CDISC CONTROLLED TERMINOLOGY RULES 20 April 2016
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.
o For test names that include a hyphen, the character after the hyphen should be capitalized.
· 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 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.
o Multiple synonyms are separated by a semicolon and a space.
o 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 Definitions should be written in sentence case, and always end with a period.
o Definitions should not contain bullet points or other specialized formatting. Special characters (e.g. , &, etc.) should be spelled out.
o Definitions should not contain information that unnecessarily narrows the meaning and use of the terms (e.g. method information in test definitions, etc.).
o The CDISC submission value and the definition should be at the same level of granularity. The CDISC 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.