Procedural Change to Industry Sponsored Clinical Trials
February 2, 2017
As part of the Campaign to Improve Research Administration Effectiveness (CIRAE), the Office of Research and Research Accounting Services are reviewing processes and procedures to improve efficiency and reduce administrative burden. One area where redundancies were found was the process for submitting industry sponsored clinical trial proposals.
Effective March 1, 2017, this process will be changed to eliminate the requirement that a budget revision be submitted via Coeus when the clinical trial agreement is finalized. New industry sponsored clinical trials will now be set up in Banner by Research Accounting Services with a $1 budget at contract execution. When payments are received from the sponsor, the budget will be increased by the amount of funds received. Expenses for all clinical trials should be charged directly to the clinical trial fund when it is established.
Also effective March 1, 2017, the indirect costs on new and existing industry sponsored clinical trials will be automatically calculated using a 30% indirect cost rate. This calculation will occur once per day when expenditures are posted to the clinical trial fund. The indirect costs generated will be distributed to the dean’s org of the school or college. The administration of the school or college will be responsible to submit journal entries through the Journal Entry Workflow to distribute to departments and/or principal investigators based on their school or college’s procedures.
All clinical trials that were active prior to March 1, 2017, will receive the same treatment for cash received and expenditures posted after March 1, 2017. Research Accounting Services will be working to reconcile all cash posted directly to an industry sponsored clinical trial fund and migrating that to an accounts receivable account. Research Accounting Services will then make an entry to equate actual revenues on the award with the expenses posted to date and adjust the budget to the total amount of cash received to date. This will happen over the course of the next several months and will be handled by the RAS team. Department administrators with industry sponsored clinical trials will not have to do anything to convert to the new methodology.
Fund numbers will no longer be automatically issued during the initial COEUS routing of clinical trials. In lieu of referencing a fund number, the clinical trial agreements will now reference the protocol and principal investigator in the billing section to ensure funds received are credited to the correct account. Any request for an industry sponsored grant fund in advance of the execution of the clinical trial agreement will require the use of the Advanced Grant/Fund Request Form. We highly encourage the use of Advance Funds to ensure that expenses are charged timely to the award and to eliminate an unnecessary administrative work. Once fully executed, clinical trials will be set up in the same manner as all other new research awards. Clinical trials will follow the same process and timelines. Notification will be sent out to all effected areas once the setup is complete.
For questions regarding COEUS records for clinical trial agreements, please contact Meghan Van Horn at firstname.lastname@example.org. Questions related to advance accounts and clinical trial expenses should be directed to Evelyn Balabis at email@example.com.
We thank you for your continued support as we work together with the research community to improve our operations for the benefit of all.
Aleister J. Saunders, PhD
Senior Vice Provost for Research
Patricia J. Russo, MBA, CPA, CFE
Associate Vice President and Comptroller