What Happens When Analysis and Display Are Independently Produced as Analysis Results DataSets (ARDS) and TFLs?

About this session

Part of Session 5, Track C: Innovation/AI (Chair: Asif Karbhari, AstraZeneca).

Lilly is piloting a process to split Analysis Results DataSets (ARDS) and TFLs into separate deliverables. Our new system treats creation of ARDS files in the same vein as CDISC datasets. This system creates, stores, and maintains standards for SDTM, ADAM, and ARDS datasets. Code is directly produced from these standards to create datasets that maintain consistency and traceability from data collection through analysis results. The code will facilitate transparency since the configured standards will be automatically reflected in the generated code. A separate TFL system consumes ARDS files and generates the displays. TFL standards were re-written to use ARDS as input rather than ADAM making the TFLs a cosmetic step. This enables a user-friendly GUI TFL tool to be created which focuses on displaying ARDS results as TFLs without concern for deriving the analysis results. This presentation will report on the progress and findings of the pilot studies.

Speaker

• AM

  Andrew Miskell

  Eli Lilly and Company

  Speaker