病例报告表格 GCP对个案报告表格(CRF)的定义如下:“一份印刷的、光学的或电子的文件,用于记录报告给发起人的关于每个试验主题的所有协议要求的信息”(ICH GCP 1.11)因此,CRF可以是研究小组成员在临床完成的打印文档,也可以是从实验室直接发送到数据管理中心的电子文档。crf的目的是以标准化格式收集研究数据,以便将数据...
ICHEfficacyGuidelines 胡红喜 2018-01-01 E1长期用药的临床安全性 ClinicalSafetyforDrugsusedinLong-TermTreatment E3临床研究报告 ClinicalStudyReports E1长期用药的临床安全性 ClinicalSafetyforDrugsusedinLong-TermTreatment 目的：提出一套用于无生命威胁疾病长期治疗(超过6个月的慢性或间断使 用)的药物安全性评价的...
The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline. 在不同的国家,独立的伦理委员会的法律地位...
The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline. 在不同的国家,独立的伦理委员会的法律地位...
GCP:良好的临床规范:统一的指南 E7: Studies in Support of Special Populations: Geriatrics 对特定族群的支持的研究:老人病学 E8: General Considerations for Clinical Trials 对临床试验的总的考虑 E9: Statistical Principles for Clinical Trials 临床试验的统计原则 E10: Choice of Control Group and Related Issu...
E3 Clinical Study Reports/临床 研究报告 E4 Dose-Response Studies/剂量反 应研究 E5 Ethnic Factors/种族因素 E6 GCP/药物临床试验管理规范 E7 Clinical Trials in Geriatric Population/老人中开展的临床试验 E8 General Considerations for Clinical Trials/临床试验的一般 性考虑 E9 Statistical Principles for Clini...
Consolidated Guideline GCP:良好的临床规范:统一的指南 E7: Studies in Support of Special Populations: Geriatrics 对特定族群的支持的研究:老人病学 E8: General Considerations for Clinical Trials 对临床试验的总的考虑 E9: Statistical Principles for Clinical Trials 临床试验的统计原则 E10: Choice of Control ...
安全性(Safety Guidelines) 有效性(Efficacy Guidelines) E1 Clinical Safety for Drugs used in Long-Term Treatment/长期使用的药物的临床安全性 E2A - E2F Pharmacovigilance/药物警戒性 E3 Clinical Study Reports/临床研究报告 E4 Dose-Response Studies/剂量反应研究 E5 Ethnic Factors/种族因素 E6 GCP/药物...
GCP:良好的临床规范:统一的指南 E7: Studies in Support of Special Populations: Geriatrics 对特定族群的支持的研究:老人病学 E8: General Considerations for Clinical Trials 对临床试验的总的考虑 E9: Statistical Principles for Clinical Trials 临床试验的统计原则 E10: Choice of Control Group and Related Issu...
GCP:良好的临床规范:统一的指南 E7: Studies in Support of Special Populations: Geriatrics 对特定族群的支持的研究:老人病学 E8: General Considerations for Clinical Trials 对临床试验的总的考虑 E9: Statistical Principles for Clinical Trials 临床试验的统计原则 E10: Choice of Control Group and Related Issu...