NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – NCI/DCTD Responsibilities
of the NCTN Program as these Co-Program Directors have major responsibilities in assisting the Lead
NCTN Program Director for the scientific and programmatic stewardship of the awards for particular
key components of the NCTN Program.
Each Network Group and key component will also have a staff physician, statistician, and/or other
professional staff member from NCI/DCTD assigned to them who acts as liaison for scientific and
administrative matters. These NCI/DCTD liaison (also referred to as a Project Scientist) serves as the
primary contact for scientific inquiries, including information concerning the content of specific
protocols, LOI, or Concept reviews, and feedback on general scientific direction of the Network Group
or key component. On occasion, the Lead NCTN Program Director and Co-Program Directors may also
serve as Project Scientists.
The Project Scientist monitors the Network Group's or other key component’s progress, attend their
meetings, and is responsible for understanding the Network Group's or key component’s repertoire of
studies and scientific activities, including areas of special interest, expertise, and unique resources. The
Project Scientist is also responsible for providing the Lead NCTN Program Director with ongoing
assessments of the key component’s activity from a scientific and administrative perspective, including
general information on its budget. Primary responsibility for the budgets of Network Groups and all
key components of the NCTN Program, however, resides with the Lead NCTN Program Director who is
assisted by the NCI/DCTD Senior Program Specialist. (See Parts 2 and 3 of these Guidelines for
information on budgetary issues for the key components of the NCTN related to new applications as
well as non-competing continuing applications.)
The NCI/DCTD Senior Program Specialist may be delegated by the Lead NCTN Program Director to
request and receive budgetary and administrative materials from the Network Groups/key components
on either an ad hoc or routine basis. The NCI/DCTD Senior Program Specialist will frequently perform
liaison activities concerning budgetary and administrative matters on behalf of the responsible NCI
Program Director, interfacing primarily with the primary Administrators for the Network Groups/key
components.
2.3 NCI/DCTD Attendance at Meetings of the Key Components of the NCTN Program
NCI/DCTD Project Scientists and other NCI staff, as designated by the NCTN Lead Program Director, will
attend the regular Network Group meetings and core scientific Network Group meetings as well as
those of other key components of the NCTN Program, as appropriate. As part of their liaison
responsibilities, Project Scientists, when available, will attend other Network Group and key
component scientific meetings and may also attend Network Group and other key component
Executive Committee meetings.
2.4 Coordination of Resources to Enhance Accrual/Completion of NCTN Trials
NCI/DCTD staff will take an active role in promoting the timely completion of important studies, for
example, by encouraging and facilitating collaboration among the Network Groups and collaborations
with other NCI-supported programs and investigators when appropriate or by assisting in the
mobilization of other available and required resources to enhance accrual to and completion of NCTN
trials.
3. Study/Trial Proposal Review & Protocol Development and Review Process
The NCI/DCTD study proposal, protocol development, and review processes are described in detail 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). This Handbook describes the
processes for Network Groups to submit trial proposals for treatment and advanced imaging clinical trials,
information related to the specific forms to be used for study proposal submissions, and description of the
review or evaluation/prioritization processes used to approve study proposals for further development as
clinical trials to be conducted by the NCTN.
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