Hyperlink of CRF origin Pages to Annotated PDF

Hi Priyanka,I believe…

Hi Priyanka,

I believe version 2.2.0 uses stylesheet from the Define-XML 2.0 release package (unless you are creating Define-XML 1.0) which does not create links to pages in the "Derivation/Comment" column. I think this functionality was already added in the ARM stylesheet and is definitely supported in the latest stylesheet version which can be downloaded from the CDISC stylesheet library: https://wiki.cdisc.org/display/PUB/Stylesheet+Library

Dmitry.

Hyperlink of CRF origin Pages to Annotated PDF

To add to Dmitry's answer:

Be aware that it is the sponsor's responsibility to provide a suitable stylesheet for the define.xml when doing a submission. If that is your responsibility, do you really blindly trust the stylesheet from a third party? Whatever is the source of the stylesheet, you should carefully evaluate what it is doing. Stylesheets can also be used to manipulate (meta)data, but of course CDISC, Phuse nor Pinnacle21 would ever do that (well, we hope).
So, not a bad idea to have someone in house who really understands define.xml (as XML of course) and has good knowledge of stylesheets.

P.S. There is also another stylesheet from Phuse which is documented at: https://www.phusewiki.org/wiki/index.php?title=Define-XML_Stylesheet
and can be obtained from the SDRG package at: https://www.phusewiki.org/wiki/index.php?title=Data_Reviewer%27s_Guide_in_XML

With best regards,

Jozef Aerts
XML4Pharma

Lex

on June 4, 2019

Stylesheet

Jozef,

The PhUSE stylesheet that you mention is the one that Dmitry refers to, but then linked from the CDISC stylesheet library.

The one from the SDRG package is the original stylesheet that came with the Define-XML v2 release in 2013. I would not recommend using this, sine the CDISC stylesheet library (https://wiki.cdisc.org/display/PUB/Stylesheet+Library) has much improved stylesheets.

Lex