e-signatures

[Christina Salinas]

Hello,
I’m looking for information/recommendations from other sponsor companies in how they manage e-signatures on key regulatory documents. What requirements does your company have and what type of documentation do you expect from participating sites that utilize e-signature?

I’m noticing that more institutions/sites are beginning to utilize e-signature, party due to the impact of COVID-19 and more regulatory documentation being maintained electronically and managed remotely.

We have been asking many of our sites to provide a copy or access to their policy that describes how their institution/site complies with FDA 21CFR Part 11. We are finding that many sites do not have a policy in place and are utilizing Adobe Sign to electronically sign key regulatory documents (such as FDA Form 1572, protocol signature pages). Several sites have directed us to Adobe’s statement related to Part 11.

I’m interested in hearing from other sponsor companies what they consider to be acceptable and what minimum requirements they require from participating sites in order to accept electronically signed key regulatory documents.

Thanks in advance.

[Author]

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