臨床研究護士與臨床研究專員之角色與職責

The Roles and Responsibilities of Clinical Research Nurses and Clinical Research Associates

陳惠君(Hui-Chun Chen) ； 陳依兌(Yi-Tui Chen) ； 彭瓊芳(Lily Peng) ； 劉介宇(Chieh-Yu Liu)

《台灣醫學》 16卷1期 (2012/01) Pp. 40-64

https://doi.org/10.6320/FJM.2012.16(1).06

摘要

本研究之目的在使用系統性文獻回顧來進行臨床研究護士（clinical research nurse, CRN）與臨床研究專員（clinical research associate, CRA）角色與職責之研究。在系統性文獻回顧法分析中，包含ABI／INFORM等五個中、英文資料庫，總共選出1252篇文章，透過篩選條件，最後共20篇文章符合篩選標準，納入研究。結果顯示臨床研究護士（CRN）主要之角色為研究機構或醫院之受試者相關護理照護執行者，其職責為受試者管理（個案招募、篩選（screening）、知情同意、返診安排規劃、監測等）、數據登錄、異常事件通報、執行試驗、以及受試者的教育工作。而臨床研究專員（CRA）主要之角色為負責委託機構（sponsors）試驗品質之監測與維護，其主要職責為受試者權益維護、試驗的管控（管理與品質維護）、分析並確認數據的完整性、正確性、監測試驗進行、以及研究團隊的教育工作。綜合納入文獻，臨床研究護士（CRN）與臨床研究專員（CRA）角色與職責之關係，某一部分有其各自專精負責部分，另外卻有一部分需要互相合作。本系統性文獻回顧，一方面可以提供CRN與CRA角色與職責定義之釐清，另一方面也有助於未來新進入臨床試驗產業成員，熟悉角色與職責及其生涯發展規劃，並且可以提供未來臨床試驗產業教育訓練之參考。

關鍵字

臨床研究護士 ； 臨床研究專員 ； 臨床試驗 ； 角色 ； 職責

並列摘要

The aim of this study was to investigate the roles and responsibilities of clinical research nurses (CRN) and clinical research associates (CRA) by adopting systematic literature review. The search strategy was set to look for published peer-reviewed papers from five electronic databases: ABI/INFORM, EBSCOhost, PubMed, Airiti Library (CEPS) and Google scholar. According to screening criteria, a total of 20 published papers from 1252 literatures were included in the systematic review. The findings showed CRNs mainly played the roles in trial conduction and clinical care of study participants, and they were responsible for participant management (case recruitment, screening, informed consent, follow-up appointment and monitoring...et al), case report forms (CRF) completion, adverse events (AE) and serious adverse events (SAE) reporting, conducting trials, and study participants education. On the other hand, CRAs mainly played trial monitors for a sponsor and were responsible for protecting study participants' rights, maintaining trials' quality, data inspection, study site monitoring and study team education. In conclusion, this study showed that CRNs and CRAs had their specific roles in clinical trials. The paper is useful for new CRNs/CRAs to be familiar with their roles, and for planning training programs of clinical trial team.

並列關鍵字

clinical research nurse ； clinical research associate ； clinical trials ； roles ； responsibility