Does the US Department of Health and Human Services (DHHS) have regulations regarding clinical study record retention that apply to studies that are not FDA-regulated?Yes, DHHS’ regulations on the protection of human research subjects apply even if the study is not FDA-regulated. DHHS’ study record retention regulations require institutions to retain records of IRB activities and certain other records frequently held by investigators for at least three years after completion of the research. Retained records must include the signed informed consent form or the short form with written research summary unless the IRB waived the requirement for informed consent or the requirement for documentation of informed consent. The “study completion date” as defined in the ClinicalTrials.gov glossary, is the date that the final data for a clinical study were collected because the last study participant has made the final visit to the study location (that is, 'last subject, last visit'). | |
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