Common Data Elements
Introduction
Common Data Elements (CDEs) are data elements (or variables) that are defined and used the same way across multiple studies, to standardize the way data is collected. The use of CDEs supports the 2023 NIH Data Management and Sharing Policy by making data from different studies more interoperable.
The ImmPort team has reviewed the 184 CDEs that have been endorsed as of Septemeber, 2024. These CDES have been compared to data element fields in ImmPort to indicate overlap between CDEs and ImmPort data fields. CDEs with mappings or partial mappings to ImmPort data elements as shown below. Partial matches reflect situations where the preferred values may differ or the concept might be phrased slightly differently but the data could be mapped between the endorsed CDE and the ImmPort data element.
ImmPort will continue to monitor CDEs as they are newly endorsed, and update the list of mappings accordingly.
Please see below a current list of mappings of CDEs to ImmPort data elements:
ImmPort CDE Mappings
Current Mappings
NIH-Endorsed CDE | CDE Project Steward | ImmPort Template | ImmPort Template Column | Mapping Type | Notes |
---|---|---|---|---|---|
Age | ScHARe | Human Subject | Min Subject Age | Partial | Concept of "age" vs. "min subject age" results in partial match |
Age | Project 5 (COVID-19) | Human Subject | Min Subject Age | Partial | Concept of "age" vs. "min subject age" results in partial match |
Age Units | ScHARe | Human Subject | Age Unit | Partial | Permissible values do not match |
Age Units | Project 5 (COVID-19) | Human Subject | Age Unit | Partial | Permissible values do not match |
Comorbidity or Underlying Condition Occurrence Indicator | Project 5 (COVID-19) | Assessments | Name Reported / Result value reported | Partial | Permissible values for CDE are "Yes," "No," "Unknown," and "N/A." In ImmPort, "Yes" implied by data entry in Assessments Template |
Concomitant Medication Name | Project 5 (COVID-19) | Interventions | Compound Name Reported | Partial | Implied in Intervention - concurrence with clinical trial |
COVID-19 Disease Severity | Project 5 (COVID-19) | Human Subject | Disease Stage Reported | Yes | N/A |
COVID-19 Related Death Indicator | Project 5 (COVID-19) | Assessments | Name Reported / Result value reported | Partial | Free text in ImmPort vs. value list for CDE |
Gender | ScHARe | Human Subject | Gender | Partial | Permissible values do not match |
Health Conditions - Disease Disorders | ScHARe | Assessments | Name Reported / Result value reported | Partial | Question text is not exact match; Free text in ImmPort vs. value list for CDE |
Health Conditions - Disease Disorders - Specify Other | ScHARe | Assessments | Name Reported / Result value reported | Partial | Question text is not exact match |
Health Conditions - Medication or Other Treatments | ScHARe | Assessments | Name Reported / Result value reported | Partial | Question text is not exact match; Free text in ImmPort vs. value list for CDE |
Health Conditions - Medication or Other Treatments - Specify Other | ScHARe | Assessments | Name Reported / Result value reported | Partial | Question text is not exact match |
Patient Vital Status | Project 5 (COVID-19) | Assessments | Name Reported / Result value reported | Partial | Free text in ImmPort vs. value list for CDE |
Physical Exam Date | Project 5 (COVID-19) | Assessments | Study Day | Yes | N/A |
Physical Exam Findings/Sign Specify Other Type | Project 5 (COVID-19) | Assessments | Name Reported / Result value reported | Yes | N/A |
Physical Exam Findings/Sign Type | Project 5 (COVID-19) | Assessments | Name Reported / Result value reported | Partial | Free text in ImmPort vs. value list for CDE |
Planned time point for the inpatient measurement | NHLBI | Assessments | Time of Day | Partial | Partial match to "Time of Day;" Free text in ImmPort vs. value list for CDE |
Race | Project 5 (COVID-19) | Human Subject | Race | Partial | Permissible values do not match |
Race/Ethnicity Self-Identification | ScHARe | Assessments | Name Reported / Result value reported | Yes | N/A |
SARS-CoV-2 Test COVID-19 Infection Detection | Project 5 (COVID-19) | Lab Test Results | Result value reported | Partial | Result interprestation is not part of lab tests but could be entered as part of bundle; alternative would be to separate this data element and align it with Assessments template |
SARS-CoV-2 Test Overall Result | Project 5 (COVID-19) | Lab Test Results | Result value reported | Partial | Free text in ImmPort vs. value list for CDE |
SARS-CoV-2 Test Type | Project 5 (COVID-19) | Lab Test Results | Name Reported | Partial | Permissble values do not match |
Self-Reported COVID-19 Symptom Type | Project 5 (COVID-19) | Assessments | Name Reported / Result value reported | Partial | implied if speified cov-19 for disease |
Sex | Project 5 (COVID-19) | Human Subject | Gender | Partial | Question text would result in different values |
Study Identifier | NHLBI | Basic Study Design | Study ID | Partial | Intent is the same but described as "study ID" in ImmPort with "Protocol ID" being a different field |
Subject ID | NHLBI | Human Subject | Subject ID | Yes | N/A |
Unique ID | Project 5 (COVID-19) | Human Subject | Subject ID | Partial | Equivalent of Subject ID; defined as Unique ID assigned to a person |
Vital Signs Date and Time | Project 5 (COVID-19) | Assessments | Study Day / Time of Day | Partial | ImmPort uses study day rather than specific date to avoid unncessary identifiable information |
Vital Signs Measurement | Project 5 (COVID-19) | Assessments | Result value reported | Yes | N/A |
Vital Signs Measurement Occurrence Indicator | Project 5 (COVID-19) | Assessments | Name Reported / Result value reported | Partial | Permissible values for CDE are "Yes," "No," "Unknown," and "N/A." In ImmPort, "Yes" implied by data entry in Assessments Template |
Vital Signs Specify Other Timepoint | Project 5 (COVID-19) | Assessments | Time of Day | Partial | Concepts are not completely aligned, CDE has assessment type specificity for vital signs |
Vital Signs Timepoint | Project 5 (COVID-19) | Assessments | Name Reported / Result value reported | Partial | ImmPort handles time of day as free text, however, this could be part of a bundle entered as within an overall assessment panel to define the bundle |
Vital Signs Type | Project 5 (COVID-19) | Assessments | Name Reported | Partial | Vital signs has been entered as assessment panel; however, value list is not a complete match |
Vital Signs Unit Of Measure | Project 5 (COVID-19) | Assessments | Result Unit Reported | Partial | Vital signs has been entered as assessment panel; however, value list is not a complete match |