mapping-scenarios

The standard SDTM mapping scenarios include direct carry forward, rename, attribute change, combine, split, derivation, value mapping, structure transformation, and supplemental qualifiers. These nine patterns provide a structured framework to map raw clinical trial data accurately into SDTM-compliant datasets.

To generate a mapping specification, provide your source data schema and target SDTM domains. Apply the nine-scenario framework workflow to define transformation functions, specify mapping tooling, and document validation steps required to implement the clinical data transformations.

Supplemental qualifiers are needed during SDTM data transformation when raw clinical trial data contains variables that cannot fit into standard domain structures. This mapping scenario preserves non-standard variables by mapping them to supplemental qualifier records compliant with regulatory submission standards.

The best way to handle structure transformation and value mapping in SDTM is applying the defined nine-scenario framework. This approach standardizes converting data from wide to long formats and remapping raw clinical trial values to controlled terminology for regulatory submissions.

Yes, you can validate derivation and split mappings without external dependencies. The framework specifies validation steps and documentation procedures directly within the workflow to verify transformation accuracy and ensure SDTM compliance for regulatory submissions.

Yes, the SDTM mapping framework supports direct carry forward across all clinical data domains. It provides example-guided templates and transformation functions that apply universally, enabling data teams to standardize raw clinical trial data into compliant datasets.