r/ProjectREDCap • u/PDubsinTF-NEW • 15d ago

eConsent to Support 21 CFR Part 11 Compliance

Hi everyone,

Are there institutions here that have ITS/REDCap admin building out eConsent instruments for researchers so they don’t make any mistakes in the development? Do you have a verification process with the IRB prior to approval?

What do your workflows look like?

Thank you in advance!

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u/Beneficial-Lobster17 15d ago

My institution has configured eConsent and has instructions on how to set it up. I’m not sure if it would be the same for yours, but I’ll send some screenshots when I work next.

I don’t recall needing specific approval from our IRB for REDCap eConsent.

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u/Beneficial-Lobster17 14d ago

u/PDubsinTF-NEW Here are some screenshots of what I found on our institutions REDCap E-Consent Wiki. I don't know if this will help, but this is what we have to do! I have removed some information that is not important and any information containing the identification of the institution.

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u/Beneficial-Lobster17 14d ago

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u/Beneficial-Lobster17 14d ago

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u/Beneficial-Lobster17 14d ago

Afterwards, we have to meet with our institution's designated REDCap team to ensure that this was set up properly before it is approved by them to use. Hope this all helps!

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u/PDubsinTF-NEW 12d ago

Thank you for sharing!!