Subjects in this data repository include all who meet the enrollment criteria of any linked/participating IRB-approved protocol, or if they meet one of the following inclusion criteria:

• Suspected SARS CoV-2 infection (Person Under Investigation) and/or
• Laboratory proven SARS CoV-2  infection and/or
• Primary admitting diagnosis of SARS CoV-2 infection.

Subject data are included in the COVID-19 Integrated Data Repository. The IDR ensures that data are collected, stored, and used in accordance with Duke Health data quality controls and compliance. The IDR is designed to enable long term use, data sharing, harmonization, quality, and security. The data attributes are available as a download.

Specimens consist of residual clinical samples from the testing and treatment of patients with COVID-19 at Duke. The repository currently has more than 20,000 specimens including serum, whole blood, plasma, nasal swab, nasopharyngeal swab, combined nasopharyngeal/oropharyngeal swab, nasopharyngeal lavage, and bronchoaveolar lavage from more than 4,400 unique individuals. All specimens were processed in the clinical laboratory as part of standard operating procedure and retained for future research use under Duke IRB protocol Pro00105316.

Patient demographics associated with the specimens.

DNA specimens will only be available for 124 consented participants. Identifiable data will only be available for consented participants or patients meeting waiver of informed consent; any data for patients who were not approached for consent or do not fall under a waiver will only be shared in a deidentified manner.

No data or specimens will be shared until there is an IRB-approved protocol for the specific use. Investigators must have a PACE account to receive identifiable data.

The CSDSR Review Committee is responsible for ensuring the ethical conduct of research and appropriate prioritization of the CSDSR resource.  The CSDSR Review Committee is comprised of individuals from Duke SOM basic, translational, clinical, and data science research.

The CSDSR Review Committee will review scientific proposals for samples, data, or both and prioritize based on significance, approach, feasibility, data sharing plan, and funding source.

Duke investigators must complete the short-form scientific proposal to request specimens, data, or both and submit via email to CovidIDRandSpecimensRequest@duke.edu. 

Investigators may expect a decision from the Review Committee within three (3) week of submitting the short-form proposal. Investigators seeking a commitment to use the data or specimens in a grant proposal should accommodate this schedule in the planning of their projects.

If the request for data and/or specimens is approved, the CSDSR will provide a letter of support for grant applications, if applicable. The CSDSR will also provide a cost estimate to the investigator. Funding is required to cover biospecimen costs (sample storage, aliquoting, transfer, etc.), data preparation, data storage, data transfer, and integration of results.

The following must be completed by the requesting investigator and approved prior to access to biological specimens and/or data

• Institutional Approval, including IRB Approval or Determined Exempt
• Data Management and Sharing Plan
• Funding must be confirmed if relevant
• Data Usage Agreement (DUA) and/or Materials Transfer Agreement (MTA) executed, if required

Research projects that use biospecimens or data from the CSDSR are expected to contribute all clinical, molecular, and imaging data generated from the project back to the Integrated Data Repository. Data are expected to be shared via secure transfer as soon as is practical, but no later than 9 months after collection is complete. Residual materials from derived samples should be made available for sharing through the CSDSR.

The Duke SOM is committed to open science and data sharing. Investigators are expected to disseminate their findings through meeting presentations and publications in peer-reviewed journals within 12 months of completing their studies.

Research projects that use biospecimens or data from the CSDSR are expected to collaborate with the Medical Directors of the DUHS Clinical Laboratories and DUHS Clinical Microbiology Laboratory and include on publications. All publications using CSDSR specimens and/or data must be reviewed by the CSDSR Review Committee prior to submission.

The first publication of the results will be a joint publication that includes at least one member of the Review Committee, with the standards of authorship being defined by the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals established by the International Committee of Medical Journal Editors (see www.icmje.org).

REDCap Citation: The CSDSR uses REDCap for data collection and management. Publications should cite the REDCap publication.

Funding Acknowledgement: Duke School of Medicine provides direct funding to create and maintain the CSDSR. The Duke Clinical & Translational Science Award (CTSA) provides funding for infrastructure that supports the CSDSR. Publications should acknowledge Duke’s CTSA grant and register in PubMed Central.