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Clinical research professionals are a busy group. Drug development efficiency, cost and performance among pharmaceutical and biotechnology companies is changing rapidly, particularly during the current global economic crisis. These changes are redefining drug development strategies, practices and relationships.
The newest rules from FDA and OHRP for registration of IRBs are intended to be a step on the road to measuring workload for the IRBs and eventually the monitors at sites. Most monitors have never had feedback from an IRB audit of site monitoring plans, site monitoring reports or seen the investigation of whistleblower allegations against a site or the monitor. Faster resolution of whistleblower allegations, and resolving investigations through advanced reliance on monitoring visits is a benefit to subjects, sites and sponsors, but, not all IRBs exercise discretionary authority for the investigation to include the monitor. Even the best of sites can get better with advanced monitoring practices, including documentation to the IRB of training to prevent any problems resolved at monitoring visits.
This webinar applies the lessons learned from IRB audits and investigations that provide a unique perspective, coming full circle to improve practices, for monitoring investigative sites. Participants are provided the opportunity to learn 8 methods to improve and expedite the monitoring of sites:
Achieve Faster IRB Reviews When Monitors Understand the Differences Between:
Sponsor site qualifying visit and what about the site and investigator are in front of the IRB
Sponsor training or IRB ethics training required for the investigator and staff at the site
Protocol deviation logs and protocol deviation reports being provided to the IRB
Follow up to training of the investigator and the site by the monitor or self reporting
The reporting of the consequences, in the opinion of the investigator and of the sponsor, to protocol deviations
The evidence of training and corrective actions as a CAPA at the site (IRB wants the event reported & resolved)
Mirror audits of regulatory binders at sites with appropriate level of reviews to separate items
Faster IRB reviews when monitors understand when the IRB cannot do the review by itself
a. Lead IRBs in multi center studies b. When IRBs report to the FDA rather than retain oversight for resolution of problems c. When IRBs find CRO rather than site deficiencies that should be resolved with a CAPA d. When CROs do not recognize sponsor liabilities that are unmet
Key Reasons To Attend:
Monitors will see an increased speed of IRB reviews for monitored sites
Site representatives will see an increased speed of IRB reviews and double use of monitoring visits, particularly as a viable alternative to accreditation of the site
Sponsors will see an increased speed of IRB reviews for monitored sites and tips for strategies for improved site monitoring plans
Speakers:
Fred Fox, Chairman Emeritus, BioMed IRB
Don't Forget to Register!
Customer Service: 800-817-8601
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