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For tabulation datasets, conformance to standards is minimally ensured by:
| Metadataspec |
|---|
| Num | Conformance | Implementation |
|---|
| 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.| All data generated as part of documentation (Protocol?), collected as part of study conduct |
| - 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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| - 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 |
| 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:
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