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| Metadataspec |
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| Num | Conformance | Implementation |
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| 1 | Representing all collected, assigned, and relevant derived data in applicable datasets. | All data generated per scientific and regulatory requirements are included in standardized tabulation datasets. | | 3 | Using domain specifications in this guide wherever applicable. | A dataset is created using a domain specification in this guide when the scientific nature or role of the data is within the scope of a domain. Custom domain specifications are only used when data are different in nature and are not in scope for domains in this guide. | | 2 | Following conventions for dataset naming. | The dataset name is standardized per naming conventions and per controlled terminology where applicable. | | 3 | Following guidance for dataset record structure. | The dataset record structure is aligned with the structure specified per the applicable domain specification. | | 38 | Following domain specifications in this guide wherever applicable. | The dataset | 4 | - Using specified standard domain names and prefixes per controlled terminology where applicable
| Core designations. | All Required and Expected tabulation variables are included as columns in the dataset. Required tabulation variables are populated for all records in the dataset. | 5 | Following SDTM-specified controlled terminology and format guidelines for variables, when provided | | 6 | Following conventions for variable namesnaming. | The names of variables in the dataset are standardized per tabulation guidance for all variables in the datasetdomain specifications and other applicable guidance. Controlled terminology is used as specified for variable naming. | | 7 | Following conventions for variable labels. | The labels for variables in the dataset are standardized per tabulation guidance for all variables in the dataset.domain specifications and other applicable guidance. | | 9 | Conforming to guidance in CDISC Notes column and general and domain-specific assumptions. | Populating variable values in alignment with this guide. | All variables in the dataset are populated as expected per this guide including per general and domain-specific guidance, controlled terminology, and formatting | 8 | Following Core designations. | All Required and Expected tabulation variables are included as columns in the dataset. Required tabulation variables are populated for all records in the dataset. |
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For analysis datasets, conformance to standards is minimally ensured by:
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