| Summary: | 碩士 === 國立臺灣大學 === 護理學研究所 === 105 === Objective：The purpose of this study is to construct the competence and draft ladder system of the Clinica Research Nurse in Taiwan.
Method：The process of this study can be divided into "the process of systematic literature review, focus group discussion, the implementation of modified Delphi research method" three stages and two-round experts meeting to carry out. First, I used the way of two-round systematic review to find papers, which discussed about the professional core competence/competency of CRNs, to appraisal it. Enrolled criteria of papers were 1) To discuss about the professional competence or competency of CRNs, or CRC or Clinical professionism 2) The research population were CRNs ,CRCs, CRA, and Investigators 3) Papers which published by Chinese or English with full text and I could get the full text.
Second, I used PubMed (1950s-2016), MEDLINE via Ovid online (1951-2016), CINAHL (2004-2016), Cochrane Library (2004-2016), NDLTD (2007-2016), and Airiti Library (2007-2016), ACRP (2013-2016), and Google Scholar (1979-2016) as my database. By using key words to search these databases, there were 12 related articles for me to appraisal it and I selected 16 articles for questionnaire. After extracting the role, scope, and job description for CRN`s competence, I invited three experts to make face validity for my questionnaire.
The data were collected by utilizing structural questionnaires, including fundamental attributes, competencies and ladder system , among 46 clinical research professionism from the teaching hospitals distributed in the Northern, Middle, and Southern district of Taiwan, Clinical Research Organization, Site Management Organzation and Pharmacy Industry Company. Quantitative and qualitative data were analysed using SPSS 22.0. According to the results of 46 expert questionnaires, replies and recommendations of the replies in the second round, the amendments are as follows: Mean< (4.0) and standard deviation (SD)> 1.
Results：The key results are：(1) Eight professional core competence (Clinical Research Pracitice, Care, Research, Communication and Team Work Collaboration , Management amd Leadership, Ethics Thinking and Shared Decision Making, Education and Professional Development, and International Vision and cultural competence) were identified and ninety-six competencies were constructed；(2) CRN`s ladder system and five levels (CRN I Novice, CRN II Advanced Beginner, CRN III Cometent, CRN IV Proficient, and CRN V Expert) were constructed by their competence；(3) Foundation and advanced education curriculum were recommended according to the competence and ladder system of CRN`s` level.
Conclusions：The identified professional core competence and professional competencies classification system of the CRNs could be used as a reference for the performance indicators and rewards of clinical research nurses ''functional benchmarks, employment conditions and clinical research nurses'' work assessment. Clinical site and Stakeholders will use them to develop the training program and performance evaluation standard (clinical research practice implementation, management and leadership, education and research facets) for CRNs and optimize the quality of clinical trials in Taiwan.
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