In the CDISC context, controlled terminology refers to bindingly defined codelists and permissible values for individual data elements in standardised study datasets. It ensures that, for example, sex, assessment method, unit, or result status are not transmitted in freely chosen variants, but using predefined codes and terms. CDISC develops this terminology together with the Enterprise Vocabulary Services of the US National Cancer Institute, which maintain and distribute it as part of the NCI Thesaurus.<\/p>\n
A codelist assigns a limited set of permitted entries to a data field. For a laboratory parameter, these may be predefined test names; for a classification, defined categories; and for a unit, permitted spellings. In addition to the transmitted value, the terminology includes definitions, synonyms, codes, and membership in a code system. This enables a recipient to recognise that two differently named datasets in fact describe the same concept.<\/p>\n
The terminology operates at the level of a field\u2019s content, not at the level of the table structure. SDTM, ADaM, SEND, CDASH, Define-XML and DDF can each contain terminology requirements. For external medical dictionaries, such as MedDRA, it does not replace their governance; rather, it specifies where and in what coded form the relevant reference is used in a CDISC dataset.<\/p>\n
It is important to distinguish between a display name and a submission value. An eCRF can offer a user-friendly selection, while the dataset variable must carry the code defined for it. Only the clearly documented relationship between the two prevents a conversion from visible text from producing a transmitted value that differs in content.<\/p>\n
CDISC is responsible for the subject-matter development and alignment of terms with its standards. NCI EVS maintains and distributes the terminology products within the NCIt. This interplay matters because a codelist is not just a file: it must remain consistent with definitions, identifiers, and relationships to the data elements. The terminology packages documented on the CDISC pages are published quarterly; earlier versions remain available for traceability.<\/p>\n
If a suitable term is missing for a planned collection, a free-text substitute value is not an equivalent solution. CDISC provides an application process for new or changed terms. Until a decision is made, the study protocol, eCRF specification, data management plan, and later mapping rules must clearly distinguish whether a value is standardised, assigned to an approved extension, or project-specific.<\/p>\n
The specific publication is decisive for technical implementation. A mapping developed with an older list may, under a newer terminology version, contain a preferred term that has since changed, a different definition, or a changed assignment. Therefore, the specification must include not only the name of the codelist but also the release version used. Before switching, changes must be assessed for whether they affect data capture, conversion, validation, or submission metadata.<\/p>\n
Controlled terminology does not determine what information a study should collect in the first place. It answers only how an already collected data element is expressed in the electronic dataset. This is what distinguishes it in particular from CDASH: CDASH describes standardised elements for data collection, whereas controlled terminology provides the permissible values for such elements.<\/p>\n
The neighbouring entry CDISC Standards is also broader in scope. A data model can define variables, domains, and relationships; a codelist makes the values within that structure semantically unambiguous. The terminology is therefore not a substitute for SDTM or ADaM, but a prerequisite for ensuring that their contents are understood consistently across sponsors, service providers, and authorities.<\/p>\n
In a clinical trial, work with controlled terminology begins with defining response options in the eCRF and extends through to the submission package. Data managers must verify whether codes from the capture system can be transferred into SDTM without loss of meaning. Otherwise, inconsistent spellings, local lists, or undocumented recoding create avoidable findings during data review and make it harder to compare study arms or studies.<\/p>\n
Full-service CROs such as Mediconomics support the selection of suitable codelists, the alignment of eCRF values with CDASH and SDTM, terminology mappings, and the review of Define-XML metadata. When updates occur, they can also assess whether new terms affect ongoing databases, programming, and the planned regulatory submission.<\/p>\n
Is controlled terminology a medical dictionary?<\/strong><\/p>\n It can reference external dictionaries, but at its core it is the CDISC-governed compilation of codelists and valid values for CDISC data elements. Its focus is on consistent representation in standardised datasets.<\/p>\n May a study use its own response values?<\/strong><\/p>\n Project-specific values may be necessary for data collection. However, for a CDISC-compliant delivery, it must be documented how they are converted into the applicable permissible terminology, or why a deviation remains.<\/p>\n Who publishes CDISC terminology?<\/strong><\/p>\n CDISC develops and maintains the terminology together with NCI EVS. The Enterprise Vocabulary Services of the National Cancer Institute maintain and distribute the terminology as part of the NCI Thesaurus.<\/p>\n In the CDISC context, controlled terminology refers to bindingly defined codelists and permissible values for individual data elements in standardised study datasets. It ensures that, for example, sex, assessment method, unit, or result status are not transmitted in freely chosen variants, but using predefined codes and terms. CDISC develops this terminology together with the Enterprise […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[25],"class_list":["post-8044","glossary","type-glossary","status-publish","hentry","glossary-cat-datenmanagement-eclinical"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/8044","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/8044\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=8044"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=8044"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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