我可以在未经所有者同意的情况下使用现有的研究报告进行注册吗？

我可以在未经所有者同意的情况下使用现有的研究报告进行注册吗？

Can I use existing study reports for my registration without having the owner’s consent?

使用已发表的数据来满足您的信息需求需要您拥有引用完整研究报告的权利。因此，如果您想在注册档案中引用已发表的完整研究报告，您必须与版权所有者核实您可以在多大程度上将其用于您自己的档案。在这种情况下，您应该协商一份许可证或其他形式的协议（例如访问函），以允许您引用已发表的数据。出于效率原因，此类协议应确保联合提交的所有成员都有权引用数据。版权仅涵盖表达形式，而不涵盖作品中包含的事实和数据。因此，只要不将研究文本原封不动地复制到您的注册档案中，事实和数据就可以包含在档案中，而无需版权所有者的同意。换句话说，您可以使用这些数据来制作您自己的研究摘要，但您必须对原始研究进行适当的引用和引文，以注明信息来源。此外，即使您自行撰写研究摘要，您也必须有权参考完整的研究报告进行注册。更多信息，请参阅数据共享指南第 9 部分。

The use of published data to satisfy your information requirements requires you to have the right to refer to the full study report. Therefore, if you want to refer to a published full study report in your registration dossier, you have to check with the copyright owner to what extent you are allowed to use it in your own dossier.In this case, you should negotiate a license or other form of agreement (e.g. letter of access) that will allow you to refer to the published data. For efficiency reasons, such an agreement should ensure that all the members of the joint submission have the right to refer to the data.Copyright covers only the form of expression but not the facts and data included in the work. Therefore, facts and data can be included in the dossier without the consent of the copyright owner provided that the text of the study is not copied as such into your registration dossier. In other words, you can use the data to produce your own study summary but you have to make appropriate references and quotations to the original study to acknowledge the source of information. In addition, also in cases where you produce the study summary yourself, you must have the right to refer to the full study report for your registration. For more information, see the Guidance on data sharing, section 9.