In 2012, the Office of Clinical and Translational Research (OCTR) instituted the OCTR policy that requires budget initiation meetings for all clinical trials before or at the time that the trial opens for accrual.
For all studies which required a Budget Workbook, a budget initiation meeting is scheduled when final IRB approval is issued. The meeting should occur prior to the enrollment of the first study participant, but may occur due to scheduling conflicts within two weeks of the opening of the study.
It is strongly recommended that the study coordinator, department administrator and/or billing coordinator, and the PI attend the budget initiation meeting. The purpose of the meeting is as follows:
- To review the Medicare Coverage Analysis prepared by OCTR personnel
- To review and confirm accuracy of procedure codes and time and effort (T&E) allocations in the Budget Workbook
- To amend the workbook with any new charges or changes to charges in the original Budget Workbook
- To review process for opening and maintaining Banner account
- To review payment procedures and research rates to be paid for UMG and JDH protocol induced charges
- To review the sponsor’s budget, if applicable, and clarify what may be charged to insurance and what is being paid by research
- To identify charges to be invoiced to a research sponsor
- To review coding procedures for RC and PIC medical services