IRB Pre-Review Services

CTSI Clinical Trials Office’s IRB Navigation & Pre-Review Service for Investigators

Overview

The Pre-Review Service provides assistance and information to all clinical and translational investigators. Its purpose is to help with IRB submissions, conduct pre-reviews of regulatory documents, and support education regarding regulatory requirements.

This service provides:

  • Pre-Review of IRB Submissions: Pre-review of documents includes a comprehensive review of all investigator draft documents to assure they are completed correctly and that the information presented is consistent among the study documents. In addition, the protocol review includes analysis of recruitment strategies and procedures, data collection, risks, safety precautions, and protection of confidentiality. This review is done to assist investigators in presenting complete, accurate, and thorough applications to the IRB. Assistance for full board, exempt, and expedited submissions is provided. A Pre-Review typically results in a significant reduction in submission errors to the IRB.
  • General information or brief consultation regarding resources and services to support clinical and translational research
  • Education and training in meeting regulatory requirements for clinical research

Hours: Monday – Friday 7:30 am4:30 pm

Common users of the service: New investigators and research staff

Rate: There is no charge for this service

Contact:

Charlotte Klis

Program Coordinator, Clinical Trials Office
(414) 805-7183
cklis@mcw.edu