Unified representation of metadata structure for clinical analysis
& reporting (A&R) by leveraging the Analysis Data Model (ADaM)
datasets.
Overview
The metalite framework is designed to:
- Standardize function input for analysis and reporting.
- Separate analysis logic from data source.
- Enable the use of pipes (
|>).
- Reduce manual steps to develop and maintain documentation in
clinical trial development.
- Ensure consistency between analysis specification, mock, and
results.
Use cases
The metalite package offers a foundation to simplify tool development
and create standard engineering workflows. For example, metalite can be
used to:
- Standardize input and output for A&R functions.
- Create analysis and reporting planning grid.
- Create mock table.
- Create and validate A&R results.
- Trace analysis records.
Note: metalite is a low-level R package that needs to work with other
R packages to complete the work. The idea is illustrated in the diagram
above.
Design principles
We built metalite with the following principles:
- Automation: prefer a function call more than a checklist.
- Single-entry: enter in one place, sync to all deliveries.
- For example, enter data source one time for all AE analysis.
- End-to-end: cover all steps in software development lifecycle (SDLC)
from define to delivery.
