eConsent: New FDA/OHRP Final Guidance
View event flyer. Program Agenda:
- 11:00 am ET & 5:00 pm ET – Webinar Replays
- *Note: The same webinar will be played at both times.
Program Description:In December 2016, the US Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) finalized a regulatory guidance supporting the use of electronic Informed Consent (eIC/eConsent) to promote improved process, innovation, patient centricity and more. Join us for this session which outlines how the new guidance and electronic approaches to informed consent development, use, management, oversight and archiving can address the age old problems of paper informed consent.
Upon completion of this Webinar, attendees should be able to:
- Recognize how electronic informed consent impacts recruitment, retention and compliance
- Discuss electronic consent integration and audit readiness
- View examples of eConsent approaches
Speaker, Sandra “SAM” Sather, is an industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 25 years of clinical experience, with a Bachelor of Science in Nursing and a Master of Science in Education with a Specialization in Training and Performance Improvement.
Speaker, Michael Conde, is the Senior Director of Technical Solutions at CRF Health. As part of the Technical Solutions team he is responsible for supporting the Business Development stream with eCOA / eConsent system design, best practices and technical implementations. He has worked at CRF Health since 2007 as a software developer, project manager and technical solutions engineer.
REGISTRATION REQUIREMENTS:Pre-registration on the ACRP website is required for this event. Additionally, upon joining the webinar, you must “sign-in” by entering your name and email address. This is required to track participation. CEUs cannot be awarded unless all required webinar registration elements are completed.