Frequently Asked Questions
What is the purpose of this registry?
The goals of the registry is to rapidly define the impact of COVID-19 on patients with IBD and how factors such as age, comorbidities, and IBD treatments impact COVID outcomes.
How is the data from this registry going to be shared/disbursed?
The data will be shared 1) directly on the website http://www.covidibd.org , 2) through listservs and social media, and 3) via scholarly publications. We plan to update the website three times weekly, with reports including number of cases (and COVID outcomes) by country, number of cases by treatment, etc.
What steps have been taken to ensure the security of the data?
We have created a registry that contains only de-identified data, in accordance with HIPAA Safe Harbor De-Identification standards. The UNC-Chapel Hill Office for Human Research Ethics 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 the University of North Carolina at Chapel Hill. 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.
When should I fill out a Case Report Form?
If you have a patient with inflammatory bowel disease (IBD) and confirmed SARS-CoV-2/COVID-19 testing than please complete the form after the patient has had COIVD-19 for a long enough duration to experience partial or complete recovery, hospitalization, or death. If the patient’s clinical status changes after a form has been completed, please refer to question #5.
Once a survey has been submitted, can it be re-accessed or edited at a later time? What if I have updated information about a case after submission?
Once a survey has been submitted it can not be re-accessed or edited at a later time. However, if you have updated information or any changes since you have reported a case, please re-report the case and email COVID.IBD@unc.edu to ask our team to remove the duplicate entry.
Who should fill out the Case Report Form?
Health care providers taking care of patients with IBD and documented COVID-19.
Can patients fill out the Case Report Form?
No, the Case Report Form is designed to be filled out by a health care provider. Patients with IBD and documented COVID 19 should encourage their health care provider to complete a Case Report Form on their behalf.