This document outlines a workshop on electronic informed consent and a transition from paper-based to digital, multi-media consent delivery to improve patient comprehension and experience. The objectives are to increase patient enrollment and retention through a better consent process, improve compliance to reduce protocol violations, and allow real-time monitoring to rapidly enhance the patient experience. Next steps include piloting eConsent on existing trials in 2014, gathering feedback, and continuing to improve the digital experience and content.

1. Electronic Informed Consent
Patient Centric Workshop
Nov 14, 2014

2. Vision
Improved patient comprehension
and consent experience via digital
content delivery

3. Transformation
From…
To…
Sponsor Centric
Patient Centric
Paper
Multi-media digital
Poor patient
comprehension
Focus on patient
comprehension
Lengthy and difficult to
understand
Shorter, simplified
content

4. Mutually Beneficial
Objectives
An improved patient consent/trial experience will
increase patient enrollment
An improved patient comprehension will improve
compliance and patient retention
Improved compliance to consent related
procedures means fewer consent related protocol
violations/audit findings
Real-time monitoring and data gathering enables
more rapid patient experience improvement cycles

5. Next Steps
Pilot eConsent on 3-4 trials in 2014 using existing
content – start with limited sites and then expand
the scope
Gather input from patients and sites to improve the
multi-media experience
Then focus on improving the content to enhance
patient comprehension and compliance
The transformation continues today with gathering
your feedback…