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Determining whether a product faithfully implements a standard or specification is essential to creating robust, interoperable solutions. Specific points for assessing and to take into account when practicing for conformance are below

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Conformance of tabulation datasets with standards in this guide is minimally indicated by:

• Representing all collected, assigned, and relevant derived data in appropriate 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 providedIncluding 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 guidance in CDISC Notes column and general and domain-specific assumptions

Standards for Analysis

conformance rules