The flowchart and steps below outlines the best practice for processing industry-written and sponsored clinical trials at UAB. There are many small steps in each of the larger defined steps (see flow ...

All human research studies conducted by personnel affiliated with the University at Buffalo must be submitted to the Institutional Review Board (IRB) for review and approval. Research cannot commence ...

The US Food and Drug Administration (FDA) is continuing to enforce a controversial policy involving the regulation of stem cell therapies, which the agency defends as enforcing established authority ...

For research involving medical devices, the University IRB will comply with the requirements set forth in 21 CFR Part 812. Per FDA regulations at 21 CFR 812, FDA’s regulations specify the ...

If you are submitting a grant to the National Institutes of Health (NIH) or the National Science Foundation (NSF), you may receive a notification that your study is likely to be funded and that more ...