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Determining whether a product faithfully implements a standard or specification is essential to creating robust, interoperable solutions. 

Data Collection

Data Tabulation

From SDTMIG

Conformance with the SDTMIG domain models is minimally indicated by:

• Following the complete metadata structure for data domains
• Following SDTMIG domain models wherever applicable
• Using SDTM-specified standard domain names and prefixes where applicable
• Using SDTM-specified standard variable names
• Using SDTM-specified data types for all variables
• Following SDTM-specified controlled terminology and format guidelines for variables, when provided
• Including all collected and relevant derived data in one of the standard domains, special-purpose datasets, or general observation class structures
• 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 all business rules described in the CDISC Notes column and general and domain-specific assumptions

Conformance with the SENDIG domain models is minimally indicated by:

• Following the complete metadata structure for data domains
• Following SENDIG domain models wherever applicable
• Using SENDIG-specified standard domain names and prefixes per controlled terminology
• Using SENDIG-specified standard variable names
• Using SENDIG-defined variable labels for all standard domains
• Using SDTM-specified data types for all variables
• Following SDTM/SEND-specified controlled terminology and format guidelines for variables when provided
• Including all collected and relevant derived data in one of the standard domains, special-purpose datasets, or general-observation class structures
• 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 all business rules described in the CDISC Notes column and general and domain-specific assumptions
• Ensuring that the datasets are in SAS v5 transport file format or other transport file format required by a regulatory agency

Data Analysis