OECD Harmonized Templates for Research Data (OHT-R)

The objective of this project is to develop extensions to OECD Harmonized Templates (OHTs) for reporting research data called OHT-Rs. An OHT-R includes an XML schema definition, picklist, and accompanying documentation of fields with help text and examples. OHT-Rs will improve harmonisation and standardization of research data for consideration in regulatory assessments including:  Research funders who can refer to this OHT-R in the design, monitoring and evaluation of research. Researchers generating data can use this OHT-R to design, perform, and report their research in a way that maximises scientific and regulatory value of reported data. Editors, publishers, reviewers of articles submitted to scientific journals and repository managers can use this OHT-R to refine and enforce publication policies aiming at improving accessibility to data, clear reporting of methods, scientific quality, regulatory and societal relevance. Assessors can use this OHT-R to improve efficiency and harmonise assessment workflows for screening, evaluating, extracting, and analysing research data. Assessors will be able to reuse data reported in this OHT-R saving resources in that a task is harmonised across member countries. Decision makers benefit from developing policies with an enhanced evidence base with information not covered by regulatory testing. These activities will enable the implementation of the legal requirements to consider all available evidence in regulatory assessments. 

Impact/Purpose

The primary focus of this project is to standardize and harmonize structured elements, vocabularies, and reporting templates of research data that could potentially inform hazard, exposure, and/or risk assessments of chemicals. Research data refers to non-guideline data typically reported in peer reviewed published literature and encompasses data as defined in the draft OECD Guidance Document on Regulatory Use of Research Data. The objective of this project is to develop extensions to OECD Harmonized Templates (OHTs) for reporting research data called OHT-Rs. An OHT-R includes an XML schema definition, picklist, and accompanying documentation of fields with help text and examples. The proposed OHT-Rs will improve harmonisation and standardisation of reported research data that could potentially inform hazard, exposure, and/or risk assessments of chemicals.  The proposed OHT-Rs will allow access to reported research data saving resources in that the data are reported in a harmonized template that can be reused across member countries and data repository. This proposal addresses the need for improved standardisation of reporting research data and is a companion to the OECD Guidance Document On Regulatory Use Of Research Data. The OECD expert panel is drafting the document on use of research data and this OHT can serve as a standard template for use by research data funders, producers, users, and regulators. 

Citation

Angrish, M. AND S. Watford. OECD Harmonized Templates for Research Data (OHT-R). 8th Meeting of the Working Party for Hazard Assessment, Paris, FRANCE, June 24 - 25, 2024.