A concept must meet all the criteria below for a Clinical Trial Working Group to approve it for development as a Big Ten CRC study:
 

• Big Ten CRC studies must be Phase II or earlier investigator-initiated studies with a strong likelihood of successfully accruing within the Big Ten CRC. The Big Ten CRC will not conduct Phase III industry-sponsored studies. The Steering Committee (SC) may approve exceptions to permit the Big Ten CRC to conduct investigator-initiated Phase III studies with a strong likelihood of successfully accruing within the Big Ten CRC given the accrual goals, the number of Big Ten CRC sites committed to participating in the studies, those sites’ feasibility assessments, and the compatibility of the studies with the research strengths of the Big Ten CRC. Sponsor Investigators seeking such exceptions should provide a written description to the SC justifying the granting of the exception based on the above considerations. The exception must be approved by a vote of two-thirds of SC members as documented by e-mails from SC members.
• The SC also may approve exceptions to permit the Big Ten CRC to conduct non-interventional investigator-initiated oncology studies, such as population science, quality of life, or cancer prevention studies. Such studies must have a strong likelihood of success within the Big Ten CRC given the accrual goals, the number of Big Ten CRC sites committed to participating in the studies, those sites’ feasibility assessments, and the compatibility of the studies with the research strengths of the Big Ten CRC. Before seeking SC approval, sponsor investigators seeking such exceptions should provide a written description to the SC justifying the granting of the exception based on the above considerations. The exception must be approved by a vote of two-thirds of SC members at a meeting or as documented by e-mails from SC members. If approved, such a study may be exempted from the requirements that it include a translational component and sample banking, at the discretion of the Steering Committee, if such requirements would not be relevant and/or appropriate for the study. The SC may refer such studies to an appropriate CTWG for review prior to considering the studies for approval
• A Big Ten CRC member institution employs the sponsor-investigator leading the study.
• Studies must include a translational component (see above exception for non-interventional studies subject to SC approval).
• At a minimum, studies will include baseline whole blood for PBMC, DNA/RNA, pre- and post-treatment serum and plasma for future use (see above exception for non-interventional studies subject to SC approval).
• The study involves mentorship of a junior researcher by a senior researcher with one serving as sponsor investigator and the other collaborating in ways that make significant contributions to the development and implementation of the study, and it is strongly encouraged that the junior and senior researchers be from different institutions.
• The study involves multi-disciplinary research and/or cross collaboration among Big Ten CRC institutions in the trial design whenever appropriate.
• The sponsor-investigator has identified potential funders.

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