NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Lead Academic Sites
4.1 Clinical Trial Program
4.1.1 Scientific Leadership & Contribution to NCTN Activities
Investigators at Lead Academic Participating Sites can demonstrate scientific leadership for
NCTN trials as well as support of and participation in other NCTN activities in a variety of way
through their membership in the Network Groups, including but not limited to the following:
� Offering eligible patients participation in NCTN studies and entering sufficient patients to
meet accrual targets;
� Participating in research design and protocol development for NCTN studies, including
collaborations between Network Groups and other NCI-supported programs and
investigators, particularly at their institution;
� Providing primary or co-authorship on Network Group publications;
� Participating in the Scientific and Administrative Committees of the Network Groups;
� Participating in major meetings of the Network Groups and in other meetings deemed
necessary for performance of the activities of Network Groups;
� Participating in NCTN activities and initiatives such as the NCI Scientific Steering Committees
and associated Task Forces and Working Groups and their activities such as NCI Clinical
Trials Planning Meetings; and
� Participating as members on the NCI Central IRBs.
4.1.2 Young Investigator and Leadership Mentoring/Training
The Lead Academic Participating Site should provide a mentorship program or activities to
involve young investigators at their institution in clinical trial research and to help train them
eventually take on senior leadership responsibilities for components of clinical trial research at
the institution.
4.1.3 Operational Management (Governance/Organization, Institutional Support, Affiliates)
Governance & Organizational Structure: The Network Lead Academic Participating Site is under
the leadership of the Site Principal Investigator(s), who coordinate(s) all the scientific and
administrative policies at the institution related to NCTN activities as well as coordination with
the Network Groups of which the Network Lead Academic Participating Site is a member. 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, the Lead Academic
Participating Site should designate a “Contact PI” 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.
The Lead Academic Participating Site is responsible for development and maintenance of a
governance and organizational structure to coordinate NCTN activities at the institution. The
organizational structure of the Lead Academic Participating Site should be established with clear
and appropriate staff roles and reporting responsibilities, especially with respect to the role and
reporting responsibilities of any multiple PIs.
It is anticipated that the Principal Investigator(s) will be well integrated into the scientific and
administrative senior leadership in clinical research at the Cancer Center or other academic
institution, thereby fostering collaboration between the Network and other clinical and
translational research investigators at the institution. In addition, the Principal Investigator(s)
should be well integrated into the scientific and clinical activities of each of Network Group to
which the institution belongs.
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