Keynote Speaker for this Event:

Glenn Veit, JD, CIP, Chairperson, Copernicus Group IRB  

Reduce the reporting burden on sites, sponsors, CROs and review boards while raising the bar on providing meaningful protection of the subjects participating in clinical trials.

Responsibility
Clinical research involves a shared responsibility among sponsors, CROs, investigators and institutional review boards (IRBs) to safeguard the rights, safety and welfare of human subjects.

Impact
A major component of this shared obligation is the meaningful review and communication among the clinical trial stakeholders of new safety information that may develop during the trial. Multiple federal guidance documents have been issued over the past few years to assist the research community with interpreting the regulations. The intent of the new guidance was to respond to concerns among IRBs, and others, that an overwhelming number of reports were inhibiting, rather than enhancing the protection of human subjects…but, has anything changed?

Goals
This presentation is to bring clarity to the recent guidance and describe an effective approach to safety reporting for sponsors, CROs and investigative sites. Ultimately, the goal is to 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.

This program will help you put the guidance into action in the following ways:

• Identify responsibilities of each stakeholder
• Identify what events must be reported to the IRB
• How best to report safety information events
• What information the IRB needs to conduct a thorough review

Clinical Operations, Clinical Development, Therapeutic Heads, Clinical Monitoring, Medical Affairs, Regulatory and Safety, Investigators, Nurse Coordinators

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.

Copernicus Group IRB (CGIRB) is an independent institutional review board (IRB) whose primary responsibility is to ensure that the rights and welfare of human research subjects are protected.

The CGIRB Board reviews research protocols and study-related information, as well as investigator qualifications and resources to assure regulatory compliance. CGIRB provides:

• Multiple weekly CGIRB Board meetings
• Initial, continuing and expedited reviews
• Promptly communicated Board decisions
• Online submission and tracking via CGIRB Connexus®
• Continuing review reminders
• Education and training resources

Copernicus Group IRB may review studies for a single investigator or serve as a central IRB for multi-center trials involving upwards of several thousand investigators. Additionally, CGIRB may function as the IRB of record for studies conducted at hospitals or academic institutions. CGIRB was inspected by the FDA in 1999, 2005 and again in 2010 with no Form FDA 483 issued. CGIRB’s human research protection program has maintained full accreditation by AAHRPP®, The Association for the Accreditation of Human Research Protection Programs, Inc., since 2004. In 2010, CGIRB became the first central IRB to achieve ISO 9001:2008 certification.