COVID Case Report Forms, Standards, and Protocols

Inventory of COVID Case Report Forms (CRFs) & Phenotyping Standards

Below is a list of known CRFs for triage, intake, and patient-focused phenotype/metadata collection efforts. This inventory is intended primarily for knowledge exchange, with the aim of creating a computable standard for phenotype data sharing. Additional entries welcome.

The Centers for Disease Control and Prevention (CDC)

The Centers for Disease Control and Prevention (CDC) created a Human Infection with 2019 Novel Coronavirus Person Under Investigation (PUI) and Case Report Form.

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University of Pennsylvania

University of Pennsylvania coordinated with multiple CTSAs to develop a Case Report Form and its accompanying REDCap data dictionary. Contributors: Columbia, Harvard, UT Southwestern, University of Washington, University of Pittsburgh, UCLA, UCSD, University of Kansas, and USC

Columbia University

Columbia University developed a Case Report form already in use. It is being translated into Spanish, Italian, German, French, Polish, Japanese, Chinese, and Korean.

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The Global Alliance for Genomics and Health (GA4GH)

The Global Alliance for Genomics and Health (GA4GH) Phenopackets standard has been implemented in citizen tracking applications.

CDISC

CDISC is developing an Interim User Guide for COVID-19 with WHO, CDC, FDA including Study Data Tabulation Model (SDTM) domains, variables, and Controlled Terminology. CRFs are then based on and align with these specifications. The controlled Terminology is in NCIt, includes cross NIH IC CDEs.

See especially signs and symptoms.

GO FAIR

The Virus Outbreak Data Network (VODAN) of GO FAIR has several projects. The first project within this implementation network aims at making the clinical/screening data collection based on the WHO case record form (CRF) for Corona ("rapid" version) FAIR for both humans and machines. A semantic data model representing this CRF was also just launched. URI

NIH Public Health Emergency and Disaster Research Response (DR2)

The National Institute of Environmental Health Sciences (NIEHS) and the National Library of Medicine (NLM) host the DR2 site, which now includes a list of COVID-19 surveys and the domains assessed in the surveys.

PhenX Toolkit

The PhenX Toolkit, funded by the National Human Genome Research Institute (NHGRI) and other NIH Institutes and Centers, now includes a list of COVID-19 related measurement protocols drawn from the surveys listed in DR2.

COVID-19 Collaboration Platform

CovidCP aims to publicize protocols from PIs that are open to collaboration: joining forces with other research teams to create a core protocol; admitting new sites under the existing PI and IRB; sharing anonymized interim and/or final data through Vivli with other sites that choose to independently operate a trial under a similar protocol.

To Cite the N3C: "The analyses described in this [publication/report/presentation] were conducted with data or tools accessed through the NCATS N3C Data Enclave https://covid.cd2h.org and N3C Attribution & Publication Policy v 1.2-2020-08-25b supported by NCATS Contract No. 75N95023D00001 and [insert additional funding agencies or sources and reference numbers as declared by the contributors in their form response above]. This research was possible because of the patients whose information is included within the data and the organizations (https://ncats.nih.gov/n3c/resources/data-contribution/data-transfer-agreement-signatories) and scientists who have contributed to the on-going development of this community resource [https://doi.org/10.1093/jamia/ocaa196]."

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