CDISC CONTROLLED TERMINOLOGY RULES
18 September 2015
General Rules
- A CDISC terminology concept is defined as the c-code, synonym(s), and definition.
o CDISC terminology concept can be associated with multiple codelists.
o CDISC submission value can be the same or different across multiple codelists.
o CDISC terminology concept used across multiple codelists must have the same NCI C-code, CDISC synonym(s)
and CDISC definition.
- The CDISC submission value, synonym(s), and definition should use the American English spelling.
CDISC Submission Values
o Within a codelist, there cannot be duplicate CDISC submission values (i.e. two different CDISC terminology
concepts with the same CDISC submission value).
o Within a codelist, there can only be one CDISC submission value for each CDISC terminology concept.
o Within a codelist, if a term is in use as a CDISC submission value, that same term cannot also be a synonym for a
different CDISC terminology concept.
o The CDISC submission value for a test code cannot be the same as an existing codelist CDISC submission value
(codelist short name).
o The CDISC submission value for a codelist name must be 8 characters or less.
o All codelist names must have a unique CDISC submission value.
o The CDISC submission value for a codelist name should not be the same as the SDTM variable name (excluding
legacy codelists).
o Test code/test name paired codelists (including long name/short name and parameters/parameters code):
 Test code value should be 8 characters or less, cannot start with a number, and cannot contain characters
other than letters, numbers, or underscores.
 Test name value should be 40 characters or less.
o CDISC submission values are generally in upper case.
 Exceptions include:
 Test names in the paired code and name codelists (for example: test code/test name or long
name/short name or parameters/parameters code codelists) are in title case.
 Units of measure
 Genetic sample type codelist: dsRNA (Double-stranded RNA), etc.
 Tumor response result codelist: nPR (Nodular Partial Response), CRi (Complete Remission with
Incomplete Blood Count Recovery), etc.
o CDISC submission values for organs containing the term left/right:
 If the structure and function are exactly the same, then the left/right can be split off and stored in the SDTM
laterality variable.
Synonyms
o
o
o
Synonym values are mixed case. For example: the first letter of each noun is upper case and all other letters are
lower case.
 Synonyms for microorganism and animal names follow the usual convention of capitalized genus name and
a lower case species name.
Multiple synonyms are separated by a semicolon and a space.
Synonyms should only be used when the CDISC terminology concept may not be clear without them. A synonym
can be added only if the additional meaning is not otherwise covered by existing synonyms, CDISC submission
values, or within the definition.
Definitions
o
o
o
o
Definitions should be written in sentence case, and always end with a period.
Definitions should not contain bullet points or other specialized formatting. Special characters (e.g. >, &, etc.)
should be spelled out.
Definitions should not contain information that unnecessarily narrows the meaning and use of the terms (e.g. method
information in test definitions, etc.).
The submission value and the definition should be at the same level of granularity. The submission value should be
descriptive for what is being defined. A more general term should have a general, broad definition that fits all uses
and contexts for the use of that term and a more granular/specific term should have a definition that matches the
exact use and context for the use of that term.