NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III.B.2.5 – Review Criteria
Network RT & Imaging Core Services Centers
Do implementation plans for the functional services provided by the Radiotherapy
Core Services Center appear that they are or will be implemented efficiently and in a
cost-effective manner? Do the standard operating procedures (SOPs) as well as tool
generation and evaluation by the proposed Radiotherapy Core Services Center appear
to be effective and efficient?
How well would the proposed Radiotherapy Core Services Center be able to provide
core services support for NCTN collaborative trials with other NCI-sponsored
investigators and programs (e.g., NCI/DCTD early phase clinical trials programs)?
Does the proposed Radiotherapy Core Services Center have the appropriate
infrastructure to provide appropriate uniform quality assurance (QA) procedures and
review for advanced radiotherapy trials, including dosimetry, that are developed by
the NCTN, including digital data capture, rapid analysis of volumetric treatment
planning data, and physical dose assurance capabilities?
Does the proposed Radiotherapy Core Services Center have the infrastructure and
ability to provide appropriate quality assurance support for the following elements
associated with multi-institutional clinical trials: radiation dose delivery by photons,
electron and protons for external beam radiotherapy and brachytherapy, use of
anthropomorphic phantoms for complex treatment delivery, archiving and remote
review of digital data including 3D and 4D images and RT objects?
Does the proposed Radiotherapy Core Services Center have the ability to provide
uniform credentialing of institutions that might participate in applicable NCTN trials
including those which use advanced radiotherapy treatment and assist Network
Group Operations Centers and their associated SDMCs in the development of
applicable trials with advanced radiotherapy, especially related to the need for
specialized quality assurance, target volume definitions, and data submission
requirements?
2.5.4 Scored Review Criteria – Criterion B. Imaging Core Services Center Program
(Note: The entire Criterion B will receive one individual score; the subcategories and
aspects listed will be assessed but not scored separately).
Does the plan for providing support services for imaging in clinical trials adequately
address the key functional needs for an Imaging Core Services Center, including
collection, distribution, analysis, and storage/archiving of all primary and adjunct
imaging delivery data for applicable NCTN trials?
Does the plan for providing support services for imaging in clinical trials include an
adequate approach, with appropriate policies and procedures, for how information
and services will be coordinated with the Radiotherapy Core Services Center?
Does the proposed Imaging Core Services Center provide continued maintenance of
robust physical hardware and information technology (IT) networks which ensure the
operational integrity and security of the core services? How well does it appear the
proposed Imaging Core Services Center could incorporate data from legacy trials of
potential Network Group Operations Centers and their associated Network Group
Statistics and Data Management Centers (SDMCs)?
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