In order to participate as an Enrolling Institution, an Institutional Review Board (IRB) must approve the USIDNET protocol at your medical center. Most centers have their own local IRBs, which review and approve clinical protocols involving their faculty. If your medical center does not have its own local IRB, please reach out to USIDNET at contact@USIDNET.org. We are happy to explore additional options with you.
To enroll in the registry, all patients must sign an approved informed consent document (unless a waiver of consent is obtained by the overseeing IRB). Below, you will find the USIDNET protocol and informed consent documents that have been reviewed and approved by the Advarra IRB. These approved documents can be used as a boilerplate for you to modify and submit to your IRB for approval. You can also find these documents on our Regulatory Resources page.
After the site has secured IRB approval, the site's principal investigator will review and sign a copy of the USIDNET PI Agreement.
By signing this document, the enrolling physician (PI) agrees to abide by all rules and regulations surrounding the conduct of this research study as established by the USIDNET Registry.
If required by your institution, we will consider modifications to this document. Please send any proposed changes to USIDNET staff to obtain the necessary approvals.
Once a fully executed PI Agreement is on file, qualified members at an institution must apply for registry user privileges before gaining access to the USIDNET registry. Each new user must complete a Username and Password Application and have it signed by the site's principal investigator.
Registry users can only see, enter, or edit patient data from their own Enrolling Institution. Only USIDNET staff have global administrative access to the USIDNET Registry data in its entirety.
New users are encouraged to visit Registry User Resources before starting to enter data. The registry tutorial can be accessed from this page, and is an excellent introduction to the process of data entry.
Approved enrolling institutions are eligible to receive reimbursement for entering their consented patients' data into the USIDNET Registry.
A fully executed chart reimbursement agreement must be in place between USIDNET and the enrolling site. USIDNET will reimburse a fixed amount for data entry, which does not include indirect costs.
Enrolling sites may reimburse for:
Once a chart reimbursement agreement is in place, your site should complete the chart submission form that contains an approximate number of consented patients and their diagnoses that you plan to enter and subsequently for which you will request reimbursement. This allows us to track progress and ensure that all charts submitted meet the reimbursement criteria.
To issue payment for submitted cases, please submit an invoice for reimbursement. You may use an existing invoice template from your own institution if desired. Otherwise, you are welcome to use the USIDNET template below to enter your institution’s information and charge items.
Invoices must include (either on the invoice itself or as supplemental information):
Remember - USIDNET will reimburse for initial entries that are at least 90% complete & two-year follow up entries that have updated infections/conditions, labs and medications.
You can submit your invoices requesting chart reimbursement to Julie Magnusson, Registry Manager Click to Email.