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Developing the Clarity and Openness in Reporting: E3-based (CORE) Reference user manual for creation of clinical study reports in the era of clinical trial transparency

机译：开发报告的清晰度和开放性：基于E3（CORE）的参考用户手册，用于在临床试验透明的时代创建临床研究报告

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Samina Hamilton; null null; Aaron B. Bernstein; Graham Blakey; Vivien Fagan; Tracy Farrow; Debbie Jordan; Walther Seiler; Anna Shannon; Art Gertel;
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1. Developing the Clarity and Openness in Reporting: E3-based (CORE) Reference user manual for creation of clinical study reports in the era of clinical trial transparency [J] . Samina Hamilton, Aaron B. Bernstein, Graham Blakey, Research Integrity and Peer Review . 2016,第1期

机译：开发报告的清晰度和开放性：基于E3（CORE）的参考用户手册，用于在临床试验透明的时代创建临床研究报告
2. Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States [J] . Ina Jazic, Olivia M Shopshear, Jocelyn Ulrich, BMJ Open . 2017,第9期

机译：临床试验透明度：重新评估行业对美国临床试验注册和报告要求的遵守情况
3. More transparency for clinical trial data The decision by the European Medicines Agency to make clinical trial reports publicly available could provide a boon for biomedical research [J] . Hunter Philip EMBO reports . 2015,第1期

机译：提高临床试验数据的透明度欧洲药物管理局决定公开提供临床试验报告，可能为生物医学研究带来福音
4. Developing a traceable domain reference architecture to support clinical trials at the National Cancer Institute. An experience report [C] . Barber, K.S., Graser, . 2001

机译：开发可追溯的领域参考架构，以支持美国国家癌症研究所的临床试验。经验报告
5. Hypersensitivity Adverse Event Reporting in Clinical Cancer Trials: Barriers and Potential Solutions to Studying Severe Events on a Population Level [D] . ?Eldredge, Christina 2020

机译：临床癌症试验中的超敏反不良事件报告：障碍和潜在的解决方案，用于研究人口水平的严重事件
6. Developing the Clarity and Openness in Reporting: E3-based (CORE) Reference user manual for creation of clinical study reports in the era of clinical trial transparency [O] . Samina Hamilton, Aaron B. Bernstein, Graham Blakey, 2016

机译：开发报告的清晰度和开放性：基于E3（CORE）的参考用户手册用于在临床试验透明的时代创建临床研究报告
7. Critical review of the TransCelerate Template for clinical study reports (CSRs) and publication of Version 2 of the CORE Reference (Clarity and Openness in Reporting: E3-based) Terminology Table [O] . Samina Hamilton, Aaron B. Bernstein, Graham Blakey, 2019

机译：对临床研究报告（CSR）的转发模板的批判性审查以及核心参考版本2的公布（报告中的清晰度和开放性：基于E3的）术语表
8. FDA Resource Manual for Clinical Investigations: Regulations, Guidelines, and Other References for Conducting Clinical Trials under Investigational New Drug Applications [R] . Couig, M. P. 1991

机译：FDa临床研究资源手册：在研究性新药申请下进行临床试验的法规，指南和其他参考文献

Developing the Clarity and Openness in Reporting: E3-based (CORE) Reference user manual for creation of clinical study reports in the era of clinical trial transparency

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