Pilot 7: Agentic data standardization¶
Pilot 7 uses publicly available pilot studies and synthetic clinical trial data to demonstrate and evaluate agentic workflows for clinical data standardization.
Pilot studies¶
AI agents review pilot submission packages and generate derivation specifications in YAML format. The yamaa engine executes these specifications to derive ADaM datasets from SDTM. We compare the yamaa outputs with the published ADaM datasets from the original submissions.
| Study | Status | Datasets | Columns | Cells |
|---|---|---|---|---|
| Overall | - | 20 / 20 (100%) | 847 / 847 (100%) | 13.7M / 13.7M (100%) |
| CDISC Pilot 01 | Done | 10 / 10 (100%) | 415 / 415 (100%) | 9.1M / 9.1M (100%) |
| Submission Pilot 3 | Done | 5 / 5 (100%) | 216 / 216 (100%) | 2.3M / 2.3M (100%) |
| Submission Pilot 5 | Done | 5 / 5 (100%) | 216 / 216 (100%) | 2.3M / 2.3M (100%) |
Values are fully matched / reference total (percentage); M means one million.
Synthetic studies¶
We use synthetic studies to develop and demonstrate the full workflow:
EDC data extraction -> SDTM mapping -> ADaM derivation -> define.xml generation.
These outputs support eCTD submission package preparation.
| Study | Status |
|---|---|
| KN189 | Ongoing |
| KN564 | Ongoing |
Agentic SDLC workflow¶
We use yamaa within four stages of the software development lifecycle (SDLC):
- Plan: define specifications, derivation rules, and acceptance criteria. Record decisions.
- Develop: implement mappings, derivations, metadata, and custom functions.
- Evaluate: run specification checks and dataset comparisons. Review discrepancies and evaluation reports.
- Deploy: release reviewed programs, specifications, and outputs.
Human reviewers work with AI agents to refine plans and evaluate results throughout the workflow.
Responsibilities¶
| Role | Responsibility |
|---|---|
| Human reviewers | Define clinical and statistical requirements and acceptance criteria. Review and approve specifications, code, results, and releases. |
| AI agents | Draft specifications, custom functions, evaluation reports, and GitHub Actions workflows. Propose fixes for human review. |
Tools¶
| Tool | Purpose |
|---|---|
| yamaa | Check and execute YAML specifications to generate datasets and define.xml. |
| GitHub Issues | Record requests, discussions, and decisions. |
| GitHub Actions | Run automated checks and dataset comparisons. Build and deploy the project website through CI/CD. |