title: [An Investigation of the Role Responsibilities of Clinical Research Nurses in Conducting Clinical Trials].
abstract: BACKGROUND
  Clinical research nurses (CRNs) play an important role in improving the quality of clinical trials. In Taiwan, the increasing number of clinical trials has increased the number of practicing CRNs. Understanding the role responsibilities of CRNs is necessary to promote professionalism in this nursing category.
  
  
  OBJECTIVE
  This study investigates the role responsibilities of CRNs in conducting clinical trials / research.
  
  
  METHODS
  A questionnaire survey was conducted in a medical center in Taipei City, Taiwan. Eighty CRNs that were registered to facilitate and conduct clinical trials at this research site completed the survey.
  
  
  RESULTS
  "Subject protection" was the CRN role responsibility most recognized by participants, followed by "research coordination and management", "subject clinical care", and "advanced professional nursing". Higher recognition scores were associated with higher importance scores and lower difficulty scores. Participants with trial training had significantly higher difficulty scores for "subject clinical care" and "research coordination and management" than their peers without this training (p < .05). Participants who had participated in a long-term trial-training course earned higher importance scores for "CRN four-subthemes role responsibilities" (p <.05) and lower difficulty scores for "subject protection", "research coordination and management" (p <.005) than their short-term course peers. "Recognition of overall responsibilities" and "receiving trial training" were the significant predictors of difficulty in performing CRN role responsibilities, explaining 21.9% of the total variance.
  
  
  CONCLUSIONS
  To further promote CRN as a professional career in Taiwan, the findings of this study recommend identifying the core competences of CRNs and adding CRN-related study materials into the advanced nursing curriculum. Long-term and systematic educational training may help CRNs understand the importance of their role responsibilities, better recognize their professional role, and reflect these responsibilities in clinical practice.
authors.affiliation: Taiwan Academy of Clinical Research Nurses, Taiwan, ROC.
authors.forename: Chi-Yin
authors.initials: CY
authors.lastname: Kao
authors.affiliation: School of Nursing, National Taiwan University, Taiwan, ROC.
authors.forename: Guey-Shiun
authors.initials: GS
authors.lastname: Huang
authors.affiliation: School of Nursing, National Taiwan University, Taiwan, ROC.
authors.forename: Yu-Tzu
authors.initials: YT
authors.lastname: Dai
authors.affiliation: National Taiwan University Hospital, Taiwan, ROC.
authors.forename: Ya-Ying
authors.initials: YY
authors.lastname: Pai
authors.affiliation: School of Nursing, National Taiwan University, Taiwan, ROC. weyuhu@ntu.edu.tw.
authors.forename: Wen-Yu
authors.initials: WY
authors.lastname: Hu
mesh_terms: D000328:Adult; D035843:Biomedical Research; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D024802:Nurse's Role; D011795:Surveys and Questionnaires
keywords: clinical research nurse; clinical trial; responsibility; role