Minimum CDEs Required by NIH

This resource describes the minimum common data elements (CDEs) required for awardees collecting prospective human subjects data. A minimum set of CDEs has been released by NIH for the RADx program. All RADx-rad projects that prospectively collect human participants data are required to collect and use those CDEs in their studies. DCC understands the minimum CDEs requirement may affect ongoing studies as well as those in planning stages (e.g., awardees may have to amend existing IRB protocols and some questions may affect recruitment processes).   The documents below are developed to transfer additional information provided by NIH including RADx Executive Communications and Guidance as well as NIH supervision of collection of NIH RADx-rad Minimum CDEs.

FINAL-RADx-Exec-Comm-required-minimum-CDEs-for-human-subject-studies

FINAL-RAD-x-Exec-Guidance-regarding-required-minimum-CDEs

Process for NIH Supervision of Collection of NIH RADx-rad Minimum CDEs

RADx-rad_MinimumCDE_REDCapDataDictionary_2021-04-08_PREVIEW

RADx-rad_MinimumCDE_REDCapDataDictionary_2021-04-08

 

For Zip Code, Dates and Age, NIH has provided additional guidance.  These are in:

https://www.radxrad.org/wp-content/uploads/2021/09/RADx-Proposed-Data-Sharing-Policies_final-Date_Age_ZipCode.docx

 

Below are the Spanish translations of the RADx EXEC Communication and RADx EXEC Guidelines for ready reference.

Elementos-comunes-de-informacion-CDE-solicitados-por-el-Comite-Ejecutivo-de-RADx-de-los-NIH

Elementos-comunes-de-informacion-CDE-solicitados-por-el-Comite-Ejecutivo-de-RADx-de-los-NIH-3.25.21

 

Below are the Brazilian Portuguese translations of the RADx EXEC Communication and RADx EXEC Guidelines for ready reference.

Brazilian Portuguese Translated CDEs- Required CDEs_ed

Brazilian Portuguese Translated CDEs-Exec Guidance