Controlled Terminology

what is controlled terminology? controlled terminology (ct) is used to standardize data values when collecting study data for example, when collecting a subject’s sex, the cdisc nci terminology standard defines the permitted data values as “f”, “m”, “u” and “undifferentiated” the use of consistent terminology within and between studies helps with consistency, transparency and efficiency across your studies for example, if the same ct is used in related forms and sdtm datasets, then mapping between collected data and submission datasets is more straightforward ct is a requirement for fda submission cdisc and nci provide submission ready terms and their definitions and these nci controlled terminologies are available as docid\ cfxhicjrwafszsp rlwej in ryze these published standards include the following adam nci cdash nci sdtm nci send nci in ryze, there are three types of controlled terminology code/decode each term has a code with an accompanying decode (display) used in forms and edcs enumerated each term has a coded value only used in datasets external this type of terminology links to an external system or dictionary for example, meddra dictionary using published standard terminology the published nci terminology standards are extensive and allow you to implement https //www cdisc org/standards/terminology/controlled terminology codelists in ryze, terminology is managed using terminology assets and their associated terms assets when managing nci terminologies, you may want to subset and maintain your own version of the published nci standard or you can pull content from the published nci version directly into your study maintaining your own terminology standard is more time consuming but is more efficient if you’re going to extend/modify and then reuse modified ct subsetting you can choose to subset a published nci standard and maintain your own centralized version of the published standard this option means that you can find content faster instead of importing the full list of nci terminologies at study level but also means that you’ll have to invest time in maintaining your terminology standard by importing from the published standard you provide traceability to the published nci standard this means that you are able to update your version in future by running a docid\ xkn0c nq07uo8wqrpcopl with the updated published standard use this option if you want to extend the nci ct to create your own proprietary ct library as well as align with nci as new versions are released you can also implement your own rules using by cloning nci ct import the published nci terminology the other option is to import nci terminology at the standard/study level this means you import the nci terminology directly into your standard/study this provides direct traceability to the published nci standard and ensures compliance with cdisc you can still subset and extend the imported terminology but you might have to do it more frequently and for each study changes to codelist items are flagged as a deviation from the derived nci terminology standard best practice you can use a mix of subsetting and importing when working with assets an example of how you can manage ct is shown in the following diagram, where nci terminology has been subsetted to company specific ct company ct can then be edited but maintains a link to the nci standard company ct is then imported into forms and datasets as required maintaining ct new versions how you maintain your ct depends on how it is organized for example, if you have standardized terminology then you might want to retire old versions as new updates are made, this ensures that the older content can’t be used in a future study you can also use version labels to add human readable labels to versions of a standard for content that is imported from another standard, you can use the comparisons tool to check for changes between your existing ct and the new version working with terminologies terminologies can be created as well as imported from other sources formedix provides published standards for use in your repository for example, the sdtm nci standard includes terminologies and terms that can be imported into your repository imported terminologies may have rules that limit extensibility creating a terminology you can create a terminology within any asset group type from the asset group you wish to create the terminology, select the plus icon next to terminologies specify the following label name identifier data type external dictionary (only if your terminology is external) click validate & save adding terms to a terminology terms can be created or existing terms can be associated with a terminology to create a new term click create term and specify the following label name identifier data type external dictionary (only if your terminology is external) click validate & save to associate an existing term, click associate term and select from the list of existing terms in your asset group