Sarah Cannon Cancer Institute, Denver, CO.
Semin Oncol Nurs. 2020 Apr;36(2):151000. doi: 10.1016/j.soncn.2020.151000. Epub 2020 Apr 3.
To review the US Food and Drug Administration (FDA) Bioresearch Monitoring clinical investigator inspection process from start to final classification to support clinical research nurses in practice.
Published articles, websites, and author's expertise with FDA inspections.
Clinical research nurses should conduct and manage every clinical trial as if it were to be inspected by the FDA. This recommendation is considered best practice for clinical research nurses to prevent last-minute preparations to organize and clean up research data and records retrospectively.
This article will assist the oncology research nurse and interdisciplinary research members at the research site in the preparedness for an FDA inspection.
审查美国食品和药物管理局 (FDA) 的生物研究监测临床研究人员检查过程，从开始到最终分类，为临床研究护士的实践提供支持。
已发表的文章、网站和作者在 FDA 检查方面的专业知识。
临床研究护士应按照临床试验将接受 FDA 检查的标准来进行和管理。这一建议被认为是临床研究护士的最佳实践，以防止最后一刻才准备对研究数据和记录进行有组织和回溯性的清理。
本文将帮助肿瘤研究护士和研究现场的跨学科研究成员为 FDA 检查做好准备。
