audit trail
Definition
An audit trail is a comprehensive, chronological record of all analytical steps, data transformations, decisions, and modifications made during a research investigation. In life sciences, audit trails document the complete workflow from raw data collection through analysis to final conclusions, including parameter selections, filtering criteria, statistical methods applied, and version control. This documentation ensures reproducibility, regulatory compliance (particularly for FDA and EMA submissions), and scientific transparency. Audit trails enable researchers to trace back through complex analytical pipelines, verify results, identify sources of variation, and demonstrate that conclusions are supported by rigorous, documented methodology. They are essential for Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) compliance.
Visualize audit trail in Nodes Bio
Nodes Bio can visualize audit trails as temporal network graphs where nodes represent analytical steps, data transformations, or decision points, and edges show the sequential flow and dependencies between operations. Researchers can track how network models evolved through iterative refinement, document parameter changes in pathway analyses, and create visual records of hypothesis testing workflows that link data sources to conclusions through intermediate analytical nodes.
Visualization Ideas:
- Workflow dependency networks showing sequential analytical steps and their relationships
- Temporal graphs tracking how network models and parameters evolved across analysis iterations
- Provenance networks linking raw data sources through transformations to final biological conclusions
Example Use Case
A pharmaceutical team conducting multi-omics analysis for a cancer drug candidate needs to document their entire analytical workflow for regulatory submission. Their audit trail captures initial RNA-seq data processing, quality control filters applied, differential expression analysis parameters, pathway enrichment methods, integration with proteomics data, and network-based target identification. When reviewers question why specific biomarkers were selected, the team uses their audit trail to demonstrate the complete decision-making process, showing how 15,000 initial genes were systematically filtered to 23 validated targets through documented, reproducible steps.