Clinical Research Operations
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| Richard Lush, III, Ph.D., Executive Director |
Access
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Hours: 8 a.m. - 5 p.m.
Location: Moffitt Clinic Building, room 10302 (ground floor)
Mailstop: CRO-CB
Contact: 813-745-1689 |
Description
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| The Clinical Research Operations administrative office is located on the ground floor of the Moffitt Clinic Building. This office houses the executive director, the directors of the Protocol Monitoring System (PRMS) and the Clinical Research Support System (CRSS), the entire PRMS staff and the CRSS supervisors. |
Protocol Review and Monitoring System (PRMS) provides the following services:
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- Assists in writing Scientific Review Committee and Institutional Review Board applications
- Assists in writing informed consents
- Coordinates and facilitates the agenda and correspondence for both the Scientific Review Committee and the Protocol
- Monitoring Committee
- Facilitates the submission of regulatory documents
- Coordinates the operational review of clinical trials
- Maintains regulatory documents pertaining to clinical trials for the institution
- Provides information pertaining to clinical trials on the Moffitt Web site
- Assists in providing information about cancer trials to physicians and staff
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Clinical Research Support System (CRSS) provides the following services:
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- Supports the investigator in screening and enrolling patients onto clinical trials
- Provides data management support for clinical research trials
- Provides staff education and training pertaining to clinical trials
- Coordinates and implements protocol-related orders for study patients
- Prepares medical charts for audits
- Coordinates the operational review of clinical trials
- Maintains regulatory documents pertaining to clinical trials for the institution
- Provides information pertaining to clinical trials on the Moffitt Website
- Assists in providing information about cancer trials to physicians and staff
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| CRSS staffing for clinical trials at the Cancer Center is centrally managed, yet assigned to clinical programs where the CRSS staff members function as part of interdisciplinary teams under the direct leadership of their respective scientific investigators. In addition to the functions noted above, the CRSS is responsible for recruiting and training clinical research staff. Staff assignments are based upon accrual, utilizing a staffing ratio of approximately 30 to 40 patient accruals (therapeutic) to 1.0 full-time employee. Annual patient accrual of the Cancer Center for fiscal year 2001 exceeds 4000, with over 1000 patients on therapeutic studies. |
The Cancer Center is an active participant in Eastern Cooperative Oncology Group (ECOG), Gynecologic Oncology Group (GOG), Radiation Therapy Oncology Group (RTOG), and the New Approaches to Brain Tumor Treatment (NABTT) Consortium. The CRSS provides single point-of-contact data management support for these cooperative groups to coordinate the Cancer Center's activities, thus ensuring timely and efficient institutional performance. |
Quality assurance is ensured by the cooperation of the CRO with Research Compliance, which is part of the Cancer Center's Corporate Compliance department. With direction from the Protocol Monitoring Committee, Research Compliance initiates internal clinical trial audits, coordinates the audit team and summarizes audit findings in reports to the principal investigator, associate center directors and the Protocol Monitoring Committee. |
Clinical Research Operations Personnel
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| Executive Director, Research Operations: Richard Lush, III, Ph. D. |
| Dr. Lush oversees the staff of the Clinical Research Operations (CRO). He directs the overall processes associated with data management and regulatory issues within the CRO. |
Protocol Review and Monitoring System (PRMS)
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| Director, Lynn Smith, J.D., C.I.M., C.I.P. |
PRMS Research Teams
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| Clinical Research Support System (CRSS) |
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Director, Catherine Wiernasz, M.S.N., F.N.P.
Ms. Wiernasz graduated from Northeastern University in 1992 with a Bachelor of Science degree in nursing. After working as a staff nurse at Massachusetts General Hospital on a surgical thoracic unit she enrolled in a master's program at Michigan State University and graduated in 1996 with a Master's degree in Nursing. During her graduate education she worked on a research grant evaluating caregiver burden with cancer patients. Upon completion of her graduate education she worked as a nurse practitioner in a Flint, Mich., high school teen wellness center. In 1997 Ms. Wiernasz took a job as a nurse coordinator/nurse practitioner with the University of Virginia Cancer Center, division of gynecologic oncology. She then moved into the Cancer Center Clinical Trials Office as the nurse coordinator for investigator-initiated melanoma vaccine trials. In 2001 she became the manager of the University of Virginia Cancer Center Clinical Trials Office and in 2002 she became the Director of the Office of Collaborative Studies in the Human Immune Therapy Center at University of Virginia.
