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  1. NTU Theses and Dissertations Repository
  2. 醫學院
  3. 護理學系所
請用此 Handle URI 來引用此文件: http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/90411
完整後設資料紀錄
DC 欄位值語言
dc.contributor.advisor胡文郁zh_TW
dc.contributor.advisorWen-Yu Huen
dc.contributor.author李岳瑩zh_TW
dc.contributor.authorYueh-Ying Leeen
dc.date.accessioned2023-09-28T16:16:39Z-
dc.date.available2023-11-10-
dc.date.copyright2023-09-28-
dc.date.issued2023-
dc.date.submitted2023-08-14-
dc.identifier.citation中文文獻
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dc.identifier.urihttp://tdr.lib.ntu.edu.tw/jspui/handle/123456789/90411-
dc.description.abstract研究目的: 建立CRC的分級制度,明確其核心能力的定義、內容、工作職責和教育需求,旨在提升CRC的認同度,推動職涯發展,優化專業養成提升人才素質。
研究目的:
建立CRC的分級制度,明確其核心能力的定義、內容、工作職責和教育需求,旨在提升CRC的認同度,推動職涯發展,優化專業養成提升人才素質。
方 法: 本研究採立意取樣,分為兩個階段:第一階段使用修正式德爾菲法。搜尋2012至2022年期間正式出版的資料庫文獻,納入13篇文章或專書進行評析,以建構CRC分級年資、核心能力清單和檢核表的內容。第二階段則進行了德爾菲問卷的兩個回合發放,並使用Excel和統計軟體SPSS 26.0進行資料分析。共有27位受訪專家進行問卷填寫與調查,以達成專家共識,並進行結果分析,而後CRC的「五個層級」和「八大核心能力」,以及其「核心能力內涵」和「教育需求」。
結 果: 最終確認 (1) CRC能力分級為五級跟對應的年資;(2) CRC能力分級之八大核心能力之定義,(3) CRC核心能力之相關性與教育需求。
結論與應用: 本研究確立CRC分級、年資、必備核心能力的定義和教育需求。適用於確定CRC的工作條件和能力指標,逐步培訓多元人才,涵蓋臨床研究的各層面,提升CRC在臨床研究中的角色和貢獻,持續提升研究品質。確定核心能力和專業認定標準,進而推動CRC在研究團隊的認同度,並促進台灣在生物醫藥領域的多元化發展。
關鍵詞: 臨床研究協調員、核心能力、分級制度、認同度、教育需求
zh_TW
dc.description.abstractObjective: The purpose of this study is to establish a grading system for clinical research coordinators, clarify the definition, content, job responsibilities and educational needs of their core competencies, aiming to enhance the recognition of clinical research coordinators, promote their career development, and promote the further development of related fields.
Method: This study is in purposive sampling, using survey method the first phase uses the modified Delphi method. Firstly, the database documents officially published from 2012 to 2022 were searched, total of 13 articles or books were included for review and analysis. Then, the content of graded seniority, core competency list and checklist is developed. Two rounds of Delphi questionnaire were distributed, and Excel and statistical software SPSS 26.0 were used for data analysis. There are 27 experts involved, "five levels" and "eight core competencies" of clinical research coordinators, as well as the "core competency content" and "educational needs".
Results: This study finally confirmed (1) CRC five levels and seniority, (2) the definition of eight core competencies of CRC five levels, (3) CRC five levels of educational needs. By determining the core competencies and professional identification standards, the recognition of clinical research coordinators in the research team can be promoted, and the diversified development of Taiwan in the field of biomedicine can be promoted.
Conclusions: This clinical study has established CRC classification, seniority, definitions of required core competencies, and educational needs. The results are suitable for determining the working conditions and ability indicators of CRC, gradually training diverse talents, covering all aspects of clinical research, promoting the growth of CRC and enhancing their role and contribution in clinical research, and continuously improving the quality of clinical research in Taiwan. By identifying core competencies and professional identification standards, it is expected to become a benchmark for CRC functions, thereby promoting the recognition of CRC in clinical research teams and promoting Taiwan's diversified development in the field of biomedicine.
Keywords: Clinical Research Cooridinator, Core competencise, Competency, Recognition, Eductional Needs
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dc.description.tableofcontents目 錄
致謝 I
中文摘要 II
Abstract III
表目錄 VII
圖目錄 IX
第一章 緒 論 1
第一節 背景分析 1
第二節 臨床研究動機 5
第三節 臨床研究目的 7
第四節 名詞定義 8
第二章 文獻查證 11
第一節 CRC之角色發展與職責範疇 12
第二節 CRC能力分級與在臨床研究團隊之認同度 17
第三節 CRC之教育需求 28
第四節 CRC和臨床研究護理師核心能力及分級制度 33
第三章 臨床研究方法 40
第一節 臨床研究設計 40
第二節 德爾菲法介紹 46
第三節 臨床研究對象 53
第四節 臨床研究工具的信度和效度評估 54
第五節 資料蒐集與分析 55
第六節 臨床研究倫理 57
第四章 臨床研究結果 58
第一節 系統性文獻查證與文獻評核 58
第二節 修正式德爾菲法臨床研究結果 79
第三節 CRC年資與分級以及八大核心能力定義之調查結果 85
第四節 CRC八大核心間相關性分析與教育需求調查 110
第五章 討論 127
第一節 國內、外CRC能力分級與年資之異同 128
第二節 國內、外CRC必備核心基礎能力 141
第三節 CRC之教育需求 148
第六章 結論與建議 150
第一節 結論 150
第二節 CRC核心能力與教育需求之發展與建議 151
第三節 臨床研究限制 155
參考文獻 156
附 錄 164
附錄一 臺大醫院IRB新案核准函……………………………………..164
附錄二 臺大醫院IRB變更案核准函……………………..……….......167
附錄三 問卷同意使用信……………..……………………………….....168
附錄四 專家臨床研究職稱、年資……………..…………………........169
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dc.language.isozh_TW-
dc.subject認同度zh_TW
dc.subject臨床研究協調員zh_TW
dc.subject核心能力zh_TW
dc.subject分級制度zh_TW
dc.subject教育需求zh_TW
dc.subjectCompetencyen
dc.subjectEducational Needsen
dc.subjectRecognitionen
dc.subjectCore Competenciesen
dc.subjectClinical Research Coordinatoren
dc.title臨床研究協調員角色職責之認同度與教育需求之研究zh_TW
dc.titleResearch on the Job Recognition and Education Demands of the Clinical Research Coordinatorsen
dc.typeThesis-
dc.date.schoolyear111-2-
dc.description.degree碩士-
dc.contributor.oralexamcommittee林家齊;張榮珍zh_TW
dc.contributor.oralexamcommitteeChia-Chi Lin;Jung-Chen Changen
dc.subject.keyword臨床研究協調員,核心能力,分級制度,認同度,教育需求,zh_TW
dc.subject.keywordClinical Research Coordinator,Core Competencies,Competency,Recognition,Educational Needs,en
dc.relation.page170-
dc.identifier.doi10.6342/NTU202303091-
dc.rights.note同意授權(全球公開)-
dc.date.accepted2023-08-14-
dc.contributor.author-college醫學院-
dc.contributor.author-dept護理學研究所-
dc.date.embargo-lift2028-08-11-
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