Office of Clinical Research and Innovative Care Compliance (OCRICC). What You Need To Know About Conducting Research at Froedtert Hospital. Roberta Navarro, BSN, RN, Manager of OCRICC Nancy Schallert, Executive Director of Corporate Compliance. Learning Objectives.
What You Need To Know About Conducting Research at Froedtert Hospital
Roberta Navarro, BSN, RN, Manager of OCRICC
Nancy Schallert, Executive Director of Corporate Compliance
FMLH was the host to research without knowing it.
Pricing was variable
No opportunity to determine operational feasibility.
FMLH had studies that did not cover its cost – funding source without knowing it, and without FMLH approval.Purpose - Background
Variable assurance that FMLH leaders understood requirements and needs of the project.
Party to the CTA, but never reviewed or approved.
Project staff did not always have what they needed once they were enrolling – variable commitment from FMLH.
Did not have valid contracts with FMLH.Purpose - Background
FMLH was not consistently meeting regulatory requirements related to the project.
Other Hospital Regulations (JCAHO, COP)
RISK!!!!Purpose - Background
Research projects that use FMLH resources:
For projects with IRB approval on 2/1/11 or after
This depends, OCRICC activities are specific to the project …
All research projects utilizing FMLH resources must obtain final OCRICC approval prior to enrolling subjects.
Thank you for your time today!