Copernicus Group – Independent Review Board

Press Release: CGIRB Chairperson to speak at Global Clinical Trial Symposium

May 8, 2012, Research Triangle Park, N.C. – Copernicus Group IRB (CGIRB), a leading independent institutional review board, today announced the selection of IRB Chairperson Glenn Veit as a speaker for the May 15 “Creating a Global Clinical Trial Platform: Partnering for Synergy” symposium. The event is sponsored by…READ MORE

Press Release: Copernicus Group IRB collaborating with the Drug Information Association and Duke Clinical Research Unit on Global Clinical Trial Conference

April 19, 2012, Research Triangle Park, N.C. – Copernicus Group IRB (CGIRB), a leading independent institutional review board, will have two representatives on the program committee for a May 15 symposium sponsored by Drug Information Association and the Duke Clinical Research Institute, the company has announced. CGIRB Vice President…READ MORE

Press Release: CGIRB Yvonne Higgins speaks at Second APREC Conference

March 15, 2012, Durham, N.C. – Copernicus Group IRB (CGIRB) Quality Management Director Yvonne Higgins spoke at the Asia Pacific Research Ethics Conference, held March 7-9 at the Grand Copthorne Waterfront Hotel in Singapore. Ms. Higgins’ presentation, “Building a Quality Institutional Review Board/Ethics Review Committee,” included discussions of the…READ MORE

Press Release: Copernicus Group IRB announces the release of CGIRB Connexus^® 2.0.

March 20, 2012, Research Triangle Park, N.C. – Copernicus Group IRB (CGIRB), a leading independent institutional review board, today announced the release of CGIRB Connexus® 2.0. Connexus, CGIRB’s award-winning e-document management system, is utilized by sponsors, CROs and sites to manage every phase of the IRB review process. Connexus 2.0…READ MORE

Press Release: Copernicus Group IRB receives Training Top 125 award

Copernicus Group IRB (CGIRB), a leading independent institutional review board, this month accepted Training Magazine’s annual Training Top 125 award, which highlights companies’ excellence in employer-sponsored training and development programs. Sydney Douglas, CGIRB’s corporate trainer, accepted the award at Training’s 2012 Conference and Expo, held Feb. 13-15 in Atlanta….READ MORE

CGIRB associate project manager speaks at Campbell University

Copernicus Group IRB’s Nathan Schepker presented a lecture at Campbell University’s School of Pharmacy this week. The CGIRB Associate Project Manager spoke to undergraduates at the Buies Creek, N.C., school about Informed Consent. Schepker’s lecture featured information on the history of institutional review boards, the Tuskegee study, IRB formation…READ MORE

CGIRB Board Chair serves as guest lecturer

Copernicus Group IRB Chair Glenn Veit, JD, CIP, this month served as a guest lecturer at Campbell University’s School of Pharmacy. Veit taught a three-hour class in Vulnerable Populations to graduate students in Campbell’s Clinical Research program. It was the third year Veit was invited to present at the…READ MORE

CGIRB to attend MAGI East

May 20, 2012

CGIRB will attend MAGI East conference in Arlington Virginia on May 20- 23, 2012 90+ sessions and workshops in seven tracks: sponsor operations, site operations, regulatory compliance, contra... Read More

DIA 48th Annual Meeting

June 24, 2012

CGIRB will be in booth #740 at the DIA Annual Meeting Collaborate to Innovate is the largest multidisciplinary event that brings together a global network of professionals to foster innovation that w... Read More

CGIRB 16th Anniversary

July 1, 2012

July 1st marks the 16th anniversary for CGIRB! Established in July 1996, Copernicus Group IRB (CGIRB) is an independent institutional review board (IRB or “Board”) organized and operating in com... Read More

MAGI West

October 21, 2012

CGIRB will attend MAGI West conference in San Diego, CA on October 21-24. The MAGI West conference will include over 90 sessions and workshops in seven tracks; sponsor operations, site operations... Read More

AAMC Annual Meeting

November 2, 2012

CGIRB will attend the Association of American Medical Colleges (AAMC) in San Francisco, California on Nov 2-7. The AAMC serves and leads the academic medicine community to improve the health of al... Read More

The role and use of Impartial Witnesses in the informed consent process

By Patience Stevens,  MD, MPH, CIP Board Vice Chair Person Federal regulations for the protection of human subjects assign the principal investigator with the ultimate responsibility for ensuring the safety, rights and welfare of research subjects. Chief among those responsibilities is the obligation to ensure that the regulatory and…READ MORE

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

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

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

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