Office of Compliance & Quality
The Office of Compliance and 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 School of Medicine 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. The office's Research Participant Advocacy Program is part of the School of Medicine's efforts to assure equitable and responsible treatment of research volunteers.
To be a national leader in compliance management by maintaining a comprehensive program using internal monitoring, education, and communication to prevent, detect, and correct potentially non-compliant practices in the medical education, research, and clinical enterprises of the School of Medicine.
The Office of Compliance and Quality will promote a culture of compliance in the School of Medicine and serve as a liason to the network of compliance officers within the university to enhance the school's value to its students, faculty, staff and the public through a commitment to compliance and quality.
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 Laura Ward at (573) 882-8957.
Compliance and 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 Laura Ward at (573) 882-8957.
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 website 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 website, go to clinicaltrials.gov. To get a login account for clinicaltrials.gov protocol registration, contact Susan Koenig, the University's designated PRS administrator, at firstname.lastname@example.org or (573) 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)
What We Do
Susan Koenig, director of compliance and quality and compliance officer for the School of Medicine, works to deliver a comprehensive compliance program that promotes a culture of compliance within the School of Medicine. Susan assists the school's leadership by operationalizing the strategic plan for compliance, investigating potential non-compliance, performing periodic audits of activities within the School, delivering a compliance training program, and collaborating with other compliance units on the campus and within the system to minimize overall risk.
Research visit claims and continuing education
Laura Ward, administrative associate for research billing, monitors research subject claims in the billing system on a daily, weekly and monthly basis. Laura provides a link between the clinical trials support staff and the patient accounting staff, helping resolve claims questions and making sure research claims are paid correctly. Anyone who has a question about a research claim should contact Laura at (573) 882-8957. In addition, Laura organizes the training schedule, coordinates CE/CME certificate processing with the School of Nursing, prepares training materials and PowerPoint presentations, maintains the Sharepoint compliance and quality web version of orientation and compliance resources, and provides administrative support.
Monitoring and auditing programs
Greg Clawson, health care compliance coordinator, is responsible for the monitoring and auditing program for clinical research, and assists investigators and their support staff in navigating regulatory requirements and minimizing compliance risk. Audits are conducted in conjunction with the network of compliance programs that oversee research in the School of Medicine. The audit programs are continuously modified to address areas of concern. The health care compliance coordinator participates in planning and delivering training programs and serves as a resource for staff with regulatory questions.
Research participant advocacy
Kathy Donovan, research participant advocacy coordinator, provides direct oversight of the informed consent process and other clinical trials activity, communicates with participants and trains investigators and support staff. Kathy assists investigators in reviewing and determining appropriate action with regard to adverse events, reviews protocols with investigators and their teams and participates in developing data safety and monitoring plans. She maintains a presence in clinical trials areas and assists participants and their families. In her role as Advocate, Kathy conducts training programs for the community as well as investigators and their staff and maintains frequent communication with the IRB and the Office of Clinical Effectiveness.