NIH RADx Data Hub Glossary

The RADx Data Hub Glossary Quick Links B C D F H I M N P R S Letter Word Definition B BioPortal Ontology Repository (BioPortal) A web portal, providing easy discovery and access to a large, standardized biomedical vocabulary and ontology collection through content analysis, search, browsing, and visualization. C Center for Expanded Data Annotation and Retrieval (CEDAR) A web-based computational metadata management platform, facilitating experiment-based, high-quality biomedical metadata development, evaluation, use, and refinement. User Code of Conduct A formal agreement, executed between the RADx Data Hub and the user, defining the terms and conditions for RADx Data Hub study data secondary research use. Common Data Elements A health data specification commonly used in clinical and research settings to capture and bind together complex phenomena, like depression, through standardized, consistent, well-defined questions (variables), paired with a description of allowable responses (values or value type) used in a standardized, machine readable manner across studies or trials to prevent avoidable variability. Coordination and Data Collection Center [(C)DCC] An organization or entity responsible for study data management, monitoring, and analyses during clinical studies. The four RADx (C)DCCs include RADx-rad, RADx Tech, RADx-Up, and DHT. Curator RADx Support Team members who assist with RA Dx Data Hub data submission by answering user questions, providing guidance on data d e-identification, reviewing and approving study submissions, etc. Please contact the RADx Data Hub Administrator at [email protected] to contact RADx curators. D Data Repository A system that centralizes data to facilitate data discovery and management. Data Files Individual files contain data generated from research studies. RADx studies typically have multiple data files, consisting of phenotypic data collected on study participants, such as demographics, survey, laboratory results, etc. Data Dictionary A document providing detailed data attribute descriptions, including their names, definitions, data types, possible values, and relationships with other data file elements. 1 The RADx Data Hub Glossary Letter Word Definition dbGaP The database of Genotype and Phenotype (dbGaP), developed by National Center for Biotechnology Information (NCBI), archives and distributes high density genotyping study results. The RADx Data Hub uses dbGaP to manage study-level data file access. To request dbGaP study access, please review this link. Documents Research study documentation (e.g. README files, study protocols) publicly available for secondary use. Digital Object Identifier (DOI) A DOI is a unique, permanent reference tied to metadata about the digital object. It is assigned to studies to increase findability, accessibility, and reusability. When citing RADx resource use in publications and other outputs, users should include the resources' DOI. F FAIR A best practice in data management, referring to data asset findability, accessibility, interoperability, and reusability. These principles emphasize data object discovery and reuse with minimal human intervention (i.e. automated and machine-actionable), but are targeted at human entities as well. H Harmonization Harmonization involves integrating and standardizing data from various sources or formats to make them compatible and consistent. This involves resolving data structure, terminology, and measurement unit differences, ensuring data can be effectively analyzed, compared, and combined for meaningful insights and decision-making. Harmonized Data File A data file aligns with the 12 unique, required tier 1 CDEs. Health Insurance Portability and Accountability Act (HIPAA) Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191, 45 CFR Parts 160, 162, and 164. Part 160.103) regulates individually identifiable health information related to a person’s past, present, or future health or treatment, transmitted or maintained in any form or medium by a covered entity. I Investigator An individual conducting a study or project; RADx Initiative clinicians, researchers, and partners/agencies funded through a RADx (C)DCC. M Metadata File A file describing the data contained in a study. 2 The RADx Data Hub Glossary Letter Word Definition N NIH Common Data Elements (CDEs) A collection of CDEs (see Common Data Elements) developed by the NIH’s Scientific Data Council, NIH CDE Task Force, and C DE Governance Committee, in response to COVID-19 data. These carry NIH endorsement due to meeting meaningful criteria and are available through a co mmon discovery platform (such as the NIH CDE Repository). NIH RADx-Required Common Data Elements (CDEs) A collection of CDEs (see Common Data Elements) required by the NIH in the RADx Initiative, including Race, Ethnicity, Sex, Age, Education, Domicile, Employment, Insurance Status, Disability Status, Medical History, Symptoms, and Health Status. While a CDE is typically a single field definition, NIH RADx-Required CDEs are collections of field definitions addressing a single topic. Non-Harmonized Data File A data file, based on an organization’s individual codebook, that has not been harmonized, also referred to as a “raw” data file. P Protected Health Information (PHI) Also known as "Individually identifiable health information," includes demographic data, related to an individual’s: ● Past, present, or future physical or mental health o r condition, ● Healthcare ● Past, present, or future healthcare payment ● Identity (or potential identifiers), including many common identifiers (e.g., name, address, birth date, Social Security Number) Personal Protected Information (PII) Any representation of information that permits an in dividual’s identity to be reasonably inferred directly or indirectly, including information that may help someone: ● Directly identify an individual (e.g., name, address, social security number or other identifying number or code, telephone number, email address, etc.) ● Identify an in dividual in co njunction with other data elements (e.g.,,a combination o f gender, race, birth date, geographic indicator, and beyond). ● Contact an individual online or in person (information ca n be maintained in either paper, electronic, or other media) Published Manuscript A report publicly detailing study, protocol, or research findings through inclusion in a recognized print or online outlet. 3 The RADx Data Hub Glossary Letter Word Definition R RADx Analytics Workbench A cloud-enabled, functional space where users can download or analyze their approved data and publicly available datasets using one of the scalable, integrated Workbench tools, such as JupyterLab or SAS. RADx Data Dictionary A document (typically a csv file) defining study core data element characteristics (the name, description, coded values,and actual values). One data dictionary is submitted per each high level data file (i.e., a harmonized or non-harmonized data file). RADx Global Codebook The NIH RADx Data Hub Global Codebook is a data dictionary for all RADx required CDEs, precisely mapping and organizing (C)DCCspecific Data Elements into 12 unique, required CDEs categories. S Secondary Research A new study using existing data to explore new hypotheses, analyses, or research topic investigations. Site Map A graphical representation of the RADx Data Hub organization and workflow, accessible from the Homepage and available in the site footer. Study A research protocol (including interventional and observational research) or set of experiments investigating a research question and/or evaluating biomedical or health-related outcomes. The RADx Data Hub includes NIH-defined clinical COVID-19 trials and other types of clinical research run by one of the (C)DCCs (RADx Tech, RADx-Rad, RADx-Up, DHT). Study Registration The process by which investigators submit their studies to the RADx Data Hub so they are available for secondary research. Submitter Individual(s) responsible for submitting studies, data files, and other RADx Data Hub documentation, often representing the four RADx (C)DCCs. 4