2015-12-08 ClinicalTrial.gov and EudraCT registries and CTR-XML Specification Document

 The CDISC CTR-XML Specification document needs Controlled Terminology's assistance in handling the ClinicalTrial.gov and EudraCT registries (and possibly the WHO registry) and combining the information in these registries into the existing Trial Summary Parameter Test Code/Name codelists.  The General Terminology team is adding these new terms into the TSPARM codelist that were requested from Jozef Aerts.  The additional information needed is to know what the preferred term is from the ClinicalTrial.gov and EudraCT registries and what CDISC term does this line up with in the TSPARM codelist.  There have been two suggestions on how to deal with this:

• 1 - create separate codelists in NCI/EVS publication for the EudraCT codelist and the ClinicalTrial.gov codelist.  They would share the same c-code with the correct matching term in the CDISC TSPARM codelist.
• 2 - create a mapping codetable that would contain two extra columns in the TSPARM codelist - one column for ClinicalTrial.gov preferred term and one column for EudraCT preferred term.  On the same row, one could see the CDISC term, the ClinicalTrial.gov term and the EudraCT term.  This mapping document can be created immediately and reside on the Controlled Terminology webpage (along with the other mapping codetable documents).  The ClinicalTrial.gov and EudraCT information is really a SUBSET of the TSPARM codetable and should not exist as separate codelists but should be entered into SHARE as a subset.  This needs to be scheduled as a top priority for SHARE subsets in 2016.