Tita Simmons, Manager of Quality Assurance and Regulatory Compliance at Copernicus Group IRB, recently spoke at the 27th Annual Society of Quality Assurance (SQA) Annual Meeting. Simmons’ session, presented in conjunction with a representative from Quintiles, was entitled,“Quality Assurance and the Protection of Research Subjects: The Sponsor, CRO and IRB QA Professionals Partnership.” The presentation was part of a three part session that tied into a larger theme, ‘Good Clinical Practices.’
Simmons delved into Institutional Review Board ethics, quality assurance, regulatory compliance and protection of research subjects. She discussed how partnerships between Sponsors, CROs and IRB Quality Assurance professionals enhance the protection of the safety, rights and welfare of research subjects. Her talk included an analysis of CGIRB case studies illustrating effective sponsor, CRO and IRB QA professional partnerships in the prevention, detection, and handling of investigator noncompliance.
“I appreciated the opportunity to raise awareness on improving partnerships to enhance the protection of human safety,” said Simmons. “At CGIRB, we are always looking for innovative new ways to apply and share our experiences in ethical review.”
CGIRB’s dedication to providing educational resources will continue with a webinar on May 4. The webinar will focus on safety reporting to the IRB and cover effective approaches to safety reporting for sponsors, CROs and investigative sites. Ultimately, the goal is to reduce the reporting burden while raising the bar on providing meaningful protection of the subjects participating in clinical trials.
For more information on the upcoming webinar, please visit xtalks.com/.
For more information on the SQA, please visit sqa.org/.
About Copernicus Group IRB
Experience and innovation in ethical review™
Copernicus Group IRB (cgirb.com), 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.