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Good morning,
I was interested in taking a general poll of our members to get an idea of your IRB volume (IRB of Record studies and ceded studies), # of audits conducted per month, and team size (FTEs, etc.). We would like to expand our Post-Approval Monitoring program and would like to be able to use other institutions as an example when presenting to leadership.
Thanks!
Our IRB reviewed over 1400 studies in 2023.
200 studies reviewed by external IRB
We have a compliance team of 2. In 2023, we had 1 for cause audit and 13 not for cause audits. We also manage clinicaltrials.gov, research related injury review, complaints related to human subjects research, and other non-compliance issues found at time of continuing review. We also conducted education with sites regarding proper consent.
Our IRB has over 14,000 studies that are our program performs reviews for and about 1,300 studies reviewed by external IRB. We have is 1.5 FTEs and have the support of a member of the research integrity team that acts as second analyst during our routine audits. In 2023 we conducted 16 routine reviews and 2 directed/for cause reviews. In addition, we performed 155 abbreviated reviews of exempt and expedited studies.
