Oct. 1, 2015:

From a contracts perspective, what does a Big Ten institution need to do to open as a site in a Big Ten Cancer Research Consortium (BTCRC) study?

Each BTCRC institution signed a master site agreement, called an Institutional Participant Agreement (the “IPA”), when it joined the BTCRC. If an institution wants to participate as a site in a particular study, BTCRC Administrative Headquarters (AHQ) will provide a study-specific work order under the IPA. The work order will include a site budget and any study-specific terms required by the study funder or sponsor investigator’s institution (e.g., study-specific intellectual property terms).

How does the overall study funding contract work?

AHQ will work with the funder and sponsor investigator’s institution to negotiate a three-party Clinical Trial Agreement (CTA) to fund the study. The CTA will include the overall study budget and a statement of work outlining responsibilities for study conduct and management. The funder will pay the study funds to AHQ, and AHQ will subcontract with and pay the BTCRC sites, including the sponsor investigator’s site, using the work order process described above. Upon approval of a protocol, the sponsor investigator’s institution should prepare a preliminary coverage analysis to aid in building the overall study budget and to inform the creation of the budgets provided in the site work orders.

Do BTCRC studies require any other types of contracts?

BTCRC studies may require ancillary contracts for additional items such as lab analyses, statistical analyses, and drug distribution. AHQ will contract with the service providers for these items and will pay for them with funds it receives under the CTA.

How can a site help keep the contracting process moving?

Sites can help keep the contracting process moving by concurrent review of the work order language and the proposed study budget. Sites also can help keep the process moving by reviewing the work order and budget concurrently with IRB review rather than waiting for completion of IRB review.

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.