V2EX case report form

Case Report Form

定义 Definition

case report form(CRF)病例报告表/病例报告表格。在临床试验或医学研究中,用于系统记录每位受试者(患者)数据的标准化表格或电子表(如 eCRF),包括入组信息、检查结果、不良事件、用药情况等。

发音 Pronunciation

/kes rprt frm/

例句 Examples

The nurse filled out the case report form after the visit.
护士在随访结束后填写了病例报告表。

Before database lock, the monitor reviewed each case report form to ensure the adverse events were recorded consistently across sites.
在数据库锁定之前,监察员审查了每份病例报告表,以确保各研究中心对不良事件的记录一致。

词源 Etymology

该短语由 case(个案/病例)+ report(报告/记录)+ form(表格)构成,字面意思是“用于记录病例报告的表格”。在现代临床研究语境中,CRF 特指按照试验方案与监管要求收集与管理受试者数据的关键文档(纸质或电子)。

相关词 Related Words

文献与作品 Literary Works

  • International Council for Harmonisation (ICH), ICH E6(R2) Guideline for Good Clinical Practice(多处讨论源数据与 CRF/数据记录要求)
  • U.S. Food and Drug Administration (FDA), E6 Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry(涉及 CRF 与数据可追溯性相关表述)
  • Stephen B. Hulley et al., Designing Clinical Research(临床研究设计与数据收集章节常提及 CRF 的作用与设计原则)
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