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| Metadataspec |
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| Num | Guidance | Implementation |
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| 1 | Dataset Content | Data represented in tabulation datasets will include the following per regulatory requirements and standards in this guide: - Data as originally collected or received.
- Data from relevant external references (such as a protocol).
- Assigned data.
- Derived data.
| | 2 | Dataset Naming | Each domain dataset is distinguished by a unique, 2-character code that should be used consistently throughout the submission. This code, which is stored in the SDTM variable named DOMAIN, is used in 4 ways: as the dataset name, as the value of the DOMAIN variable in that dataset, as a prefix for most variable names in that dataset, and as a value in the RDOMAIN variable in relationship tables (see Section 8, Representing Relationships and Data). | | 3 | Variable Naming |
| | 4 | Splitting Datasets |
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Generally, a domain is represented by a single dataset.
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