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OECD Harmonised Templates (OHTs) for reporting non-guideline research data (OHTR)
Citation:
Angrish, M. OECD Harmonised Templates (OHTs) for reporting non-guideline research data (OHTR). IUCLID User Group Expert Panel, Paris, FRANCE, September 24 - 25, 2025.
Impact/Purpose:
Standards and harmonized language work together to ensure that scientific, technical, and regulatory information are consistent, interoperable, and reusable across people, organizations, and data management systems. Standardized and harmonized communication makes decisions transparent and reproducible, which builds confidence and trust among stakeholders and supports Executive Order 14303. Standards set the framework while harmonized language fills that framework with consistent meaning. Together they unlock data comparability and global alignment, and support automation and artificial intelligence (AI). This work positions EPA to lead global implementation of chemical data reporting requirements and supports EPA's stance to lead the globe in AI innovation and makes it easier to build and scale AI capabilities. This work is also important to data management and supports chemical risk evaluation.
Description:
The OECD recently developed the Guidance Document on the Generation, Reporting, and Use of Research Data for Regulatory Assessments (the Guidance Document or GD). Research data in general informs chemical assessment conducted in regulatory frameworks, but studies generating research data generally 1) do not follow national or international regulatory standards such as those adopted by the OECD (OECD TGs), 2) do not report data in regulatory frameworks or standardized formats, and 3) often fail to report critical information needed in regulatory assessment to assess study quality and reliability. The OECD Harmonized Templates are well-suited for standardized reporting of information on chemicals from guideline studies but lack reporting structure and elements needed for non-guideline research studies. Recognizing that there is no current standardized reporting template for research data, the OECD Harmonized template for Research data (OHTR) project was initiated and is an implementation of the GD that describes core reporting elements foundational to the assessment of data quality in a regulatory context. The OHTR aims to standardize and simplify data reporting requirements for research data, targeting use by all stakeholder groups (funders, researchers, editors, publishers, peer reviewers, assessors, and risk managers) who can use the OHTR as specifications for data entry screens in data management systems including IUCLID.