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Common Data Element (CDE) Resource Portal

Resource Summaries

Click on any of these Resources to learn more, or scroll down to browse all Resources. For each of the Resource Summaries, the full name links to the home page while the abbreviated name links directly to the resource.

Descriptions of all four groups of Resources can be found in the Glossary. Additional Resources will be added to the Portal as they are identified.
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1. NIH CDE Initiatives  Summary table  Subject areas  Jump to summaries

2. CDE Tools and Resources  Summary table  Subject areas  Jump to summaries

3. Other CDE Resources  Jump to summaries

4. Relevant Standards  Jump to summaries

 


 

NIH CDE Initiatives

 

EDRN - Early Detection Research Program

  • Lead IC / Contact: NCI
  • Summary: The goal of this initative is to accelerate the translation of biomarker information into clinical applications and to evaluate new ways of testing cancer in its earliest stages and for cancer risk. These efforts include an information architecture with data that is annotated and/or implemented using common information models and data elements.
  • Subject areas: Cancer. CDEs are used to describe samples and data collected in cancer biomarker research, focused on improving molecular diagnostics for cancer.
  • Number of elements (approximate): 1,600 elements.
  • Status: Not available at this time.
  • Reference: Srivastava, et al. Early detection research program at the NCI. Int J Cancer. 1996; 69(1): 35-7. PMID: 8600056
  • Provenance: Value sets of some CDEs have a listed provenance.
  • Availability: Web-based resource. Free. No registration required.
  • Core CDEs / Mandated use: No core CDEs.

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eyeGENE® - National Ophthalmic Disease Genotyping and Phenotyping Network

  • Lead IC / Contact: NEI
  • Summary: eyeGENE®’s primary function is as a biorepository for many inherited eye conditions and collects data through a disease specific survey mechanism. eyeGENE® (Clinical trials ID: NCT00378742) is a unique collaboration between government (NIH/NEI), private practice eye clinics, educational institutions, CLIA-certified testing laboratories, patients, and researchers.
  • Subject areas: Ophthalmology. As part of eyeGENE, CDEs have been developed for collecting phenotypic data associated with more than 30 inherited ophthalmic diseases.
  • Number of elements: 300 elements.
  • Status: More diseases are added periodically. CDEs are updated and streamlined as needed.
  • Reference: Goetz, et al. eyeGENE®: a novel approach to combine clinical testing and researching genetic ocular disease. Curr Opin Ophthalmol. 2012; 23(5): 355-363. PMID: 22847030
  • Provenance: CDEs were developed by eyeGENE® working group.
  • Availability: Available for free to registered database users and others upon request.
  • Core CDEs / Mandated use: eyeGENE® provides data for other studies. None of the CDEs in eyeGENE® are required.

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GRDR - Global Rare Diseases Patient Registry and Data Repository

  • Lead IC / ContactORDR
  • Summary: The main goals of the GRDR CDE effort are to:  1) develop a set of CDEs to facilitate data collection for the GRDR in a standardized and meaningful manner; 2) assist organizations that have no patient registry to establish a registry and be able to share data with the GRDR or other databases; 3) facilitate harmonization among the many organizations collecting patient information. NIH has developed Model Registry CDEs (ORDR CDEs) for patient data entry to be used in any rare disease registry, including a subset of CDEs (GRDR CDEs) to collect only de-identified information for the GRDR data repository.
  • Subject areas: Currently available CDEs include: contact information, socio-demographic information, diagnosis, family and birth history, anthropometrics, clinical research participation and biospecimens, administrative, and treatments.
  • Number of elements (approximate): 70 elements.
  • Status: General CDEs for all patient registries, GRDR disease related, and disease specific CDEs are under development.
  • Reference: Rubinstein, et al. Creating a Global Rare Disease (Patient) Registry Linked to a Rare Diseases Biorepository Database: Rare Disease-HUB (RD-HUB). Contemporary Clinical Trials. 2010; 31(5): 394-404. PMID: 20609392 PMCID: PMC2930109
  • Provenance: Many CDEs have a clearly defined provenance. GRDR CDEs are established in collaboration with NIH institutes and centres and other professional patient organizations which have already developed related CDEs or are in the process of developing them.
  • Availability: Downloadable Excel file. Free. No registration required.
  • Core CDEs / Mandated use: Contains core CDEs that must be used by researchers in the GRDR program.

