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- Representing all collected, assigned, and relevant derived data in appropriate applicable datasets.
- Following the complete metadata structure for data domains
- Following SDTMIG domain models wherever applicable
- Using specified standard domain names and prefixes per controlled terminology where applicable
- Using specified standard variable names
- Using specified standard variable labels
- Following SDTM-specified controlled terminology and format guidelines for variables, when provided
- Including all Required and Expected variables as columns in standard domains, and ensuring that all Required variables are populated
- 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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