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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

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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