Glossary for Referencing Data Types and Terms in Your Data Management and Sharing Plan

So, you’re writing a Data Management and Sharing (DMS) Plan for your NCI-funded research. You’re using the “alpha” or “bravo” templates that NIH provides through the Federal Demonstration Partnership or other templates where you could use broad data types. Refer to this glossary to see how you can use some broad data types and terms in your plan.

Please note:

• For the purposes of DMS Plans, we define data types in a broad sense (e.g., “Clinical data” serves as a broad term that includes but is not limited to “intervention responses,” “clinical trial data,” “EHR,” etc.)
• Some data types and their sub-categories may overlap with other data types and their sub-categories. If applicable, reference all that apply.
• Data types and sub-categories may not be comprehensive. If you need to give more specific context, please do so in an appropriate “Additional Information” field within your plan.
• Examples of data type or content that are query-able:
  • Childhood Cancer Data Initiative Data Catalog
  • NCI Thesaurus
  • HealthIT.gov
  • NIH Behavioral and Social Sciences Research

Assay

• NCI Thesaurus Definition: A qualitative or quantitative analysis performed to determine the amount of a particular constituent in a sample or the biological or pharmacological properties of a drug.
• NCI Dictionary of Cancer Terms Definition: A laboratory test to find and measure the amount of a specific substance.
• PQCMC Definition: Tests which measure the content of the active ingredient in the drug substance or drug product. Synonymous with strength or purity which is commonly used to define the content of the active ingredient in a drug product.

Clinical Data

• NCI Thesaurus Definition: Data obtained through patient examination or treatment.
• CDISC-Glossary Definition: Data pertaining to the medical well-being or status of a patient. Category also includes clinical reports and individual patient data (IPD) as defined in the EMA Policy 0070 Implementation Guide.

Clinical Trial Data

• NCI Thesaurus Definition: Information collected during the course of a scientifically controlled study of the safety and efficacy of a therapeutic agent, such as a drug or vaccine, using consenting human subjects.
• CDISC-Glossary Definition: Data collected in the course of a clinical trial. A superset of this is “clinical trial information,” which is data collected in the course of a clinical trial or documentation related to the integrity or administration of that data.

Digital Health/Wearable (Sensor)

• NCI Thesaurus Definition: A device that responds to a stimulus, such as heat, light, or pressure, and generates a signal that can be measured or interpreted.

Electronic Health Record/Electronic Medical Record (EHR/EMR)

• NCI Thesaurus Definition: A digital version of a patient's medical history.
• CDISC-Glossary Definition: An electronic record for healthcare providers to create, import, store, and use clinical information for patient care, according to nationally recognized interoperability standards. Note: The EHR has the following distinguishing features: able to be obtained from multiple sources; shareable; interoperable; accessible to authorized parties.

Epidemiology

• NCI Thesaurus Definition: The study of the causes, incidence, and distribution of disease in the population and its application for prevention or control.
• NCI-Glossary Definition: The study of the patterns, causes, and control of disease in groups of people.

Genomics

• NCI Thesaurus Definition: The study of the structure, function, expression, evolution, mapping and editing of genomes.
• NCI-Glossary Definition: The study of the complete genetic material, including genes and their functions, of an organism that are usually conducted by high throughput sequencing technologies where the scale of DNA sequencing or microarray can range from targeted genes to whole exome or whole genome.

Histopathologic Examination/Review

• NCI Thesaurus Definition: The microscopic study of characteristic tissue abnormalities by employing various cytochemical and immunocytochemical stains.
• CDISC-Glossary Definition: Microscopic evaluation of tissues for detection of abnormalities.
• NCI Dictionary of Cancer Terms Definition: The study of diseased cells and tissues using a microscope.

Imaging or Imaging Technique

• NCI Thesaurus Definition: A process that produces pictures of the inside of a body. Imaging includes any technology or method that aids in the visualization of any biological process, cell, tissue, or organ for use in screening, diagnosis, surgical procedures, or therapy.

Medical Imaging

• NCI Thesaurus Definition: Any technology which helps in visualization of any biological process, cell, tissue or organ for the screening, diagnosis, surgical procedure, or therapy.

Metabolomics

• NCI Thesaurus Definition: The study of the biological metabolic profile of a cellular specimen in a specific environment at an isolated timepoint. This discipline depicts the physiological states of cells and organisms by focusing on carbohydrates, lipids, and other metabolites. Several analytical techniques are utilized to quantify the metabolic content of specimens such as mass spectrometry and electrophoretic applications.

Metadata

• NCI Thesaurus Definition: Data about data; information that describes another set of data.
• CDISC-Glossary Definition: Data that describe other data, particularly XML tags characterizing attributes of values in clinical data fields.

Omics Data

• Data includes DNA/RNA sequence data, proteomic data, transcriptomic data, metabolomics data, etc. Other omics include microbiome, lipidomics, peptidomics, metagenomics, etc.

Patient Registry Study

• NCI Thesaurus Definition: Observational studies which include an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, health care services, and/or procedures) and that serves a predetermined scientific, clinical, or policy purpose. Patient registries may be single purpose or ongoing data collection programs that address one or more questions.

Population Sciences

• NCI Thesaurus Definition: As defined by various divisions within NCI, they include: Epidemiology, Nutrition, Behavioral Medicine, Genetics, Public Health, Anthropology, Tobacco Control Research, Demography, Bioethics, Sociology.

Preclinical Models

• NCI Thesaurus Definition: Theoretical models before being tested clinically.

Proteomics

• NCI Thesaurus Definition: The global analysis of cellular proteins. Proteomics uses a combination of sophisticated techniques including two-dimensional gel electrophoresis, image analysis, mass spectrometry, amino acid sequencing, and bioinformatics to resolve comprehensively, to quantify, and to characterize proteins, proteoforms, and posttranslational modifications (PTMs). The application of proteomics provides major opportunities to elucidate disease mechanisms and to identify new diagnostic markers and therapeutic targets. Similarly, the scale of proteomic profiling can range from targeted proteins/peptides to whole proteomes including PTMs such as phosphorylation, acetylation, and glycosylation.
• NCI Dictionary of Cancer Terms Definition: The study of the structure and function of proteins, including the way they work and interact with each other inside cells.

Simulation/Algorithm/Modeling

• NCI Thesaurus Definition: A technique which attempts to provide an abstract model of a particular system. It utilizes a mathematical model, which attempts to predict the behavior of the system from a set of parameters and initial conditions.
• NCI Dictionary of Cancer Terms Definition: In cancer treatment, a process used to plan radiation therapy so that the target area is precisely located and marked.

Social, Psychological and Behavioral Data

• This term represents many types of data like alcohol use, depression, and social determinants of health. For more, read this online book chapter from the National Academies Press website.

Surveillance

• NCI Thesaurus Definition: The systematic collection, analysis, and interpretation of health data on an ongoing basis.
• NCI Dictionary of Cancer Terms Definition: In medicine, the ongoing collection of information about a disease, such as cancer, in a certain group of people. The information collected may include where the disease occurs in a population and whether it affects people of a certain gender, age, or ethnic group.

Survey

• NCI Thesaurus Definition: A document used in a method of data collection that involves interviewing (or giving questionnaires to) a representative and often large group of people.
• CDISC-Glossary Definition: Any means (e.g., questionnaire, diary, interview script, group of items) that is used to collect patient-reported outcome data. Note: “Survey” refers to the content of the group of items and does not necessarily include the training and scoring documents generally not seen by respondents.

Transcriptomics

• NCI Thesaurus Definition: The study of the complete set of RNA transcripts that are produced by the genome, under specific circumstances or in a specific cell.