中文版xml文件的生成

Chinese Define-XML

Unlike SAS-XPT, which was never meant to support chinese characters (current usage is abuse), define.xml is based on XML, and has UTF-8 encoding by default. So you can of course have chinese characters (encoded as UTF-8) characters in define.xml. The tags will of course remain ASCII (English) as that was the way the Define-XML standard was defined.

Thanks for your reply, and…

Thanks for your reply, and that helps a lot.

Sergiy

on September 21, 2020

P21

能支持。您可以用Pinnacle 21…

能支持。您可以用Pinnacle 21 Community或者Enterprise Define.xml工具生成中文版Define.xml。另外，我们将会在几天后开始支持中文Define.xml验证，还会发布一份中文版的Define.xml样式表。现在的话还可以注册我们即将在2020年9月29日（周二）召开的网络研讨会：“针对向中国NMPA递交CDISC数据做准备”，获取更多信息。

Chinese Define-XML

Just as an addition to Sergiy's response: ANY tool to generate Define-XML normally support chinese characters, as Define-XML is based on XML which has universal UTF-8 encoding "out of the box". So you can also use any of the many Define-XML generating tools that allow you to generate Define-XML BEFORE study end: many companies generate the define.xml long before the datasets themselves are generated, which is best practice. For example, many sponsors use a define.xml at study start as a specification of which datasets, with which variables, etc they expect to be delivered at the end of the study.

好的 感谢  试着做了一份Define.xml…

好的 感谢  试着做了一份Define.xml，是自行先写好define spec的Excel再利用P21生成的，请问这个流程没错吧  

另外其实我不太明白为什么define…

另外其实我不太明白为什么define.xml文件要在数据集生成之前做呢   感觉它是方便审阅用  在数据集做完了再做define好像更方便啊

继续请教一下，关于研讨会这类会议消息一般是在哪里公布 …

继续请教一下，关于研讨会这类会议消息一般是在哪里公布  感谢

Define.xml before generation of datasets

I did not say "should". I only said that the better option and practice is to generate it before the datasets. When doing so, one wins a lot of valuable time, and one will surely have a much higher quality define.xml. There are many articles available in internet that demonstrate this.
If you e.g. look at a software program like SDTM-ETL, you will see that the define.xml is used as the mapping specification for generating the datasets. The use of define.xml thus goes far beyond just being something that one must submit for regulatory review: it allows you to automate a number of tasks that otherwise are cumbersome and sometimes error prone. This is also what we teach during the CDISC Define-XML trainings.

Jozef Aerts
CDISC Define-XML Development team and CDISC Define-XML authorized instructor.

Sergiy

on September 23, 2020

P21

Wookie：您好！我完全同意您的观点：Define…

Wookie：您好！

我完全同意您的观点：Define.xml应该在恰当的时机生成。不仅如此，Pinnacle 21的建议是先不要生成Define.xml文档，除非研究数据已经是最终版，而且您100%肯定不会再有改动了。这样可以节约很多精力，也可以避免出错。

很多人还分不清研究数据规范（specifications）和将Define.xml用于研究数据描述（description）之间的区别，把Define.xml当作数据规范的格式使用。但是这样做效果不好，原因有很多。比如：Define.xml的结构不包含数据规范需要的元素，也不够灵活，不能根据用户需求和进程进行调整。同时，数据规范是实时元数据，也就是说，在开发进程中，数据会不断发生变化。

在Community版的Home页面有一个叫“Recent Updates”的区块，需要发布行业新闻或是教学性质的网络研讨会通知时，我们会从那里与用户沟通。

谨此致意，
Sergiy

旧辩论

这是Define-XML标准的开发人员与P21之间长达10年的争论。
至少我们同意我们不同意。
关于此讨论的文章中有几篇。
例如：

https://www.formedix.com/how-define-xml-can-be-used-to-design-datasets-upfront/
https://www.lexjansen.com/pharmasug/2016/AD/PharmaSUG-2016-AD18.pdf