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CDISC Controlled Terminology codelists are either extensible or nonextensible. For extensible codelists, new terms (those not already listed as either a CDISC Submission Value, a CDISC Synonym| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-359 |
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, or an NCI Preferred Term) may be 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.
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-655 |
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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....
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| Standards for Collection | Standards for Tabulation | Standards for Analysis |
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- Ask specific questions on the CRF (e.g., Temperature)
- Collect data values using terminology (e.g., Y or N)
- Name variables in the operational database (e.g., TEMP_VSORRES for the collection of vital sign data when a unique variable name must be created for each vital sign result)
| - Name domain datasets and variables in datasets when applicable
- Represent collected, assigned, and derived values in datasets
| - Represent the level of imputation for numeric date/time variables
- Represent the subject status at different phases of the trialstudy
- Represent the derivation method for cases of data imputation
- Represent values for analysis concepts as applicable
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