Can we close a study with IBC when the last subject goes “off study”?
It depends on the protocol and the biology of the rDNA product. According to the NIH, the local IBC has the responsibility to decide when IBC oversight can end. Each local IBC will make its own determination about this. For the IBC, the study is certainly active as long as there is product at the site, or future dosing could occur. Even if the IBC allows the study to close before the end of long-term follow-up (LTFU), the study will still be under oversight by the IRB, the FDA, and the NIH.
