Seattle, WA (PRWEB) September 11, 2012
Quorum Review’s Regulatory Attorney, J. Claire Carbary, JD, CIP, will present “Electronic Consent for Research: Understanding the Requirements and Working with the IRB” at the upcoming ACRP San Diego Chapter meeting on Tuesday, September 18th, 5:30-7 PM, at Scripps Green Hospital, 10666 N. Torrey Pines Road, La Jolla, CA.
When considering the latest technologies to facilitate electronic consent and electronic signature, research organizations are looking to the current FDA regulations for guidance. Drawing upon her solid experience in ethics review and technology, Ms. Carbary will outline electronic consent requirements relating to FDA Part 11 compliance and HHS regulations, as well as recommendations on how to prepare an electronic consent process for IRB review.
Ms. Carbary regularly delivers succinct IRB-focused presentations covering social media trends and research, HIPAA requirements for researchers, and safety reporting to the IRB. Ms. Carbary is a member of the Northwest Association for Biomedical Research and Public Responsibility in Medicine and Research. She received her Juris Doctor from Seattle University in 2007, and was admitted to the Washington State Bar Association (WSBA) in the fall of 2007. Prior to joining Quorum Review in 2009, Ms. Carbary worked as a Regulatory analyst at Western IRB.
The Greater San Diego Association of Clinical Research Professionals (ACRP) Chapter supports its local membership with regular events that foster educational growth and professional interaction. Chapter events are open to ACRP members and non-members. For more information about ACRP membership, visit the ACRP website. For the latest on Quorum Review News and Events, visit http://www.quorumreview.com.
About Quorum Review
Quorum Review is an independent ethics review board fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and has been providing ethics review of drug and device trials since 1992. Quorum oversees research in accordance with U.S. and Canadian human research subject protection regulations and guidelines set forth by the International Committee on Harmonisation (ICH), and principles of the Belmont Report.
Quorum’s best-in-class service and support includes 13 Board meetings each week plus expedited review, 24 hour site review turnaround, 36 hour amendment review turnaround, a secure web portal, and Smart Forms for online submissions. Quorum’s full service offerings include full study review in the US and Canada, a specialized Phase I team, and unique processes for post-approval and registry studies.