Research & Registry

FAQs

Which cases can and cannot be included?

DO INCLUDE any patients not already enrolled in the CARRA Registry who:

  • Develop COVID-19 illness OR test positive for SARS-CoV-2
  • Have any pediatric rheumatic disease, including inflammatory brain disease, or
  • autoimmune eye disease, including primary idiopathic uveitis
  • Are under the age of 19 at the time of onset of illness or diagnosis

DON’T INCLUDE

  • Existing CARRA Registry subjects – if they test positive for SARS-CoV-2, your site should report this as an Event of Special Interest (ESI) in the registry. As with any ESI report, your site will be paid for entering these.
  • Patients 19 years old or older – they should be reported to the adult COVID-19 Global Rheumatology Alliance Provider Registry
  • Patients residing in Europe – they should be reported to the EULAR- COVID-19 Database

Should I report to multiple databases?

No, please do not duplicate reporting to multiple databases. If you have already reported a case to the adult COVID-19 Global Rheumatology Alliance Provider Registry, EULAR database, or other national database, please do not duplicate data entry here. We are closely collaborating and will be sharing all of the data for combined analyses.

When should I report a case?

Please report after at least 7 days from symptom onset/COVID-19 diagnosis and allow sufficient time to have passed to observe the disease course through resolution of acute illness and/or death before reporting. We appreciate your time is pressured and precious currently and you may not know all of the details of your case. Report what you know. You may not have access to information to answer all questions. Do your best.

Where will the data be stored?

Boston Children’s Hospital has contracted with REDCap Cloud (nPhase Inc, Encinitas, CA), a commercial data collection platform that is compliant with the regulations and requirements of U.S. 21 CFR 11, U.S. HIPAA, and E.U. GDPR, for the data collection for this project.

What agreements are in place for contributing and sharing data from this project?

For data entry and return of de-identified data sets, we are using an electronic 'click-through' agreement between data contributors and Boston Children's Hospital. In order to contribute data to this study, we will require that you attest your understanding of this agreement and will abide by the terms indicated therein. If you would like to obtain a copy of the data for your own scientific analyses, you can submit a limited dataset application to CARRA. If you are a CARRA member, please use the CARRA Members-only portal to submit a Data and Sample Sharing request. If you are not a CARRA member and wish to submit an application, please email Natalie Aumann, Research Director at CARRA.

When will I find out about any results?

Data from this study will be displayed on the CARRA webpage, shared with our collaborators at the COVID-19 Global Rheumatology Alliance Provider Registry.

What ethical approvals are in place?

This is a CARRA-sponsored effort, separate from the CARRA Registry, established at Boston Children’s Hospital. The study protocol, entitled "Surveillance of COVID-19 Illness in Individuals with Pediatric Rheumatic and Autoimmune Diseases" (Marc Natter, PI), has been approved for international enrollment by the Boston Children's Hospital Institutional Review Board (BCH IRB). Under the procedures of 45 CFR 46.110, category 5, this study is able to collect a limited data set, including full dates and 5-digit zip codes or their equivalent, with waiver of informed consent/authorization. The IRB approval letter can be found in the accompanying Documents and Policies page for this study.

How do I report a case of COVID-19?

To report a case of COVID-19 in a pediatric patient under 19 years of age with any type of rheumatic disease, click here INSERT HYPERLINK. Detailed instructions and some “How To’s” are available here.

If you want to report a case of COVID-19 in an adult patient with a rheumatic disease outside of the EU click here for the COVID-19 Global Rheumatology Alliance Provider Registry.

If you are in the EU and want to report a case of COVID-19 for any patient with a rheumatic or musculoskeletal disease click here for the EULAR-COVID-19 Database.