NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget/Research Plan
Network Group Ops Center
Center thought its members would credit to the Network Group and thus might need to be
paid via the Network Group Operations Center’s capitation funding). This would include
both trials led by the Network Group as well as trials led by other Network Groups when
the accrual to those trials is credited to the Network Group. The NCI/DCTD will use this
information to adjust the final funding plan for the Network Group Operations Center
award based on which institutions will receive Lead Academic Participating Site awards.
This is essentially the “Accrual Input Table” described on page 236 of these Guidelines and
includes information on for the upcoming 5-year project period for the estimated number
of per patient accruals by category (basic intervention – therapeutic including pilot studies;
basic intervention –advanced imaging; screening; and biospecimen accrual counted as 1
collection by enrolled patient by trial) by member institution with corresponding NCI
institution code.
In addition, the Network Group Operations Center applicant will also be requested to
provide information on any travel funds it included in its budget for staff at member
institutions to attend regular Group meetings as “Just-in-Time” information so that
appropriate adjustments can be made in the funding plan for the Center if any of the
member institutions received Lead Academic Participating Site Awards. The Operations
Center should also provide the total number of patients it anticipates will be accrued to
trials it leads over the 5-year project period - i.e., accrual to trials it leads from all
institutions (CCOP and non-CCOP) that credit the Network Group with the accrual as well
as all institutions (CCOP and non-CCOP) that credit other Network Groups with the accrual.
Lastly, the Network Group Operations Center will also be requested to supply a list of
legacy trials that it wishes to transition to the new NCTN program. Only studies previously
supported under the NCI-sponsored Cooperative Group Clinical Trials Program funded by
the Division of Cancer Treatment and Diagnosis (DCTD), including primary advanced
imaging trials funded by the NCI Cancer Imaging Program, can be transitioned to the new
NCTN program. The Network Group Operations Center should specify all legacy trials that
do not have a status of “complete” in the NCI/DCTD enterprise system, both open and
closed, this it wishes to transition to the new program. The Network Group Operations
Center must specify which trials it anticipates will still be open to accrual at the time of
transition to the new program.
4.5 Data and Safety Monitoring Boards/Plans and Updates
The Network Group Operations Centers should have a Data and Safety and Monitoring
Board (Data Monitoring Committee) policy for randomized phase 2 and phase 3 NCTN trials
that complies with the “NCI NCTN Program Data and Safety Monitoring Board Policy” as
provided in Part 4 – Appendices – Section VIII of these Guidelines. In addition, the Network
Group Operations Center must have Data and Safety Monitoring plans for all other Network
Group studies (e.g., phase 1 and phase 2 studies, pilot studies, etc.) that comply with the NIH
policy for data and safety monitoring, posted on the NIH website at:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html, with additional description
at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
These policies/plans should be provided in the research application; however, prior to
funding of an award, all Data and Safety Monitoring Board (Data Monitoring Committee)
policies/plans (and any updates to these policies/plans) will also need to be reviewed and
approved by NCI/DCTD program staff prior to funding of an award to ensure that they are in
compliance with NCI/NIH regulations.
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