A. The MSHA Corporate Department of Research serves as the central office for multi-specialty research oversight in the Mountain States Health Alliance (MSHA) healthcare system which is composed of 14 hospitals and provides an integrated comprehensive continuum of care to people in 29 counties in Tennessee, Virginia, Kentucky, and North Carolina. The MSHA Corporate Department of Research is located in Suite 45 of the 408 Office Building on the Johnson City Medical Center’s main campus and also houses the department’s main clinical facilities.
In addition to providing oversight for all types of research conducted at MSHA facilities, the office also provides support to Principal Investigators in a variety of therapeutic areas which currently include cardiology, oncology, rheumatology, endocrinology and orthopedic. The MSHA Corporate Department of Research was established in 2006 under the leadership of Kathy Roach for the implementation, administration, support and oversight of clinical trials, and has evolved into a group of full-time employees including our current Department Director, Nonna Stepanov, MD, four RN clinical research coordinators and a research assistant. Research Department receives a support from Finance and Legal Departments at MSHA.
Nonna Stepanov, MD, CCRC. , received Master Degree in Medicine from Kyrgyzstan. She has 15 years of research experience in both industry-sponsored and federal trials as well as investigator-initiated trials. She oversees the day to day functions of the department. Under the leadership of Dr. Stepanov, the research department is responsible for the review of incoming protocols, assignment of protocols to appropriate investigators and the conduct of trials. The research department provides support to investigators in collaborative, industry-sponsored and investigator-initiated studies through facilitating review of confidentiality agreements, clinical trial agreements, budget development/negotiations, regulatory submissions, appropriate collaborative arrangements, establishment of internal contracts, subject recruitment, and staff training. The research department is also responsible for administrative functions required to manage projects, financial reconciliation of budgets, and maintaining regulatory compliance.
The research department has participated in several large-scale, industry-sponsored multi-center trials with subject retention at a nearly unheard of 100% rate. Several of the trials in which we have participated have resulted in FDA approval for new medications used to treat acute coronary syndrome, acute myocardial infarction and atrial fibrillation. With MSHA physicians’s stellar reputation in the research community, we have developed strong partnerships with many sponsors, and as new, well-qualified investigators join our team, we will continue to strengthen our position in the pharmaceutical industry-sponsored clinical trial arena.
The research group brings a wealth of experience and expertise in the conduct of clinical trials while continually expanding its investigator and therapeutic area experience. We have average between 7 and 15 open trials at any given time.
B. The Clinical Research Team: The clinical research team is formed under the leadership of the Principal Investigator with the sub-investigators, the Department Director, Nonna Stepanov, MD.CCRC, Clinical Research Coordinators (Research Nurses), and a Clinical Research Assistant. Communication between study staff members is ongoing and occurs on a daily basis in most cases.
C. Clinical Research Staff: Currently the Clinical Research Office is staffed by the Department Director, Nonna Stepanov, MD, CCRC; Margaret Hilton, RN, Clinical Research Coordinator, Team Leader for cardiology trials; Patsy Spears, RN, Clinical Research Coordinator, Chemotherapy/Biotherapy Administration Certified; Team Leader for onco/rheumatology trials and Christy Duncan, Research Administrative Assistant. All staff members are trained in Human Subjects Research, GCP and ICH Guidelines. All research staff is CITI Certified. Clinical Research Coordinators are cross-trained in research quality data collection, protocol required procedures, EKG measurements, phlebotomy, study drug administration (as appropriate and per licensing requirements), AE and SAE reporting. They are well-versed in case report form completion, study documentation, investigational product accountability, electronic data entry, and IVRS/IWRS. All have received additional training at investigator meetings and annual training in-house.
D. Administration: Dr. Stepanov also oversees the administrative functions of the research department and its management. She is responsible for the hiring and training of new staff, establishing community collaborations and providing project oversight. Quality assurance for industry sponsored trials is performed by sponsor representatives. Staff meetings are conducted monthly with research team meetings occurring at more frequent intervals; however, there is daily communication within the study team and with the PIs. Christy Duncan with assistance from Accounting Department works on the establishment and monitoring of subject stipend payments.