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Neuro-QOL - Quality of Life Outcomes in Neurological Disorders

  • Lead IC / Contact: NINDS
  • Summary: Neuro-QOL consists of a core set of quality of life questions that cut across chronic neurologic disorders, plus sets of supplemental questions that address concerns specific to targeted diseases or subgroups of patients.
  • Subject areas: Neurological disorders.
  • Number of elements (approximate): 302 adult items; 203 pediatric items.
  • Status: Untested item pools or items that are not currently being used may be developed in the future.
  • Reference: Cella, et al. The Neurology Quality-of-Life Measurement Initiative. Arch. Phys. Med. Rehabil. 2011; 92(10 Suppl): S28-36. PMID: 21958920 PMCID: PMC3193028
  • Provenance: Items selected and vetted by domain experts and subject to validation.
  • Availability: Short, fixed form versions of the Instruments are available for download in PDF format from the Neuro-QOL website, with no registration required. Notification of project manager is requested. Online versions, including computerized adaptive tests, will be made available through the Assessment Center. Registration is required for the Assessment Center. Free.
  • Core CDEs / Mandated use: No core CDEs or mandated use.

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NIDA - NIDA Substance Abuse Electronic Health Record Data Elements

  • Lead IC/ Contact: NIDA
  • Summary: The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) has leveraged its infrastructure and expertise and brought relevant stakeholders together to develop consensus on brief screening and initial assessment tools for SUDs in general medical settings.  The creation and adoption of a core set of validated common data elements and the inclusion of such consensus-based data elements for general medical settings will enable the integration of SUD treatment within mainstream health care, and support the adoption and 'meaningful use' of the US Office of National Coordinator for Health Information Technology (ONC)-certified EHRs, as well as CMS reimbursement.  Futhermore, CDEs for SUD are urgently needed for the nation's eHealth Exchange.
  •  Subject areas: Substance Use Disorders
  • Number of elements: 45
  • Status: Existing data elements will be reviewed and updated based on published evidence for new validated instruments for general medical care.  Additional data elements are planned to extend standardized data collection for SUD in speciality care and CTN clinical trials.
  • Reference: Ghitza UE, Gore-Langton RE, Lindblad R. Shide D, Subramaniam G, Tai B.  Common data elements for substance use disorders in electronic health records: the NIDA Clinical Trials Network experience.  Addition. 2013 Jan;108(1):3-8. PMID: 22563741
  • Provenance: Where available, published and validated instruments.  See Reference above for specific references.
  • Availability: Freely available
  • Core CDEs / Mandated use: Yes.  Current resource consists of a core set of CDEs intended for EHR vendor use for SUD in general medical care.  Resource is not mandated but strongly encouraged for inclusion in EHRs for the general medical setting.  This will address the need for standardized and validated data collection for SUD in EHRs of this setting.

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NIH ToolboxNIH Toolbox for Assessment of Neurological and Behavioral Function

  • Lead IC / Contact: NIA
  • Summary: NIH Toolbox provides a standard set of measures that can be used as a common currency across diverse study designs and settings. By using multiple constructs of each domain, the NIH Toolbox monitors neurological and behavioral function over time, and measures the domain constructs across developmental stages for subjects between the ages of 3 and 85. This facilitates the study of functional changes across the lifespan, including evaluating intervention and treatment effectiveness.
  • Subject areas: Cognitive, emotional, motor, and sensory function.
  • Number of elements (approximate): The NIH Toolbox consists of 4 batteries of tests, each containing between 5 and 24 measures (tests). Supplemental measures are also available within each battery.
  • Status: The complete NIH Toolbox was launched in September 2012.
  • Reference: Gershon, et al. Assessment of neurological and behavioural function: the NIH Toolbox. Lancet Neurol. 2010; 9(2): 138-139. PMID: 20129161
  • Provenance: Measures were selected by teams of experts in each subject area covered. All measures have been validated and normalized for national use.
  • Availability: Measures are available free of charge to NIH-funded researchers. Fees may apply for use of the NIH Toolbox in projects not funded by NIH. See the NIH Toolbox terms and conditions.
  • Core CDEs / Mandated use: NIA encourages the use of all four batteries of tests in funded studies.

