Link to CRF in define.xml

Pinnacle 21 Support Define.xml
1

Hi Ram,

A current version of define.xml generator is quite limited. It does not automate a population of variables Origin. You need to edit xml file manually.

Please wait for upcoming release of OpenCDISC Community for a new free define.xml tool.

A commercial version of define.xml tool is already available in Enterprise edition. See a recorded webinar on http://www.pinnacle21.net/blog/creating-define-xml-2-0-webinar-recap#more-158

Kind Regards,

Sergiy

2

Thanks Sergiy, for the info. I was able to edit XML file to populate origin columns with CRF page numbers but was having trouble creating links to the respective page numbers. can you please help me figure out how to create the links.

Thanks

Ram

3

Hi Ram,

Hyperlinks are populated by define.xml stylesheet.

CDISC team created a special stylesheet for v1.0. When Origin value includes any “CRF Page x” or “CRF Pages x” string the stylesheet generates a hyperlink to “blankcrf.pdf#page=x” assigned to “x” value.

Therefore in define.xml you need to generate Origin value like

<ItemDef OID=“AE.AESER” Name=“AESER” DataType=“text” Length=“1” Origin="CRF Page 21" d ef:Label=“Serious Event”>

<ItemDef OID=“CM.CMTRT” Name=“CMTRT” DataType=“text” Length=“23” Origin=“CRF Pages 9, 22” def:Label=“Reported Name of Drug, Med, or Therapy”/>

<ItemDef OID=“SUPPQS.QNAM.RTRINIT” Name=“RTRINIT” DataType=“text” Length=“3” Origin=“QSMM-CRF Page 13; QSCS-CRF Pages 14; QSCG-CRF Page 17” def:Label=“Rater Initials”/>

The similar approach is used for v2.0. Hyperlinks are populated in a browser by stylesheets. However define.xml v2.0 standard is more logical and well-structured. There are special Elements/Attributes for Origin. E.g.,

  • def:DocumentRef
  • def:PDFPageRef / Type, PageRefs, FirstPage, LastPage

CDICS team provided many good examples in define.xml package, Pilot I data, Metadata Package, etc.

Kind Regards,

Sergiy

4

Thanks again Sergiy, I populated the origin as “CRF Page x” but couldnt get the links but was wondering why am I not getting links, so, I guess stylesheet is the issue. I was using the style sheet that came with OpenCDISC validator 1.5.

Thanks so much for providing all the information.

Ram

5

Hello everyone,

I recently started to use opencdisc to create define.xml but wasnt able to figure out how to link the annotated CRF to define.xml, can someone please help me understand how to link the CRF so that I can get the hyperlinks in origin column.

Thanks

Ram