Regulatory Resources

IRB Documents

USIDNET has developed a clinical protocol and associated informed consent documents that have been reviewed and approved by Advarra IRB. These documents can be used as boilerplate templates for submission to the principal investigator's local IRB for approval.

Principal Investigator Agreement

By signing this document, the enrolling physician (principal investigator or 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.

Chart Reimbursement Agreement

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.

Chart Submission Form

Once a chart reimbursement agreement is in place, your site should complete the chart submission form that contains an approximate number of consented patients 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.

Chart Reimbursement Invoice

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 to enter your institution’s information and charge items.