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The following table illustrates minimum conformance to standards for tabulation datasets. 

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NumConformanceImplementation
1

Representing all collected, assigned, and relevant derived data in applicable datasets

All data generated per scientific and regulatory requirements are included in tabulation datasets.
2

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. Domains are extended or custom domain specifications are only used when data are different in nature and are not in scope for domains in this guide.

3

Following conventions for dataset naming

The dataset name is standardized per naming conventions and per controlled terminology where applicable.
4

Following guidance for dataset record structure

Dataset content is aligned with the record structure specified per the domain specification.
5Following core designations

All Required and Expected tabulation

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5Following core designations

791
All Required and Expected tabulation variables are included as columns in the dataset. Required tabulation variables are populated for all records in the dataset. Permissible variables used to collect data are included in the dataset, even when no data for those variables were collected.

6Following conventions for variable namingThe names of variables in the dataset are standardized per domain specifications and other applicable guidance. Controlled terminology for domain prefixes is used as specified for variable naming.
7

Following

conventions for variable labelsThe labels for variables in the dataset are standardized
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per domain specifications and other applicable

guidance

8

Following guidance for variable types

The variables in the dataset are standardized for either numeric or character values as specified per the domain specification.

98

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.

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