eConsent
CRIO’s eConsent automates the completion and execution of the Informed Consent, and is built right into CRIO’s eSource workflow.
Use any commercially available PDF tool to add field elements on top of the underlying PDF, (e.g.) checkmarks, initials, signatures, etc. CRIO’s eConsent will read these annotations, capture values associated with completion, and assign them to roles.
Electronic consent forms minimize patient and site staff error, but they don’t solve the problem of missed re-consents. You can avoid this protocol deviation with CRIO’s integrated eSource and eConsent. The system checks to see if the patient is up to date on the latest version of the ICF at the outset of each visit and pulls in the appropriate ICF as needed.
As soon as they are executed, the electronic consent forms go straight into CRIO’s Reviewer tool, giving the CRAs a single place to view not only subject source but also their executed consent forms. The electronic consent forms will be associated with the subject visit at which they were executed.