Copernicus Group IRB Safety Reporting Webinar
Copernicus Group IRB (CGIRB) led 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, described an effective approach to safety reporting for sponsors, CROs and investigative sites. The goal of the webinar was 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.”