Prelude’s unique eConsent functionality is the latest in a long line of enhancements aimed at eliminating paper from clinical trials. Up until now, most clinicians have obtained owner and subject consent on paper forms that are then uploaded into the system. Now sites can obtain owner and subject consent electronically the same as for any other user signature for the study.Animal Studies
For animal studies, the process for obtaining owner signatures begins with an owner profile added by the site. The owner then logs on and immediately signs an electronic signature agreement. After the generic agreement is signed the owner is able to electronically sign any study-specific consent forms. Once the subject is enrolled the owner is free to fill in their own demographic information as well as any forms that are required for the study such as a dosing schedule or owner diary.
For human studies, brand-new technology has been implemented to attach the signed consent form directly to the appropriate PDF document. No personal data will be collected about the subject until the informed consent is signed electronically by the subject.
The eConsent feature of VISION includes the ability to send (and re-send) notifications to the subject to remind them to sign relevant forms. A notification can also be sent to site personnel to alert them when a form has been signed. The forms can also be provided with multiple language options for studies enrolling non-English-speaking subjects.
An electronic signature is a distinctive mark appended to a document for verification. It offers the same validity as an ink signature yet with an even higher degree of contemporaneousness as it also includes the time/date stamp and logged-on user information. It is a safer, faster, and more cost-effective approach for capturing signatures.