The NIH Common Data Elements (CDE) Repository has been designed to provide access to structured human and machine-readable definitions of data elements that have been recommended or required by NIH Institutes and Centers and other organizations for use in research and for other purposes. Visit the NIH CDE Resource Portal for contextual information about the repository.

The purpose of the NINDS Common Data Elements (CDEs) Project is to standardize the collection of investigational data in order to facilitate comparison of results across studies and more effectively aggregate information into significant metadata results. The goal of the National Institute of Neurological Disorders and Stroke (NINDS) CDE Project specifically is to develop data standards for clinical research within the neurological community. Central to this Project is the creation of common definitions and data sets so that information (data) is consistently captured and recorded across studies. To harmonize data collected from clinical studies, the NINDS Office of Clinical Research is spearheading the effort to develop CDEs in neuroscience. This Web site outlines these data standards and provides accompanying tools to help investigators and research teams collect and record standardized clinical data. The Institute still encourages creativity and uniqueness by allowing investigators to independently identify and add their own critical variables. The CDEs have been identified through review of the documentation of numerous studies funded by NINDS, review of the literature and regulatory requirements, and review of other Institute''s common data efforts. Other data standards such as those of the Clinical Data Interchange Standards Consortium (CDISC), the Clinical Data Acquisition Standards Harmonization (CDASH) Initiative, ClinicalTrials.gov, the NINDS Genetics Repository, and the NIH Roadmap efforts have also been followed to ensure that the NINDS CDEs are comprehensive and as compatible as possible with those standards. CDEs now available: * General (CDEs that cross diseases) Updated Feb. 2011! * Congenital Muscular Dystrophy * Epilepsy (Updated Sept 2011) * Friedreich''s Ataxia * Parkinson''s Disease * Spinal Cord Injury * Stroke * Traumatic Brain Injury CDEs in development: * Amyotrophic Lateral Sclerosis (Public review Sept 15 through Nov 15) * Frontotemporal Dementia * Headache * Huntington''s Disease * Multiple Sclerosis * Neuromuscular Diseases ** Adult and pediatric working groups are being finalized and these groups will focus on: Duchenne Muscular Dystrophy, Facioscapulohumeral Muscular Dystrophy, Myasthenia Gravis, Myotonic Dystrophy, and Spinal Muscular Atrophy The following tools are available through this portal: * CDE Catalog - includes the universe of all CDEs. Users are able to search the full universe to isolate a subset of the CDEs (e.g., all stroke-specific CDEs, all pediatric epilepsy CDEs, etc.) and download details about those CDEs. * CRF Library - (a.k.a., Library of Case Report Form Modules and Guidelines) contains all the CRF Modules that have been created through the NINDS CDE Project as well as various guideline documents. Users are able to search the library to find CRF Modules and Guidelines of interest. * Form Builder - enables users to start the process of assembling a CRF or form by allowing them to choose the CDEs they would like to include on the form. This tool is intended to assist data managers and database developers to create data dictionaries for their study forms.

Title of data: CTE & SAE Data Inventory. Description of data: List of common data elements in clinical trials with domain, availability/completeness, occurrence in trials, semantic codes and definition. (XLSX 34 kb)

The Commonly Used Data Element Standard aims to update and consolidate FEMA's existing data element standards, ensuring a consistent and high-quality approach to managing commonly used data elements. Incorrect data ingestion can lead to decision-making errors and challenge analysts with limited resources to correct these errors. Ensuring data quality begins with identifying and structuring key data elements that are vital to business operations. By standardizing the management of these elements, we can eliminate inconsistencies, reduce errors, and foster a culture of data excellence. This document provides comprehensive guidelines for adopting these data elements across systems and analytical reports to enhance data accuracy and support our strategic objectives. While compliance to these standards is not mandatory, it is highly recommended to achieve the full benefits of standardized, high-quality data practices within FEMA. By offering these standards as flexible recommendations rather than strict requirements, we allow programs and systems the flexibility to adapt while guiding FEMA towards exemplary data practices. Implementing these standards is crucial for improving our data management strategy, resulting in higher data quality and better alignment with our strategic goals.

