The Clinical Research Team

Baer, Allison R.; Zoň, Robin; Devine, Susan; Lyss, Alan P.

doi:10.1200/jop.2011.000276

Cited by 31 publications

(26 citation statements)

References 4 publications

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“…There has been limited research related to delegation of clinical research activities, and many researchers who have studied the roles and experiences of clinical research coordinators have not differentiated the roles of nurses and non-nurses working in clinical research in their studies (Duane, Granda, Munz, & Cannon, 2007;Getz, 2012;Granda, Duane, Munz, & Cannon, 2009;Gwede, Johnson, Roberts, & Cantor, 2005;Kellen et al, 1994 Baer, Zon, Devine, and Lyss (2011) described tasks often assigned to research staff including "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" (p. 188). Olson et al (2012) studied role descriptions and research activity delegation practices for nurse and nonlicensed, nonnurse research personnel in a single-site study in Minnesota to determine whether scopes of practice violations existed.…”

Section: Introductionmentioning

confidence: 97%

Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators

2015

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Section: Introductionmentioning

confidence: 97%

Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators

2015

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“…The most essential component of a successful research program is developing a well-qualified research staff or team. Clinicians, research nurses, data managers, and study coordinators are an example of research team [1]. Some of their responsibilities are regulatory compliance, protocol maintenance, patient care, tissue acquisition and transmittal, data collection and submission, and general administration.…”

Section: Introductionmentioning

confidence: 99%

“…Once staff are trained and the data management system implemented, this infrastructure must be maintained and continuously updated. Ultimately, an effective leader in research plans must recognize the value of each member while fostering team culture and commitment to quality patient care [1]. More than 30% of the total time and effort needed to implement a clinical trial research is the contribution of nurses, as well as data manager [2].…”

Section: Introductionmentioning

confidence: 99%

Effect of educational intervention on knowledge and attitude towards research, research ethics, and biobanks among paramedical and administrative teams in the National Liver Institute, Egypt

Elkhadry

Abdallah

Yousef

et al. 2020

Egypt Liver Journal

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Background: Medical research has increased greatly in many developing countries during the recent decade, motivated by the need to improve health in these countries. Such research needs to be guided by fundamental ethical principles to ensure the protection of patient's rights and welfare. Also, biobanks have become increasingly important for the study of health and disease. There is a significant public interest in the outcomes of genetic research, which include diagnostic, therapeutic, and preventive health methods. This study was conducted assess and raise the knowledge and attitude towards several aspects of research, related ethics, and biobank ethical issues for paramedical and administrative teams working at the National Liver Institute (NLI). Results: The education intervention study was effective in increasing percentage of good knowledge in paramedical and administrative teams (p value < 0.001). Also, the education intervention study was effective in increasing percentage of positive attitude in paramedical and administrative teams (p value < 0.001). Conclusion: There were good knowledge and attitude about research and related ethics, but poor knowledge and attitude about biobanking. The educational intervention study significantly increased knowledge and attitude about research, related ethics, and biobanks.

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“…A clinical research team composed of various professionals with various occupations and various roles is known to promote clinical research [ 1 - 4 ]. On these teams, clinical research coordinators (CRCs) play an essential role [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

Present Status and Perspectives on Future Roles of Japanese Clinical Research Coordinators

et al. 2018

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BackgroundThe new Clinical Trials Act that recently came into effect in Japan emphasizes the reliability of investigator-initiated clinical trials. Although Japanese clinical research coordinators have been mainly engaged in operational roles in industry-initiated clinical trials for drug approval (registration trials), broadening their contribution to cover more types of clinical research may lead to quality improvement of clinical research. To ultimately establish a clinical research infrastructure that meets the needs of the new era of Clinical Trials Act, here we gathered basic information on how clinical research coordinators might make such contributions.MethodsWe conducted a survey using self-reporting questionnaires in clinical research-related personnel to examine present status and the perspectives toward broader contribution of clinical research coordinators. The study participants were attendee of group discussion of a clinical research-related meeting in Shikoku area of Japan held in August 2017.ResultsAmong 88 participants, 69 responded (response rate: 78.4%) and 68 respondents (98.6%) were engaged in support and management of clinical research. The main area of involvement was industry-initiated registration trials (48, 69.7%), and main roles of involvement were cooperators who plays roles under the guidance of investigators (41, 59.5%). When divided by occupation into clinical research coordinators (n = 41) and other clinical research-related personnel (n = 28), approximately half of the respondents in each group replied positively to wanting broader involvement of clinical research coordinators as a clinical research professional.ConclusionThe present study revealed that about half of the clinical research coordinators and other clinical research-related personnel view a broadening of involvement of clinical research coordinators in research activities positively. Accordingly, a structured practical program aimed at encouraging such involvement may help to expand and strengthen their contribution into the future. Whether greater involvement of clinical research coordinators in clinical research will help to ensure the reliability of investigator-initiated clinical research warrants further study.

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The Clinical Research Team

Abstract: Developing and maintaining an exemplary research team is essential to the success of a quality clinical research program.

Cited by 31 publications

References 4 publications

Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators

Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators

Effect of educational intervention on knowledge and attitude towards research, research ethics, and biobanks among paramedical and administrative teams in the National Liver Institute, Egypt

Present Status and Perspectives on Future Roles of Japanese Clinical Research Coordinators

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