eConsent adoption is on the rise, and with that comes a heightened focus on the compliance of eConsent platforms and the protection of data. This webinar will walk through the security and privacy requirements related to eConsent, as well as other compliance considerations for sponsors, CROs, research sites, and IRBs. Specifically, attendees will learn the practical impact of:
- 21 CFR Part 11 (Part 11)
- The HIPAA Privacy and Security Rules
- FDA Guidance on eConsent
- Little-Known Other Requirements Related to eConsent
Who should watch:
Executives, directors, and managers who work for sponsors, CROs, research sites and IRBs. Also, members of these organizations who are charged with ensuring compliance amidst the proliferation of research technology.
Mitchell Parrish, JD, RAC, CIP
Vice President, Legal & Regulatory Affairs for Kinetiq
The consulting and technology division of Quorum Review IRB
This webinar is eligible for continuing education credits.
Continuing Education Credits
This webinar is pre-approved for 1.0 contact hours of continuing education credit for the Certified IRB Professional (CIP) certification, and for Maintenance of ACRP’s CCRC®, CCRA®, CCTI® or CPI® certifications. If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements. Information for CE credits for SOCRA can be found here. Visit our Webinar Help page for more information on certification credits.
Certificate of Attendance
You must watch this webinar in its entirety to receive a certificate of attendance. The certificate will include your full name and it will be emailed to you at the end of the webinar. Please note that if your organization has other staff members who wish to earn CE credits for this webinar, each person must register for and watch the webinar in its entirety in order to receive a certificate. Visit our Webinar Help page for more information on certificates of attendance.
For questions or concerns, please email ClientRelations@QuorumReview.com
Tags: 21 CFR Part 11, Central IRB, Clinical Trials, eConsent, eConsent for Research, electronic informed consent, FDA, FDA Guidance, HIPAA, human subject research, Informed Consent, Part 11, Quorum Review IRB, webinar, webinar on demand