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Electronic Consent: in the scope of REDCap, electronic consent refers to the electronic capture of a ‘wet' signature from a participant using the e-consent framework. This requirement covers the ‘Electronic Signature’ definition found in the FDA part 11 regulations.
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Electronic Signature (E-Signature): in the scope of REDCap, an E-signature refers to the individual verifying the data being captured electronically, digitally signing, and authenticating their identity. This requirement covers the ‘Digital Signature’ definition found in the FDA part 11 regulations.
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View the FDA Title 21 Chapter I Subchapter A Part 11 regulations here.
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