Penn Medicine Clinical Research

Closures

After enrollment is closed, all follow-up data has been collected, utilization of subject PHI is no longer required, and the final data analysis is complete, the study is considered to be in the Closeout Phase. During this phase, data is prepared for final analysis, regulatory and reviewing bodies are notified of study closure, investigational product inventory is reconciled, and final reports are submitted. Below is a list of places

IRB

It is the PI responsibility and expectation to closeout all IRB protocol. Additional information from the IRB and their process can be found here. 

Research Billing Application (RBA)/PennChart

Your Business Administrator must log into the RBA and initiate the study close out process. Once the request is submitted in the RBA. A Clinical Research Finance representative will complete the closeout request in PennChart. 

Penn Clinical Research Management System (PennCRMS)

A study team member with access to PennCRMS must log into the system and update the study status to closed. Tipsheet on updating study status.  All studies should have a final completed status and date.

Residual Balance Transfers

Fixed price contract awards are awards in which an agreed upon, set price is determined for the project to be completed. When there is any unspent balance left on the account, the request will be made to OCR to transfer the balance to the designated accounts. Residual Balance Transfers require the completion of the Residual Balance Transfer Request Form regardless of the residual balance amount. To find the form navigate to Forms, Tools, Templates library, search Residual Balance Transfer Request Form. View the related PSOM policy on the ORSS website. 

Current Process

  • Department/Study Team will review the account to ensure that all sponsored funds have been received and all award requirements have been met.
  • Department/Study Team will confirm a final figure with OCR that indicates all expenditures have been posted to the fund, all effort that has been charged to the project is in line with the work performed, and that the expenses are allocable and allowable.
  • Once the final unexpended balance is determined, Department will calculate the amounts of direct and indirect costs based on the agreed upon rate.
  • The Department/PI at the time of the closeout; will get the total amount of direct costs of the remaining balance. The indirect costs portion of the balance will be transferred to the school-specific designated fund.
  • The PI, Department Chair and Business Administrator will complete, sign and submit the Residual Balance Transfer Request Form to OCR (psom-ocrfin@pobox.upenn.edu).