Role Of Clinical Research Nurse Research Articles

Expert consensus on clinical research nurse management in China

ObjectiveWith the rising number of clinical trials conducted in China, the role of clinical research nurses (CRNs) within clinical trial organizations has become increasingly crucial. However, in the absence of industry guidelines, the management of CRNs lacks clarity. This study aims to address this gap by establishing a consensus on CRN management. MethodsThe International Association of Clinical Research Nurses (IACRN)-Shanghai Chapter assembled a panel of experts to develop a consensus on the management of clinical research nurses. This consensus was formulated through an extensive literature review, expert evaluations, and collaborative conference discussions. ResultsThe consensus document offers a comprehensive professional definition of CRNs and provides detailed insights into their management. It covers aspects such as job settings, qualifications, responsibilities, training, assessment, workload management, staffing allocation, performance evaluation, and career progression. ConclusionsEstablishing a professional definition for CRNs creates a standardized reference point for clinical trial institutions to effectively manage these professionals. Consistency in CRNs’ roles, training, staffing, and corresponding assessments is essential for promoting their sustainable and healthy development within the field of clinical research.

How clinical research nursing is shaping the future of urology trials

Nursing research has been developing, particularly over the past 15 years. The role of the clinical research nurse (CRN) is vital because of nurses' high level of patient contact. They are therefore involved in the identification of suitable study participants, initial contacts, enrolment, monitoring and follow-up. The COVID-19 pandemic has emphasised the importance of research to government, the NHS and patients. In this article, the author describes three research studies in which she has taken part and emphasises the importance of research and the role of CRNs in bringing together nursing, medicine and science through the CRN's specialist knowledge and how this particular career choice in nursing is now gaining greater attention and momentum.

Clarifying the role of clinical research nurses working in Sweden, using the Clinical Trial Nursing Questionnaire - Swedish version.

AimTo explore the role of CRNs in Sweden and differences in competences and tasks, using the Clinical Trial Nursing Questionnaire – Swedish version (CTNQ‐SWE).DesignA cross‐sectional survey.MethodsParticipants were identified through strategic sampling. Data were analysed by descriptive and comparative statistics.ResultsThe respondents were experienced nurses who felt proficient in their role, they felt more acceptance by the principal investigators than by nursing colleagues. A majority of CRNs are involved in all procedures specified in the CTNQ‐SWE. The most often performed tasks, also rated as the most important by the CRNs, concerned informed consent and management of investigational products. The education was often informal: with a lack of job descriptions and professional development plans. Need of formal specialist education was expressed.ConclusionsKnowledge about the role description can be used by clinical research enterprise internationally and healthcare organizations aiming to support CRNs in their role.

Extending the description of the clinical research nursing workforce.

The role of Clinical Research Nurses across the globe has not been evaluated to identify similarities or differences among specific activities. This study's aims were to determine differences in Clinical Research Nurses most frequently performed activities, if these activities are reflective of those previously described in the literature, and job titles Clinical Research Nurses use to self-identify. An online cross-sectional survey distributed via snowball sampling through email, social media, and research nurses' networks included questions on frequency of activities performed and information related to job titles. Pearson's chi-square test is analyzed for associations between the groups. Respondents returned 252 questionnaires, 233 were eligible for analysis. Research nurse activities performed internationally showed both similarities and differences. Any between country comparisons will be limited to the United States and the United Kingdom. The three most common tasks reported were recruitment 120 (51.5%), monitoring the research participant for potential adverse events 187 (80.2%) and providing nursing leadership within the interdisciplinary team 169 (72.5%). Considering the context and range of activities of the original Clinical Research Nursing Domain of Practice, broadening the framework to include the leadership domain will better serve as a foundation for the specialty practice.

The role of clinical research nurses in minority recruitment to cancer clinical trials

Clinical trials (CTs) are the established research mechanism designed to examine how new medical therapies are tested for safety and effectiveness. Specifically, non-Hispanic White patients still account for most CT participants and Black patient participation has declined over the past decade. Clinical Research Nurses (CRNs) whose scope of practice includes the recruitment of participants for CTs, have the potential to significantly increase minority patients participation in cancer clinical trials (CCTs). The aim of this phenomenological study was to describe adult oncology CRNs' lived experiences of recruiting minority cancer patients to participate in CTs. A total of 19 nurses participated in semi-structured one-to-one interviews and data analysis was based on Colaizzi's method. The role of CRNs was described as advocates who coordinate care, establish trust, and provide education for CT patients within physician-driven recruitment structures. The CRN's role was also described as self-taught or learn on the go with no formalized recruitment training and lack of robust cultural training. To achieve diverse patient enrollment in CCTs, CRNs and study staff need to receive training on culturally competent clinical research care and the diversity of CRNs and study teams must be increased. Further, meaningful federal and hospital policy change must occur so that minority patients have equitable access to novel cancer therapies and the role of the CRN is delineated from other healthcare staff to optimize research patient care.

