Nov. 2, 2015:

What is the process for submitting a budget with the LOI to the funder?

The process begins with the Principal Investigator sending the proposed Letter of Intent (LOI) or protocol to Big Ten CRC Administrative Headquarters (Admin HQ). Each PI completes a brief questionnaire regarding the different elements that the budget should include. Once all necessary costs are added into the budget, Admin HQ will send the budget, along with the LOI or protocol to the funder for review. Admin HQ will negotiate the overall study budget directly with the funder, and the contracts department will then generate and negotiate a work order with each participating institution for payments that the sites will receive for participating in the trial.

What is the timeline for budget submission to a funder?

Once all necessary information is collected to develop the budget, Admin HQ seeks to complete the draft budget as quickly and efficiently as possible, within 10 business days or less. Since there are many different components to the budget, it might take some time to gather the necessary costs that need to be included.

How will participating institutions be compensated?

Admin HQ pays the start-up costs as soon as each institution is open to accrual, depending on the terms negotiated in each individual work order. For patient care costs, Admin HQ pays on a quarterly basis for all data that has been completely entered into the database in the previous quarter. Invoices are only necessary for annual renewal fees and any invoiceable items that are included in the work order, should there be any.

Is the budget submitted with the LOI the final budget?

No, this is considered a draft budget only. While Admin HQ seeks to include all costs into the draft budget, the budget will only be considered final once a study protocol is also considered final, to ensure all costs are captured as accurately as possible.

How do you determine site start-up and patient care costs?

When developing the clinical trial budgets, Admin HQ seeks to include costs that will compensate the sites as fairly as possible. Admin HQ tracks the costs from previous sites that have been negotiated with Hoosier Cancer Research Network, acknowledging that academic institutions are historically more expensive than community sites. Admin HQ takes the average of historical start-up, lab, effort, and other costs for both academic and community sites and includes those in the budget.

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium creates a unique team-research culture to drive science rapidly from ideas to treatment-changing paradigms. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 14 Big Ten institutions will provide over $200 million in direct financial support to almost 9,500 students for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s ice hockey and men’s and women’s lacrosse since 2013. For more information, visit www.bigten.org.