| 基金项目:国家重点研发计划资助（2023YFC2706100）；国家自然科学基金面上项目（82373971）；“浙江省‘尖兵’‘领雁’研发攻关计划资助”项目（2023C03003）；浙江省自然科学基金资助项目（LY22H270004） |
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| 中文摘要: |
| 目的 了解儿科临床研究协调员（clinical research coordinator，CRC）职业培训现状，探讨儿科CRC基地化培训建设，以促进儿科CRC的能力提升。方法 采用匿名问卷调研法，于2023年7月25日至10月16日期间，通过问卷星向调查对象发放自行设计的问卷，以进行儿科CRC职业培训及基地化培训需求相关情况的调查分析。采用Excel对数据进行整理。计数资料以例数或者率表示。结果 回收有效问卷328份。调查结果显示，认为当前CRC培训充分且可以满足实际工作需求的仅为7.62%（25人），另有4.88%（16人）的人认为没有CRC培训，46.34%（152人）的人认为培训不足以支撑实际工作的要求。87.50%（287人）的人认为CRC需要持续的培训。46.95%（154人）的人选择了有经验的CRC是较为合适的带教人员之一，但是需要3年及以上CRC工作经验。46.95%（154人）选择了CRC合适的培训时长为3个月。培训方式的选择从高到低为：有经验的CRC带教实习（90.85%，298人）、实操技能手把手带教（88.41%，290人）、案例分析讨论（87.20%，286人）、流程模拟（83.23%，273人）、授课（76.52%，251人）。培训后考核方式的选择从高到低为：案例分析（76.52%，251人）、操作模拟（74.09%，243人）、流程模拟（73.17%，240人）、笔试（66.16%，217人）、面试（63.72%，209人）。结论 目前，儿科CRC的培训还不足以满足实际工作需求，急需制定一个符合工作需要的CRC培训体系并进行推广实践，从基础上促进中国儿科临床研究健康生态的构建。 |
| 英文摘要: |
| Objective To investigate the current status of vocational training for pediatric clinical research coordinators (CRC), and discuss the construction of base-based pediatric CRC training, and to promote the ability of pediatric CRCs.Methods From July 25 to October 16, 2023, an anonymous self-designed questionnaire survey was conducted through the Wenjuanxing platform to investigate the current situation of pediatric CRC vocational training and base training needs. The data were collated using Excel. Categorical data were described as numbers and percentages.Results A total of 328 usable questionnaires were returned. Only 7.62% (25 people) believed that existing CRC training was sufficient and could meet actual work needs; 4.88% (16 people) responded that there was no training; 46.34% (152 people) believed that the training was insufficient to support actual work needs; 87.50% (287 people) believed that continuous CRC training was needed; 46.95% (154 people) preferred experienced CRCs for teaching, who should have at least 3 years of CRC work experience; and 46.95% (154 people) preferred a duration of 3 months for CRC training. The preferred training methods were: practice under the direction of experienced CRCs (90.85%, 298 people), step-by-step teaching of practical skills (88.41%, 290 people), case analysis and discussion (87.20%, 286 people), process simulation (83.23%, 273 people), and lecture-based teaching (76.52%, 251 people). The preferred post-training assessment methods were: case analysis (76.52%, 251 people), operation simulation (74.09%, 243 people), process simulation (73.17%, 240 people), written examination (66.16%, 217 people), and interview (63.72%, 209 people).Conclusions The current pediatric CRC training is not enough to meet actual work needs. It is urgent to develop and promote a CRC training system that can meet work needs, laying the foundation for the construction of pediatric clinical research ecology in China. |
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