As the leader and primary resource for compliance management in the MU School of Medicine, the Office of Compliance and Quality maintains a comprehensive program that promotes a culture of compliance across the MU Health.

Comprehensive Compliance Program

Through internal monitoring, education and communication, the Office enhances the School’s value to students, faculty, staff and the public by helping to prevent, detect and correct potentially noncompliant practices in clinical research.

Program Components & Services

The Director of Academic Compliance puts the strategic plan for compliance into operation and leads an expert team in assisting the dean, associate deans, faculty and staff with a wide range of activities, such as:

  • Responding to questions about compliance, training requirements, reports of potential noncompliance, regulatory requirements related to clinical research and conflict of interest
  • Investigating potential noncompliance situations
  • Performing periodic audits of activities within MU Health
  • Delivering a compliance training program
  • Centralizing communication for research subject billing
  • Advocating for research participants to assure equitable and responsible treatment of research volunteers
  • Collaborating with compliance units on campus and within the University system to minimize overall risk

For more information about the MU Health compliance program, contact:

Lori Wilcox, EdD
Director of Academic Compliance
wilcoxl@health.missouri.edu
573-882-2460

Program Monitoring & Auditing

Our health care compliance coordinator holds the responsibility for initial review for clinical research programs. This initial review will culminate in a coverage analysis, which can be used to ensure research billing compliance.

In addition, the compliance coordinator:

  • Helps investigators and their teams navigate regulatory requirements and minimize compliance risk
  • Participates in planning and delivering training programs
  • Serves as a resource for MU staff with regulatory questions

Find out more about research program monitoring and auditing. Contact:

Greg Clawson
Health Care Compliance Coordinator
clawsong@health.missouri.edu
573-882-3654

Coordinators Council

Coordinators Council offers a forum for communication that’s open to all research staff. Meetings provide a blend of regulatory updates and an open exchange of ideas to:

  • Promote good clinical practices
  • Identify the most pressing training needs of clinical trials staff

Clinical Trials Registries

The MU School of Medicine encourages investigators to list their clinical trials on the federal government website clinicaltrials.gov. Developed to meet requirements of the Food and Drug Administration (FDA), the website provides easily accessible information about clinical trials research across the nation.

According to the FDA, the International Committee of Medical Journal Editors, the World Health Organization (WHO) and the Association of American Medical Colleges (AAMC), information about clinical trials should be made public by the time subject enrollment begins. Creating a project flowchart to reflect organizational or regulatory requirements can help investigators decide whether to list a trial.

The University of Missouri appears as an institutional listing in the clinical trials Protocol Registration System (PRS). To set up an account for protocol registration, contact the University’s designated PRS administrator:

Susan Kady
Research Participant Advocate
kadysj@health.missouri.edu
573-884-1925
888-280-5002 toll-free

Learn more about clinical trials through the University of Missouri School of Medicine.

Research Participant Advocate

To help assure equitable and responsible treatment of research volunteers, the Research Compliance & Quality Office advocates to assist clinical trial participants and their families.

In addition to direct oversight of the informed consent process and other clinical trials activities, our research participant advocate:

  • Communicates frequently with participants and families, the MU Institutional Review Board (IRB) and the MU Office of Clinical Effectiveness
  • Trains investigators and support staff
  • Reviews informed consent documents with investigators and their teams

Learn more about our research participant advocates. Contact:

Susan Kady
Research Participant Advocate
kadysj@health.missouri.edu
573-884-1925
888-280-5002 toll-free

Research Subject Visit & Billing Coordination

Rely on the Office of Compliance & Quality to coordinate communication about research claims issues between clinical trials research staff and MU Patient Accounts personnel. We monitor research subject claims within the billing system daily, weekly and monthly, and help resolve claims questions between the two offices to ensure research claims are paid correctly.

When you need assistance with research claims questions, contact:

Laura Ward
Coordinator, Research Compliance Billing
wardla@health.missouri.edu
573-882-8957

Education & Training

Take advantage of educational sessions and seminars related to clinical research compliance. Programs include the Basic Research Training and the monthly Research Seminar Series.

The Research Compliance & Quality Office also organizes the training schedule, coordinates CE/CME (continuing education) certificate processing with the Sinclair School of Nursing, maintains educational resources and provides administrative support.

Research Seminar Series

Each month, the seminar series offers opportunities for investigators and their teams to learn more about good clinical practice and the responsible conduct of research. Participants can receive continuing education (CE) or continuing medical education (CME) credits. Topics include:

  • Research ethics
  • Responsible authorship
  • Research integrity
  • Conflict of interest
  • Export controls
  • Budget building
  • Biostatistics
  • Research at the VA

To register or learn more about compliance education and training opportunities, contact:

Laura Ward
Coordinator, Research Compliance Billing
wardla@health.missouri.edu
573-882-8957