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NINDS CDEs - NINDS Common Data Elements

  • Lead IC / Contact: NINDS
  • Summary: The goal of the initiative is to streamline sharing of clinical research data through standards that enable systematic collection and analysis of data. NINDS strongly encourages researchers who receive funding from the Institute to use the CDEs to ensure their data is compatible with these common data elements.
  • Subject areas: 12 neurologic diseases, including Parkinson's, Huntington's, ALS, MS, Fredric's Ataxia, Epilepsy, TBI, Spinal Cord, and Stroke.
  • Number of elements (approximate): More than 7,000 CDEs, hundreds of instruments.
  • Status: More disease areas are being added and existing elements are being updated.
  • Reference: Grinnon, et al. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clinical Trials. 2012 Jun; 9(3): 322-9. PMID: 22371630
  • Provenance: Provenance for each CDE is provided; many refer to LOINC, ISO, caBIG, and references where available. CDEs are developed by a group of scientific experts; each CDE represents the best clinical research practice at that time. Not all CDEs have publications to support them, so CDEs are organized into three categories: core, supplemental and exploratory.
  • Availability: Downloadable in a variety of formats. Form Builder allows creation of forms. Free; no registration required.
  • Core CDEs / Mandated use: There is a core set of CDEs under the General CDEs and a Core set of CDEs for each Disease-specific area. The disease-specific area Core CDEs are "gold standard" measures that could be collected in all types of studies within that disease. There are requirements for mandated use if coming in under certain NINDS PARs.

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PhenX - Consensus Measures for Phenotypes and eXposures

  • Lead IC / ContactNHGRI
  • Summary: The goal of this initiative is to help integrate genetics and epidemiological research by providing investigators with high-quality, relatively low-burden measures for inclusion in genome-wide association studies (GWAS) and other large-scale genomic and epidemiologic research efforts. Measures are well-established, broadly applicable, reproducible, and low burden to both investigators and study participants.
  • Subject areas: The PhenX Toolkit provides standard measures related to complex diseases, phenotypic traits and environmental exposures.
  • Number of elements (approximate): 428 protocols, containing more than 15,000 variables.
  • Status: Elements will be reviewed and updated as needed; additional domains will likely be added.
  • Reference: Hamilton, et al. The PhenX Toolkit: Get the Most From Your Measures. American Journal of Epidemiology. 2011; 174(3): 253-60. PMID: 21749974 PMCID: PMC3141081
  • Provenance: CDEs have been mapped to (or created in, if existing CDEs were not available) caDSR and LOINC.
  • Availability: The PhenX Toolkit is a web-based resource that is publically available at no cost.
  • Core CDEs / Mandated use: Contains core CDEs. Greater than 20 Funding Opportunity Announcements (FOAs) across the NIH strongly encourage the use of PhenX CDEs.

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PROMIS - Patient Reported Outcomes Measurement Information System

  • Lead IC / ContactNIAMS
  • Summary: PROMIS is a system of item banks measuring patient-reported health status. These banks can be administered as paper or web-based short forms, or as web-based computer adaptive tests (CAT) via the Assessment Center. PROMIS measures can be used as primary or secondary endpoints in clinical studies across a wide variety of chronic diseases and conditions and in the general population.
  • Subject areas: PROMIS covers patient reported physical, mental, and social health domains applicable across clinical populations (i.e. not disease specific). PROMIS also includes a 10-item global health scale.
  • Number of elements (approximate): Approximately 50 item banks have been released to date.
  • Status: Version 1 has been completed. Additional banks are being developed in PROMIS Version 2, and independent investigators collaborating with PROMIS are anticipated to continue to add new item banks to PROMIS.
  • Reference: Cella, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. Journal of Clinical Epidemiology. 2010; 63: 1179-1194. PMID: 20685078 PMCID: PMC2965562 A full list of references is available at the PROMIS website.
  • Provenance: PROMIS items were derived from the pool of all existing items for each domain, and appropriate intellectual property permissions were obtained as necessary for use in the PROMIS banks. Copyright of the PROMIS items is held by the PROMIS Health Organization.
  • Availability: The Assessment Center allows creation of online and downloadable assessments. Free; registration is required.
  • Core CDEs / Mandated use: There are no core CDEs. However, a set of basic demographic collection questions may be included in the assessment. None of the CDEs are required for use.

