About Us

Centralized Communication

The Office of Compliance & Quality serves as the first point of contact for compliance in the School of Medicine. The Director of Compliance assists the Dean, Associate Deans, faculty and staff of the SOM with compliance questions, training requirements, reports of potential noncompliance, regulatory requirements related to research, medical education, conflict of interest, and other areas, and acts as a liaison to campus and system compliance personnel. The Office serves as a centralized communication point for research subject billing, creating a bridge between research support staff and patient accounting staff.

Orientation to Clinical Research Compliance

Clinical Research Compliance Orientation is provided for new clinical trials support staff. The Orientation was developed in response to a pressing need identified by the Coordinators Council to train new employees who come to the job with varying degrees of experience in clinical trials support. Orientation is designed to equip the new employee with a quick start of basic requirements. In-depth information is also provided on staff training, project approval channels, budget basics, research subject billing, and specific internal policies and external regulations. The overview is delivered in a two-hour presentation that includes two CEs. Each attendee is given a manual for desk-top reference, along with a link to a web page for downloadable versions of all the material in the Orientation. To register or learn about upcoming Orientation sessions, contact Pam Buhr at 882-8957.

Compliance & Quality Seminar Series

The Seminar Series provides monthly opportunities for investigators and their staff to learn more about specific aspects of Good Clinical Practice and the Responsible Conduct of Research. Topics include Research Ethics, Responsible Authorship, Research Integrity, Conflict of Interest, Export Controls, Budget Building, Biostatistics, and Research at the VA. CE and CME credits are offered. The calendar of events lists dates, times, topics and presenters. To register or learn more about upcoming events, contact Pam Buhr at 882-8957.

Coordinators Council

The Coordinators Council provides a communication forum that promotes good clinical practices and identifies the most pressing training needs of the clinical trials support staff. Meetings are open to all support staff, and the agenda consists of a blend of regulatory updates and an open exchange of ideas.

Clinical trials registries

Investigators are increasingly encouraged to list their trials on clinicaltrials.gov. The FDA, International Committee of Medical Journal Editors, World Health Organization and the Associate of American Medical Colleges have all recommended that clinical trials be made public by the time subject enrollment begins. The web site clinicaltrials.gov was developed to meet the FDA requirement, and provides information to the public about clinical trials research. The Protocol Registration System (PRS) includes an institutional listing for the University of Missouri – Columbia. To review the web site, go to www.clinicaltrials.gov. To get a login account for clinicaltrials.gov protocol registration, contact Susan Koenig, the University’s designated PRS administrator, at koenigse@health.missouri.edu or 882-2460. A flowchart can help an investigator decide whether to list a trial, depending on organizational or regulatory requirements.

Research subject claims

The Office serves as a centralized contact point between clinical trials support staff and Patient Accounts personnel for research claims issues. A centralized process has been developed through a collaborative effort of Patient Accounts and the School of Medicine. (https://docushare.umh.edu/dsweb/View/Collection-1011)