臨床研究護理師執行臨床試驗角色職責之探討

Translated title of the contribution: An investigation of the role responsibilities of clinical research nurses in conducting clinical trials

Chi-Yin Kao, Guey Shiun Huang, Yu Tzu Dai, Ya Ying Pai, Wen Yu Hu

Research output: Contribution to journalArticle

3 Citations (Scopus)

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. Purpose: This study investigates the role responsibilities of CRNs in conducting clinical trials /research. Method: 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.

Original languageChinese
Pages (from-to)30-40
Number of pages11
JournalJournal of Nursing
Volume62
Issue number3
DOIs
Publication statusPublished - 2015 Jan 1

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Nurses
Clinical Trials
Research
Taiwan
Nursing
Nurse's Role
Curriculum
Professional Role
Clinical Competence

All Science Journal Classification (ASJC) codes

  • Nursing(all)

Cite this

Kao, Chi-Yin ; Huang, Guey Shiun ; Dai, Yu Tzu ; Pai, Ya Ying ; Hu, Wen Yu. / 臨床研究護理師執行臨床試驗角色職責之探討. In: Journal of Nursing. 2015 ; Vol. 62, No. 3. pp. 30-40.
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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. Purpose: This study investigates the role responsibilities of CRNs in conducting clinical trials /research. Method: 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.",
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臨床研究護理師執行臨床試驗角色職責之探討. / Kao, Chi-Yin; Huang, Guey Shiun; Dai, Yu Tzu; Pai, Ya Ying; Hu, Wen Yu.

In: Journal of Nursing, Vol. 62, No. 3, 01.01.2015, p. 30-40.

Research output: Contribution to journalArticle

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N2 - 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. Purpose: This study investigates the role responsibilities of CRNs in conducting clinical trials /research. Method: 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.

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