The discussion about the use of electronic systems in research continues, with the FDA releasing a draft guidance titled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers.” While the guidance is a draft, it appears to touch on most of the topics we hear about when discussing the use of electronic systems in research. (It should touch on most of these topics — it’s 32 pages long. One nice little factoid — the draft says the FDA does NOT consider signatures created by using a stylus or fingertip on a tablet or signature pad to be an electronic signature.)
The FDA is accepting comments on the draft through May 15. Click on the link to read more.