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The Clinical Research Team. Allison R. Baer, RN, BSN,Robin Zon, MD, FACP,Susan Devine, CCRP, and Alan P.
Lyss, MDAmerican Society of Clinical Oncology, Alexandria, VA; Michiana Hematology Oncology and Northern Indiana Cancer Research Consortium, South Bend, IN; Clinical Trial Support Unit Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada; Missouri Baptist Cancer Center and Heartland Cancer Research, Saint Louis, MOCorresponding author: Allison Baer, RN BSN, American Society of Clinical Oncology, 2. Mill Rd, Suite 8. Alexandria, VA 2. B. nosill. A. Accepted 2. Mar 2. 3. Copyright © 2.
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American Society of Clinical Oncology. This article has been cited by other articles in PMC.
Abstract. Developing and maintaining an exemplary research team is essential to the success of a quality clinical research program. Staff is one of the most important, yet expensive, components of a research program. Of the total time and effort required to conduct a clinical trial, nurses and data managers each contribute > 3. Although investigators appreciate the research team's value, they are often uncertain about how to properly develop and manage the team. To help investigators develop the required knowledge and skills to run a clinical research program, Journal of Oncology Practice (JOP) chose to publish several articles on this topic. This article is part of the series on exemplary attributes of clinical trial sites, highlighting the attributes of sites conducting quality clinical trials. In the most recent issue of JOP is an original research article reporting on the Ontario Protocol Assessment (OPAL) tool, which is an evidence- based tool for assessing trial complexity and associated workload.
The OPAL tool is an important addition to the field because it accounts for trial complexities that were not addressed in workload tools developed in previous decades. Delegation of Research Tasks. A research site's principal investigator is responsible for oversight of clinical trials but can delegate research tasks to appropriately trained staff (investigator responsibilities are discussed in the previous article in the JOP series on exemplary attributes).
Matching individuals with suitable tasks ensures that the program's resources are being used appropriately and that staff enjoy and remain challenged by their responsibilities. Knowing what task can be delegated to individuals on the research team can be challenging because it varies on the basis of an individual's experience and licensure. A research team may include clinical research associates (CRAs), research nurses, data managers, and study coordinators.
Depending on a program's organizational structure, the responsibilities assigned to each may differ greatly from one research program to another, both within and outside the United States. Tasks assigned to the staff include screening for potential study candidates, determining eligibility, coordinating the patient calendar, preparing documents for submission to institutional review boards, filing amendments, submitting safety data, conducting patient education, obtaining informed consent, and assessing potential adverse events. When resources permit, it is also helpful to have a manager or coordinator who supervises the program by overseeing quality assurance, staffing, budgeting, and site audits. This person will work closely with the primary investigator to ensure that all investigator responsibilities are being met. A common mistake to avoid is delegating tasks to someone who is overqualified, such as assigning the task of photocopying to a registered nurse. Poor delegation leads to inefficient use of the program's resources and may cause staff to become dissatisfied with their duties. The clinical research manager can help ensure that tasks are being delegated appropriately.
Once tasks have been delegated, many sites will use a delegation log to document which staff person has been delegated each specific study task (Figure 1). A delegation log should be completed for each study open at the site, because staff responsibilities often vary among trials. The site should also keep documentation of training modules that have been completed by each staff member. Training logs might be divided into (1) training that must be completed by new members of the research team (Figure 2), and ongoing training that must be maintained by the entire research team (Figure 3). Standard operating procedures (SOPs)6 that address training requirements can further document the process and ensure it is sustainable. In addition to pursuing basic research training requirements, CRAs and research nurses should be encouraged to pursue specialty certification because instruction about conducting clinical research is generally not taught in health science or nursing education programs. Certifications are offered by the Society of Clinical Research Associates.
Association of Clinical Research Professionals. Clinical Trials Support Unit task delegation log. AE, adverse event; CRF, case report form; IRB, institutional review board. From Hospital for Sick Children, Toronto, Ontario, Canada.
Adapted with permission. Training log for new clinical research associates (CRAs). P& P, policies and procedures; SOP, standard operating procedure; AE, adverse event. From Hospital for Sick Children, Toronto, Ontario, Canada. Adapted with permission. Training log for clinical trials core tasks. TCPS, Tri- Council Policy Statement; NIH, National Institutes of Health; COG, Children's Oncology Group; CRA, clinical research associate; GCP, good clinical practice; CCRP, certified clinical research professionals..
It is most effective when research staff are assigned solely to the research program. For example, if the research program can only support 0. When one position is split between both research and clinical practice, the research tasks often get neglected. The Extended Research Team. The research team extends well beyond the individuals who are directly employed by the research program.
For example, infusion nurses are generally not on the payroll of the research program but are often responsible for administering investigational drugs and monitoring trial participants during infusion of the agent. The same is true of pharmacists, who may or may not be employed directly by the research program.
It is important that pharmacists who support the research program receive training regarding drug accountability, because requirements vary greatly between standard practice and clinical research. There are also administrative roles that might be delegated to individuals external to the research program, such as billing and contracting. Patient navigators and advocates also play a critical role at many clinical research sites. Collaboration among all individuals who support the clinical research program will enable the full potential of the program to be realized.
Physician colleagues are vital to the success of the research program even when they are not listed as an investigator on the protocol. Surgeons, pathologists, radiologists, and many other specialists play an integral role in the conduct of quality clinical trials. It is important that all of these individuals are knowledgeable about the requirements of clinical trials to which they will be contributing, especially specific laboratory or diagnostic imaging requirements. The site's clinical trial implementation process should include collaboration with these specialists, who provide invaluable perspective regarding the feasibility and site- specific logistics of the protocol requirements.
Outreach to primary care providers is also important. Every physician who interacts with a patient can influence the patients' understanding and desire to participate on clinical trials.
Because the direct benefit of clinical research may not be apparent to all medical professionals, efforts to promote support among staff are essential. Awareness about clinical trials needs to occur at all levels of the institution and should be incorporated in the mission and vision of the site.
For some professionals, education and awareness activities can make a positive impact on their willingness to contribute. This can be done via in- person meetings in which individuals can connect with the research team and have their questions answered. Clinical professionals should also be educated about specific trials open at the site. For example, an informal lunch might be held to educate infusion nurses about current clinical trials open at the site and any special requirements associated with infusion of the investigational agent and potential adverse effects for which patients should be monitored.
Beyond education, there are several other ways to promote staff support of the research program, such as discussing how the research program can be a source of revenue for various departments. For example, although a special laboratory test may require increased effort on behalf of the staff in the laboratory, it might also represent a new way for the lab to generate income.
Because private trial sponsors usually reimburse at cost, reimbursement for the tests might be higher than what is paid by third- party payers. Physician colleagues might also benefit from discussions about how the clinical research program can contribute to research that is important to them. For example, a pathologist who conducts basic or translational research might volunteer time to the clinical research program because specimens that are collected for the purpose of research ultimately enable the progress of the pathologists' research. Working collaboratively and understanding the opinions and needs of colleagues at the site will promote a culture of clinical research.
Promoting Staff Satisfaction. Even in a challenging economy, a number of things can be done to promote staff satisfaction and maintain, or improve, staff retention. Foremost, it is important that the program's leadership show respect and esteem for all staff.