FAQs

FREQUENTLY ASKED QUESTIONS

Please refer to the FAQs below. If you have any questions, please contact Julie Magnusson at jmagnusson@primaryimmune.org

What is the status of the USIDNET Registry as of April 1, 2020?
As of April 1, 6,645 participants (across all sites) have been enrolled into the registry.

A request for a No-Cost Extension (NCE) was submitted and approved by the NIH to continue some of our operations. The NCE allows sites additional time to continue enrolling and entering follow up visits.

Please note that we are not able to provide compensation for continued data entry, as funds are no longer available for chart reimbursement. Likewise, if your site wishes to continue entering patient charts, we ask that you enter complete information required for a patient record. This includes:

• Patient Demographics
• Consent
• Initial Registry Visit
Can I still submit invoices for initial and follow up entries?
No. All invoices must have been submitted by March 1, 2020.
Is there anything particular that I need to do at my site?
• Please be sure that all CRF data have been entered into the registry. Please review the data for completion and accuracy.

• Please resolve all pending queries in the registry between now and October 1, 2020. We will be reaching out to sites in the near future to notify you of any pending queries/CRFs that need to be completed.

• If your site has a Data Use Agreement on file, please consult your IRB to assess whether the DUA will allow for continued use of existing data in the registry if there is a change in funding mechanism or scope of the project.
Am I required to submit a Continuing Review to my IRB?
Yes. Continuing review activities must continue as long as the research remains open to follow-up of subjects.
Will I need to submit study closure to the IRB?
We will advise you of this once all study activity for the current project has ceased. USIDNET is exploring other mechanisms to continue this important work and we will provide study updates as information becomes available.
Will queries of the database continue?
Yes, queries of the data will continue. We are exploring ways to provide future access to the data via an online, free and open data query instance. For now, you may continue to submit requests for registry data using the Query Request Form on the USIDNET website. Click HERE to access the form.
I’m interested in publishing a paper using Registry data. Are there any approvals that I need to obtain?
Yes. Before submitting an abstract or manuscript for an investigation using registry data, it needs to be reviewed by the USIDNET Steering Committee. Please send your abstract or manuscript by email to USIDNET at contact@usidnet.org

Include your intended date of submission, and the meeting or journal to which you plan to submit. We ask that you send submissions at least 2 weeks before the intended submission date.

Please review the USIDNET Data Use Policy and the USIDNET Publication Policy, which can be found on the USIDNET website, for additional guidelines.