For Epic Cheers go-live support, please contact NYP IS at nypres.service-now.com/nyp-portal or 212-746-4357

How can the study team get access to the completed forms in DocuSign?

The consenting investigator will automatically have access to the completed ICF and should ensure they download it for their research records as soon as possible as it will only be stored in DocuSign for 12 months. DocuSign can be designed to send a link to other study team members as well. Please refer to the DocuSign knowledge base article for guidance.

Will participants get a copy of their consent from DocuSign?

Yes. Once the ICF is completed by all parties, the participant will receive an email with a link to download the fully executed ICF. The study team should explain to participants that they should download the PDF as soon as possible, because it will only be stored in the DocuSign repository for 12 months.

Does DocuSign eConsent support ICF amendments or changes?

DocuSign eConsent supports version control of the ICF documents.

Once the IRB has approved a protocol amendment or continuing review that includes changes to the ICF, the updated ICF can be uploaded into DocuSign by the study team. It is the study teams’ responsibility to keep the eConsent up-to-date, including amending the project every year after the IRB issues a newly stamped ICF (even if there are no other changes).  The JCTO does not need to review any updates to the eConsent in DocuSign.

I have created my eConsent in DocuSign, can I begin consenting?

Yes, you can begin a soon as you have created your template. You do not need validation from the JCTO.

How do I login to DocuSign?

Once your account has been activated by the JCTO, login via app.docusign.com and enter your WCM/NYP email address and follow the single-sign-on process.

How do I request a DocuSign eConsent?

Please contact econsent-support@med.cornell.edu to request an account.

Can my external site collaborators use my eConsent project?

It’s strongly recommended that non-WCM sites use their own institution’s eConsent system. The regulations required for eConsent may vary per local and/or state laws, as well as institution-specific policy which WCM-supported systems may or may not be able to adhere to. 

 

Do I need to upload the eConsent into Epic and OnCore since it’s stored in REDCap?

Yes, REDCap eConsent will create a PDF of the document which you will need to download and upload into OnCore and Epic.

How can the study team get access to the completed consent forms?

Signed consent documents will be housed electronically in REDCap's File Repository.

Will participants get a copy of their consent?

The REDCap eConsent form can be designed to send the participant an email that includes a PDF of their signed consent form. Please email econsent-support@med.cornell.edu for guidance.