This dataset tracks the updates made on the dataset "NIH Common Data Elements Repository" as a repository for previous versions of the data and metadata.

Sample predictors as presented in the common data element guidelines.

Common Data Elements to use in medical research

In 2020, the Neurocritical Care Society’s Curing Coma Campaign launched an international initiative to create common data elements (CDEs) for disorders of consciousness (DoC). This CDE initiative is motivated by the recognition that ongoing progress in our field depends on the development of harmonized and uniform data elements. We formed multidisciplinary Work Groups with expertise in 1) Behavioral Phenotyping; 2) Hospital Course/Confounders/Medications; 3) Neuroimaging; 4) Electrophysiology; 5) Biospecimens; 6) Physiologic Data/Big Data; 7) Therapeutic Interventions; 8) Outcomes/Endpoints; and 9) Goals of Care/Family Data. Here, we disseminate the initial recommendations of this CDE development process and version 1.0 of the case report forms (CRFs) with CDEs that can be used in DoC studies. We aim for these CDEs to support progress in the field of DoC research and to facilitate multi-institutional collaboration.

We welcome feedback and are committed to revising the CDEs and CRFs to ensure that they reflect developments in our field. To provide feedback about the current CDEs and CRFs, and to make recommendations about updates for future versions, please email cde.curingcoma@gmail.com.

Proportion of data elements found in IPD data that are also present in the data dictionary.

This FAIRsharing record describes: Semantic data model of the set of common data elements for rare disease registration. To make rare disease registry data Interoperable (the 'I' in FAIR). Version 2.0. License CC0. Here, we present a semantic data model of the set of common data elements for rare diseases registration recommended by the European commission joint research centre. There are 16 data elements: ‘Pseudonym’, ‘Date of Birth’, ‘Sex’, ‘Patient’s status’, ‘Date of death’, ‘First contact with specialised centre’, ‘Age at onset’, Age at diagnosis’, ‘Diagnosis of the rare disease’, ‘Genetic diagnosis’, ‘Undiagnosed case’, ‘Agreement to be contacted for research purposes’, ‘Consent to the reuse of data’, ’Biological sample’, ‘Link to a biobank’, ‘Classification of functioning/disability’. The semantic data model is presented in 11 modules describing the different 16 data elements. Central to each module is the 'person'. Each module has in addition different characteristics assigned to the person.

List of 6 selected forms (out of 40 total) present in the forms dictionary for NCT01751646: ‘Vitamin D Absorption in HIV Infected Young Adults Being Treated With Tenofovir Containing cART’.

Objective(s): Momentum for open access to research is growing. Funding agencies and publishers are increasingly requiring researchers make their data and research outputs open and publicly available. However, clinical researchers struggle to find real-world examples of Open Data sharing. The aim of this 1 hr virtual workshop is to provide real-world examples of Open Data sharing for both qualitative and quantitative data. Specifically, participants will learn: 1. Primary challenges and successes when sharing quantitative and qualitative clinical research data. 2. Platforms available for open data sharing. 3. Ways to troubleshoot data sharing and publish from open data. Workshop Agenda: 1. “Data sharing during the COVID-19 pandemic” - Speaker: Srinivas Murthy, Clinical Associate Professor, Department of Pediatrics, Faculty of Medicine, University of British Columbia. Investigator, BC Children's Hospital 2. “Our experience with Open Data for the 'Integrating a neonatal healthcare package for Malawi' project.” - Speaker: Maggie Woo Kinshella, Global Health Research Coordinator, Department of Obstetrics and Gynaecology, BC Children’s and Women’s Hospital and University of British Columbia This workshop draws on work supported by the Digital Research Alliance of Canada. Data Description: Presentation slides, Workshop Video, and Workshop Communication Srinivas Murthy: Data sharing during the COVID-19 pandemic presentation and accompanying PowerPoint slides. Maggie Woo Kinshella: Our experience with Open Data for the 'Integrating a neonatal healthcare package for Malawi' project presentation and accompanying Powerpoint slides. This workshop was developed as part of Dr. Ansermino's Data Champions Pilot Project supported by the Digital Research Alliance of Canada., NOTE for restricted files: If you are not yet a CoLab member, please complete our membership application survey to gain access to restricted files within 2 business days. Some files may remain restricted to CoLab members. These files are deemed more sensitive by the file owner and are meant to be shared on a case-by-case basis. Please contact the CoLab coordinator on this page under "collaborate with the pediatric sepsis colab."

