This message was posted by a user wishing to remain anonymous
I have a question I don't know the answer to, we currently use a validated version of DocuSign that includes the 21 CFR enabled module to comply with expectations. However we've had a customer ask if we are using the biometric aspects of DocuSign, to my knowledge this wasn't required. The guidance we have been provided with is that f
or most CTIMPS, and other research involving more than minimal risk, burden or intrusion, simple eSignatures that involve the participant tracing their handwritten signature using a finger or a stylus or biometric eSignatures should normally be used as they allow for direct comparison with eSignatures and/or wet-ink signatures previously used by the participant for the purpose of audit or where the consent is contested.
Where the CTIMP involves risks no higher than that of standard medical care (categorised as "type A" under the MHRA's risk-adapted approaches to the Management of CTIMPs) then any simple electronic signature may be used (including typewritten or scanned signatures) For CTIMPs involving risks somewhat higher (Type B trials) or markedly higher (Type C trials including Phase I studies) than that of standard medical care typewritten or scanned images of handwritten signatures should not normally be used.
My question is this, is the standard 21 CFR compliant DocuSign adequate, or should we be looking for an alternative tool, that allows biometrics, and if so, does anyone have any suggestions of tools?