# Clinical Data Interchange Standards Consortium

Source: https://onco.cc/institutions/cdisc/  
OnCo record `cdisc` (Institution). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The non-profit that writes the clinical trial data standards (SDTM, ADaM, CDASH) that FDA, PMDA and NMPA require for every cancer drug submission.

## Summary

Founded in 1997, CDISC develops open, global standards for collecting, structuring and submitting clinical research data. Its Study Data Tabulation Model and Analysis Data Model are mandatory for new drug applications to the US FDA and Japan's PMDA and accepted by China's NMPA, and its Controlled Terminology, CDASH data collection standards and Therapeutic Area User Guides (including for breast, prostate and lung cancer and for oncology endpoints such as RECIST) make trial data comparable across sponsors. CDISC standards underpin data sharing platforms such as Vivli and Project Data Sphere and the pooled analyses that regulators and academics run on legacy oncology trials. It works with HL7 on mapping trial standards to FHIR healthcare data.

## Fields

- Kind: Institution
- Last checked: 2026-09-09
- Also known as: CDISC
- City: Austin, TX, US
- Type: consortium
- Website: https://www.cdisc.org

## Sources

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

## Connected records

- fronts: [AI & Computation](https://onco.cc/fronts/ai-computation/)
- institutions: [FDA Oncology Center of Excellence](https://onco.cc/institutions/fda-oce/), [HL7 International](https://onco.cc/institutions/hl7/), [National Cancer Institute (NIH)](https://onco.cc/institutions/nci/), [National Medical Products Administration / Center for Drug Evaluation](https://onco.cc/institutions/nmpa-cde/), [Pharmaceuticals and Medical Devices Agency](https://onco.cc/institutions/pmda/), [Vivli](https://onco.cc/institutions/vivli/), [Yale University Open Data Access (YODA) Project](https://onco.cc/institutions/yoda-project/)
- terms: [Real-world evidence](https://onco.cc/terms/real-world-evidence/), [RECIST](https://onco.cc/terms/recist/)
- people: [Chris Decker](https://onco.cc/people/chris-decker/)
- bottlenecks: [Data silos](https://onco.cc/bottlenecks/b-data-silos/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)

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