E. Regulatory Compliance: Research staff with assistance from the clinical staff, is responsible for obtaining initial protocol approval from the Institutional Review Board (IRB) prior to study initiation, for obtaining timely continuing review approvals during the course of the study, and for ongoing communication with the IRB regarding any amendments/changes, or other items such as study closure. SAE reporting is handled by the clinical study staff. All MSHA facilities are under the oversight of the East Tennessee State University Office of Human Research Subjects Institutional Review Board with a typical turn-around time for initial IRB approvals from submission to approval of approximately five weeks. Site allows to use central IRB(s) of sponsor’s choice. Research staff is responsible for final study closure after review of final documentation has been completed by the respective clinical research coordinator. Christy Duncan, Research Assistant is responsible for the archiving of study documents at our secure off-site storage location.
F. Research Facilities: The primary location for clinical trials is at the 408 State of Franklin Rd, Suite 45, Johnson City, TN location which is listed on our Federal Wide Assurance along with many of our other system hospitals and MSHA owned oncology centers. At the primary location four exam rooms are designated for research use and we have adequate storage space for study supplies/binders. All study documentation and subject information is maintained in a confidential manner in a locked, restricted-entry office.
The site is equipped with a designated secure pharmacy area which is double-locked and is under continuous temperature monitoring control. Site personnel also have access to a locked refrigerator for secure investigational product storage. Our designated research pharmacists are Priscilla Dollard, Pharm D. and Marie Shinkle, Pharm D.
Our site utilizes the on-site Johnson City Medical Center Laboratory to process and send laboratory specimens. The laboratory is CLIA and state certified and is equipped with a centrifuge, a refrigerated centrifuge, a refrigerator and a freezer (-20° F and -70° F). Our designated laboratory research coordinator is Sarah Jenkins.
Several MSHA hospitals/clinics in Tennessee, Virginia, Kentucky and North Carolina may function as sub-sites under supervision of MSHA Research Department. They all equipped for conducting research activities on site.
G. Subject advocacy and Safety: The Investigators and research staff are all responsible for subject recruitment. Depending on the nature of a trial, subjects may be approached about their interest in one of the enrolling clinical trials while they are in-patients at the Johnson City Medical Center, or are being seen as out-patients in one of the investigators clinics. Additionally subjects may enter a clinical trial through a referral from another physician. Once a subject has been identified as having an interest in a clinical trial, they are provided with an overview of the study and the IRB approved consent form for review by the study staff. If the trial is not of an acute nature, potential participants may take the informed consent home to review at their leisure and discuss with their family and friends and study staff will arrange a convenient time to contact the patient to assess their interest and/or set up a screening visit.
As some trials in which we participate are of an acute nature, informed consent may be obtained during the subjects’ hospitalization after they have had sufficient time to consider their participation within the time constraints of the protocol. Or, in the case of a trial that is not such an urgent nature, consent will be obtained at a later time during a clinic visit or at a separate visit by trained study staff. In all cases, consenting is done in a private area where the study is explained in detail and all of the participants questions are answered to their satisfaction prior to subject’s signature of the IRB approved consent form. During the review of the study and consent form, patients have an opportunity to review the informed consent in private, ask questions, initiate discussion, and have time to think about their participation in the study, if necessary after discussing it first with the principal investigator, their family, or others. Investigators, with the assistance of clinical research coordinators obtain informed consent and HIPAA authorization (IC/HIPAA) at the time of clinic visit and prior to performing any study-related activities. In general this process takes about 1-2 hours. A copy of the signed and dated IC/HIPAA authorization to share study information is given to subjects once they decide to participate in the research study and sign the IC/HIPAA. Research Coordinators serve to monitor subject safety and alert the physician investigators to any adverse events or safety issues.
H. Contact Information: The general phone number for the MSHA Research Department is (423) 431-5647 and the address is 408 North State of Franklin Rd., Suite 45, Johnson City, TN 37604 Contact person is Nonna Stepanov at firstname.lastname@example.org.
I. Additional Information: Curriculum Vitae (s) are available upon request.