NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 1: Overview of NCTN Program Section III – General Management & Network Operating/Funding Principles If a Network Group in the NCTN Program (including the Canadian Collaborating Clinical Trials Network) does not have a CCOP Research Base grant from DCP, “Quality of Life Per Case Management” funding for DCP-approved quality of life studies incorporated into NCTN trials led by other Network Groups can be provided by the NCI/DCTD grant to the Network Group Operations Center and/or the Canadian Collaboration Clinical Trials Network for participation in these studies by the member institutions/sites of the Network Group which is not a CCOP Research Base. Note: This exception is provided in order to ensure that DCP-approved quality of life studies incorporated into NCTN trials are available to all members of the Network participating in the NCTN trial. However, NCI/DCTD funding cannot be used, under any circumstances, by a Network Group that does not have a CCOP Research Base grant to develop quality of life studies or provide “quality of life per case management” for NCTN trials that it leads as the NCI/NIH peer-review for such research activities is part of the CCOP Research Base grants (i.e., it is not part of the NCI/NIH peer review of the NCTN Program grants). If a Network Group that does not have a CCOP Research Base wishes to include such a “quality of life” sub-study in an NCTN treatment trial that it is leading, the Network Group may wish to collaborate with another Network Group which does have a CCOP Research Base grant to conduct the quality of life sub-study as part of a collaboration. � Non-NCI/DCTD Funding for Patient Enrollment: Other funding may be given for data collection/management and biospecimen collection for patients enrolled on NCTN trials which is not provided by NCI/DCTD under the Cooperative Agreements for the NCTN Program. This funding is usually provided by other NCI programs (e.g., “per case” funding for QOL data collection through grants funded by the Division of Cancer Prevention) or by industry collaborators. These funds are permitted as long as they cover costs not already paid for under the NCTN Program’s Cooperative Agreements. All data and biospecimens collected via these funding mechanisms are still subject to the complete Terms and Conditions of Awards under the Cooperative Agreements of the NCTN Program. 2.6 Notification of “Per Case Management” Funding for Trials Prior to activation of a trial by a Network Group Operations Center, the specific mix of per case funding provided by NCI/DCTD for data collection/management and/or biospecimen collection must be specified and approved by the Lead NCTN Program Director for all categories (Screening, Base Intervention, Special, Advanced Imaging, and Biospecimen Collection) except for “High-Performance” per case funding which is based on threshold accrual levels and not by trial. Additional funding provided by other NCI/NIH programs as well as by industry, charitable organizations, and other sources must also be specified. This type of funding also requires review and approval by NCI/DCTD in order to verify that the funding does not duplicate NCI/NIH funding. It is a fundamental requirement of the NCTN Program that the “per case management” funding, whether provided by NCI/DCTD, other NCI programs, or other entities (e.g., industry collaborators), for a specific trial MUST be provided to ALL qualified institutions/sites participating in that trial. It is understood that qualified institutions/sites would need to meet general program requirements (e.g., be a member in good standing in the NCTN Program, meet protocol-specific requirements related to safe delivery of the protocol intervention) to be able to enroll patients and receive funding. Funding cannot be restricted based on membership in a particular Network Group. To ensure transparency and fairness across the Network, all payments associated with an NCTN trial will be required to be listed for each NCTN trial according to the categories described above on the member side of the Cancer Trials Support Unit (CTSU) website. 3. Program Income for Key Components of the NCTN Program Under the Cooperative Agreement grants awarded for all key components of the NCTN Program, awardees are allowed to accept funds from non-governmental sources to support NCTN research that is not supported in part or in full by the NCI (e.g., additional per case management funding supplementing the Page 30 of 241
PART 1: Overview of NCTN Program Section III – General Management & Network Operating/Funding Principles NCI/DCTD basic intervention per case funding, support for correlative science studies associated with trials conducted under the NCTN Program). These funds are considered “Program Income” and must be reported under the Terms and Conditions of Award for the key components of the NCTN Program as outlined in Part 1 - Section IV.A.2. of these Guidelines unless they are exempted under the NIH grant policy for program income available at: http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch8.htm#_Program_Income. These funds are considered a valuable resource to help further the clinical research of the entire Program. Nevertheless, the Cooperative Agreements for the NCTN Program always define the operational principles under which the awardees must function to ensure the independence of the research conducted regardless of whether program income is or is not available for specific clinical trials conducted by the NCTN. Page 31 of 241
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NCI National Clinical Trials Network (NCTN) Program Guidelines

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