How to Use Controlled Terminology and Formats

TIG metadata and domain specifications refer to controlled terminology and formats defined both within and external to this guide. CDISC controlled terminology may be referenced here:

• https://www.cdisc.org/standards/terminology/controlled-terminology

Some codelists, such as Laboratory Test Codes (LBTESTCD), are extensible. This means that values that are not already represented in that list (either as a CDISC Submission Value, a synonym, or an NCI preferred term) may be added as needed. Other codelists, such as AE Action Taken with Study Treatment, are non-extensible and must be used without adding any terms to the list. Where no CDISC Controlled Terminology exists, implementers should develop sponsor-defined terminology to ensure consistency and transparency. If gaps are identified, sponsors should submit requests to add values to CDISC CT by using the Term Suggestion form (available at http://ncitermform.nci.nih.gov/ncitermform/?version=cdisc).

Data Collection

Using controlled terminology during data collection builds in traceability and transparency and supports mapping of data to tabulation datasets. Controlled terminology can be used in the following ways during data collection:

1. To collect data using controlled terms (e.g., Mild, Moderate, Severe)
   1. When appropriate a subset of a terms may be used rather than all available terms.
2. To ask a specific question on the CRF (e.g., Temperature)
3. To create a variable name in the database (e.g., TEMP for the collection of vital sign data when a unique variable name must be created for each vital sign result)

In tabulation datasets,

Terms from controlled terminology should be in the case that appears the source codelist or code system (e.g., CDISC codelist or external code system such as MedDRA). See Section 4.2.4, Text Case in Submitted Data.

Storing topic variables for general domain models

The topic variable for the Interventions and Events general observation-class models is often stored as verbatim text. For an Events domain, the topic variable is --TERM. For an Interventions domain, the topic variable is --TRT. For a Findings domain, the topic variable --TESTCD should use controlled terminology (e.g., "SYSBP" for systolic blood pressure). If CDISC Controlled Terminology exists, it should be used; otherwise, sponsors should define their own controlled list of terms. If the verbatim topic variable in an Interventions or Event domain is modified to facilitate coding, the modified text is stored in --MODIFY. In most cases—other than Physical Examination (PE)—the dictionary-coded text is derived into --DECOD. Because the PEORRES variable is modified instead of the topic variable for PE, the dictionary-derived text would be placed in PESTRESC. The variables used in each of the defined domains are:

CREATE TABLE?

Standards for tabulation require representation of dates and/or times, intervals of time, and durations of time in ISO 8601 format as defined by the International Organization for Standardization (ISO) (http://www.iso.org).  Included in specifications...