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CGIRB Quality Management Director Yvonne Higgins to speak in Singapore
Copernicus Group IRB Quality Management Director Yvonne Higgins, CIP will speak at the Asia Pacific Research Ethics Conference in Singapore this March, CGIRB announced today. Higgins will present on Quality Management and Quality Improvement in Research – one of the featured tracks of the March 7-9 conference at the Grand Copthorne…READ MORE
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Copernicus Group IRB’s Veit, Higgins speak at PRIM&R conference
Two members of the Copernicus Group IRB team spoke at the 2011 Advancing Ethical Research Conference in National Harbor, Md., on Dec. 4. CGIRB Chairperson Glenn Veit, JD, CIP, spoke on “Sponsor Responsibilities in Unanticipated Problems and Adverse Event Reporting.” His presentation reviewed new FDA regulations on adverse event…READ MORE
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Press Release: Copernicus Group IRB named a Training Magazine Top 125 company
CGIRB sits among top national, international brands Dec. 6, 2011, Research Triangle Park, N.C. – Copernicus Group IRB (CGIRB), a leading independent institutional review board, has been named a finalist in Training Magazine’s annual Top 125, which ranks companies’ excellence in employer-sponsored training and development programs. The final rankings…READ MORE
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CGIRB Associate Project Manager Guest Speaker at Campbell University
Melody Sawyer, Associate Project Manager at Copernicus Group IRB, spoke to undergraduate students in Campbell University’s Pharmacy School in Buies Creek, NC on Wednesday, November 9, 2011. Sawyer’s lecture included a general overview of the IRB process, with a focus on Human Subject Protection history and the IRB role in…READ MORE
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CGIRB’s Director, Quality Management Featured Speaker at OHRP Quality Assessment Workshop
Yvonne K. Higgins, Director, Quality Management at Copernicus Board IRB spoke at an OHRP Quality Assessment Workshop on Wednesday, October 5, 2011. The workshop was held at the Durham Convention Center in Durham, NC and featured Higgins’ firsthand account of how one institution brought about improvement of its human…READ MORE
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Press Release: Copernicus Group IRB Named Finalist for NCTA 21 Award
“Leading Environmental Steward Company Award” category November 1, 2011, Research Triangle Park, NC — Copernicus Group IRB (CGIRB), a leading independent institutional review board, today announced it has been named a finalist in the 2011 North Carolina Technology Association (NCTA) 21 Awards. CGIRB was selected in the “Leading Environmental…READ MORE
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Press Release: Copernicus Group IRB Webinar
CGIRB case study with Duke University Clinical Research Unit October 12, 2011, Research Triangle Park, NC – Copernicus Group IRB will be leading a webinar on Tuesday October 18, 2011. This is a free educational webinar entitled, “Reducing the Barriers to the Conduct and Oversight of Clinical Trials: A…READ MORE
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Webinar-Reducing the Barriers to the Conduct and Oversight of Clinical Trials: A Case Study
October 18th, 2011 at On-line – Copernicus Group IRB will be leading a webinar “Reducing the Barriers to the Conduct and Oversight of Clinical Trials: A Case Study,” This is a free educational webinar run by Copernicus Group IRB and Duke University. Date: October 18, 2011 Time: 11 am EST Click here for more information…READ MORE
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DIA 48th Annual Meeting
June 24th, 2012 – June 28th, 2012 at Philadelphia, PA – Collaborate to Innovate is the largest multidisciplinary event that brings together a global network of professionals to foster innovation that will lead to the development of safe and effective health care products.
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Dealing with over-reporting: Understanding the FDA’s new regulations
By Glenn Veit, JD, CIP, Copernicus Group IRB Chairperson The Food and Drug Administration this year published revised regulations pertaining to safety reporting for drug and biologic products under an Investigational New Drug (IND) application. The FDA also made bioavailability (BA) and bioequivalence (BE) studies conducted to support the…READ MORE
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Advanced Notice of Proposed Rulemaking (ANPRM): Enhancing Protections for Research Subjects & Reducing Burden, Delay & Ambiguity for Researchers
by Yvonne Higgins, AB, CIP, Director, Quality Management Background On July 22, 2011, the U.S. Department of Health and Human Services (HHS) announced a proposal that may result in significant changes to federal regulations on the protection of human research subjects. In the notice, published in the federal register,…READ MORE
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Reducing the Reporting Burden: Guidelines for Improving the Protection of Trial Subjects
by Glenn Veit, JD, CIP, Copernicus Group IRB Chairperson To safeguard the rights, safety and welfare of human subjects, clinical research is a shared responsibility among sponsors, investigators, contract research organizations (CROs) and institutional review boards (IRBs). Central to this shared obligation is the meaningful review and communication of…READ MORE
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Protecting Vulnerable Populations During Research: Guidelines for safeguarding the health and welfare of children
by Yvonne Higgins, AB, CIP, Director, Quality Management According to federal regulations regarding human research, the principal investigator holds the ultimate responsibility for protecting the safety, rights and welfare of research subjects. Of particular importance is obtaining informed consent according to strict regulatory and ethical requirements. Complicating the issue,…READ MORE


