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What are the 3 Rs of IACUC?

What are the 3Rs? ReductionMinimize the number of animals used, without jeopardizing statistical validity. RefinementEmploy techniques that reduce pain and distress. ReplacementSubstitute animals with non-animal methods (i.e., computer simulation) or lower animal species.

What are the FDA annual reporting requirements?

Specifically, this annual summary must include the name of the investigational drug, the number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events. FDA is required to specify the deadline for such reporting submissions.

What are the FDA guidelines for reporting adverse events?

Submit an initial report with a new control number (Item 24b) on a Form FDA-1639 for a new, subsequent experience. Form FDA 1639 (and narrative increased frequency report if indicated) and submitting it to FDA. If it is a serious, unlabeled event, the Form FDA 1639 should be submitted within 15 days.

When must adverse events be reported?

An investigator (if he/she is not a sponsor-investigator) must report to the sponsor any serious adverse event within 24 hours of investigator learning about the event, whether or not considered drug related, including those listed in the protocol or investigator brochure and must include an assessment of whether there

What are the 4 criteria for adverse event reporting?

There are only four requirements for a valid adverse drug reaction report: patient identifier, medicine, reaction, reporter details.

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