NOTE: The following information only applies to Pinnacle 21 Community (P21C) Validator versions 2.x
CDISC Controlled Terminologies are commonly used to constrain variable values used in standards such as SDTM, ADaM and SEND. The terminology files are maintained and distributed as part of the NCI Thesauraus and versioned by date. For more information, visit the CDISC Terminology and NCI EVS websites.
Because CDISC Controlled Terminology is freely available to the public, Pinnacle 21 includes the most recent versions for SDTM, ADaM and SEND as of the P21C Validator release date. For example, the 2.2.0 version of the validator currently ships with SDTM terminologies of 2015-06-26, 2015-09-25, 2015-12-18, 2016-03-25 and 2016-06-24. These options are available out of the box for use in both the GUI and Command Line Interface.
When new versions become available they will be installed through the Auto-update feature if enabled.
There is also an option to manually configure CDISC Control Terminology. P21 Community 2.x requires the use of the ODM formatted CT files. Because CDISC does not release these files in the proper format required for validation, the files from the CDISC website are modified before packaging with P21 Community. Adding raw *.odm.xml files to P21 Community will have adverse consequences.
Files needed for validation of all versions of CDISC CT can be downloaded from Pinnacle 21 website (https://www.pinnacle21.com/downloads/cdisc-terminology).
After successful installation of P21 Community Validator, navigate to the following folder:
components à config à data à CDISC
This is where you will find folders for each standard (ADaM, SDTM, SEND). Within each standards folder, there will be folders versioned by date in the format of YYYY-MM-DD. If you want to add a new version, simply create a subfolder in the appropriate standard and add the CT XML file from the Pinnacle 21 website. The .xml file will contain the name of the date such as “SDTM Terminology 2016-12-16.odm.xml”. You need to remove the date portion from the file name. Below shows the terminology structure shipped with the validator v2.2.0 and a custom added terminology file.
│ ├───2011-06-10/ ADaM Terminology.odm.xml
│ ├───2011-07-22/ ADaM Terminology.odm.xml
│ ├───2014-09-26/ ADaM Terminology.odm.xml
│ ├───2015-12-18/ ADaM Terminology.odm.xml
│ └───2016-03-25/ ADaM Terminology.odm.xml
│ ├───2015-06-26/SDTM Terminology.odm.xml
│ ├───2015-09-25/SDTM Terminology.odm.xml
│ ├───2015-12-18/SDTM Terminology.odm.xml
│ ├───2016-03-25/SDTM Terminology.odm.xml
│ ├───2016-06-24/SDTM Terminology.odm.xml
│ └───2016-12-16/SDTM Terminology.odm.xml
Selecting Controlled Terminology with the GUI
After selecting your standard and source data files, simply select the CT drop down box. By default, the latest available terminology is chosen when you first open the GUI.