is subject to the requirements of 21 CFR 56.111, which states in part: (a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied: (1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes

Clinical Scenarios Where DOAC Measurement May Be Beneficial While there is no established therapeutic range for plasma DOAC concentration, ascertaining the presence and amount of circulating DOACs may be beneficial for urgent and non-urgent situations if it would change management7

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