Frequently Asked Questions
Has this data collection been approved by an Institutional Review Board?
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. However, if you have questions about whether your patients’ deidentified data can be uploaded to the registry, it is recommended you consult with your local IRB. If an IRB application is required (e.g. application for exempt status), we have attached a protocol, case report form and IRB letter from UNC confirming NHSR status.
Why are there two registries (SECURE-Cirrhosis and COVID-Hep.net)?
When we launched, our launch occurred simultaneously with the team running Covid-Hep from the University of Oxford in the United Kingdom. Both projects had and have similar aims.
The two projects started with separate research board approvals, separate links with major societies and individuals, and separate data collection tools with different data points.
In recognition that both datasets would be more powerful if they could be easily combined, we have subsequently collaborated and are now collecting identical data points to better understand COVID-19 in liver disease together.
As such, two complimentary and mutually supportive collaborative projects have developed. We have agreed to ask that submitting centers decide which portal to send their case reports of COVID-19 in liver disease to based on their geography: see the map below. Ultimately, we will work together to build the most comprehensive dataset possible.
Where should I submit my case?
As described above, we are working collaboratively with Covid-Hep in the United Kingdom. We are asking submitters to direct their case reports based on geography.
Please see the map above: red for SECURE-Cirrhosis and blue for COVID-Hep.net. Broadly, for The Americas and China, Japan, and Mongolia, use SECURE-Cirrhosis; for the rest of the world, use COVID-Hep.net.
Please feel free to email firstname.lastname@example.org with any further questions.
What steps have been taken to ensure the security of the data?
As mentioned above, we have created a registry that contains only de-identified data, in accordance with HIPAA Safe Harbor De-Identification standards. 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 chronic liver disease or post-liver transplantation 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 email@example.com 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 chronic liver disease and post-liver transplant 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 chronic liver disease and post-liver transplant and documented COVID 19 should encourage their health care provider to complete a Case Report Form on their behalf.
I am a patient. How can I help?
Thank you for your interest in helping with this international effort! Please consider asking your health care provider to report on our website (www.covidcirrhosis.org) if you or any of their chronic liver disease and post-liver transplant patients contract COVID-19. We encourage you to check our website frequently, as we will be posting data and updates at least weekly.
How long will it take to complete the survey?
It will take approximately five minutes to complete the survey.
Can health care providers anywhere in the world report a case to this registry?
Yes. This is an international effort, and we encourage health care providers around the world to report to this registry. We are working in partnership with European collaborators who will be running the COVID-HEP registry (www.covid-hep.net).
Will this registry lead to care recommendations or guideline development?
Yes, we hope that this will produce sufficient data to inform care of chronic liver disease and post-liver transplant patients.
Is there a collaborative goal with the users of the database?
This is a collaborative, world-wide effort. We are working in partnership with European collaborators who will be running the COVID-HEP registry (www.covid-hep.net). With users reporting cases in real time, we hope to rapidly determine the impact of COVID-19 on patients with of chronic liver disease and post-liver transplant patients and ascertain how medications, comorbidities, and demographic factors modulate their risk. As above, these data will be made available on our project website and frequently updated.
What cases have been reported so far?
Please see the Updates and Data tab on our website (www.covidcirrhosis.org) for updated reports, including number of cases (and COVID outcomes), number of cases by etiology, etc.
Who is organizing this project?
This project is being led by Drs. Andrew Moon (Gastroenterology/Hepatology Fellow, University of North Carolina at Chapel Hill), Theodore James (Gastroenterologist, University of North Carolina at Chapel Hill, A. Sidney Barritt IV (Medical Director of Liver Transplant, University of North Carolina at Chapel Hill), Renumathy Dhanasekaran (Transplant Hepatologist, Stanford University) and Nneka N. Ufere (Gastroenterology/Hepatology Fellow, Massachusetts General Hospital), Ponni Perumalswami, MD (Transplant Hepatologist, Icahn School of Medicine at Mount Sinai), Patricia D. Jones, MD (Transplant Hepatologist, University of Miami), and Feng Su, MD (Transplant Hepatology Fellow, University of Washington).
If I have additional questions, whom should I contact?
Please direct questions to firstname.lastname@example.org