NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II – Budget/Research Plan
Network Group Ops Center
institutions/sites of the Network Groups (including the Network Lead Academic
Participating Sites) through DCP grants to the Network Groups as CCOP Research Bases.
If a Network Group in the NCTN Program (including the Canadian Collaborating Clinical
Trials Network) does not have a CCOP Research Base grant from DCP, “quality of life per
case management” funding for approved quality of life studies incorporated into NCTN
trials, which are led by other Network Groups, can be provided in the grant to the
Network Group Operations Center and/or the Canadian Collaboration Clinical Trials
Network by NCI/DCTD for participation in these studies by the member institutions/sites
of that Network Group which is not a CCOP Research Base.
Note: This exception is provided in order to ensure that approved quality of life studies
incorporated into NCTN trials are available to all members of the Network participating
in the NCTN trial. However, NCI/DCTD funding cannot be used, under any
circumstances, by a Network Group that does not have a CCOP Research Base grant to
develop quality of life studies or provide “quality of life per case management” for NCTN
trials that it leads as the NCI/NIH peer-review for such research activities is part of the
CCOP Research Base grants (i.e., it is not part of the NCI/NIH peer review of the NCTN
Program grants). In this situation, a Network Group that does not have a CCOP
Research Base grant may wish to collaborate with a Network Group which does have a
grant and can conduct the quality of life study.
1.5 Per Case Management Funding - Pediatric Network Group Operations Center Budget
(Restricted)
NCI/DCTD funding given to the pediatric Network Group Operations Center for its member
institutions/sites which are not CCOPs or MB-CCOPs is provided to these sites through
purchase service agreements or subcontracts using a special algorithm for either “Basic
intervention per case management” or “High-Performance per case management” funding
to a site as well as other funding “per case” categories as described above for adult Network
Group Operations Centers. The amounts to be used for budget requests for Type 1
applications are specified in Part 4: Appendices – Section IV for these Guidelines. The “High-
Performance per case management” funding is based on a different threshold for patient
accrual than that used for adult patient accrual given the smaller pediatric patient
population and more limited sources of private funding available for pediatric trials.
Guidelines for this threshold as a percentage of all interventional accrual (anticipated
therapeutic accrual and ½ of advanced imaging interventional accrual) is provided in the
same section.
1.6 Infrastructure Funding for Pediatric Network Group Member Institutions/Sites
The pediatric Network Group Operations Center may also provide additional infrastructure
support to “high-performance” pediatric sites based on the overall level of patient accrual at
those sites since they are not eligible for the adult Network Academic Participating Site
awards which provide this type of support to high-performance sites engaged in NCTN trials
that enroll adult cancer patients. Guidelines for this component of the pediatric Network
Group Operations Center budget are also provided in Part 4 – Appendices – Section IV of
these Guidelines. The pediatric Network Group Operations Center application may also
include a specification/algorithm with justification for distributing this infrastructure support
over a broader range of sites (i.e., distribute this funding over a wider group of sites and/or
at more than 1 set dollar level). This justification can be presented in the Budget Section of
the application.
1.7 Consortium Arrangements
Consortium arrangements and all other contractual arrangements, including all mechanisms
for providing per case management funding, must be formalized in writing in accordance
Page 107 of 241