w wookie
on

 

请教:请问目前能支持中文define.xml的生成吗  不能的话一般大家用什么做的中文版xml呢   

j Jozef
on September 21, 2020

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.

w wookie
on September 21, 2020

Thanks for your reply, and that helps a lot.

Sergiy
on September 21, 2020

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,我将会在几天后开始支持中文Define.xml验证布一份中文版的Define.xml式表。在的话还可以注册我即将在2020929日(周二)召开的网会:针对向中国NMPACDISC数据做准取更多信息。

j Jozef
on September 22, 2020

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.

w wookie
on September 22, 2020

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  

w wookie
on September 22, 2020

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

w wookie
on September 22, 2020

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

j Jozef
on September 22, 2020

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

Wookie:您好!

我完全同意您的点:Define.xml应该在恰当的机生成。不如此,Pinnacle 21的建是先不要生成Define.xml文档,除非研究数据已是最版,而且您100%肯定不会再有改了。这样可以节约很多精力,也可以避免出

很多人分不清研究数据范(specifications)和将Define.xml用于研究数据描述(description)之的区别,把Define.xml当作数据范的格式使用。但是这样做效果不好,原因有很多。比如:Define.xml构不包含数据范需要的元素,也不够灵活,不能根据用需求和整。同,数据范是实时元数据,也就是,在开发进程中,数据会不断化。

Community版的Home面有一个叫“Recent Updates”的区,需要布行或是教学性的网会通知,我会从那里与用沟通。

谨此致意,
Sergiy

j Jozef
on September 24, 2020

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

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