NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Statistics and Data Management Centers (SDMCs) 2.4 Conflict of Interest Policy The Network Group Statistics and Data Management Center (SDMC) receiving NIH funding from a grant or cooperative agreement must be in compliance with all of the DHSS regulatory requirements for conflict of interest as outlined by NIH grants policy available at: http://grants.nih.gov/grants/policy/coi. This policy should ensure that there is no reasonable expectation that any investigator or staff member of the Network Group Statistics and Data Management Center involved in the design, conduct, or reporting of research will be biased by any conflict of interest (using the definition of investigator provided in the NIH grants policy). The SDMC policy should also be in compliance that of its affiliated Network Group Operations Center and with the general policies of the NCI and the NIH and with the NCI/DCTD/CTEP’s Conflict of Interest Policy for NCTN Phase 3 Clinical Trials found on the CTEP website at: http://ctep.cancer.gov/investigatorResources/default.htm#guidelines_policies. Page 60 of 241
PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Integrated Translational Science Centers 3. Specific Awardee Rights & Responsibilities - Network Group Integrated Translational Science Centers Throughout these Terms and Conditions of Award, “Network Group Integrated Translational Science Center” refers to the organizational structure which is composed of the key personnel (including the scientific and administrative leaders of the Center) responsible for implementing translational science studies to be incorporated into NCTN trials as well as appropriate pilot studies to enable collection of preliminary data for further research. 3.1 Integrated Translational Science Program 3.1.1 Scientific Team Expertise/Leadership The Network Group Integrated Translational Science Center Trials Principal Investigator(s) should provide the needed scientific expertise for development and design of research strategies for incorporating translational science studies into associated NCTN trials of the supporting Network Groups (i.e., Network Group Operations Center and the associated Network Group SDMCs). The Principal Investigator(s) and their associated staff should also be able to provide appropriate expertise to help Network Groups in hypothesis formulation and trial design during the early stages of development for trial proposals. 3.1.2 Governance, Organizational Structure, & Facilities and Equipment Governance & Organization Structure: The Network Group Integrated Translational Science Center awardees are under the leadership of one or more Principal Investigators, who coordinate scientific activities conducted under this award in support of the translational science to be incorporated in associated Network Group(s)’ clinical trials. The Multiple Principal Investigator (PI) option is encouraged for these awards given the team science approach of the research effort. Information on the Multiple PI Option is available at http://grants.nih.gov/grants/multi_pi/index.htm. If this option is used, a “Contact PI” should be designated from among the multiple PIs. The Principal Investigator (or Contact Principal Investigator under the Multiple PI option) or designee is also responsible for all grant-related activities related to this award and for communication about these activities with the appropriate NCI/DCTD staff. Network Group Integrated Translational Science Center awardees are responsible for development and maintenance of a governance and organizational structure to incorporate appropriate integral and/or integrated translational science studies into clinical trials led by their associated Network Group(s). The organizational structure for the Integrated Translational Science Support for Network Trials award should include clear and appropriate staff roles and reporting responsibilities, especially with respect to the role and reporting responsibilities of any multiple PIs. The governance and organizational structure for the award, including the senior leadership team, should also include representatives from the associated Network Groups that support the award. Facilities and Equipment: The institutional facilities of the Network Group Integrated Translational Science Center Principal Investigator(s) should provide (in their physical plant and equipment) access to the necessary components for integrating translational science into the associated Network Group trials with respect to basic laboratory and investigator support. 3.1.3 Quality Assurance and Onsite Auditing The Network Group Integrated Translational Science Center Principal Investigator(s) should have policies and procedures in place to assure quality assurance and control of any assays or other tests provided as part of pilot studies to obtain preliminary data. The Principal Investigator(s) Page 61 of 241
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NCI National Clinical Trials Network (NCTN) Program Guidelines

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