A 21 CFR Part 11 validated eConsent provides a simple-to-use workflow technology powered by our FDA approved partner, DocuSign. The eConsent accommodates a broad range of signers, enables remote consenting for low-risk consents, and alerts sites of new versions so a re-consent is never missed.
ClinOne has mastered the challenges associated with eConsent workflow. The technology allows the coordinator and patient to complete a consent document on the provided Apple® iPad Pro while allowing the PI/Sub-I to complete the consent through their smartphones. Upon the coordinator and patient completion, the PI or Sub-I is immediately notified through a text message to complete the final step of the consent via DocuSign electronic signature. The coordinator is notified when all parties have completed the consent and the patient may proceed with study procedures.
ClinOne’s eConsent technology documents the entire informed consent process. The technology captures the step by step process by name, role and duration on each page and section of the consent. Researchers can confidently rely on the informed consent process being documented properly per FDA standards. Further, patients immediately receive a copy of their signed informed consent via secure email or by simply downloading and printing.
ClinOne’s technology provides research sites an active compliance monitoring system which helps manage the completion of every consent. In addition, the solution immediately notifies the research staff when upcoming patient visits will need to include a re-consent under a new or renewed consent version. The technology even notifies the patient that they will need to be re-consented in their next visit.