The Clinical Trials Office (CTO) staff works closely with research teams at 91PORN to build billing calendars within our Clinical Trial Management System based off the approved Clinical Trial Agreement for your study. These administrative and patient calendars assist the CTO team with sending invoices to the Sponsors on your behalf.
Velos eResearch is our Clinical Trial Management System (CTMS) utilized here at 91PORN. Velos is used to assist 91PORN in managing studies and the tracking and reporting of patient-related activities.
- Administrative Start-up and Annual Invoicing: Invoicing for Administrative fees will be completed by CTO staff. These fees are not directly associated to a patient:
- For example: Study Start-up, Pharmacy Start-up, Laboratory Start-up, Administrative Annual Fees, Monitoring Visits, Budget Modification Fees, Chart Reviews and Close-out.
- Patient-Related Procedures: Tracking of patient receivable and invoiceable items for patient-related procedures as agreed upon in your study’s Clinical Trial Agreement will be completed by CTO staff. The study team is responsible for tracking patient enrollment in Velos and the patient’s progress completed on the study. Once the study team’s enters information, receivable and Invoiceable milestones will be triggered; this will generate an invoice on CTO’s end to submit to the Sponsor.
- For example: Patient visits (Receivable/Invoiceable), Conditional Procedures, Re-Consent, Serious Adverse Event Reporting, Travel Reimbursement for Patients, etc.
- IRB Approval and IRB Continuing Reviews: Invoicing for Initial IRB approval fees and ongoing re-approval fees will be completed by CTO staff. These fees are not directly associated to a patient:
- For example: IRB Initial Internal IRB fees, IRB initial External IRB fees, and Continuing Review Annual Progress Report IRB fees.
What does this mean to you?
- Administrative and patient calendars are built from your study’s budget and/or Coverage Analysis. This makes input from the study team VERY IMPORTANT. Please let us know if your admin or patient calendar do not line up with your Coverage Analysis.
- When your patient calendar is activated and ready to enroll patients, you will receive an
e-mail from VPRCTO@uthscsa.edu labeled “Velos eResearch Activation Notice” with detailed instructions on study and patient management in Velos. - The study team is required to associate their patients with the specific study and complete the patient’s current patient status (Consent, Enrolled, Off-study). Patients must be registered to the study within 24 hours of signing consent. Visits after that should be entered within 24-48 hours after the occurrence.
- When invoicing the Sponsor for chart reviews and monitoring visits, please ensure that all backup documentation is submitted to ResearchPayments@uthscsa.edu. This step is necessary to make sure there are no delays in processing the invoice.
- Once an invoice is sent out from the CTO, there will be collection activities performed on the invoice at 30, 60, and 90 days past due.
- Once payment is received at our site, CTO staff will claim the payment on your behalf with applicable F&A and department overhead. This payment will be reconciled in Velos, so study teams can have an overview of the invoices sent out and payments received for their study.
For any questions regarding invoices or payments on your study, please reach out to ResearchPayments@uthscsa.edu and we can provide you with updates.