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概念:epro [2022/02/25 04:01]
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概念:epro [2022/02/25 04:14] (当前版本)
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| ====== 患者报告结局（PRO / ePRO） ====== | ====== 患者报告结局 PRO / ePRO ====== |
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| **患者报告结局**：是任何来自患者直接报告且不被他人修改或解读的对自身疾病和相应治疗感受的评估结局。(([[法规:患者报告结局在药物临床研究中应用的指导原则|患者报告结局在药物临床研究中应用的指导原则（试行）]]. [[概念:国家药品监督管理局]]. 2021)) | **患者报告结局**：是任何来自患者直接报告且不被他人修改或解读的对自身疾病和相应治疗感受的评估结局。(([[法规:患者报告结局在药物临床研究中应用的指导原则|患者报告结局在药物临床研究中应用的指导原则（试行）]]. [[概念:国家药品监督管理局]]. 2021)) |
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| [[https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims|{{ :概念:pro_guidance.png?nolink&300|Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims}}]]A **PRO (Patient Reported Outcome)** is any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. (([[https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims|Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims]]. [[https:www.fda.gov|FDA]]. December 2009)) | [[https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims|{{ :概念:pro_guidance.png?nolink&300|Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims}}]]A **PRO (Patient Reported Outcome)** is any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. (([[https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims|Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims]]. [[概念:FDA|FDA]]. December 2009)) |
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