Facilitate Clinical Research Study Budget Plan

It is important to ensure that the investigator has sufficient funds to conduct the proposed clinical research study. Clinical Trial Financial Management (CTFM) will be notified of all new studies requiring a budget once Section 1.02 (Budget Industry) has been submitted in SIFTER (Study Intake Form to Expedite Research). SIFTER is the intake module for all new industry or non-industry sponsored studies that have hospital/professional billable research services (including through the CHPS program), which require a budget and invoicing by CTFM, as these studies will need to be built and maintained in OnCore Clinical Trial Management System.

Upon receiving a request for a new OnCore study build from SIFTER, the OnCore Support Team (OST) will begin creating the study's protocol and calendar. Once complete, the OnCore Specialist will advise the CTFM Budget Analyst that work on the budget can begin. At any point during the process of building the protocol, calendar and budget, it may be necessary to collaborate with the study team to ensure completeness and accuracy of all elements of the OnCore build. This could include preliminary review of the calendar structure and/or the budget draft by the study team before it is negotiated with the sponsor. Contact your Budget Analyst to track progress with budget negotiations.

• For industry-sponsored studies, CTFM will negotiate the budget with the sponsor.
• For federally funded and foundation-supported studies, CTFM is available to work with the Research Business Administrator (RBA) to draft a proposed budget when there are patient care related costs.
• New pricing requests can now be submitted within SIFTER.
• If you will be using research services provided by the Center for Human Phenomic Science (CHPS), please make sure that you select "yes" to the CHPS question in the IRB submission. By submitting "yes" in IRB, a link to eCHPS will be created for the study team to complete the eCHPS resource requests sections. The CHPS resource requests must be completely filled out in order for the CHPS services to be added to the research budget. Any delays in submitting the resource request in eCHPS may result in a delay in the budget.
• Beginning FY22, all new studies or amendments approved by CHPS with study protocol specific training will be charged an hourly fee per CHPS staff completing each required training. This includes but is not limited to in person and webinar training, manual reviews with required signoff, demonstration of skills (i.e. DXA scan samples), and skill certification. Please make sure your budgets include funds for this activity. In addition, please note that an upcoming revised eCHPS application will have a section to indicate training needs for all Cores.

After the budget and contract are fully executed, the Primary study coordinator will participate in the review and signoff of both the protocol and calendar/budget in OnCore, while the Principal Investigator will only need to participate in the review and signoff on the calendar/budget. In order for a study to be considered fully live in OnCore, it must have a protocol status of Open to Accrual and a Released calendar/ budget.

For more information regarding eSIFTER and OnCore Financials visit OnCore Study Start Up. Additionally, OnCore training materials associated with the processes described above are available to review.