临床研究人员的挑战和培训需求——一项调查

Niranjan S. Kulkarni, A. Bhatt, J. Dalal
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引用次数: 0

摘要

本文的目的是了解临床研究助理(CRAs)对监测所需时间和精力的看法;它们在保护受试者的权利、安全和福祉以及数据完整性方面的重要性;以及他们对培训需求和方法的期望。为此目的,对192名具有监测经验的专业人员进行了调查。在其他研究结果中,结果表明,cra认为源数据验证是最耗时的活动,共同监测访问是学习监测的最首选方法,cra需要更多的培训来学习与主要研究者的互动。评级机构对监测活动重要性的认识与在这些活动上花费的时间之间存在差距。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Challenges and Training Needs for Clinical Research Associates—A Survey
The objective of this articls is to understand the perceptions of clinical research associates (CRAs) about the time and effort required for monitoring; their importance in protecting the rights, safety, and well-being of subjects and data integrity; and their expectations about training needs and approaches. To these ends, a survey was conducted among 192 professionals with monitoring experience. Among other findings, the results show that CRAs rated source data verification as the most time-consuming activity, co-monitoring visits are the most preferred approach to learn monitoring, and CRAs need more training to learn to interact with principal investigators. There is a gap between CRAs’ perception of the importance of monitoring activities and the time spent on them.
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