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Guide to 21 CFR part 11 systems at UMN

July 29, 2021

Which electronic data system is right for your study? The decision of whether to use REDCap, OnCore, or Advarra EDC—the three systems available at the University of Minnesota—will depend on the unique needs of the research. 

21 CFR Part 11 overview

One important consideration is the Food and Drug Administration's (FDA's) regulations for electronic documentation and signatures, known as 21 CFR Part 11. This is the FDA’s way of allowing electronic records to be used for keeping data secure, tracing data changes, approving electronic signatures, identifying any possible falsified records, and more.

Compliance with 21 CFR part 11 makes these records and signatures as valid as their paper counterparts. It’s also considered best practice regardless of whether the study is FDA-regulated.

FDA guidance on 21 CFR part 11

Comparison: Electronic data systems

While only Advarra EDC is fully compliant with 21 CFR part 11, OnCore and REDCap may be a better fit for some situations, depending on the degree of FDA oversight in their trials.

  Advarra EDC

REDCap

OnCore
21 CFR Part 11 compliant Yes Partially (only e-consent) No
Data export types Excel, SAS SPSS, R, Stata, Excel Excel, SAS
Allows data import No Yes No
Who enters data Study team Study team, plus participants can fill out surveys Study team or the OnCore team can enter studies for you)
Allows surveys No Yes No
Who creates the protocol/project EDC admin team Study team or REDCap team Study team or OnCore team

FDA-regulated studies can use OnCore in conjunction with either Advarra EDC or REDCap. An OnCore protocol is typically set up for studies using Advarra EDC as well.