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.
Does REDCap eConsent support ICF amendments or changes?
REDCap eConsent supports version control of the ICF documents.
Once the IRB has approved a protocol amendment or continuing review that include changes to the ICF, these changes can be made in REDCap by the study team. Any change to the ICF requires re-review by the JCTO by emailing econsent-support@med.cornell.edu. 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 at the time of continuing review (even if there are no other changes). For instructions on how to amend a REDCap eConsent project, please read this knowledge article HowTo: Amend REDCap for eConsent.
I have created the REDCap project. Can I begin consenting?
Once you have created the REDCap eConsent project in development status, the next step is to promote the project to production status within REDCap and email econsent-support@med.cornell.edu.
Once it has been submitted, the project will undergo review by the JCTO. The study team will be notified within one week if the eConsent project has been approved or additional changes need to be made. Consenting within REDCap cannot begin until the REDCap eConsent project has been approved.
