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| Metadataspec |
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| Num | Conformance | Implementation |
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| 1 | Representing of all collected, assigned, and relevant derived data in applicable datasets. | Representing of all collected, assigned, and relevant derived data in applicable datasets. |
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Guidelines for Tabulation Datasets
Tabulation dataset conformance with standards in this guide is minimally indicated by:
| - Following the complete metadata structure for data domains
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| - Following SDTMIG domain models wherever applicable
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| - Using specified standard domain names and prefixes per controlled terminology where applicable
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...
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| - Following SDTM-specified controlled terminology and format guidelines for variables, when provided
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| - Using specified standard variable names
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| - Using specified standard variable labels
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| - Including all Required and Expected variables as columns in standard domains, and ensuring that all Required variables are populated
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| - Ensuring that each record in a dataset includes the appropriate Identifier and Timing variables, as well as a Topic variable
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| - Conforming to guidance in CDISC Notes column and general and domain-specific assumptions
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For analysis datasets, conformance to standards is minimally ensured by:
Tabulation and analysis dataset conformance can be formally evaluated by comparing dataset content
Conformance to standards in this guide can be proactively ensuring
and assessing conformance Conformant collection and representation of data is ensured by full adherence standards per this guide.
Conformance may be by data collection
Conformance to standards may be minimally assessed by confirming intended implementation per the guidelines below and by evaluating tabulation and analysis datasets in relation to conformance rules.
<Add references to conformance rules here>