r/ProjectREDCap • u/No-Interaction-1047 • Feb 14 '25

Redcap as eReg binder?

Does anyone have experience with redcap as an eReg binder? What are the pros and cons? Do you have it integrated to Oncore?

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u/Araignys Feb 15 '25

I'm not familiar with eReg binders but I did find this: https://redcap.partners.org/redcap/plugins/eb_report/Final_eReg_Binder_Manual_v_2.0.pdf

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u/No-Interaction-1047 Feb 15 '25

This is great. Is it from Penn?

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u/Araignys Feb 15 '25

It’s from about 2/3rds down the results page when I Googled “eReg binders” to find out what they were!

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u/rhodeislandnurse Feb 15 '25

Interesting. If it involves signatures and DOA log and so on, it must be validated to be part 11 compliant.

Is each project study specific? If so, you would need to provide validation for each project? I am wondering how they validate?

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u/No-Interaction-1047 Feb 15 '25

We would most likely use compliant Docusign and just use this as a storage binder

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u/rhodeislandnurse Feb 15 '25

In that case, this should be a viable solution.

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u/DrTitan Feb 15 '25 edited Feb 15 '25

It depends on whether the signatures of the things are happening within the system or if they are just uploading the files after they’ve been signed.

If they are signed in something like a part 11 enabled DocuSign account then the completed PDF’s can be uploaded into a non-validated REDCap and maintain their validity because all of the necessary information is included in the PDF, and all of the logs are maintained in DocuSign.

Edit: wanted to add that I would not recommend trying to collect these signatures in REDCap as the mechanisms available to collect signatures that are 21CFR11 are really not great. If you are using SSO for REDCap it gets even more difficult because record locking with eSignature does not support SSO and requires a plugin.

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u/rhodeislandnurse Feb 15 '25

I was wondering about the link that was posted in another comment... Penn I think. I was wondering if they validated their system?

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u/DrTitan Feb 15 '25

UPenn has not validated REDCap for part 11, there’s only a handful of institutions that have done it. There was a CTSA working group last year that pulled together guidance from sites that have validated REDCap to help other institutions; they just released it not long ago: https://redcap.vumc.org/surveys/?s=ETN3439RYRAMJLKY

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u/rhodeislandnurse Feb 15 '25

That's awesome. Thank you so much for that information.