This data is a subset of the Smart Discharges Uganda Under 5 years parent study and is specific to the Phase I observational cohort of children aged 0-6 months. Objective(s): Used as part of the Smart Discharge prediction modelling for adverse outcomes such as post-discharge death and readmission. Data Description: All data were collected at the point of care using encrypted study tablets and these data were then uploaded to a Research Electronic Data Capture (REDCap) database hosted at the BC Children’s Hospital Research Institute (Vancouver, Canada). At admission, trained study nurses systematically collected data on clinical, social and demographic variables. Following discharge, field officers contacted caregivers at 2 and 4 months by phone, and in-person at 6 months, to determine vital status, post-discharge health-seeking, and readmission details. Verbal autopsies were conducted for children who had died following discharge. . Data Processing: Created z-scores for anthropometry variables using height and weight according to WHO cutoff. Distance to hospital was calculated using latitude and longitude. Extra symptom and diagnosis categories were created based on text field in these two variables. BCS score was created by summing all individual components. Limitations: There are missing dates and the admission, discharge, and readmission dates are not in order. Ethics Declaration: This study was approved by the Mbarara University of Science and Technology Research Ethics Committee (No. 15/10-16), the Uganda National Institute of Science and Technology (HS 2207), and the University of British Columbia / Children & Women’s Health Centre of British Columbia Research Ethics Board (H16-02679). This manuscript adheres to the guidelines for STrengthening the Reporting of OBservational studies in Epidemiology (STROBE). NOTE for restricted files: If you are not yet a CoLab member, please complete our membership application survey to gain access to restricted files within 2 business days. Some files may remain restricted to CoLab members. These files are deemed more sensitive by the file owner and are meant to be shared on a case-by-case basis. Please contact the CoLab coordinator on this page under "collaborate with the pediatric sepsis colab."

Additional file 1. Summary of categorized data elements identified by environmental scan mapped to common data elements of Value Set Authority Center.

Data repository of de-identified patient data, aggregated in a standardized manner, to enable analyses across many rare diseases and to facilitate various research projects, clinical studies, and clinical trials. The aim is to facilitate drug and therapeutics development, and to improve the quality of life for the many millions of people who are suffering from rare diseases. The goal of GRDR is to enable analyses of data across many rare diseases and to facilitate clinical trials and other studies. During the two-year pilot program, a web-based template will be developed to allow any patient organization to establish a rare disease patient registry. At the conclusion of the program, guidance will be available to patient groups to establish a registry and to contribute de-identified patient data to the GRDR repository. A Request for Information (RFI) was released on February 10, 2012 requesting information from patient groups about their interest in participating in a GRDR pilot project. ORDR selected 30 patient organizations to participate in this pilot program to test the different functionalities of the GRDR. Fifteen (15) organizations with established registries and 15 organizations that do not have patient registry. The 15 patient groups, each without a registry, were selected to assist in testing the implementation of the ORDR Common Data Elements (CDEs) in the newly developed registry infrastructure. These organizations will participate in the development and promotion of a new patient registry for their rare disease. The GRDR program will fund the development and hosting of the registry during the pilot program. Thereafter, the patient registry is expected to be self-sustaining.The 15 established patient registries were selected to integrate their de-identified data into the GRDR to evaluate the data mapping and data import/export processes. The GRDR team will assist these organizations in mapping their existing registry data to the CDEs. Participating registries must have a means to export their de-identified registry data into a specified data format that will facilitate loading the data into the GRDR repository on a regular basis. The GRDR will also develop the capability to link patients'''' data and medical information to donated biospecimens by using a Voluntary Global Unique Patient Identifier (GUID). The identifier will enable the creation of an interface between the patient registries that are linked to biorepositories and the Rare Disease Human Biospecimens/Biorepositories (RD-HUB) http://biospecimens.ordr.info.nih.gov/.

NIH RECOVER tissue pathology common data elements.

