- Module A - IRB Processes
Instructor: Faye Overly, QA/QI Specialist
Purpose: This interactive session focuses on the MCW IRB submission process and the use of eBridge for human study submissions.
Agenda: Discuss the MCW IRB submission process, common misconceptions, content of forms for submission, reportable events, and insight into the protocol review process by the IRB committee. It focuses on eBridge; the electronic human studies submission process for the MCW/FH Institutional Review Boards (IRBs). eBridge Human Research Training is a suggested pre-requisite.
- Module B - IRB News (Topics rotate between Banking and other IRB news topics)
1. Banking Session
Instructor: David Clark, PhD, Assistant Dean for Clinical Research
Purpose: This interactive session focuses on elements of banking for human research purposes. Individual questions are welcome in this small group session.
Objectives: Review MCW IRB policy on banking data and bio-specimens; Discuss definition of "data"; Differentiate among identified, coded, de-identified and anonymous (anything) and its relationship to banks; Compare banking consent documents and study consent documents; Define role and responsibilities of the bank custodian; Review IRB requirements for conducting research with banked data or specimens
2. IRB News - Topic Varies
Instructors: Panel Varies
- Module C - Conducting Human Research at a Froedtert Entity: What you need to know
By: Office of Clinical Research and Innovative Care Compliance (OCRICC)
Instructor: Presented by Nancy Schallert, Director, Corporate Compliance & Internal Audit
Purpose: This session provides an opportunity to learn directly from the source about the services that are provided and required by OCRICC.
Agenda: Overview of OCRICC, identify which human research conducted at FH requires OCRICC approval, identify timeline for approval and where to find tools & resources.