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CDE Tools and Resources

 

caDSR - Cancer Data Standards Registry and Repository

  • Lead IC / Contact: NCI
  • Summary: A database of CDEs related to cancer, including CDEs from a variety of sources. caDSR contains a set of APIs and tools to create, edit, control, deploy, and find CDEs. The CDEs are developed by the National Cancer Institute Center for Biomedical Informatics and Information Technology (NCI CBIIT) and caBIG® partners in the research community, to be used as metadata descriptors for research and caCORE-like applications.
  • Subject areas: Cancer and related topics relevant to cancer research.
  • Number of elements (approximate): More than 46,000 variables.
  • Status: Additional elements are continually added.
  • Reference: Not available at this time.
  • Provenance: References are provided for individual measures, where available.
  • Availability: Web-based resource. Free: no registration required.
  • Core CDEs / Mandated use: No core CDEs are provided. CDEs available in caDSR may be encouraged for use within particular types of research studies, but caDSR does not mandate such use.

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dbGAP - database of Genotypes and Phenotypes

  • Lead IC / ContactNCBI
  • Summary: This data repository was developed to archive and distribute the results of studies that have investigated the interaction of genotype and phenotype. Included are the CDEs used in each study. It provides access to protocols that describe the data collected in each study and indicates which studies have used data elements from PhenX.
  • Subject areas: Genome-wide association studies.
  • Number of elements (approximate): More than 130,000 variables.
  • Status: Additional elements are continually added.
  • Reference: References are provided for individual measures, where available.
  • Provenance: Not disclosed.
  • Availability: Web-based resource. Free. No registration required to browse studies and data element descriptions.
  • Core CDEs / Mandated use: No core CDEs provided.

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FITBIR - Federal Interagency Traumatic Brain Injury Research

  • Lead IC / ContactNINDS
  • Summary: Developed to share data across the entire TBI research field and to facilitate collaboration between laboratories, as well as inter-connectivity with other informatics platforms.
  • Subject areas: TBI, concussion, loss of consciousness.
  • Number of elements (approximate): 2,000 elements.
  • Status: Continually updating.
  • Reference: Not available at this time.
  • Provenance: A reference section indicates the origin of many instruments.
  • Availability: Web-based resource. Free; registration is required.
  • Core CDEs / Mandated use: Core CDEs are provided.

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GEM - Grid-Enabled Measures

  • Lead IC / ContactNCI
  • Summary: An interactive website that enables researchers to submit, rate, and comment on measures and associated constructs. GEM encourages the use of common measures, and facilitates the sharing of harmonized data.
  • Subject areas: Social science research. Clinical and health-services related domains are also included.
  • Number of elements: As of November 8, 2012, there were 238 constructs associated with 462 measures. The number of domains is expected to increase as users with other disciplinary backgrounds begin to use GEM.
  • Status: GEM runs on a wiki platform and is being continually updated by users. Over time, the number of domains is expected to increase as users with different disciplinary backgrounds add information about constructs and measures.
  • Reference: Moser et al. Grid-Enabled Measures: Using Science 2.0 to standardize measures and share data. American Journal of Preventive Medicine. 2011: 40(Suppl 2); S134-S143. PMID: 21521586 PMCID: PMC3088871
  • Provenance: A reference section indicates the origin of many instruments.
  • Availability: Some instruments are available for download while others include only a description. Free; no registration required to peruse site. Registration is required to add or edit information on the site or to download measures. Registered users are also able to set up custom collaborative workspaces.
  • Core CDEs / Mandated use: There are no core CDEs and none are required for use of this resource.

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NCCOR - National Collaborative on Childhood Obesity Research

  • Lead IC / contactCDC, NIH, USDA
  • Summary: Searchable database of diet and physical activity, intended to promote consistent use of common measures and research methods across childhood obesity prevention and research at the individual, community, and population levels. The registry includes questionnaires, instruments, diaries, logs, electronic devices, direct observations of people or environments, protocols, and analytic techniques.
  • Subject areas: Diet and physical activity measures include individual dietary behavior, food environment, individual physical activity behavior, and physical activity environment.
  • Number of elements (approximate): 893 measures.
  • Status: Additional measures are in development.
  • Reference: Not available at this time.
  • Provenance: References, validation, and reliability information are provided for individual measures, where available.
  • Availability: Some measures are freely available, while some require a fee.
  • Core CDEs / Mandated use: No CDEs are mandated for use in any study.