Translation and validation of the Clinical Trial Nursing Questionnaire in Swedish-A first step to clarify the clinical research nurse role in Sweden.

To translate the Clinical Trial Nursing Questionnaire (CTNQ) into Swedish and test it for face and content validity as well as internal consistency and reproducibility using test-retest procedures. In many countries, as in Sweden, a registered nurse can be involved in research by becoming a clinical research nurse. The clinical research nurse plays a pivotal role in clinical studies as a part of the research team. Scales have been developed and used with the objective to clarify the role of clinical research nurses: one of them is the CTNQ. A quantitative cross-sectional design with a test-retest procedure was applied to validate the translated questionnaire. By using a snowball sampling method, relevant participants were identified and 49 registered nurses working in the field of research as clinical research nurses answered the questionnaire on two occasions. An expert panel of three clinical research nurses evaluated the questionnaire for face and content validity. The STROBE checklist for observational research has been followed for presenting the research (see File S1). Face and content validity was agreed upon in the expert panel group. Tests for internal consistency of the CTNQ was calculated and showed a high Cronbach's alpha for both the frequency and importance subscales. The test-retest correlation analysis (reproducibility) also revealed a high correlation coefficient for both subscales. The CTNQ-SWE is a valid and robust instrument in a Swedish version. The instrument can be of importance in assessing the role of clinical research nurses in Sweden in future studies. Use of the CTNQ-SWE in future research can be of value for clarification and professional development of the clinical research nurse role in Sweden. The further use of the CTNQ in Sweden can be of value in understanding the process where licensed nurses make a transition into becoming a clinical research nurse, and to identify needs for customised education.

Recruiting to cohort studies in specialist healthcare services: Lessons learned from clinical research nurses in UK cleft services.

To explore the experiences of clinical research nurses recruiting patients in a large specialist care-based cohort study. Longitudinal studies are vital to better understand the aetiology and moderators of health conditions. This need is especially salient for congenital conditions, such as cleft lip and/or palate, where establishing large, comprehensive data sets from birth is vital to improve understanding and to inform interventions. Various barriers exist in recruiting patients to large cohort studies. The role of clinical research nurses embedded within health settings has grown over past decades to facilitate data collection, yet challenges remain. Qualitative descriptive study. Individual semi-structured interviews with 12 clinical research nurses based in 10 National Health Service cleft services across the UK, recruiting to the Cleft Collective Birth Cohort Study. Of seven emergent themes, three highlighted challenges to recruiting patients, another three described facilitative factors, and one theme overlapped challenges and facilitators. Challenges included the life circumstances of potential participants; language barriers; and limited clinical research nurse time for study. Facilitative factors included integrating research into clinical practice; patient information shared with clinical research nurses; and support from the university-based research study team. The theme "Method of data collection" related to both challenges and facilitators. The qualitative data from clinical research nurses recruiting to a large birth cohort study provide helpful practical detail for specialist healthcare teams, specialist nurses, clinical research nurses and researchers looking to optimise recruitment and data collection in longitudinal studies. The findings suggest the importance of specialist clinical services and research study teams cooperating to embed research into everyday clinical practice, without compromising care. This should facilitate patients' willingness to participate in important research like the Cleft Collective study and provide them with a positive experience of research.

Ethical challenges experienced by clinical research nurses:: A qualitative study.

Clinical investigation is a growing field employing increasing numbers of nurses. This has created a new specialty practice defined by aspects unique to nursing in a clinical research context: the objectives (to implement research protocols and advance science), setting (research facilities), and nature of the nurse-participant relationship. The clinical research nurse role may give rise to feelings of ethical conflict between aspects of protocol implementation and the duty of patient advocacy, a primary nursing responsibility. Little is known about whether research nurses experience unique ethical challenges distinct from those experienced by nurses in traditional patient-care settings. The purpose of the study was to describe the nature of ethical challenges experienced by clinical research nurses within the context of their practice. The study utilized a qualitative descriptive design with individual interviews. Participating nurses (N = 12) self-identified as having experienced ethical challenges during screening. The majority were Caucasian (90%), female (83%), and worked in outpatient settings (67%). Approximately 50% had > 10 years of research experience. The human subjects review board approved the study. Written informed consent was obtained. Predominant themes were revealed: (1) the inability to provide a probable good, or/do no harm, and (2) dual obligations (identity as a nurse vs a research nurse). The following patterns and subthemes emerged: conflicted allegiances between protocol implementation, needs of the participant, desire to advance science, and tension between the nurse-patient therapeutic relationship versus the research relationship. Participants described ethical challenges specific to the research role. The issues are central to the nurse-participant relationship, patient advocacy, the nurse's role in implementing protocols, and/or advancing science. Ethical challenges related to the specialized role of clinical research nurses were identified. More research is warranted to fully understand their nature and frequency and to identify support systems for resolution.

