NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – NCI/DCTD Responsibilities
� The Cancer Diagnosis Program with other NCI/DCTD staff may be involved in planning and
oversight of trials that require an investigational device exemption (IDE).
As previously stated, NCI/DCTD (including CTEP and CIP) uses a system of Letters of Intent (LOIs) as a
mechanism for developing rational strategies for investigational drug/agent development studies as
described in the Investigator Handbook (A Handbook for Clinical Investigators Conducting Therapeutic
Clinical Trials Supported by CTEP, DCTD, NCI) available at:
http://ctep.cancer.gov/investigatorResources/investigators_handbook.htm) which includes a full
description of the process for the clinical development of investigational agents and summary of the
responsibilities of investigators conducting these trials.
7. Compliance with Federal Regulatory Requirements Review
CTMB and RAB staff will review general policies and procedures periodically, as needed, and provide advice
regarding mechanisms established by the Network Groups to meet FDA regulatory requirements for studies
involving DCTD/CTEP-sponsored investigational agents and OHRP requirements for the protection of human
subjects.
8. Budget Levels for Per Case Management Funding & Budget Adjustments for the NCTN Program
Although the collective management team (i.e., NCTN Leadership Management Committee) composed of
the senior leadership from the NCTN key components and the NCI/DCTD recommend priorities for trials to
receive special per case management funding as well as other categories of “per case management”
funding as described in Part 1 – Section III.D.2. of these Guidelines, the final decision regarding funding for
the all NCTN awards, administrative supplements, and amounts selected for all “per case management”
funding, including “special per case management” funding and” biospecimen per case management”
funding for specific trials, rests with the NCI/DCTD. NCI/DCTD also sets the threshold levels for accrual for
“high-performance” sites for the NCTN Program (i.e., for Lead Academic Participating Sites, CCOPs/MB-
CCOPs, and pediatric institutions as well as other sites, depending on the availability of funding).
In addition, because of the integrated nature of the NCTN Program, applications from Network Group
Operations Centers may include budgets that request “per case management” funding for patients enrolled
on study from member institutions/sites that eventually receive a Network Lead Academic Participating Site
award based on a Type 1 new application (or potentially Type 2 competing applications in the future). In
order to adjust budgets appropriately, the Lead NCTN Program Director approves the final budgets for all
key components for the NCTN Program after consultation with the Associate Director, CTEP, and DCTD
Division Director, with final adjustments made to Network Group Operations Center budgets based on
which institutions/sites are awarded Network Lead Academic Participating Site awards and the projected
accrual across the Network for those institutions/sites.
9. Changes in Principal Investigator(s) for Any Key Component of the NCTN Program
The Lead NCTN Program Director must approve any proposed changes in the Principal Investigator (PI) for
any key component for the NCTN under the Cooperative Agreement. The institution’s business office
should forward the name of the proposed Principal Investigator in a memorandum to the Lead NCTN
Program Director requesting approval, with a copy to the NCI/DCTD Senior Program Specialist. The
curriculum vitae (CV) of the proposed Principal Investigator should be included as an attachment. The
memorandum should be countersigned by the current Principal Investigator (if available), the business
official who has responsibility to sign for the grant, and the proposed Principal Investigator.
10. Changes in Awardee Institution for Any Key Component of the NCTN Program
Only under exceptional circumstances will NCI permit transfer of a Cooperative Agreement from one
institution to another for Network Group Operations Centers and Network Group Statistics and Data
Management Centers as the recipient institution would not have undergone peer review. Any such request
should be approved in accordance with the Network Group’s Constitution and By-laws (e.g., approval
required by the Group’s oversight committee such as its Board of Governors or Executive Committee). The
responsible Lead NCTN Program Director and the NCI/DCTD Senior Program Specialist should be consulted
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