eConsent; New FDA/OHRP Final Guidance
Speaker: Sandra Sather
Registration Cost:
- $0 Chapter Members
- $5 all other attendees
Program Agenda:
- 5:30 – 6:15 pm – Registration & Networking
- 6:15 – 7:15 pm – Educational Presentation
- 7:15 – 7:30 pm – Group Discussion
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
Target Audience: CRC’s, Project Managers, Investigators, Regulatory, Compliance, CRA’s, any other research focused personnel.
Speaker: Speaker, Sandra “SAM” Sather, is an industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. 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.
Contact hours: 1.0 Contact hours have been applied for through ACRP. Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the registration desk, and attend the program. Log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- Chapter Members $0
- ACRP Members $5
- Non-Members $5
Refund Policy: No refunds will be honored unless the program is cancelled by the chapter.
Level: Intermediate