Define pdf

Hi Frederic, I know that

Hi Frederic, I know that about 4 years ago Lex Jansen developed some SAS based solution to create printable define.pdf. My understanding is that, his approach is to transfer define.xml data into normalized SAS datasets and then use proc report and SAS ODS PDF functionality to make nicely formatted define.pdf file. Contact Lex for more details. An OpenCDISC tool kit does not have such functional yet. Check our website sometimes later during the summer time. Regards, Sergiy

define.pdf ?

Hi, Sergiy,

I was wondering if there is any update made in the OpenCDISC tool in this direction (generating define.pdf from define.xml).

Additional question: why is it mandatory for FDA to include a define.pdf into the dataset? One (the reviewer) could vizualize the Data Definition also by seeing define.xml in a browser after attaching a stylesheet to it for a nice display...

Try using Apache FOP

Hi,

I was investigating this option a while back - and found the following tool:

http://xmlgraphics.apache.org/fop/1.0/index.html

If you are familiar with XSL you can create a XSL file that will convert the define.xml file to define.pdf in a similar way to how define.xsl allows viewing the define.xml file in a web-browser.

Jon

FOP

Hi, Jon,

Thank you for the recommandation. FOP indeed represents a suitable tool for generating define.pdf. I recommend it also :)

Amelia

converting define.xml to difine.pdf

Sir,

Can please explain how to working with FOP to converting the define.xml to devfine.pdf.

I've not looked at this for…

I've not looked at this for a long time - but the following paper may be of use

https://www.lexjansen.com/pharmasug-cn/2014/CD/PharmaSUG-China-2014-CD04.pdf

Sergiy

on September 24, 2019

P21

why do you need define.PDF?

Hi Balaji, 

Could you explain why do you need define.PDF?

Today define.pdf is not required when submitting define.xml v2.0. Define-XML v2.0 is the only version acceptable now.

• Do you plan to submit only define.pdf?
• Do you plan to submit define.xml v1.0?
• Do you plan to submit define.pdf in addition to define.xml? 

Thank you, 

Sergiy