Electronic Data Capture Systems
FDA responses to questions about the use of electronic data capture systems in clinical investigations.
From Florence’s Complete Library of FDA eRegulatory and eSource Guidance
Which studies are required to use an electronic data capture system?
There are no requirements about which should use an EDC system. Sponsors can decide which use it and can spell that out in their protocol (from 2013). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
Does an electronic data capture system have to be part 11 compliant when doing human subject clinical research?
Yes, an electronic data capture system for FDA-regulated studies should be part 11 compliant (from 2014). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
From Florence’s Complete Library of FDA eRegulatory and eSource Guidance
The summaries presented in our library are for informational purposes only, they are not for implementation in operations. Please consult official FDA guidance documents for operational use.
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