Recently, when discussing Institutional Review Board (IRB) adverse event reporting, a Project Manager for a leading medical device Contract Research Organization (CRO) brought up a valuable question regarding reporting compliance- whose job is it to ensure an investigator is compliant with IRB reporting policies?

Being a CRO that specializes in helping companies gain FDA and world-wide approval through monitoring, auditing, training and consulting services- it’s fair to say we’ve come across a wide range of fellow CROs, investigative sites, research teams, and hospital systems. It’s amazing how much innovation exists- not just with the investigative products- but with technological advances to platforms used the healthcare industry.

I came across this MedCity News article and just had to laugh. In the article, the author Amy Siegel pokes fun at the fact we all fall into the acronym trap, admitting to a sentence like, “’The CMO called the PI about the IRB process to estimate dates for FPI and CE mark in the PDP.”