Ms. Carbary's presentation, "eConsent and the iPad," provides an overview of the process involved in eConsent activity using the ipad, including documentation, review, and approval in the consent process from both the sponsor and the IRB perspective.
Seattle, WA (PRWEB) March 28, 2013
Quorum Review IRB, the industry leader in central IRB services, announces Regulatory Attorney J. Claire Carbary, JD, CIP, as a presenter at the upcoming Association of Clinical Research Professionals (ACRP) 2013 Global Conference and Exhibition held in Orlando, FL, April 13-16, 2013.
Ms. Carbary co-presents with Joseph Kim, Clinical Operations Director at Shire, on “eConsent and the iPad,” a case study involving deployment of eConsent technology delivered on the iPad. The presentation provides an overview of the process involved in eConsent activity using the iPad, including documentation, review and approval in the consent process from both the sponsor and the IRB perspective. Ms. Carbary draws upon her solid experience in ethics review and technology to outline electronic consent requirements relating to FDA Part 11 compliance and HHS regulations, as well as offering recommendations on how to prepare an electronic consent process for IRB review.
Ms. Carbary and Mr. Kim join with Linda Harper, Medical Director, and Shawna Martin, Administrative Director, from CNS Healthcare, Inc., also participants in the case study. The presentation takes place Sunday, April 14th at 9:00-11:00 a.m.
Ms. Carbary regularly delivers IRB-focused presentations covering such topics as: social media, HIPAA requirements, and safety reporting. 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 ACRP supports the clinical research community, with a focus on fostering educational growth and professional interaction. 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 institutional review board fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), and has been providing IRB review of drug and device trials since 1992. Quorum oversees research in accordance with U.S. and Canadian human subject research protection regulations and guidelines set forth by the International Committee on Harmonisation (ICH), and principles of the Belmont Report.
Quorum’s best-in-class IRB services include 14 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 IRB 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.