Clinical Trials Post-Award Workflows

Table of Contents:

Study Start-up

  • Upon IRB approval and a fully executed contract, Clinical Trials (CT) Post-Award accountants create a study spreadsheet. Including a balance sheet, visit log, invoice log, budget tracker, and Analytic reports.
  • The Financial Console is then built in OnCore for invoicing.
  • Startup and any applicable fees are invoiced. Correspondence occurs with sponsor to ensure a UA W9 and ACH bank details are provided for payment and remittance.

CLINICAL RESEARCH ACCOUNT START-UP BEST PRACTICE CHECKLIST

Study Maintenance

  • During the study, CT Finance maintains invoicing, communications with the study team, department, PI, and sponsor to ensure all revenue is received and posted against the expenses for a financial overview.
  • Quarterly meetings occur throughout the study and CT Finance is available for any financial needs.

CLINICAL RESEARCH ACCOUNT STUDY MAINTENANCE BEST PRACTICE CHECKLIST 

Study Closeout

  • Upon IRB acknowledgement of the study closure, the Regulatory Coordinator enters the closure date into OnCore CTMS (Clinical Trial Management System) and uploads a copy of the final IRB letter.
  • OnCore sends an automatic email to the Research Administration finance email (ctfinance@arizona.edu). 
  • Final study payments in the fully executed contract will provide timelines for the final receipt of invoices from the study site to the sponsor and timelines for the sponsor to send any final payments. 
  • Research Administration sends notification email to the Hospital, Professional, Pharmacy, and Medical Imaging teams within Banner Health Research Finance (BHRF)– all final invoices for research study services must be submitted to UA within 30 days to guarantee payment •
  • Study Coordinator and Department Business Office – all vendor invoices must be paid to close out the study account. All final invoices must be submitted to the sponsor for final payments in accordance with the contract. 
  • See Clinical Research Account Closeout Checklist for best practices below. 

Clinical Research Account Closeout Best Practice Checklist