Advarra Completes Integration, Renews Focus on Efficient Research Compliance Services
Advarra, the premier provider of IRB, IBC and research quality and compliance consulting services in North America, has completed all integration activities.
eTools System Becomes eTools Archive October 2018
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.
Electronic Platform Migration Complete
Advarra has successfully completed the migration of legacy study information to the Advarra CIRBI Platform. All IRB submissions are now managed through CIRBI.
FDA Guidance Addresses Impact of Revised Common Rule on FDA-Regulated Clinical Trials
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.”
Updated IRB Handbook Now Available
Advarra has updated its IRB Handbook to reflect current policies and processes. The revised IRB Handbook is available in the Reference Materials section of the Advarra CIRBI Platform.
At this time, we do not anticipate any disruption to Advarra's IRB meeting schedule, timelines or regular office hours due to Hurricane Florence.
Updated IRB Meeting Schedule for Week of September 24
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.
Updated IRB Policy on Blood Volumes in Research
Advarra has updated its IRB policy for documenting total blood volume in research.
Updated IRB Policies for Research Involving Minors
Advarra has updated its IRB policies for research involving minors. This includes policies on obtaining a child’s assent as well as parental consent requirements.
Updated IRB Policy on ICH-GCP Compliance for Research Conducted in the US
Advarra has updated its IRB policy on applying ICH-GCP Guidelines to US research.
Holiday Meeting Schedule – Labor Day
Advarra's offices will be closed all day Monday, September 3rd. The IRB and IBC will not meet on Monday, September 3rd.
Proposed Changes Released for Review of Gene Therapy Research
NIH has published a proposal to amend the NIH Guidelines to streamline oversight for human gene transfer research and reduce duplicative regulatory reporting requirements.