Winter Edition | December 2012 As we reflect on 2012, the staff at Quorum Review is grateful for the opportunity to work with so many dedicated members of the research community protecting the rights and welfare of research participants. In … Continue reading
The Quorum Forum
12/04/2012
FDA’s Draft Guidance for IRBs, Clinical Investigators and Sponsors
Winter Edition | December 2012 The FDA announced the availability of a new draft guidance entitled “Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether … Continue reading
12/04/2012
Site Survey Winner Announced!
Winter Edition | December 2012 Congratulations to Darlene Kocher, Study Coordinator at Pinnacle Medical Research. Darlene is the winner of the Amazon Kindle Fire for the 2012 Research Site Satisfaction Survey. Quorum Review would like to express our appreciation to … Continue reading
12/04/2012
Cambridge Board’s First Anniversary
Winter Edition | December 2012 Congratulations to Quorum Review’s Cambridge Ethics Board on its first year anniversary! Quorum Review is proud of the accomplishments this IRB and the Cambridge-based support staff have accomplished throughout this past year. The Cambridge Board’s … Continue reading
09/25/2012
Linda Coleman, JD, CIP, to Present on Good Clinical Practices at MAGI West 2012
Quorum Forum, September 2012 Linda Coleman, JD, CIP, CHC, CHRC, Director of Regulatory Affairs & General Counsel, will be presenting at the upcoming MAGI West Conference in San Diego, CA. Her presentation, “Good Clinical Practice Essentials: What You Won’t Learn … Continue reading
09/25/2012
Complementary and Alternative Medicine (CAM): Legal and Regulatory Framework and Ethics Review of Research in the U.S. and Canada
Quorum Forum, September 2012 What is Complementary and Alternative Medicine (CAM)? The term “complementary and alternative medicine” or “CAM” is defined as “a group of diverse medical and health care systems, practices, and products that are not generally considered part … Continue reading
09/25/2012
Safety Reporting to the IRB on Behalf of Sites
Quorum Forum, September 2012 Safety reporting in the context of a clinical trial is no easy task. Sponsors and investigators have varying reporting responsibilities depending on which party they are reporting to. IRBs have been inundated with reports of issues … Continue reading
06/19/2012
Linda Coleman & Expert Panel to present at DIA 2012
Quorum Review, June 2012 Quorum Review IRB’s General Counsel and Director of Regulatory Affairs will present an interactive session on minimal risk research at this year’s DIA 48th Annual Meeting on Tuesday, June 26, held in Philadelphia, PA. Linda Coleman, … Continue reading
