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. The Big Ten CRC will not conduct Phase III industry-sponsored studies.
• A Big Ten CRC member institution employs the sponsor-investigator leading the study.
• Studies must include a translational component.
• At a minimum, studies will include baseline whole blood for PBMC, DNA/RNA, pre- and post-treatment serum and plasma for future use.
• The study involves mentorship of junior faculty by senior faculty.
• 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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