# Good practice standards and inspection for real-world data sources

Source: https://onco.cc/ideas/idea-data-gcp-for-real-world-data/  
OnCo record `idea-data-gcp-for-real-world-data` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Trials are inspected to check the data are real and traceable. Do the same for the hospital databases used to make regulatory decisions.

## Summary

Clinical trial data are governed by Good Clinical Practice and inspected; real-world data sources used in regulatory submissions are not. The proposal is a 'GCP for real-world data': standards for provenance, traceability to source records, curation documentation, fitness-for-purpose assessment and inspection rights, with accreditation of data sources. The FDA's RWE framework and EMA's DARWIN EU data quality framework are starting points.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Accredited data sources will produce RWE that regulators accept as supportive evidence in a substantially higher share of submissions, and audit will reveal material provenance errors in a minority of current sources.
- Rationale: Regulators discount RWE partly because they cannot verify it; accreditation with inspection is how the same problem was solved for trials and for laboratories (CLIA, ISO 15189).
- Proposed test: Pilot accreditation with five data sources (two commercial, two academic, one registry); publish audit findings and regulator uptake of RWE from accredited versus non-accredited sources over two years.
- Maturity: early-clinical
- Actor: regulator

## Sources

- EMA DARWIN EU: https://www.darwin-eu.org/
- FDA Real-World Evidence framework: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

## Connected records

- fronts: [AI & Computation](https://onco.cc/fronts/ai-computation/)
- terms: [Real-world evidence](https://onco.cc/terms/real-world-evidence/)
- bottlenecks: [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/), [Weak real-world evidence and registries](https://onco.cc/bottlenecks/b-real-world-evidence/)

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