Why are routine reviews of studies conducted?
• To review the study conduct in regards to federal regulations and institutional policies • To provide feedback to the PI, study team, and MCW/FH IRB • Ensure quality assurance • How are studies identified for routine review? Once QI has identified the MCW/FH IRB approved studies in eBridge, an email is sent to the principal investigator requesting permission to conduct a routine review of one of his/her current studies. The PI has several options available: (1) to accept or decline the invitation for review, (2) to select the study for review, and (3) identify preferred time for review. It is QI’s goal to conduct a routine review within each department and division every year. • Does the PI and/or study coordinator need to be present during the entire review? No. However, before the QI staff begins a review of study documentation we ask to meet with the PI and/or study coordinator to discuss the conduct of the study. The QI staff will make arrangements to meet with the PI and/or stud
