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NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 1: Overview of <strong>NCTN</strong> <strong>Program</strong> Section IV – Terms/Conditions of Award – <strong>Network</strong> Group<br />

Integrated Translational Science Centers<br />

3. Specific Awardee Rights & Responsibilities - <strong>Network</strong> Group Integrated Translational Science Centers<br />

Throughout these Terms and Conditions of Award, “<strong>Network</strong> Group Integrated Translational Science<br />

Center” refers to the organizational structure which is composed of the key personnel (including the<br />

scientific and administrative leaders of the Center) responsible for implementing translational science<br />

studies to be incorporated into <strong>NCTN</strong> trials as well as appropriate pilot studies to enable collection of<br />

preliminary data for further research.<br />

3.1 Integrated Translational Science <strong>Program</strong><br />

3.1.1 Scientific Team Expertise/Leadership<br />

The <strong>Network</strong> Group Integrated Translational Science Center <strong>Trials</strong> Principal Investigator(s) should<br />

provide the needed scientific expertise for development and design of research strategies for<br />

incorporating translational science studies into associated <strong>NCTN</strong> trials of the supporting <strong>Network</strong><br />

Groups (i.e., <strong>Network</strong> Group Operations Center and the associated <strong>Network</strong> Group SDMCs). The<br />

Principal Investigator(s) and their associated staff should also be able to provide appropriate<br />

expertise to help <strong>Network</strong> Groups in hypothesis formulation and trial design during the early<br />

stages of development for trial proposals.<br />

3.1.2 Governance, Organizational Structure, & Facilities and Equipment<br />

Governance & Organization Structure: The <strong>Network</strong> Group Integrated Translational Science<br />

Center awardees are under the leadership of one or more Principal Investigators, who<br />

coordinate scientific activities conducted under this award in support of the translational science<br />

to be incorporated in associated <strong>Network</strong> Group(s)’ clinical trials. The Multiple Principal<br />

Investigator (PI) option is encouraged for these awards given the team science approach of the<br />

research effort. Information on the Multiple PI Option is available at<br />

http://grants.nih.gov/grants/multi_pi/index.htm. If this option is used, a “Contact PI” should be<br />

designated from among the multiple PIs. The Principal Investigator (or Contact Principal<br />

Investigator under the Multiple PI option) or designee is also responsible for all grant-related<br />

activities related to this award and for communication about these activities with the<br />

appropriate <strong>NCI</strong>/DCTD staff.<br />

<strong>Network</strong> Group Integrated Translational Science Center awardees are responsible for<br />

development and maintenance of a governance and organizational structure to incorporate<br />

appropriate integral and/or integrated translational science studies into clinical trials led by their<br />

associated <strong>Network</strong> Group(s). The organizational structure for the Integrated Translational<br />

Science Support for <strong>Network</strong> <strong>Trials</strong> award should include clear and appropriate staff roles and<br />

reporting responsibilities, especially with respect to the role and reporting responsibilities of any<br />

multiple PIs.<br />

The governance and organizational structure for the award, including the senior leadership<br />

team, should also include representatives from the associated <strong>Network</strong> Groups that support the<br />

award.<br />

Facilities and Equipment: The institutional facilities of the <strong>Network</strong> Group Integrated<br />

Translational Science Center Principal Investigator(s) should provide (in their physical plant and<br />

equipment) access to the necessary components for integrating translational science into the<br />

associated <strong>Network</strong> Group trials with respect to basic laboratory and investigator support.<br />

3.1.3 Quality Assurance and Onsite Auditing<br />

The <strong>Network</strong> Group Integrated Translational Science Center Principal Investigator(s) should have<br />

policies and procedures in place to assure quality assurance and control of any assays or other<br />

tests provided as part of pilot studies to obtain preliminary data. The Principal Investigator(s)<br />

Page 61 of 241

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