cdiscguru.blogspot.com
Working on and with CDISC Standards: Why SUPPQUAL sucks
http://cdiscguru.blogspot.com/2013/04/why-suppqual-sucks.html
Working on and with CDISC Standards. Sunday, April 21, 2013. Following up on my previous post on NSVs (Non-Standard Variables) which are banned to SUPPQUAL datasets in SDTM, I was wondering why it would be so hard (for the FDA) to recombine such NSVs with their parent record (or group of records) in the parent domain. So I tried it myself. We (one of my Masters student and I) am also working on a "smart" viewer for such data. I will report on the "Smart SDTM Viewer" later. As we needed test files for new...
cdiscguru.blogspot.com
Working on and with CDISC Standards: FDA publishes Study Data Validation Rules
http://cdiscguru.blogspot.com/2014/11/fda-publishes-study-data-validation.html
Working on and with CDISC Standards. Thursday, November 20, 2014. FDA publishes Study Data Validation Rules. The FDA recently published its "Study Data Validation Rules" (http:/ www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. For SDTM and SEND. Unfortunately the rules come as a set of Excel files, so not vendor neutral (Excel is a product of the company Microsoft) and the rules themselves are unfortunately not machine-readable nor machine-executable. Another possibility is to use XQ...
cdiscguru.blogspot.com
Working on and with CDISC Standards: Machine executable FDA rules for SDTM
http://cdiscguru.blogspot.com/2014/12/machine-executable-fda-rules-for-sdtm.html
Working on and with CDISC Standards. Thursday, December 4, 2014. Machine executable FDA rules for SDTM. In my previous posts " FDA publishes Study Validation Rules. And " Follow up to 'FDA publishes Study Validation Rules. I showed how these rules can be expressed in XQuery, an open W3C standard query language for XML documents and XML databases. So I wonder why the FDA (with considerably more resources than I have) did not publish these rules as machine-executable rules. Xquery version "3.0";. Declare n...
cdiscguru.blogspot.com
Working on and with CDISC Standards: February 2015
http://cdiscguru.blogspot.com/2015_02_01_archive.html
Working on and with CDISC Standards. Thursday, February 12, 2015. Rule FDAC084 is just damned wrong. The FDA has recently published a set of "SDTM rules". Unfortunately in Excel format, which is not machine-executable. So I started working on an XQuery representation, which will soon be available through a set of web services. You can already find some examples in my previous blog entries. When working on these rules, I found that:. About 10% of them is just damned wrong. LBTESTCD=GLUC (glucose), LBCAT=U...
cdiscguru.blogspot.com
Working on and with CDISC Standards: Rule FDAC084 is just damned wrong
http://cdiscguru.blogspot.com/2015/02/rule-fdac084-is-just-damned-wrong.html
Working on and with CDISC Standards. Thursday, February 12, 2015. Rule FDAC084 is just damned wrong. The FDA has recently published a set of "SDTM rules". Unfortunately in Excel format, which is not machine-executable. So I started working on an XQuery representation, which will soon be available through a set of web services. You can already find some examples in my previous blog entries. When working on these rules, I found that:. About 10% of them is just damned wrong. LBTESTCD=GLUC (glucose), LBCAT=U...
cdiscguru.blogspot.com
Working on and with CDISC Standards: February 2013
http://cdiscguru.blogspot.com/2013_02_01_archive.html
Working on and with CDISC Standards. Saturday, February 2, 2013. SDTM and non-standard variables. The new draft SDTM-IG 1.4 package 2 contains an interesting statement in the "SDS Proposal for alternate Handling of Supplemental Qualifiers" (file: SDS Proposal-Alternate Handling of Supplemental Qualifiers.pdf) document. I cite:. Where "NSV" means "Non-standard variables". Essentially the above statement says that reviewers are not able to combine variables in SUPP- domains with the parent domain and bring...
cdiscguru.blogspot.com
Working on and with CDISC Standards: Why SDTM should NOT contain --TEST as a variable
http://cdiscguru.blogspot.com/2014/07/why-sdtm-should-not-contain-test-as.html
Working on and with CDISC Standards. Sunday, July 13, 2014. Why SDTM should NOT contain - TEST as a variable. All the findings domains in the SDTM have both - TESTCD (test code) and - TEST (test name) variables. There is a pure 1:1 relation between - TESTCD and - TEST: for each unique value of - TESTCD there is a single unique value of - TEST. For example for LBTESTCD=GLUC, only LBTEST=Glucose is allowed. Here is a view from a sample SDTM submission:. But did you notice that there is an error? Of course,...
cdiscguru.blogspot.com
Working on and with CDISC Standards: April 2014
http://cdiscguru.blogspot.com/2014_04_01_archive.html
Working on and with CDISC Standards. Friday, April 11, 2014. Using UCUM units for CDISC-SEND. At the European CDISC Interchange we once again discussed replacing CDISC controlled terminology for units by UCUM, the latter being the worldwide standard for units, and used everywhere in healthcare and in electronic health records (mandatory in HL7-CDA). The statement about UCUM not being usable for SEND is just not true. Consider the following "unit" used in SEND: g/animal/day. The next objection of the SEND...
cdiscguru.blogspot.com
Working on and with CDISC Standards: December 2012
http://cdiscguru.blogspot.com/2012_12_01_archive.html
Working on and with CDISC Standards. Saturday, December 29, 2012. Yesterday and today, I worked on implementing the new SDTM oncology and a number of the new draft SDTM-IG 3.1.4 domains in my SDTM-ELT(TM) software. For each new domain, I created a template define.xml file that can be read by the software. It was so frustrating! First I read the Excel file into OpenOffice Calc (a competitor of Excel). Then I exported the tables as an OpenOffice "odf" file, which is essentially a zip file containing a ...
