NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section III – General Management & Network Operating/Funding Principles
2.4 Adult Network Group Member Institutions/Sites Funding
NCI/DCTD funding given to an adult Network Group Operations Center for its member
institutions/sites which are not Lead Academic Participating Sites, CCOPs, or MB-CCOPs is provided to
these sites through purchase service agreements or subcontracts using an algorithm for “Basic
Intervention Per Case Management” funding as well as other funding “Per Case” categories as
specified in Part 4: Appendices – Section IV for patient enrollment to the entire portfolio of NCTN
trials that these member institutions/sites credit to the adult Network Group Operations Center.
These members will also be eligible for special program/initiative for “High-Performance” sites
administrated via the CTSU as described below.
2.5 Categories of “Per Case Management” Funding
The various categories of NCI/DCTD supported “per case management” funding are described below.
� Screening Per Case Management Funding: Funding to cover data management costs for patients
enrolled on a trial that require specific screening with informed consent as part of the trial (e.g.,
investigational molecular test of their tumor) and who do not subsequently undergo the study
treatment/intervention and/or randomization because of the screening results.
� Basic Intervention Per Case Management Funding: Funding to cover data management costs for
enrolled patients who undergo the study treatment/intervention and/or randomization. Basic
intervention funding is divided into therapeutic (treatment intervention or pilot studies) or
advanced imaging interventions. This base amount is set at the same level for all treatment trials;
however, the base amount for advanced imaging trials may be different. This funding category
also includes funding for average follow-up per case data management for an NCTN trial (i.e.,
separate payments for follow-up are not provided). Please note that the basic intervention per
case cost includes any screening performed on study (i.e., per case funding is provided for an
enrolled patient for either screening or intervention but not both). Likewise, intervention per case
management funding is provided at either the basic level or the high-performance level, but not
both – see the information on high-performance intervention per case management funding
below.
� Advanced Imaging Trial Per Case Management Funding: Funding to cover data management and
imaging costs for complex imaging used in advanced imaging trials (above the base intervention
per case amount described above) would be provided to all NCTN participating sites by the
Network Group Operations Center with a specialty focus in this area that leads these trials
(including providing the funding to other Network Group Operations Centers for their members
which participate in the trials) as these studies are expected to be limited in number relative to the
number of treatment trials.
� Biospecimen Collection Per Case Management Funding: Funding to cover biospecimen collection
and any associated management costs for patients enrolled on study who undergo the study
treatment/intervention and/or randomization for trials with required or optional biospecimen
collections – this category of funding would not be expected to be given in association with
screening per case funding except in unusual circumstances.
� Special Per Case Management Funding: Funding to cover additional data collection/management
costs for patients enrolled on study who undergo the study treatment/intervention and/or
randomization, usually for very complex trials and/or trials in rare disease areas or rare disease
subsets as well as any special ancillary study funding. This category of funding is approved by
NCI/DCTD on a trial by trial basis only.
� High-Performance Intervention Per Case Management Funding for Lead Academic Participating
Sites, CCOPs/MB-CCOPs and Member Institutions/Sites of the Pediatric Network Group: Funding
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