Clinical Study Record Retention Requirements Is there FDA guidance concerning retention of Electronic Case Report Forms (eCRFs) ?Yes, in November 2012, FDA released a new draft guidance entitled “Electronic Source Data in Clinical Investigations”. Based on this document, the clinical investigator should retain control of the records (i.e., completed and signed eCRF or certified copy of the eCRF). If requested, the clinical investigator should provide FDA with access to the records that serve as the electronic source data. When data elements are transcribed from paper sources into an eCRF, the clinical investigator(s) must also retain the paper sources, or certified copies.16 | |
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