B
BioPortal Ontology Repository (BioPortal)
A web portal providing easy discovery and access to a large collection of standardized biomedical vocabularies and ontologies through searching, browsing, and visualization of the content.
C
Center for Expanded Data Annotation and Retrieval (CEDAR)
A web-based computational metadata management platform focused on helping users create high-quality biomedical metadata through templates that facilitate development, evaluation, use, and refinement of experiment-based biomedical metadata.
Common Data Elements
A type of 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) that are used in a standardized, machine readable manner across studies or trials to prevent avoidable variability.
Coordination and Data Collection Center [(C)DCC]
Organization or entity responsible for study’s data management, monitoring, and analyses during clinical studies. The four RADx (C)DCCs include RADx-rad, RADx Tech, RADx-UP, and RADx DHT.
Curator
Individual/s from the RADx Support Team who assists data submissions to the RADx Data Hub, including answering user questions, providing guidance on data de-identification, reviewing and approving study submissions, etc. Please contact the RADx Data Hub Administrator at RADx-DataHub@nih.gov to contact RADx curators.
D
Data Repository
A system that serves as a centralized place for storing and managing data.
Datasets
Individual-level data files generated from research studies. RADx studies typically have multiple datasets, which typically consist of phenotypic data collected on study participants, such as demographics, survey, laboratory results, etc.
Data Use Agreement
Formal agreement executed between RADx and the user, defining the terms and conditions under which study data obtained from the RADx Data Hub can be used for secondary research.
dbGaP
The database of Genotype and Phenotype (dbGaP) that was developed by National Center for Biotechnology Information (NCBI) to archive and distribute the results of studies that have carried out high density genotyping. The RADx Data Hub uses dbGaP to manage study-level access to data files. To learn how to request access to a study in dbGaP, please review the dbGaP site
Documents
Documentation (e.g. READMe files, study protocols) associated with research studies stored in the RADx Data Hub and made publicly available for secondary use.
Digital Object Identifier (DOI)
A DOI is a unique and permanent reference tied to the metadata about the digital object and is assigned to studies, to increase findability, accessibility, and reusability. When citing use of RADx resources in publications and other research outputs, users should include the resources' unique identifier, DOI,
F
FAIR
A best practice in data management referring to the findability, accessibility, interoperability, and reusability of data assets. These principles emphasize discovery and reuse of data objects with minimal or no human intervention (i.e. automated and machine-actionable), but are targeted at human entities as well.
H
Harmonization
Harmonization is the process of integrating and standardizing data from various sources or formats to make them compatible and consistent. This involves resolving differences in data structures, terminology, and units of measurement, ensuring that the data can be effectively analyzed, compared, and combined for meaningful insights and decision-making.
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 of the HIPAA law regulates individually identifiable health information that is related to a person’s past, present, or future health or treatment and is transmitted or maintained in any form or medium by a covered entity.
I
Investigator
Individual conducting a study or project; clinicians, researchers, and partners/agencies participating in the RADx Initiative funded through a RADx (C)DCC.
M
Metadata File
A file describing the metadata contained in the study.
N
NIH Common Data Elements (CDEs)
A collection resulting from the ongoing effort, in response to COVID-19 data, developed by the NIH’s Scientific Data Council, NIH CDE Task Force, and CDE Governance Committee, for indicating NIH endorsement of CDEs that meet meaningful criteria, are available through a common discovery platform (such as the NIH CDE Repository), and avoid duplicating functions of resources that already exist.
NIH RADx-Required Common Data Elements (CDEs)
Collections of elements or “classifications,” (as opposed to single field definitions) 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, presented to study participants as survey questions with a discreet set of allowable responses. While typically a CDE is defined as a single field definition, NIH RADx-Required CDEs are collections of field definitions addressing a single topic.
O
Original Data File
A data file based on an organization’s individual codebook that has not been harmonized. Original data files are also referred to as ‘raw’ data files.
P
Protected Health Information (PHI)
Protected Health Information, also known as "Individually identifiable health information," is information, including demographic data, that relates to:
- the individual’s past, present or future physical or mental health or condition,
- the provision of health care to the individual,
- the past, present, or future payment for the provision of health care to the individual
Personal Protected Information (PII)
Any representation of information that permits the identity of an individual to whom the information applies to be reasonably inferred by either direct or indirect means. Further, PII is defined as information: (i) that directly identifies an individual (e.g., name, address, social security number or other identifying number or code, telephone number, email address, etc.) or (ii) by which an agency intends to identify specific individuals in conjunction with other data elements, i.e., indirect identification. (These data elements may include a combination of gender, race, birth date, geographic indicator, and other descriptors). Additionally, information permitting the physical or online contacting of a specific individual is the same as personally identifiable information. This information can be maintained in either paper, electronic or other media.
Published Manuscript
Report of findings of a Study, Protocol, or Research Project that is made public through inclusion in a recognized print or online outlet.
R
RADx Analytics Workbench
A cloud-enabled functional space where users can download their approved data or analyze their data and other publicly available datasets using one of the scalable integrated tools within the Workbench, such as JupyterLab or SAS.
RADx Data Dictionary
A document (typically a csv file) that defines characteristics (such as the name, description, coded values,and actual values) of the core data elements used in the study. There must be one data dictionary submitted per each high level data file (i.e. transformed or original data file).
RADx Global Codebook
The NIH RADx Data Hub Global Codebook is a data dictionary for all RADx required Common Data Elements (CDEs). It contains precise mappings that organize (C)DCC-specific Data Elements into 12 unique, required CDEs categories.
RADx Variable Category
In the RADx Data Hub, data are harmonized, or re-labeled and re-coded, so data can be uniformly interpreted across multiple studies. There are three types of RADx variables, categorized by their level of harmonization across the various RADx programs: Core (Tier I) variables, (C)DCC Common (Tier II) Variables, and Non-harmonized (Tier III) variables.
RADx Core Variables: Variables intended to be shared across all RADx studies involving human subjects, regardless of the specific RADx program. They are defined in the RADx Global Codebook and have identifiers beginning with “nih_”. Core variables are also referred to as RADx Common Data Elements (CDEs) or Tier I variables.
RADx (C)DCC Common Variables are intended to be shared across a subset of studies within a specific RADx program/(C)DCC. As a result, RADx-rad, RADx Tech, and RADx-UP each have their own set of Common Variables, defined in their respective data dictionaries. These are known as Tier II variables or RADx-rad Common Variables, RADx Tech Common Variables, RADx-UP Common Variables, respectively.
Non-harmonized Variables: Variables that are not a RADx Core Variable or RADx Program Common Variable. These are typically unique to an individual study and referred to as a Tier III variable.
S
Secondary Research
A new study using existing data for exploring new hypotheses, analyses, or investigation of a research topic.
Site Map
A graphical representation of the RADx Data Hub organization and workflow. The Site Map is accessible from the ‘Home’ page and is also available on the ‘Resource Center’ page.
Study
A research protocol (including interventional and observational research) or set of experiments designed to investigate a research question and/or evaluate biomedical or health-related outcomes. Studies available through the RADx Data Hub include NIH defined clinical trials related to COVID-19 and other types of clinical research run by one of the (C)DCCs (RADx Tech, RADx-rad, RADx-UP, RADx DHT).
Study Registration
Process by which investigators can submit their studies to the RADx Data Hub to be made available to users for secondary research.
Submitter
Individual(s) responsible for submitting studies, data files, and other documentation to the RADx Data Hub. These are often representatives from the four RADx (C)DCCs.
T
Transformed Data File
A data file that has been harmonized according to the 12 unique, required tier 1 CDEs.