As the Director of the Clinical Research Support System (CRSS) at Moffitt, Ms. Wiernasz oversees daily operations of the clinical research organization. She is responsible for monitoring workloads and determining appropriate staffing levels for the institution's clinical research teams. In addition, Ms. Wiernasz collaborates with other management staff at the institution to assist with problem solving, study coordination, and protocol review work. She provides assistance/oversight to the clinical research staff assigned to disease-specific sites within the Clinical Research Operations office so that studies are conducted within Cancer Center policy.
Supervisor Clinical Research Team I: Dani Zajac, R.N.
Supervisor Clinical Research Team II: To be determined.
The supervisors will manage the daily operation of the CRSS staff and will report to the director of the CRSS. The supervisors will be responsible for monitoring the workload, recommending staffing levels, and for the ongoing development of standard operating procedures for the CRSS staff. The supervisors will communicate with program leaders and principal investigators about the institution's clinical research activity through monthly patient accrual reports. The supervisors will be responsible for the operational review of new protocols with an emphasis on the plan for data collection and quality control, a function that may be delegated to program-based data management staff.
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CRSS Clinical Research Teams
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| The CRSS is organized into research teams, each of which consists of one to three clinical trials coordinators who provide nursing and non-nursing coordination. Teams are based in clinical programs and function as members of the interdisciplinary patient care teams. The CRSS teams coordinate the day-to-day activities associated with patient evaluation for protocol eligibility, and, once the patient is enrolled, assist in the delivery of study-related care and data collection. Together with the clinical program leaders and principal investigators, CRSS nurses help evaluate proposed protocols specifically for feasibility and implementation, assess the availability of patient populations, evaluate eligibility overlap for competing trials, monitor patient accrual to protocols, and participate in quality assurance activities associated with these studies. The non-nursing CRSS staff members are primarily responsible for providing data management support functions, such as data abstraction and collection for patients. In addition to performing data management functions, the non-nursing CRSS staff members support the research teams by providing tracking tools, such as treatment calendars, protocol order sets and schedules for study patients. In addition to these activities, they provide support in preparation for internal and external audits. |
Services
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| Protocol initiation, coordination and administration. |
| Protocol activation and implementation is coordinated through a partnership between the PRMS and CRSS staff. Each oversees their respective assignments in the evaluation, processing and activation of research protocols. The staffs integrate the clinical and administrative aspects of activating a trial. The PRMS initiates and tracks the processes associated with the scientific review, IRB approval and other regulatory approvals. The PRMS monitors the study throughout its life at the Cancer Center. The PRMS coordinates the Moffitt Internal Protocol Review Committees. |
Patient Enrollment
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The CRSS is responsible for ensuring that eligible patients are enrolled onto approved clinical trials. The CRSS utilizes clinical trials coordinators, who actively screen and evaluate new patients as potential study candidates and coordinate the process of patient enrollment onto clinical trials. The CRCC staff also plays active roles with the investigator and patient in the process of informed consent. They review the source document for eligibility criteria prior to patient enrollment with the sponsor. Patient accrual is tracked and monitored locally using RADS, a relational database system that documents patient enrollment and patient status (treatment vs. follow-up) and tracks study accrual goals. Accrual data is communicated monthly to senior management leaders, clinical program leaders, principal investigators and CRSS staff. Reports include clinical research activity accrual for Moffitt Cancer Center and affiliate institutions. With scientific leadership from program leaders and clinical investigators, research teams are responsible for ongoing evaluation of the rate of patient accrual in relation to the projected length of the study. Investigators may be required to close low-accruing studies after regular reviews by the Moffitt Internal Protocol Review Committee (formally known as the Protocol Monitoring Committee).
Coordination of study-related patient care. Working collaboratively with investigators, primary care nurses and hospital departments such as laboratory, pharmacy and specimen processing, CRSS staff members serve a primary role in the coordination of study-related patient care. These individuals work closely with investigators and primary care nurses to ensure that protocol parameters are followed, that necessary modifications are made according to the protocol and that disease-response criteria are being assessed. Data management is available for investigator-initiated, cooperative group and industry-sponsored trials. Data collection, transcription and timely submission are the responsibility of the clinical trials coordinator assigned to the clinical program. Because few protocols utilize computer data entry and remote data retrieval, the majority of studies currently require data transcription and submission of a hard copy. The Biostatistics and Informatics Core is instrumental in developing data collection tools and establishing the process of patient registration and data submission for in-house trials. Patient data from the hospital system can be retrieved via Cerner (an electronic medical records system). The CRSS staff are responsible for tracking the required forms for active trials in their corresponding programs.
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