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 proposed
Imaging 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 Imaging Core Services Center
appear to be effective and efficient?
Does the proposed Imaging Core Services Center have the capacity to provide
appropriate core services support for NCTN collaborative trials with other NCIsponsored
investigators and programs (e.g., NCI/DCTD early phase clinical trials
programs)?
How well does it appear the proposed Imaging Core Services Center would provide
quality assurance for imaging-related activities in applicable NCTN trials, including site
and scanner qualification/calibration, review of imaging data for acceptability and
protocol compliance, and central analysis and evaluation of images?
Does the proposed Imaging Core Services Center provide appropriate standardized
and harmonized imaging processes and procedures that could be used by
investigators participating in applicable NCTN trials using the Center’s core services?
How well would the proposed Imaging Core Services Center be able to provide
assistance with development of trials that have imaging as either a research objective
or use imaging in support of other research goals for applicable NCTN trials?
How well does it appear that the proposed Imaging Core Services Center would be
able to evaluate and assimilate evolving imaging technologies into future trials as well
as to incorporate new commercial tools used for image processing and analysis as
they become available? How well would the proposed Imaging Core Services Center
be able to develop and maintain processes and procedures to conduct remote central
imaging reads with the required scientific expertise? Would the proposed Imaging
Core Services Center be able to provide appropriate procedures by which the priority
and needs of imaging support could be adjusted for specific trials, including providing
both “real-time” and “post-review” of images and providing expertise as to the best
approach for a particular trial?
Does the proposed Imaging Core Services Center have an appropriate plan to
incorporate a technical capacity to segregate access-limited collection for ongoing
clinical trials from open-access collection when they are conducted by the NCTN?
Page 176 of 241