Challenges / Statistical Programming
Statistical ProgrammingOpen for solutions

Automate draft TFL generation from standardized clinical data

Generate traceable draft tables, figures, and listings from ADaM datasets, SAP intent, and TFL shells while preserving inspectable code and human review.

The problem

Statistical programmers still spend substantial time translating SAP intent, TFL shells, ADaM specifications, and standardized datasets into repetitive analysis code and reporting outputs. Much of the workflow is structured enough to automate, but existing approaches can be fragmented or difficult to audit.

Desired outcome

Generate draft TFLs automatically from standardized inputs, produce inspectable analysis code, maintain traceability to specifications and source datasets, and flag ambiguity for human review.

Requirements / constraints

  • Use ADaM as the primary analysis-ready source, with SDTM as an upstream source where relevant.
  • Understand SAP content, TFL shells, and study metadata.
  • Produce inspectable SAS, R, or equivalent code rather than opaque output only.
  • Maintain reproducibility and auditability.
  • Human programmer review and approval remain required.

What could qualify

An AI-assisted programming workflow, metadata-driven TFL engine, ARS/ARD-based solution, R or SAS framework, or configurable prototype could qualify.

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Responses are vetted by ClinExchange before qualified options are presented to the requester.

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