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New ICH Topic M11 CeSHarP新ICH主题M11结构化统一临床电子方案 A new ICH topic was endorsed by the ICH Management Committee in November 2018: ICH M11 Clinical electronic Structured Harmonized Protocol (CeSHarP). ICH管理委员会于2018年11月采纳了一个新的ICH主题:ICH M11结构化统一临床电子方案(CeSHarP)。 Current Status 当前状态The clinical protocol describes the processes and procedures directing the conductand analysis of a clinical study. According to ICH, there is currently no internationally harmonized standard template for the format and content of the clinical protocol document, though. But only that would support consistency across sponsors and exchange of protocol information. Hence, there is a lack of harmonization. And this makes it more difficult and inefficient for regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders to review and assess clinical protocols. An international ICH guideline and template would therefore support consistency in the development of structured and unstructured protocol content. In addition, a technical specification will facilitate its electronic exchange. 临床方案描述的是指导临床研究实施和分析的过程和程序。根据ICH信息,当前并没有国际统一的临床方案文件格式与内容标准模板,但只有它才可以支持申办人之间的一致性及方案信息交换。因此,缺乏统一性。这使得监管机构、申办人、伦理监管主体、临床调查员和其它干系人更难以有效审核和评估临床方案。国际性ICH指南和模板将能支持结构化和非结构化方案内容的制订一致性。此外,技术标准有助于电子交换。 In order for ICH to develop an internationally harmonized guideline, including atemplate, and a technical specification for the protocol, some issues have to be resolved first: 为起草国际化统一指南,包括方案模板和技术标准,ICH需要先解决几个问题: Alignment and coordination with other ICH E-topics including (but not limited to) E3 (Structure and Content of Clinical Study Reports), E5 (Ethnic Factors in the Acceptability of Foreign Clinical Data), E6 (Good Clinical Practice, GCP), E8 (General Considerations for Clinical Trials), E9 (Statistical Principles for Clinical Trials), E11 (Clinical Investigation of Medicinal Products in the Pediatric Population) and E17 (General principles for planning and design of Multi-Regional Clinical Trials), 与其它ICH E类包括(但不仅限于)E3(临床研究报告的结构和内容)、E5(国外临床数据可接受性中的伦理因素)、E6(优良临床规范,GCP)、E8(临床试验的一般考量)、E9(临床试验的统计学原则)、E11(儿科人群中药品的临床研究)以及E17(多地区临床试验计划与设计的通用原则)保持一致和协调 The guideline, template, and technical specification will cover a broad range of study types (alignment with the ICH “GCP Renovation” initiative), 指南、模板和技术规范将覆盖较大范围的试验类型(与ICH GCP创新倡议相一致) The need for consistency must be balanced with flexibility to comply with local regulations and practices. 一致性的需求必须与符合当地法规和规范的灵活性相权衡
Background to the Proposal 提案背景The ICH M2 (Electronic Standards for the Transfer of Regulatory Information) Expert Working Group (EWG) identified the need for harmonized protocol structure andcontent. They further indicated the agreement on perceived value from a broadly adopted harmonized document organization supported by electronic contentstructured for exchange. This would increase efficiencies anticipated in moststeps of study conduct (e.g., trial design, investigator on-boarding, study setup, study reporting, and review). The multidisciplinary EWG will combine the relevant clinical study protocol and electronic technical expertise (e.g. from the M2 EWG). ICHM2(注册资料转移的电子标准)专家工作组(EWG)发现有必要统一方案结构与内容,他们进而对有交换电子结构内容支持的广泛采用的统一文件组织所蕴含的价值表达了共同认可。这会提高大多研究实施步骤(例如试验设计、调查员入职、研究设置、研究报告和审核)中所预期的效率。该多科学EWG将包括有相关临床研究方案和电子技术专家(例如来自M2专家组)。 The Concept Paper supports a proposal for a new harmonized guideline. It would specify comprehensive clinical protocol organization with standardized content with both required and optional components. The new ICHM11 guideline will outline two main sets of harmonized approaches: 该概念文支持了新的协调指南的提案。它将明确具有强制和可选内容的标准化内容的全面临床方案组织。新的ICHM11指南将描绘出2个主要的协调方法系列: a template to include identification of headers, common text and a set of data fields and terminologies which will be the basis for efficiencies in data exchange, 一个模板,包括识别出页眉、常规正文和一系列数据域和术语,这将成为数据交换效率的基础 a technical specification that uses an open, non-proprietary standard to enable electronic exchange of clinical protocol information. 一份技术标准,用作一个开放、非产权标准促进临床方案资料的电子交换
The possible Step 2a/2b endorsement is currently expected for June 2020.More information can be found on the ICH Multidisciplinary Guidelines webpage. 目前预订2020年6月会采纳进入2a/2b阶段,更多信息参见官网。 本文摘自 Julia法规翻译
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