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NDAR - National Database of Autism Research

  • Lead IC / contact: NIMH
  • Summary: NDAR is a data repository for studies of autism. To facilitate creation of more homogenous datasets, NDAR collects instruments from researchers that contribute data. It is hoped that when researchers plan experiments, they will use existing instruments from NDAR rather than create a new instrument.
  • Subject areas: Autism and autism spectrum disorder.
  • Number of elements (approximate): Thousands of elements.
  • Status: Continually updating.
  • Reference: Hall, et al. Sharing heterogeneous data: the national database for autism research. Neuroinformatics. 2012; 10(4): 331-9. PMID: 22622767
  • Provenance: Provenance of instruments is not disclosed.
  • Availability: Downloadable CSV files. Free; no registration required.
  • Core CDEs / Mandated use: Contains core CDEs. The CDEs defined in NDAR should be used by all researchers when submitting data related to autism.

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PDBPParkinson's Disease Biomarkers Program

  • Lead IC / contact: NINDS
  • Summary: PDBP supports biomarker discovery for Parkinson's disease through the PDBP Data Management Resource (PDBP DMR) and the NINDS Repository.
  • Subject areas: Parkinson’s disease.
  • Number of elements (approximate): 2,000 elements.
  • Status: Continually updating.
  • Reference: Not available at this time.
  • Provenance: A reference section indicates the origin of many instruments.
  • Availability: Web-based resource. Free; registration is required.
  • Core CDEs / Mandated use: Core CDEs are provided.

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REDCap - Research Electronic Data Capture

  • Lead IC / contactREDCap
  • Summary: A repository for data collection instruments and forms. The REDCap software allows users to create surveys and databases quickly and securely. Surveys can be administered online or offline. This application easily allows those who have created CDEs and instruments to make them widely available.
  • Subject areas: Biomedical and clinical research.
  • Number of elements (approximate): 143 instruments.
  • Status: Additional instruments are continually approved by the REDCap committee.
  • Reference: Harris, et al. Research electronic data capture (REDCap) - a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009; 42(2): 377-81. PMID: 18929686 PMCID: PMC2700030
  • Provenance: A reference section indicates the origin of many instruments.
  • Availability: Instruments are available for download. Free; ro registration required.
  • Core CDEs / Mandated use: No core CDEs are available.

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Other CDE Resources

 

CDASH - Clinical Data Acquisition Standards Harmonization

  • Lead IC / contactCDISC
  • Summary: All CDEs in CDASH are universal, not pertaining to any single disease, condition, or body system. CDASH is a creation of CDISC, a global, multidisciplinary, non-profit organization that has established broad standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.

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FACIT - Functional Assessment of Chronic Illness Therapy

  • Lead IC / contactFACIT
  • Summary: A range of questionnaires that measure health-related quality of life for people with chronic illnesses. Many of these instruments were created specifically for cancer patients, but have been validated for other conditions and the general population. While this project is not directly funded by NIH, this resource is used by some NIH intramural and extramural researchers.

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NHANES - National Health and Nutrition Examination Survey

  • Lead IC / contactCDC
  • Summary: NHANES is a program of studies designed to assess the health and nutritional status of adults and children in the United States. The survey is unique in that it combines interviews and physical examinations.

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Relevant Standards

 

LOINC® - Logical Observation Identifiers Names and Codes

  • Lead IC or contactRegenstrief Institute, Inc.
  • Summary: The purpose of the LOINC® database is to facilitate the exchange and pooling of results for clinical care, outcomes management, and research by providing a standard vocabulary for laboratory and other clinical observations.

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RxNorm - RxNorm

  • Lead IC / contactNLM
  • Summary: RxNorm is a normalized naming system for generic and branded drugs and a tool for supporting semantic interoperation between drug terminologies and pharmacy knowledge base systems.

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SNOMED CT - Systematized Nomenclature of Medicine - Clinical Terms

  • Lead IC / contact NLM
  • Summary: A suite of designated standards for use in U.S. Federal Government systems for the electronic exchange of clinical health information. It is a required standard in interoperability specifications of the U.S. Healthcare Information Technology Standards Panel.

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