The data will be shared:
- Directly on the website covidpso.org
- Through listservs and social media
- Via scholarly publications. We plan to update the website frequently, with reports including number of cases (and COVID outcomes) by country, number of cases by treatment, etc.
We have created a registry that contains only de-identified data, in accordance with HIPAA Safe Harbor De-Identification standards.The Wake Forest Institutional Review Board has determined that storage and analysis of de-identified data does not constitute human subjects research as defined under federal regulations [45 CFR 46.102 and 21 CFR 56.102] and does not require IRB approval.
Our database system (REDCap) provides for secure web-based data entry with the data stored on secure servers at Wake Forest University. All data is encrypted during transmission. The web and database servers are monitored by the IT staff, patched frequently, and scanned by a third party vendor to ensure that they are protected against known vulnerabilities. Access is by individual user id, and is restricted to the forms and/or functions that the user needs to have.