There are many initiatives attempting to harmonize data collection across human clinical studies using common data elements (CDEs). The increased use of CDEs in large prior studies can guide researchers planning new studies. For that purpose, we analyzed the All of Us (AoU) program, an ongoing US study intending to enroll one million participants and serve as a platform for numerous observational analyses. AoU adopted the OMOP Common Data Model to standardize both research (Case Report Form [CRF]) and real-world (imported from Electronic Health Records [EHRs]) data. AoU standardized specific data elements and values by including CDEs from terminologies such as LOINC and SNOMED CT. For this study, we defined all elements from established terminologies as CDEs and all custom concepts created in the Participant Provided Information (PPI) terminology as unique data elements (UDEs). We found 1 033 research elements, 4 592 element-value combinations and 932 distinct values. Most elements were UDEs (869, 84.1%), while most CDEs were from LOINC (103 elements, 10.0%) or SNOMED CT (60, 5.8%). Of the LOINC CDEs, 87 (53.1% of 164 CDEs) originated from previous data collection initiatives, such as PhenX (17 CDEs) and PROMIS (15 CDEs). On a CRF level, The Basics (12 of 21 elements, 57.1%) and Lifestyle (10 of 14, 71.4%) were the only CRFs with multiple CDEs. On a value level, 61.7% of distinct values are from an established terminology. AoU demonstrates the use of the OMOP model for integrating research and routine healthcare data (64 elements in both contexts), which allows for monitoring lifestyle and health changes outside the research setting. The increased inclusion of CDEs in large studies (like AoU) is important in facilitating the use of existing tools and improving the ease of understanding and analyzing the data collected, which is more challenging when using study specific formats.

List of 18 HIV trials in the final set analyzed for data elements.

Objective(s): Smart Discharges is a digital health program that uses individual-level risk prediction and intervention to increase effective health seeking behavior, improve health outcomes, and reduce mortality during the post-discharge period. Health workers aim to mitigate risk by educating caregivers on post-discharge care and by scheduling follow-up visits for at-risk children in their communities. Data Description: This dataset includes an introductory video and caregiver discharge counselling videos on: 1) Hygiene; 2) Nutrition; 3) Breastfeeding; 4) Care Seeking; 5) Mosquito Net Use; 6) Medications; 7) Immunizations. Videos are available in English and local Ugandan languages of Acholi, Luganda, Lusoga, and Runyankole. This dataset contains the Lusoga version. Limitations: Videos were designed for the Ugandan context and may not be generalizable to other settings. Abbreviations: Village Health Teams (VHT) (i.e. local term for Community Health Worker (CHW)) Ethics Declaration: NA Funding Source(s): BC Children's Hospital Foundation; Grand Challenges Canada; Mining4Life; Thrasher Research Fund;, NOTE for restricted files: If you are not yet a CoLab member, please complete our membership application survey to gain access to restricted files within 2 business days. Some files may remain restricted to CoLab members. These files are deemed more sensitive by the file owner and are meant to be shared on a case-by-case basis. Please contact the CoLab coordinator on this page under "collaborate with the pediatric sepsis colab."

The Ontario Brain Institute's “Brain-CODE” is a large-scale informatics platform designed to support the collection, storage and integration of diverse types of data across several brain disorders as a means to understand underlying causes of brain dysfunction and developing novel approaches to treatment. By providing access to aggregated datasets on participants with and without different brain disorders, Brain-CODE will facilitate analyses both within and across diseases and cover multiple brain disorders and a wide array of data, including clinical, neuroimaging, and molecular. To help achieve these goals, consensus methodology was used to identify a set of core demographic and clinical variables that should be routinely collected across all participating programs. Establishment of Common Data Elements within Brain-CODE is critical to enable a high degree of consistency in data collection across studies and thus optimize the ability of investigators to analyze pooled participant-level data within and across brain disorders. Results are also presented using selected common data elements pooled across three studies to better understand psychiatric comorbidity in neurological disease (Alzheimer's disease/amnesic mild cognitive impairment, amyotrophic lateral sclerosis, cerebrovascular disease, frontotemporal dementia, and Parkinson's disease).