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|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.
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.
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?
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
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