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Research Day

Join us for Research Day 2014 on Friday, Aug. 22. Attendees will learn about creating investigator-initiated clinical research projects. Topics will include the formation of research questions, selection of study variables and research design, and determination of appropriate outcome measures. See the official Research Day brochure here.

Thank you to all of you who attended our inaugural Research Day on September 6, 2013. We had more than 115 state-wide attendees at the event. The presentations have sparked conversations and will hopefully improve our methods of conducting and reviewing research for our state’s population. In case you missed Research Day, we have summarized the key points from each session. In addition, please click on the link after each summary to access a video recording of the presentation.

The morning session was provided by Kelly Willenberg, MBA, BSN, CHRC, CHC. Her first presentation focused on “Coding, Billing, and Reimbursements for Clinical Trial Subjects.”  She discussed the necessity of providing the appropriate codes (e.g. secondary diagnosis code of v70.7, condition code 30, device revenue codes, IDE number) and modifiers (i.e. Q0 or Q1) on hospital and physician claims when submitting routine care items of a qualifying study. In addition, she stressed the importance that processes must be implemented that ensures that patients participating in research studies are identified to allow correct billing/coding and that all study documents (protocol, coverage analysis, contract, consent) should be in agreement to prevent allegations of misconduct.  Video recording

Ms. Willenberg followed up her first talk by explaining “How to Perform and Leverage a Coverage Analysis.” In brief, a coverage analysis is a document that identifies the ‘routine’ items or services that are typically provided absent of a trial versus the items that are research-related only. Routine care can be billed to the patient’s insurance, while the research-related only items/services should be reimbursed by the study itself. She also emphasized that all documents should be closely reviewed to ensure agreement (e.g. contract and consent form). Performing coverage analyses will help to ensure proper budget construction, appropriate billing of patients/insurance, and necessary documentation.  Video recording

In the presentation by Tamera Norton-Smith, PhD, MT (ASCP) entitled “Enhancing Participant Safety through Good Clinical Practice (GCP) and Self-Monitoring,” she discussed the importance of starting any new study with a clear plan for self–monitoring and understanding the various roles the FDA, Sponsor, Investigator, and IRB play in order to provide an umbrella of protection for participants in a research study. One of the objectives of her presentation was how to solve Good Clinical Practice (GCP) challenges to ensure proper conduct of research that prevent noncompliance and decreases risks to research participants. She also discussed Corrective and Preventive Action (CAPA) plans for when an issue is discovered, as well as the Bioresearch Monitoring Program (BIMO). BIMO is a comprehensive, FDA-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research.  Video recording

Souvik Sen, MD, MS, MPH, FAHA discussed “Informed Consent in Research: Practical Aspects.” His presentation covered the basic elements of informed consent, but also discussed who is qualified to obtain informed consent. An overview was provided for the general requirements of informed consent which includes areas such as voluntary participation, identification of risks, benefits, and alternative procedures, as well as how confidentiality should be maintained. Dr. Sen also noted the importance of investigator training such as following good clinical practice guidance and taking appropriate actions to ensure the rights and well-being of study participants are protected.  Video recording

Melanie Griswold, RN, CCRC presented “Recognizing Quality Source Documentation.” The session described how to incorporate best practice source documentation into the research environment. Federal regulations and International guidelines set forth the requirements for source documentation. The essential characteristics of quality source documentation can be described with the acronym ALCOA, A – attributable, L – legible, C – contemporaneous, O – original and A – accurate. She shared how to correctly make changes to source documents when necessary. Lastly, she discussed the consequences of failure to maintain quality source documentation; including damage to reputation, loss of funding and civil or criminal penalties.  Video recording

Sue Heiney, PhD, RN, FAAN, of the College of Nursing at University of South Carolina, presented an exciting and thought provoking segment on “Diversity in Research” with a focus on clinical trials.  She drove home the point that clinical trials study populations should be representative of the general population to help better determine side effect profiles, health risks for certain diseases, and potentially better health outcomes based on gender and ethnicity.  Dr. Heiney encouraged each of us to be aware of the barriers that hinder diversity in study recruitment when developing a clinical trial.  Video recording

The day ended with a lively question and answer period with a panel made up of study patients.  The panel urged research teams to speak plainly and be patient and understanding when explaining research studies during and even after the recruitment process.