Per FDA’s “Guidance for Industry, Electronic Source Data in Clinical Investigations September 2013,” yes, you should keep paper documents:
- Page 7 states, ”When data elements are transcribed from paper sources into an eCRF, the clinical investigator(s) must also retain the paper sources, or certified copies, for FDA review.”
- Page 4 states, “If a paper transcription step is used, then the paper documentation should be retained and made available for FDA inspection.”