LLM

Define-XML Questions

• Select variables needed for lab abnormality analysis
• Compare variable definitions against study XXX (multiple define.xmls)

General checks/questions

• Check descriptions for grammar and logical issues
• Check compliance with CDISC TAUG
• Check that my Define-XML conforms ADaMIG X.X
• Check for circular dependencies in variable derivations
• Check compliance with FDA SDTCG (PMDA/EMA/NMPA/FDA BIMO guide)
• Check that all Define-XML business rules are satisfied

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• Build a dependency tree of the datasets in define.xml
• Are there any variables missing, which are required by the standard (probably a CORE check and should be excluded)?
• Which dataset can support primary efficacy analysis? (SAP required as context)
• Which study-specific validation checks should I add? (Can be dataset/variable level question)
• Are there any study-specific conventions?
• Identify all datasets and variables which need to be updated to implement change XXX.
• Suggest improvements to the define.xml metadata definitions
• List all SDTM datasets used/not used in my ADaM derivations

Datasets

• Check dataset is compliant with a standard/TAUG.
• Check all CRF fields from XX page/YY section are mapped in this dataset

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• Explain the purpose of this dataset to me
• Identify non-standard things in this dataset (e.g. we derive additional age variable)
• Explain purposes for each of the ANLxxFL flags

Variables

• Check if variable names follow CDISC conventions
• Check origins
• Check if there are variables which should have codelists associated with them
• Check if VLM should be added for any variables
• Check variable names are following a consistent naming conventions
• Check all OIDs to make sure all references are present and no unused variables

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• Which variables represent baseline characteristics?
• Which datasets contains efficacy data?
• Which variables depend on variable DS.VAR?
• Find variables with incomplete or vague descriptions

Codelists

• Check if there are codelists which should be CDISC/NCI codelists
• Check if there are codes which should be from CDISC/NCI codelists instead of extended values (i.e. code values are synonyms and need to be changed)
• Check for inconsistent terminology usage across similar variables

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• Identify complex derivation algorithms that need validation

ARM

• Check all analysis variables are listed

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• What are SAP parts supporting this ARM output?
• Write a program in XXX language supporting this ARM output.

Generative Features to Consider

• Generate text for a DRG based on findings in the Define-XML
• Generate basic statistics describing how much of the Define-XML is based on standards

Very Basic Questions

• Counts, such as how many datasets are in the Define-XML or how many variables have associated value lists
• Listing of define elements, such as datasets, variables, or value-level metadata