Investigators and Study Staff
Working with Froedtert Health System
If you are looking to conduct your research at any Froedtert Health (FH) System entity (Froedtert Hospital, Community Memorial Hospital, St. Joseph West Bend or any of our clinics), and/or utilize any FH resource for your research (not all inclusive- staff, equipment, supplies, images, protected health information) your project must be reviewed by and receive FH Administrative Approval through the FH Office of Clinical Research & Innovative Care Compliance (OCRICC). OCRICC recommends that you contact OCRICC no later than submission to the IRB. You can contact us by email or visit our SCOUT site.
This page provides access to information that will be helpful as you start a new study submission. Here the IRB answers questions about who can submit new studies, provides links to OHRP decision charts, and more.
This page provides access to procedures that will be helpful if you need to change your original study submission. This can occur when study staff changes, study procedures change, when a change is need in a consent form, etc. Here you will also find a link for the procedure for submission of amendments.
Federal regulations (45 CFR 46.1 03(b)(5) & 21 CFR 56.1 08(b)) require written procedures for ensuring prompt reporting of unanticipated problems to the IRB, appropriate institutional officials, any supporting department or agency head (or designee), and OHRP. The purpose of prompt reporting is to ensure that appropriate steps are taken in a timely manner to protect subjects from avoidable harm. Investigators must promptly report any Unanticipated Problem Involving Risk to Subjects or Others (UPIRSO) associated with their research study according to this procedure.
This page provides access to procedures that will be helpful to you when you are submitting a Continuing Progress Report in eBridge for your study.
Projects or clinical trials that involve more than one institution inherently have extra issues that need to be considered by the study team and the IRB. Some of these issues are related to the logistics of conducting the project at other institutions and some are related to obtaining IRB approval from each institution. In order to provide a more coordinated IRB review for projects that are multi-site, the IRB has developed pathways to request a single IRB review. Because the term "multi-site" is used to describe a variety of studies, it's important to understand the definition from which the IRB is working.