Aug. 1, 2014:

From a contracts perspective, what does a Big Ten institution need to do to open as a site in a 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, the 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?

The AHQ will work with the funder and sponsor investigator’s institution to negotiate a three-party Clinical Trial Agreement 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 the AHQ and the 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.

Will the studies require any other types of contracts?

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 Clinical Trial Agreement.

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 student-athletes’ lives and emphasize the values of integrity, fairness and competitiveness. The broad-based athletic programs of the 12 Big Ten institutions provide in excess of $141 million in direct financial aid to more than 8,200 student-athletes playing on more than 300 teams in 43 different sports. The Big Ten sponsors 26 official conference sports, 13 for men and 13 for women, and will add men’s and women’s lacrosse as the 27th and 28th official sports for the 2014-15 academic year. For more information, visit www.bigten.org.