The collection of signatures is a critical component of clinical research. Although this has been predominantly done with pen and paper, there is increasing need in the research community for processes that collect signatures digitally (eSignature). WCM currently supports one system, DocuSign, which is 21 CFR Part 11 compliant and therefore can be used to collect signatures on informed consent forms and essential regulatory documents (i.e. FDA Form 1572, financial disclosure forms, delegation of authority logs, etc.) for FDA-regulated studies. Documents that would have been signed on paper can now be available on a computer or touch-screen device to be signed electronically either in-person or remotely.
DocuSign is fee for service; the fee schedule can be found here. For information on how to create a template in DocuSign, a Knowledgebase guide is available. The DocuSign system has been validated and will continue to be maintained by the JCTO. If needed, an attestation of the systems 21 CFR part 11 compliance is available here.
To begin using DocuSign, email email@example.com and provide the following information:
REDCap, WCM/NYP’s primary data capture system can also facilitate the collection of signatures on electronic consent forms (eConsent). REDCap is not currently FDA compliant and therefore can only be used for non-FDA regulated studies. The IRB-approved informed consent form can be built into REDCap and routed to the participant and investigator for signatures, but the system cannot manage the collection of signatures for regulatory documents.
REDCap eConsent is a free service provided by the CTSC, though enhanced services (e.g., project build-out by CTSC member) may require a fee. For instructions on how to create a REDCap eConsent project, a Knowledgebase guide is available. Please contact firstname.lastname@example.org for more information.
For guidance on whether your study is considered FDA-regulated you can utilize our eConsent Selection Tool.
All use of eConsent must be IRB approved before it can be implemented. Downloadable template language that can be used in the IRB application is available within the JCTO Researcher's Toolbox, titled "Remote Consent IRB Submission Language" under the Regulatory Tools and Templates section.
If you have questions about eConsent, or our available tools, please visit our Frequently Asked Questions (FAQ) section.