NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – General Terms/Conditions of Award for All NCTN Components
IV. Terms & Conditions of Award for Cooperative Agreements for NCTN Program Key Components
A. General Terms and Conditions of Award for All Key Components of the NCTN Program
The administrative and funding instrument used for all the key components of the NCI National Clinical Trials
Network (NCTN) Program is a Cooperative Agreement (U10 or U24 as outlined in the table in Part 2 – Section
1.A. of these Guidelines).
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of
Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services
(DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local
Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an
"assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and
otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime
responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be
shared among the awardees and the NIH as defined below.
1. General Programmatic Responsibilities
The awardees’ programmatic responsibilities for the conduct of the research supported under the
Cooperative Agreement for each of the key components of the NCTN Program are described in the
documents listed below and any subsequent modifications to these documents:
� NCI National Clinical Trials Network (NCTN) Program Guidelines (i.e., “these Guidelines”)
http://ctep.cancer.gov/investigatorResources/default.htm#guidelines_policies
� NCI/CTEP Investigators Handbook (Manual for Participants in Clinical Trials of Investigational
Agents Sponsored by the Division of Cancer Treatment and Diagnosis, NCI)
http://ctep.cancer.gov/handbook/index.html
� Guidelines for Monitoring of Clinical Trials for Cooperative (i.e., Network) Groups, CCOP
Research Bases, and the Cancer Trials Support Unit (CTSU)
http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm
Specific portions of these documents, as enumerated in the Funding Opportunity Announcement for each
of the key components of the NCTN Program (as well as in specific sections of the NCI NCTN Program
Guidelines), are incorporated by reference as program-specific Terms and Conditions of Award.
2. Program Director(s)/Principal Investigator(s) Primary Responsibility & Program Income Reporting
The PD(s)/PI(s) will have the primary responsibility for:
� Development of an overall research strategy for the development of clinical trials for the NCTN
Program as well as all key components related to the conduct of approved clinical trials.
� Awardees will retain custody of and have primary rights to the data and software developed under
these awards, subject to Government rights of access consistent with current DHHS, PHS, NIH, and
NCI policies and within the limits of any accepted binding NCI/NIH collaborative agreements with
biotechnology and pharmaceutical partners and as governed by NCI-approved Data Sharing Plans
and NCI-approved review for use of biospecimens collected in association with NCTN trials.
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