BackgroundCORE (Clarity and Openness in Reporting: E3-based) Reference (released May 2016 by the European Medical Writers Association [EMWA] and the American Medical Writers Association [AMWA]) is a complete and authoritative open-access user’s guide to support the authoring of clinical study reports (CSRs) for current industry-standard-design interventional studies. CORE Reference is a content guidance resource and is not a CSR Template.TransCelerate Biopharma Inc., an alliance of biopharmaceutical companies, released a CSR Template in November 2018 and recognised CORE Reference as one of two principal sources used in its development.MethodsThe regulatory medical writing and statistical professionals who developed CORE Reference conducted a critical review of the TransCelerate CSR Template. We summarise our major findings and recommendations in this communication. We also re-examined and edited the Version 1 CORE Reference Terminology Table that we first published in 2016, and we present this as Version 2 in this communication.ResultsOur major critical review findings indicate that opportunities remain to refine the CSR Template structure and instructional text, enhance content clarity, add web links to referenced guidance documents, improve transparency to support the broad readership of CSRs, and develop supporting resources.The CORE Reference ‘Terminology Table’ Version 2 includes estimand as a defined term and an adaptation of the original ‘worked study example’ to incorporate the recently evolved concept of ‘estimands’.ConclusionsAs TransCelerate’s CSR Template represents an important milestone in authoring CSRs, we offer CSR authors advice and recommendations on its use, similarities, and differences with CORE Reference and advise them to consider shared interpretations between the two.RegistrationCORE Reference is registered with the EQUATOR Network. The TransCelerate CSR Template is not registered with any external organisation to the knowledge of the authors of this paper.

中文翻译：

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对临床研究报告 (CSR) 的 TransCelerate 模板进行严格审查并发布 CORE 参考第 2 版（报告的清晰度和开放性：基于 E3）术语表

BackgroundCORE（报告的清晰度和开放性：基于 E3）参考（由欧洲医学作家协会 [EMWA] 和美国医学作家协会 [AMWA] 于 2016 年 5 月发布）是完整且权威的开放获取用户指南，用于支持创作当前行业标准设计介入研究的临床研究报告 (CSR)。CORE Reference 是内容指导资源，而不是 CSR 模板。生物制药公司联盟 TransCelerate Biopharma Inc. 于 2018 年 11 月发布了 CSR 模板，并将 CORE Reference 视为其开发中使用的两个主要来源之一。方法监管医疗开发 CORE Reference 的写作和统计专业人员对 TransCelerate CSR 模板进行了严格审查。我们在此通讯中总结了我们的主要发现和建议。我们还重新审查和编辑了 2016 年首次发布的第 1 版核心参考术语表，并在此通讯中将其作为第 2 版呈现。结果我们的主要批判性审查结果表明，仍有机会完善 CSR 模板结构和指导文本，提高内容清晰度，添加参考指导文件的网络链接，提高透明度以支持 CSR 的广大读者，并开发支持资源。CORE 参考“术语表”版本 2 包括作为定义术语的估算值以及对原始“术语表”的改编。结论由于 TransCelerate 的 CSR 模板代表了编写 CSR 的一个重要里程碑，我们为 CSR 作者提供有关其使用、与 CORE Reference 的相似之处和差异的意见和建议，并建议他们考虑两者之间共享解释。RegistrationCORE Reference 已在 EQUATOR 网络中注册。据本文作者所知，TransCelerate CSR 模板未在任何外部组织注册。