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What types of records should be kept for these types of studies?

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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.

FDA recommends that sponsors maintain written documentation regarding the policies and procedures followed by the specimen provider to ensure that the subject cannot be identified. FDA may request to inspect this documentation. FDA recommends that IRBs review this documentation before approving an investigation paying particular attention to privacy and confidentiality, and the potential for use of information from the investigation for clinical patient management.

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