News

Several new new and updated Advarra client resources are now available in preparation for the January 21, 2019, revised Common Rule compliance date.

Advarra has revised its policies and processes to be fully compliant with the Revised Federal Policy for the Protection of Human Subjects in Research applicable to agencies that have codified the Common Rule, effective January 21, 2019.

Advarra’s offices will be closed Tuesday, December 25th, through Tuesday, January 1st. During this time, the IRB will meet Friday, December 28th, and no IBC meetings are currently scheduled.

Advarra IRB Chairperson Luke Gelinas was recently featured in the PRIM&R blog post Recommendations for Oversight of Patient-Centered Outcomes Research

Advarra guidance on complying with revised Common Rule ICF changes is now available for clients.

Advarra, the premier provider of IRB, IBC and research quality and compliance consulting services in North America, has completed all integration activities.

Following the completed migration of ongoing studies to the Advarra CIRBI Platform, clients will have continued access to documentation for closed studies via the eTools Archive through the applicable retention period.

Advarra has successfully completed the migration of legacy study information to the Advarra CIRBI Platform. All IRB submissions are now managed through CIRBI.

FDA releases guidance on the impact of the revised Common Rule on FDA-regulated research to reduce confusion and burden associated with complying with two different sets of human subject protection regulations.”

At this time, we do not anticipate any disruption to Advarra's IRB meeting schedule, timelines or regular office hours due to Hurricane Florence.

Advarra’s offices will be open Monday, September 24th.  The training event will have no other impact on IRB/IBC meetings or regular office hours.

Advarra has updated its IRB policy for documenting total blood volume in research.