As project teams transfer data to the CDCC, the Data Science and Biostatistics Core performs quality and conformance checks as it receives the data, using the RADx-UP CDE codebook, and each project’s NIH CDE Tracking Form that documents any CDEs that the project does not intend to collect and/or share based on its agreements with community partners.

The CDCC collects appropriate RADx Data Hub data sharing forms from each project, and then NIH registers each project with dbGaP, a federal database of research studies, and with the RADx Data Hub. The CDCC then ensures that the project data has been de-identified and is compliant with the NIH RADx Data Hub data standards. Finally, the CDCC uploads each project’s data file and data dictionary to the RADx Data Hub on a quarterly basis.

Data Usage and Sharing

Before any data is shared, the CDCC works with projects on a Data Usage Agreement (DUA). The agreement outlines “disclosure and transfer of confidential information and protected health information.” DUAs include information about how data, including protected health information (PHI), will be used for research and how that data will be stored, protected and shared. The agreement represents an understanding between the NIH/RADx-UP CDCC housed at Duke University and RADx-UP project institutions, and is signed by both parties.

The DUAs do not allow the CDCC to directly share data with researchers outside of the RADx-UP program.

• RADx-UP researchers and their community partners who wish to analyze RADx-UP data can participate in one of the RADx-UP Partnering for Impact writing teams.
• Non-RADx-UP researchers and others who wish to analyze RADx-UP data should visit the NIH RADx Data Hub.

In addition to the DUA, The RADx-UP CDCC also created an Informed Consent Form (ICF) data sharing language template to help standardize the consent process for projects.

Tribal Nations Data Sovereignty and Sharing Agreements

The CDCC works directly with Tribal Nation RADx-UP projects on data sharing and usage. Each project decides how, when and if data collected pertaining to their American Indian/Alaska Native participants, will be shared internally, on public dashboards, in core analytic datasets, or in data transfers to the RADx Data Hub.

The CDCC has implemented the RADx-UP Tribal Nations Project Data Requirements and Processes and the CDCC and NIH Documentation for RADx-UP Projects with Tribal Nations Partners to ensure Tribal Nation data sovereignty where required.

The Data Hub is the central repository for COVID-19 data across the four RADx programs; RADx-UP, RADx DHT, RADx-TECH, and RADx-RAD. The Data Hub includes up to seven data types including clinical, behavioral, survey/interview, diagnostic/test, biological sample, sequencing and imaging data. The Data Hub curates and de-identifies the data, and also enables researchers to find, aggregate, and perform analyses on that data in a cloud-enabled platform.

Non-RADx-UP researchers and others who wish to analyze RADx-UP data should visit the NIH RADx Data Hub for information posted to their website and in this guide, explaining the steps for accessing their data.

During initiation, the CDCC executes a Data Use Agreement with each RADx-UP project. Once the project begins collecting data, that data is sent to the RADx-UP CDCC in accordance with the Data Use Agreement and the project’s Informed Consent Form. The projects do not send data directly to the RADx Data Hub; rather, the CDCC collects and processes the data and then uploads it to the Hub.

1. The CDCC and NIH works with each project to complete the Data Hub’s forms: the Data Sharing Plan and Submission Information form and the Institutional Certification form.
2. NIH then registers the project with the dbGaP database, a federal database of research studies. NIH also creates a new entry for that project in the Data Hub’s platform.
3. The CDCC completes data quality and conformance checks in real time, each time a project uploads a new data file to our data portal. The checks compare the data against the RADx-UP CDE codebook, as well as against each project’s NIH CDE Tracking Form, which documents any CDEs that the project does not intend to collect and/or share with the CDCC. The CDCC works with the project’s data manager in real time to resolve as many quality and conformance issues as possible.
4. For projects that have been registered with dbGaP and are in the Data Hub system, and their data has completed the quality and conformance checks, the CDCC then de-identifies and ensures the data is compliant with the Data Hub’s standards. The CDCC then uploads each project’s data file and data dictionary to the Data Hub platform, on a quarterly basis.
5. The Data Hub also completes their own data quality and conformance checks on the uploaded data, against the RADx CDEs (which make up a subset of the RADx-UP CDEs) and their data standards.

Accessing Data

Researchers from within RADx-UP follow our Partnering for Impact process for accessing the aggregated data for the development, preparation, and review of scholarly products (abstracts, scientific presentations, manuscripts).

Researchers who are outside of the RADx-UP program can only access our data through the Data Hub. The RAD-UP Data Use Agreements do not allow the CDCC to directly share data outside of our program, except for sharing with the Data Hub. The Data Hub has information posted to their website and in this guide, explaining the steps for accessing their data.