Developing good practice for clinical research nurses

This article outlines the role of clinical research in the UK government's strategy for economic growth and the role of clinical research nurses in that research. The diverse skills and knowledge required by clinical research nurses to support a range of research studies in a number of research environments are described. The development and aim of the UK Clinical Research Facility Network is discussed, with particular focus on the role of the UK Clinical Research Facility Network Education Group in supporting clinical research nurses and research teams to acquire and maintain relevant research skills. The outcomes delivered by the UK Clinical Research Facility Network Education Group are outlined along with ongoing and future work. Recommendations to ensure that the workforce will be skilled appropriately to support future clinical research are provided.

Delineating the Role of a Cohort of Clinical Research Nurses in a Pediatric Cooperative Clinical Trials Group

To describe the roles and responsibilities of the clinical research nurse (CRN). A descriptive design was used to reveal the roles of pediatric oncology CRNs. The Children's Oncology Group (COG) password protected Web site. 85 nurses who performed clinical research associate work within COG. The Clinical Trials Nursing Questionnaire was used to investigate the roles and responsibilities of CRNs. Protocol assessment, protocol planning, subject recruitment, informed consent process, investigational product, implementation and evaluation, data management, and professional nursing role. The study found that 55% of respondents (n = 47) were employed in a hospital setting, the majority (81%) had more than five years of oncology experience, and the average age of respondents was 45.56 years (range = 24-65 years). CRNs rated all role components as very important, with the consent process being of greatest importance. Eighty-nine percent reported experiencing autonomy and independence in the role. Clinical specialization of RNs has increased significantly in the past several decades. Acknowledging that nurses are responsible for performing many different roles that are critical to the successful completion of clinical trials is crucial. Evaluation of this dual role is still in its infancy, but articulating the role of CRNs in the conduct and context of clinical research is an important first step.

The Role of Clinical Research Nurses at Regional Clinical Trials Centers

Purpose: This study aimed to evaluate the performance of Clinical Research Nurses (CRNs) and the importance of their roles at the Regional Clinical Trial Centers (RCTCs). Method: A questionnaire focused on the role of CRNs was crafted by a researcher and the content validity was verified by a panel of experts on clinical research. The subjects of this study were 91 CRNs and Clinical Research Coordinators (CRCs), who were Korean registered nurses working at nine RCTCs. 77 subjects yielded valid data were analyzed using descriptive analysis, the Mann-Whitney U test, Spearman's rank order correlation coefficient, and Kruskal-Wallis test. Results: The performance of CRNs and the recognition in the importance of their roles were statistically significant different in age, education, CRN careers, positions, employment status and the phase of clinical trial. The role of direct caregiver was performed most often by CRNs. The role of coordinator of care and research (pre-study) was considered the most important role but performed the least frequent. Conclusions: The role of CRNs can easily be differentiated from CRCs who are not registered nurses. The domains of CRNs should be clearly identified and established. Moreover, research should be carried out on CRN training programs to cultivate competence in CRNs.

Clinical Research Nurses: Roles and Qualifications in South Korea

This study aimed to determine the standard roles, proficiency, and qualification of clinical research nurses (CRNs) in clinical trials/research in South Korea. Seventy-one investigators with experience working with CRNs and 79 current CRNs were conveniently sampled. Data were collected using a questionnaire including demographics, perceived roles, proficiency, and qualification of CRNs. The top three roles of CRNs perceived by investigators were scheduling subjects, communicating with investigator and sponsor, and completing case report forms. The top three roles of CRNs perceived by current CRNs were completing case report forms, communicating with investigator and sponsor, and screening subjects. The most important proficiencies perceived by investigator and current CRNs was communication and human relationship skills. Both investigators and current CRNs considered the key role of CRNs as communicating with investigator and sponsor; a bachelor’s degree and more than one year of clinical experience were seen as the minimum qualification.