Frequently Asked Questions

Will FDA need access to case records maintained by the investigator or additional background data such as hospital or other institutional records?

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Compliance & Regulatory: Biopharma
FDA Clearance
Guidelines & Standards

Yes, FDA may need to review source documents such as hospital records to verify data, whether during an on-site inspection or upon request. For example, a review division within FDA may request submission of investigator, hospital, or institutional records outside of an inspectional context. If so, these records must be made available to the Agency for FDA to rely on the data. In addition, FDA believes that informed consent documents should notify subjects that international regulatory authorities may need to have direct access to the subjects’ original medical records for verification of clinical study procedures and data. This position is consistent with ICH E6, section 4.8.10(n).

If the necessary records are not available, FDA may not accept the study data in support of an IND or application for marketing approval. If the records exist but a sponsor or applicant cannot disclose them to FDA because such disclosure is prohibited by applicable foreign law, the sponsor or applicant may seek a waiver of this requirement. For FDA to rely on such data that cannot be disclosed, the sponsor and FDA would need to agree on an alternative validation procedure.