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What should you consider animal identification in an animal study?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

You should include a table of information pertaining to animal identification, allocation to study sub-groups, type of procedure performed, and the fate or disposition of each animal. For example, if animals are purchased with a USDA identification number but then subsequently identified with an institutional identification number and then further described by a group number, this information should be clearly understood and equally well presented to FDA so that a chain of custody of any individual test or control animal is possible.

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