为统计学家提供量身定制的良好临床实践培训
Deborah D Stocken1, Helen Mossop2, Emma Armstrong3
1Leeds Institute of Clinical Trials Research, Faculty of Medicine and Health, University of Leeds, Leeds, UK. d.d.stocken@leeds.ac.uk.
现在可以为统计学家提供专门的良好临床实践 (GCP) 培训. 这种特定角色的培训确保了临床研究的质量,透明度和可重复性,解决了当前专业发展中的关键差距.
科学领域:
- 临床研究方法论 临床研究方法论
- 试验中的统计完整性
- 医疗保健中的法规合规性
背景情况:
- 目前的良好临床实践 (GCP) 培训是通用的,对研究专业人员来说缺乏统计相关性.
- 统计学家需要角色特定的培训,以便在临床试验中有效实施监管要求.
- 现有的培训变化会影响研究中的统计行为质量,透明度和可重复性.
结论:
- 对于统计学家来说,角色特定的GCP培训是必不可少的,以确保透明和可重复的统计活动.
- 开发的培训材料免费提供,可在国内和国际采用.
- 实施这种培训促进了遵守监管标准,并提高了临床研究的整体质量.
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