One of the many services offered by the Quality Improvement (QI) Staff is routine reviews. Routine reviews are a mechanism for the MCW Human Research Protection Program (HRPP) to provide internal oversight of the conduct of human research studies that are reviewed and approved by the MCW/FH IRBs. Investigators can also request a routine review of their studies by contacting any QI staff member.
Purpose of Routine Reviews
The main purpose of a routine review is to provide feedback to investigators and study team members regarding the conduct of the study in accordance with the approved protocol, MCW policies/SOPs, federal regulations and good clinical practices. This feedback can be useful for investigators and study teams in assessing their current research activities and documents and in determining future direction. Routine reviews can also provide an opportunity for the investigator and study team members to address any questions or concerns they have.
Upon completion of the QI review, the overseeing MCW/FH IRB Committee receives a copy of the report issued to the investigator by the QI staff. The IRB considers the information in the report upon receipt and during continuing review of the applicable study. This reporting allows the IRB and subsequently HRPP to better fulfill its mission to protect the rights, welfare and privacy of all individuals participating in research approved by The Medical College of Wisconsin and Froedtert Hospital IRB by ensuring the conduct of human subject research adequately meets safety, compliance, scientific quality, and ethical standards. In addition, the aggregate information obtained from the routine reviews is an important measure of the overall effectiveness of the Human Research Protection Program activities.
The Review Process
Effective 1/1/10 Routine Reviews are mandatory, and will take place as described in the Routine Review schedule. The QI staff identifies studies that are eligible for a routine review using eBridge, the electronic IRB submission system. Routine reviews are scheduled throughout the year at times that are convenient for participating investigators and study teams. The goal of the QI program is to review at least three studies from each eligible department and the divisions within the departments of Medicine and Surgery each year. The principal investigator (PI), study coordinator and the identified point of contact are notified of the upcoming routine review in advance; the QI Specialist works with members of the study team in scheduling the date and time for the onsite review activities.
During a routine review, the QI staff will review documents including the regulatory file, signed consent documents, and in some cases subject file documentation. The time that it takes for the QI staff to complete the document review can vary depending on the activity of the study, the number of subjects enrolled, and the organization of the study files. You can view Checklists similar to those used by the QI specialist during a review on the Checklists page. Before and after the review the QI staff will meet with the principal investigator (PI) and/or study coordinator to discuss the study, review activities, and any findings or recommendations. Following the review a report is prepared and sent to the PI, study coordinator, Chair and Coordinator of the reviewing IRB committee and if the study receives CTSI support, the CTSI Research Subject Advocate.
Routine Review Schedule
The Human Research Protection Program (HRPP) Routine Review Schedule was developed based upon information received from MCW departments and the divisions within the departments of Medicine and Surgery involved in human subject research. The schedule lists each department and applicable division in which the Quality Assurance/Quality Improvement (QA/QI) staff will conduct a mandatory routine review and the review periods assigned to the department/division.