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Using controlled terminology and formatting from data collection through tabulation and analysis builds in traceability and transparency across study data. Controlled terminology and formats are required to be used as specified in this guide. General guidance for use of controlled terminology and formats is provided in this section; detailed instructions are provided as part of sections specific to collection, tabulation, and analysis standards. 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:
Controlled Terminology
CDISC Controlled Terminology and supporting documentation (available at https://www.cdisc.org/standards/terminology/
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) are managed as publications separate from this guide. Users of the TIG are encouraged to reference CDISC Controlled Terminology regularly to access controlled terms and for additional information.
CDISC Controlled Terminology codelists are either extensible or nonextensible. For extensible codelists, new terms (those not already listed as either
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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 synonymCDISC Synonym, or an NCI preferred termPreferred 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 defined and used with the TIG. Terms in nonextensible codelists must be used as-is; new terms cannot be added or used. When extending a codelist, the case-sensitivity convention of the codelist will be followed. It is highly recommended that (1) new terms for CDISC Controlled Terminology extensible codelists and (2) Changes to existing terms and requests for new codelists be submitted to the National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS) for review and consideration. Submission of terminology requests to NCI-EVS helps ensure the consistency and transparency of data for all users of the TIG. Controlled terminology requests can be submitted to NCI-EVS by using the Term Suggestion form available at http://ncitermform.nci.nih.gov/ncitermform/?version=cdisc).
Data Collection
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External sources for controlled terminology
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are referenced in this guide and will be used as indicated, in alignment with regulatory requirements.
The following table summarizes how controlled terminology supports implementation of standards.
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- When appropriate a subset of a terms may be used rather than all available terms.
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Formats
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Standards for tabulation and analysis 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...The appropriate date and/or time ISO format must be used when specified. Additional ISO formats are referenced in this guide and will be used as indicated in alignment with regulatory requirements.
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