Copernicus Group IRB Selected for InfoWorld Green 15 Awards
May 2, 2011 ‐ Research Triangle Park, NC- Copernicus Group IRB (CGIRB) will be leading a webinar, “Safety Reporting to the Independent Institutional Review Board (IRB): Understanding Recent Guidance,” on May 4. This is a free educational event that focuses on safety reporting to the IRB.
CGIRB’s chairperson, Glenn Veit, JD, CIP, will describe an effective approach to safety reporting for sponsors, CROs and investigative sites. The goal of the webinar is to bring clarity to the recent guidance and to help reduce the burden on sites, sponsors, CROs and review boards while raising the bar on providing meaningful protection of the subjects participating in clinical trials.
“The truly important task is protecting the safety of the people who participate in clinical trials,” said Veit. “Central to this is the meaningful review of new safety information. By providing this presentation on understanding FDA’s guidelines and IRB reporting requirements, we hope to provide clarity regarding the responsibilities of the stakeholders involved to reduce duplicative reporting and to re‐emphasize the priorities of patient care and subject protection. I look forward to addressing several common reporting errors and to hopefully demystifying FDA guidance and IRB reporting requirements during the webinar.”
The webinar is open to all interested parties and will be held Wednesday, May 4 from 11am‐12pm EDT. For more information on the webinar and to sign up for free, please click here.
About Glenn Veit
Glenn Veit is a graduate of Duke University Trinity College of Arts and Sciences and North Carolina Central University School of Law. He was trained and practiced as a trial lawyer since 1987, concentrating on issues of medical and hospital negligence, criminal defense and civil litigation, including juvenile law and children’s issues.
Glenn has served as Chair of the Copernicus Group IRB since its inception in 1996. He is a Certified IRB Professional by Public Responsibility in Medicine and Research, the national organization for the protection of human subjects in research.
About Copernicus Group IRB
Experience and innovation in ethical review™
Copernicus Group IRB, established in July 1996, is a leading independent institutional review board (“IRB”) dedicated to ensuring the rights and welfare of research study participants. CGIRB provides ethical review of research protocols, investigators, and subject information and consent forms to ensure compliance with federal regulations set forth in 21 CFR, 45 CFR and ICH/GCP Guidelines. CGIRB achieved full AAHRPP accreditation in 2004 and ISO 9001:2008 certification in 2010.