Frequently Asked Questions

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

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Clinical Trials
Investigator: General
Guidelines & Standards

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.