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--- 概念:病例报告表 [2022/02/23 04:07]
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+++ 概念:病例报告表 [2022/02/25 04:04] (当前版本)
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-====== 病例报告表（Case Report Form / CRF） ======
+====== 病例报告表 CRF ======
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-　　**病例报告表**：指按照试验方案要求设计，向申办者报告的记录受试者相关信息的纸质或者电子文件。(([[法规:药物临床试验质量管理规范|药物临床试验质量管理规范（GCP）]]. [[https://www.nmpa.gov.cn|国家药品监督管理局]]. 2020))
+　　**病例报告表**：指按照试验方案要求设计，向申办者报告的记录受试者相关信息的纸质或者电子文件。(([[法规:药物临床试验质量管理规范|药物临床试验质量管理规范（GCP）]]. [[概念:国家药品监督管理局]]. 2020))
-　　**Case Report Form (CRF)**：A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.(([[法规:ich-gcp|ICH GCP (E6(R2))]]. [[https://www.ICH.org|ICH]]. 2016))
+　　**Case Report Form (CRF)**：A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.(([[法规:ich-gcp|ICH GCP (E6(R2))]]. [[概念:ICH|ICH]]. 2016))
-　　**Electronic Case Report Form (e-CRF)**: An auditable electronic record designed to record information required by the clinical trial protocol to be reported to the sponsor on each trial subject.(([[https://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm135196.htm|Guidance for Industry - Computerized Systems Used in Clinical Trials]]. FDA. 2016))
+　　**Electronic Case Report Form (eCRF)**: An auditable electronic record designed to record information required by the clinical trial protocol to be reported to the sponsor on each trial subject.(([[https://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm135196.htm|Guidance for Industry - Computerized Systems Used in Clinical Trials]]. FDA. 2016))
-　　**注释CRF（Annotated CRF）**：是对空白的CRF的标注，记录CRF各数据项的位置及其在相对应的数据库中的变量名和编码。(([[法规:药物临床试验数据管理与统计分析的计划和报告指导原则|]].  [[https://www.nmpa.gov.cn|国家药品监督管理局]]. 2016))
+　　**注释CRF（Annotated CRF）**：是对空白的CRF的标注，记录CRF各数据项的位置及其在相对应的数据库中的变量名和编码。(([[法规:药物临床试验数据管理与统计分析的计划和报告指导原则|]]. [[概念:国家药品监督管理局]]. 2016))
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