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...
ecdms.blogspot.com
Electronic Data Capture - Technology Blog: March 2009
http://ecdms.blogspot.com/2009_03_01_archive.html
Electronic Data Capture - Technology Blog. A forum for discussing topics related to Electronic Data Capture and Clinical Data Management. Monday, March 23, 2009. EDC Study Startup Time. EDC Guru left a comment on the Top 10 mistakes made when implementing EDC. 160; Is that how long it takes the vendor or CRO to *do* the study build, or is that how long it takes for a sponsor to be ready for EDC. I would put forward that any sponsor company that goes from no experience to executing EDC studies in 12 week...
ecdms.blogspot.com
Electronic Data Capture - Technology Blog: March 2010
http://ecdms.blogspot.com/2010_03_01_archive.html
Electronic Data Capture - Technology Blog. A forum for discussing topics related to Electronic Data Capture and Clinical Data Management. Tuesday, March 23, 2010. Apple iPad and eSource. The Apple iPhone broke new ground in offering an all in one device for Music, Phone, Games, Organizer and general applications. Other companies had introduced almost all the concepts. It was Apple that brought them all together so effectively. Initially, I see the iPad making inroads within Phase I units. Hard...Subscr...
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,...
