Clinical Study Record Retention Requirements Do the Department of Health and Human Services (DHHS) regulations require that investigators retain original hardcopy records?Yes, if investigators have been designated to retain certain records on behalf of the institution per DHHS regulations, they must retain the original consent documents, with the other study records in some form. Such records may be preserved in hardcopy, electronic or other media form and must be accessible for inspection and copying by authorized representatives of HHS at reasonable times and in a reasonable manner. Retention of multiple copies of each record is not required.14 | |
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