# Map trial case report forms to the registry standard so trial and routine data join

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

## TL;DR

Trials and hospital records describe the same things in different languages. Publish the translation so trial patients can be followed for life in routine data and trial results compared with routine care.

## Summary

Clinical trial data follow CDISC standards; routine data follow mCODE or OMOP. Formal, maintained mappings (CDISC to mCODE, CDISC to OMOP) would allow trial participants to be followed via registries after the trial ends, trial cohorts to be compared with matched real-world cohorts, and completed trial datasets to be pooled with routine data. CDISC and HL7 have a joint project; the proposal funds it to completion and requires sponsors to deliver the mapped dataset alongside submissions.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Mapped trial datasets will enable long-term follow-up of more than 80 percent of participants via registries at less than a tenth of the cost of active follow-up, and permit trial-versus-real-world comparisons for every new approval within a year.
- Rationale: Long-term follow-up is the most expensive part of many trials and the reason late toxicities and late relapses are under-documented; registries already hold the information.
- Proposed test: Map three completed phase 3 datasets to mCODE, link to a national registry, and compare registry-derived survival with trial-recorded survival; measure agreement and cost.
- Maturity: speculative
- Actor: regulator

## Sources

- CDISC: https://www.cdisc.org/

## Connected records

- collections: [ClinicalTrials.gov](https://onco.cc/collections/clinicaltrials-gov/)
- fronts: [AI & Computation](https://onco.cc/fronts/ai-computation/)
- bottlenecks: [Data silos](https://onco.cc/bottlenecks/b-data-silos/), [Trial design, endpoints and cost](https://onco.cc/bottlenecks/b-trial-design/), [Weak real-world evidence and registries](https://onco.cc/bottlenecks/b-real-world-evidence/)
- ideas: [Follow every trial participant for 30 years through registry linkage](https://onco.cc/ideas/idea-data-registry-follow-up-of-trial-participants/)

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