General FAQs about the Pediatric Covid-19 Registry
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The coordinating center IRB at St. Jude determined that other sites providing clinical (NON-HIPAA identifiable) data to this project are NOT engaged in human subjects activites based on OHRP's October 16, 2008, Guidance on Engagement of Institutions in Human Subjects Research. Therefore, sites do not need local IRB approval unless required by their local policy and procedures.
Do I need a data sharing agreement?
The coordinating center does not require a data sharing agreement be in place before entering de-identified data in the REDCap survey. If your site requires an agreement, please contact [email protected].
Should i schedule follow-up visits for my patients to collect additional data?
No. This study is secondary data analysis of data "on the shelf" that was collected for routine care. Sites should only abstract data that is available in the patients medical record.
How are the data from this registry going to be shared/disbursed?
De-identified data summaries will be available via this website. The summaries are updated multiple times a week. Eventually, summarized data will also be shared via peer reviewed journal publications.
Do I have access to my institutions data?
Only aggregate data is available via this website. We will not share individual site data on this website. If you would like a report of your individual site data, please email your request to [email protected]. In your request, please include why these data are needed and how they will be used.
Can i publish my site's data?
If you wish to publish your site's data, please submit a proposal to the coordinating center who will facilitate review by the leadership team. The submission must not interfere with the completion of the parent study or publication of the primary manuscripts.
Will there be opportunities for authorship?
Yes. There will be opportunities for authorship on future publications as the data allow.
What kind of information are you collecting?
This study will only collected secondary de-identified data from patients' medical records. Broadly, this information includes demographics, underlying conditions, health status as well as information related to their Covid-19 infection course and outcome.
What if i don't have all of the information requested in the survey available in the patients medical record?
That's fine. Just enter in the survey what is available patient's medical record.
How will this data be used?
We will share routinely updated aggregate de-identified data via this website in inform pediatric providers. Data will also be published in peer reviewed journals.
Does the registry include patients that tested negative?
Only Covid-19 positive cases are being recorded in the registry.
How long after I request my site's data can I expect a response?
Providing you with your requested data is important for us and we want to send that to you as soon as possible. Given the current volume of cases and sites we are managing, we expect your data request to be processed and sent to you within 5 business days. We will keep you updated should that timeline change.
Can I submit a case with a positive serology, but negative PCR?
Yes, any pediatric patient (< 21 years old) with a positive clinical COVID-19 diagnostic test (e.g., PCR and/or serology) for COVID-19 are eligible for the registry.
Do you have a protocol document?
Click here to see a summary of the registry study. This information may be shared with your IRB if needed.
Is there a central IRB for this study?
No, there is no central IRB for this study. Per the coordinating center IRB, sites are not required to have IRB approval in order to enter cases in the registry. However, if your institution requires IRB approval, you should submit to your local IRB.
Do you require a Data Sharing Agreement be executed prior to a site entering cases?
No, the coordinating center does note require a data sharing/transfer agreement be executed for the transfer of de-identified secondary use data. If your institution requires an agreement, please contact the coordinating center.
How will my data be secured?
In accordance with HIPAA Safe Harbor De-Identfication Standards, de-identfied data submitted to the registry is hosted in the St. Jude Children's Research Hospital REDCap platform deployed on the St. Jude secured servers. All data is encrypted during transmission. The St. Jude web and database servers are monitored by St. Jude Information Services staff and are backed up at least daily. The REDCap database is password protected with access restricted to the coordinating center team.
What do I need to begin entering cases the registry?
IRB approval or a data sharing agreement are not required by the coordinating center for a collaborating site to begin entering cases. You may begin entering eligible cases once your institution requirements are met (if applicable).
What if I have a patient who was diagnosed at another institution then transferred to my institution for care?
Please go ahead and submit this case. A question on the follow-up survey will ask for this specific information. Our coordinating center team reviews cases that are entered and will use this information to try and identify potential duplicate entries.
Can I use your dashboard for my publication?
If you would like to use information for your publication from the registry dashboard, please contact [email protected] prior to submitting any work for publication.
I have seen additional pediatric cases reported for a state(s) in the news or on other websites, why does it not show up on the dashboard?
These dashboards only include cases that have been voluntarily submitted to the Pediatric COVID-19 U.S. Registry by pediatric health care providers and institutions.