Code Map Services: Interoperability for Common Data Models
Explore how Code Map Services translates real-world data between research “languages,” or common data models like OMOP and FHIR enabling researchers faster collaboration across networks.
Bridging the Gap in Clinical Research Data
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Real-world data (RWD) holds the key to answering critical medical questions faster. However, this data is often locked in different “languages” or Common Data Models (CDMs) like OMOP, PCORnet, and Sentinel. The Code Map Services project provides the infrastructure and tools to translate these languages, enabling researchers to collaborate across networks and submit real-world data to the FDA for regulatory decision-making.
The Challenge: Data Silos in Research
Patient-centered outcomes research relies on data from diverse healthcare settings. While research networks standardize their data into CDMs to facilitate sharing, these models often lack interoperability. A researcher using the OMOP model cannot easily share findings with a colleague using PCORnet without time-consuming, manual data transformation. This disconnect creates “data silos,” duplicating efforts and delaying medical breakthroughs.
The Solution: Automated Code Mapping
The Code Map Services initiative acts as a universal translator for clinical research data. By establishing a sustainable, government-supported infrastructure, this project allows data to flow seamlessly between research networks and regulatory agencies.
The project delivers three core capabilities:
- Automated Transformation: Tools to convert data from one model to another (e.g., FHIR to OMOP).
- Semantic “Source of Truth”: A centralized repository of validated mappings hosted by the National Cancer Institute (NCI).
- Regulatory Pathways: Specialized mappings that allow electronic health record data (FHIR) to be converted into FDA-compliant standards (CDISC SDTM).
Key Tools & Services
Model Transformation Application
Developed by NCATS, this secure web-based application allows researchers to upload datasets and automatically convert them into a destination format.
- Features: Automated ETL (Extract, Transform, Load) processes, data quality metrics, and input/output validation.
- Access: Hosted within the National Clinical Cohort Collaborative (N3C) secure enclave to ensure data privacy.
caDSR Code Map Portal
The NCI Cancer Data Standards Registry and Repository (caDSR) has been extended to serve as the authoritative library for these data mappings.
- Features: Searchable Common Data Elements (CDEs), cross-terminology mappings (e.g., ICD-10 to SNOMED CT), and public APIs for developers.
- Access: Open to the public for browsing and downloading resources.
FDA Regulatory Submission Tools
In collaboration with the FDA, the project created mappings to bridge the gap between clinical care and regulatory review.
- Impact: Enables Clinical Trial sponsors to transform real-world data (FHIR) directly into CDISC SDTM format for FDA submission.
Real-World Impact: The Breast Cancer Use Case
To validate these tools, the project team partnered with the Indiana Health Information Exchange (IHIE) and the FDA to conduct a real-world safety analysis.
- The Study: Analyzed safety outcomes for patients prescribed three different Antibody-Drug Conjugates (ADCs) for breast cancer (Kadcyla, Enhertu, and Trodelvy).
- The Outcome: Using the project's standard-based queries (FHIR/CQL), the team successfully identified treatment discontinuation reasons (such as hypertension and neuropathy) and comorbidities directly from real-world data.
- Why it Matters: This demonstrated that the Code Map infrastructure can generate reliable evidence to support FDA regulatory decisions without manual data wrangling.
Project Fast Facts
- Funding: Supported by the Office of the Secretary Patient-Centered Outcomes Research Trust Fund (OS-PCORTF), administered by ASPE.
- Period of Performance: March 2023 – September 2025.
- Goal: To create a "Google Translate" for clinical research data.
Collaborating Agencies
- Lead: National Center for Advancing Translational Sciences (NCATS)
- Partner: National Cancer Institute (NCI)
- Partner: U.S. Food and Drug Administration (FDA)
- Sponsor: Office of the Assistant Secretary for Planning and Evaluation (ASPE)
For Developers & Data Scientists
The Code Map Services infrastructure is built to be extended. We provide comprehensive Application Programming Interfaces (APIs) that allow you to integrate validated mappings directly into your own ETL pipelines and software applications.
- Access APIs: NCI API Portal
- Bulk Downloads: Access cross-terminology mappings via FTP Download.
Sustainability & Governance
This project is not a one-time effort. The mappings are maintained within NCI's long-standing caDSR infrastructure, ensuring they remain available and updated. A governance framework with role-based access ensures that all mappings are reviewed by experts before being published as a “source of truth”.
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