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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


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