Clinical Trial Support Services

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.

What We Do:

• 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 a.m.-4:30 p.m.

Common Users of the Service: New investigators and research staff

Rates: These services are offered free of charge

Contact: Charlotte Klis, Program Coordinator, Clinical Trials Office
(414) 805-7183 | cklis@mcw.edu

All investigator initiated trials that are regulated by the Food and Drug Administration (FDA), require study monitoring. The MCW Clinical Trials Office (CTO) provides comprehensive study monitoring and auditing services that are based on the latest Risk Based Monitoring guidelines from the FDA. Thus, the service will cut down on the total monitoring volume and therefore the total time spent monitoring of clinical trials while achieving optimum levels of data review to ensure compliance and patient safety.

What We Do:

The CTO will perform the following activities for your trial.

• Develop a monitoring plan that details staff training, all proposed visits and budget.
• The CTO will conduct monitoring visits, both on-site and remote, per the monitoring plan
• Assess and track SAEs and AEs and theu reporting to appropriate regulatory bodies
• Meet with study teams and PIs to keep them updated with study progress
• Provide support for FDA audits
• Conduct routine, on-demand QA/QI for ongoing trials

Patient Recruitment into clinical trials remains a major challenge for researchers. There are several challenges to be overcome and there seems to be no standard approach to solve this issue. Challenges arise from the fact that trials are set up differently and target different populations including adults, children, cancer, non-cancer and community members. Additionally, recruitment occurs in different locations such as Froedtert Hospital, the Medical College of Wisconsin and Children's Wisconsin as well as community locations.

Investigators can now hire a recruitment specialist who will assess your need and draft a customized recruitment strategy. The recruiter will also be able to assist with screening of patients and on-site consenting.

To help understand this complex issue, we are happy to set up a meeting to discuss a solution.