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?

Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?

At the recent OMTEC 2012 Conference in Chicago, there was a panel discussion on the current status and future challenges facing the orthapaedic industry.  Interestingly enough, it seems similar adversities stretch across most of the clinical research industry touching various segments.

Joining the military in America is, by some, considered the most patriotic duty one can fulfill; a noble and brave decision made by young men and women to protect and fight for our country.

When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”. As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.

A report from the Institute of Medicine (IOM) was based on a workshop held with this focus: “Public Engagement and Clinical Trials.” In this report, IOM draws attention to the fact that many clinical trials are slow to enroll patients, and some studies never reach their recruitment number goal.