RESEARCH INFRASTRUCTURE
The Department of Obstetrics and Gynecology Clinical Trials Office is located at The Ohio State University main campus in the Cramblett Medical Building. This is the outpatient clinic site for the Department. Approximately 33597 (new and return) patient visits occur here per year. Clinical Trial Office of the Division of General Obstetrics and Gynecology was established in 1997 under the leadership of Lisa Keder, MD. The Division has now evolved into a group of 12 full-time faculty members. The Division is one of the largest, strongest, and well rounded General Divisions of Obstetrics and Gynecology among academic medical centers. Current faculty have expertise in the areas of colposcopy and vulvar disease, contraception and family planning, menopause, adolescent and pediatric gynecology, gynecologic ultrasound, infections diseases, sexual dysfunction, chronic pelvic pain, general obstetrics, medical education, and teenage pregnancy.
The Clinical Trials Office was established for the implementation, administration, and support of clinical trials conducted by the Department of Obstetrics and Gynecology. Lisa Keder, MD., Associate Professor is the physician charged with oversight of the Clinical Trials Office. Dr. Keder, who has a master degree in public health, has extensive training in clinical research with 11 years experience in conducting both federally funded and industry sponsored clinical trials. Under the leadership of Dr. Keder the CTO is responsible for the development of clinical trial protocols, review of incoming protocols, assignment of protocols to appropriate investigators and the conduct of trials. The CTO provides support to the General Division of Obstetrics and Gynecology 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 and faculty training. The CTO is also responsible for administrative functions required to manage projects, financial reconciliation of budgets, monitoring quality assurance and maintaining regulatory compliance.
CTO has participated in several large-scale, industries sponsored multi-center trials. The subject continuation rate was greater than 90% and data collection close to 100%. The research group is experienced in working very closely and actively with data coordinating centers; developing data collection tools and other items, working collaboratively with other members of the consortia. The OSU CTO brings a wealth of experience and expertise to the conduct of clinical research. . One of the strengths of the Division is that it continues to grow and expanded its activities in clinical research. Thanks to the quality of conducted clinical trials and importance of collected data, Dr. Lisa Keder, Dr. Jonathan Schaffir, Dr. Deborah Bartholomew, Dr. Cynthia Evans, Dr. Michael Blumenfeld and Dr. Wayne Trout have earned a good reputation in the research community. Building on our reputation for research that makes an impact, we continue to strengthen our capacity to improve women’s care. Through our partnership with different sponsors, we have four to seven ongoing clinical research projects at any given time.
The Clinical Research Team: The clinical research team is formed under the leadership of the Principal Investigator with the sub-investigators, the CTO leader Lisa Keder, MD., a Clinical Research Manager, a Clinical Research Coordinator (Research Nurse), a Clinical Research Associate (Data Coordinator). Communication between staff members, the clinical research teams and the PI is ongoing and occurs on a daily basis in most cases.
Clinical Research Staff: Currently the Clinical Research Office is staffed by the Clinical Research Manager, Nonna Stepanov, MD, CCRC; Clinical Research Coordinator, Kathy Martin, RN; Clinical Research Associate, Tricia Jones, BS, Office Associate, Julie Gunn; and a student assistant. All staff members are trained in Human Subjects Research, GCP and ICH Guidelines. All research staff is CITI Certified. Nonna Stepanov and Kathy Martin are both ACRP certified. They are cross-trained in research quality data collection, protocol required procedures, EKG measurements, phlebotomy and sample processing and shipping, study drug administration (as appropriate and per licensing requirements), radiation safety, AE and SAE reporting. They are well versed in case report form completion, study documentation, investigational product accountability, electronic data entry (dial in or via the internet) and the Smart Pen submission. All have received additional training at investigator meetings and annual training in house.
Administration: Dr. Keder is responsible for the administrative functions of the CTO and for its management. She is also responsible for the hiring and training of new staff, and for training of new investigators. She is also responsible for establishing community collaborations and providing project oversight. Quality assurance for industry sponsored trials is performed by sponsor representatives. Nonna Stepanov is responsible for quality assurance audits for federally funded or non-funded studies. She is in close communication with sponsors, the research foundation and the Institutional Review Board. Staff meetings are conducted monthly; however, there is daily communication within the groups and monthly (or as needed) meetings with the PIs. Julie Gunn is responsible for the establishment and monitoring of subject stipend accounts.
Regulatory Compliance: Nonna Stepanov, with assistance from other 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, adverse events to subjects or other items such as study closure. The Ohio State University IRB has a collaborative arrangement with the Western Institutional Review Board (WIRB) whereby the OSU IRB reviews and approves non-industry sponsored trials and WIRB reviews industry sponsored trials. Nonna Stepanov is also responsible for final study closure, review of final documentation, and archiving of study documents at off site storage locations.
Research Facilities: The primary location for clinical trials is the Ohio State University Medical Center outpatient clinic, Cramblett Medical Center. However, we also have one approved off-site satellite clinic at a suburban outpatient obstetrics and gynecology office. This site is also available for research. At the primary location one exam room is designated for research use although other rooms are available on an as-needed basis. All study documentation and subject information is maintained in locked, restricted-entry, staff offices. Site is equipped with the centrifuge, refrigerator and a freezer ( -70)
Subject advocacy and Safety: The Investigators and research staff are all responsible for subject recruitment. Informed consent is obtained at the time of a clinic visit or at a separate visit by trained staff. Potential research subjects are identified from the OSU OB/GYN practice or through referrals. The study staff contact eligible and/or interested participants either in the clinic or by telephone to explain study details and to determine their interest in participating in medical research. The study is then explained to potential participants in a private exam room or area, using the informed consent form (IC) as a basis for discussion and review. In general this process takes about 1-2 hours. Patients have an opportunity to review the IC 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 obtain informed consent and HIPAA authorization at the time of clinic visit and prior to performing any study-related activities. A copy of the signed IC/HIPAA authorization to share study information is given to subjects once they decide to participate in the research study and sign the IC. Dr. Keder serves as the subject’s advocate and the Research Coordinators serve to monitor subject safety and alert the physician investigators to any adverse events or safety issues.
Contact Information: The general phone number for the CTO is 614-293-0075 and the address is Department of Obstetrics and Gynecology, The Ohio State University, Cramblett Medical Clinic, Room 2960, 456 West 10th Avenue, Columbus, Ohio 43210. Contact person is Nonna Stepanov at Nonna.Stepanov@osumc.edu
Additional Information: Curriculum Vitae (s) are available upon request.
Contact Information: Nonna Stepanov,
614-293-0075 (ph), 614-293-7031 (f),
Nonna.Stepanov@osumc.edu