Centralized Education and Training Services for Clinical Research Personnel - Services
Development of clinical oncology research education and training programs: The CETS staff works collaboratively to design program curricula, establish behavioral objectives, identify and secure appropriate faculty, and design program evaluations to educate and train new research personnel. The curriculum is based on needs assessments, planning committee input, CETS Advisory Committee recommendations, and new regulatory and compliance information. The CETS staff collaborates with relevant Shared Resources (e.g., OHRS, Research Pharmacy, Biometrics, Bioinformatics) to expand upon previous concepts. Upon completion of programs, evaluation data are summarized by CETS staff and provided to course faculty and members of the CETS Advisory Committee. The development of curriculum and programs are closely coordinated with the Office of Education and Training, overseen by the Deputy Director in order to share educational materials, resources, and speakers. Since time of the last grant submission, two courses have been offered that are targeted for new research personnel and for continuing education of existing research personnel: Basic Clinical Research Course and Clinical Research Design Course.
Assist the OHRS regulatory affairs service in dissemination of evolving regulatory and compliance information and incorporate into education sessions: The OHRS Manager of Regulatory Affairs is a member of the CETS. He is charged with oversight of evolving regulatory and compliance issues, and assists in the task of disseminating this information by the CETS. If a new regulatory or compliance issue is identified, the OHRS Regulatory Affairs Manager or designee prepares a “CINJ Regulatory Alert” that is disseminated to all members of the OHRS, the Research Pharmacy, clinical principal investigators, and all CINJ Oncology Group research staff by the CETS Administrative Assistant; the CETS Director and Education Specialist makes certain the issue is incorporated appropriately in subsequent educational sessions and that program materials reflect such changes.
Development of specific protocol educational programs: The CETS staff works with Research Program Leaders and clinical investigators to develop specific protocol education. This ensures that the research staff is fully knowledgeable about the nuances and complexities of specific protocols before protocol initiation. Many studies require coordination, not only with the clinical research-oriented shared resources such as the OHRS and the Research Pharmacy, but also with other shared resources, such as the Biospecimen Repository Service and the Pharmacokinetics/Pharmacodynamics Shared Resources. Members of the CETS staff are responsible for ensuring that all research personnel and clinical staff involved in the trial can carry out the study in a knowledgeable and confident manner while maintaining protocol compliance. The goal of each protocol specific in-service is quality patient care as specified by each clinical trial protocol and quality data collection to support scientific validity.
Specific protocol education focuses on the most elemental research process as it involves communication and linkage between the PI, the research personnel monitoring the trial and the clinical staff delivering the protocol specifics. The usual format for specific protocol education includes overview of investigational agent(s), study objectives, study design, study population, inclusion /exclusion criteria, treatment schedule /duration, pharmacokinetics draw schedule, vital sign monitoring log, handling spills / vaccine precautions, if appropriate, monitoring for adverse events, dose modifications, patient education, patient study calendar, and nursing considerations such as, standard operating procedures.
Program material production: CETS prepares and produces program materials including course syllabi and resources to assist in participant learning, such as copies of slides and faculty publications. Such material is provided in a course binder for each of the participants. Materials to be included are provided by course faculty and reviewed by members of the CETS Shared Resource. The CETS Administrative Assistant completes program material production and transports the material to the program location.
Coordination of educational programs and meetings: Designated program assistants or specialists within CINJ’s individual sections such as nursing, CINJOG, OHRS or Research Education and Training are responsible for coordinating the scheduling of all educational programs, securing program locations, audiovisual equipment, meals, public safety and housekeeping support, and parking availability. In addition, the CETS Staff Assistant arranges meetings of the CETS Advisory Committee. Minutes of these meetings are maintained and disseminated by the CETS Administrative Assistant or designated personnel.
Provide ongoing safety and monitoring education: CETS provides ongoing safety and monitoring education to clinical research staff to help ensure compliance with the CINJ Data and Safety Monitoring Plan (Section 12.0).
Research educational needs assessments: The Manager of CINJOG and staff are in frequent contact with the research centers of the CINJ Oncology Group. Education needs are determined and where possible, tailored for the institution. Other members within CINJ are surveyed periodically about adequacy of CETS activities and to ascertain additional educational needs. The CETS Advisory Committee reviews results of these assessments.