NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network RT & Imaging
Core Services Centers
perform related to their own operations. The Centers should also have the capacity to provide
data to the Network Groups if needed for onsite auditing for their members for specific clinical
trials.
5.2 Radiotherapy and Imaging Core Services Centers
5.2.1 Scientific and Technical Expertise
The Network Radiotherapy & Imaging Core Services Centers should provide the scientific
expertise in Advanced Medical Imaging (including PET and MR), radiotherapy, and information
technology to provide appropriate quality assurance for data and image management to support
applicable NCTN trials as well as for other approved NCI-supported clinical trials (e.g., NCI early
phase clinical trials) evaluating advanced radiotherapy treatments and imaging
techniques/procedures. The PI(s)/PD(s) and Centers’ staff should also be able to provide
appropriate expertise to help Network Groups in hypothesis formulation and trial design during
the early stages of developing of trial proposals. The Centers should also provide expertise in
information technology (IT) to facilitate collection, qualification, analysis, archive, and transfer of
radiotherapy assessment and imaging data.
5.2.2 Credentialing of Institutions and Services
The Network Radiotherapy & Imaging Core Services Centers should have policies and procedures
in place to provide qualification and credentialing of institutions as needed for both delivery of
appropriate protocol-specified radiotherapy as well as performance of specific advanced imaging
technology.
5.3 Program for Collaborations and Participation in Collective Management
The Network Radiotherapy & Imaging Core Services Centers should have the capacity to provide Core
Services to NCTN trials that result from collaborations between the Network Groups and other NCIsupported
programs and investigators. The Network Radiotherapy & Imaging Core Services Centers
should also be able to develop collaborations with other NCI-sponsored programs and investigators
(e.g., SPOREs, Cancer Centers, R01/P01 investigators) to augment and enhance the core services
provided by the Centers for NCTN trials as well as to collaborate with other organizations providing
these types of services to enhance services and provide best practices and/or standards for selected
assessments of radiotherapy and advanced imaging techniques.
The Centers will also be responsible for providing similar services for collaborations with other NCIsupported
clinical trials programs (e.g., NCI early phase clinical trials) when directed by NCI as part of
the NCTN Program.
In addition, the Network Radiotherapy & Imaging Core Services Centers is also responsible for
participating in the collective management of the Network including participation in appropriate NCTN
Program activities and initiatives and through the NCTN Leadership Management Committee by making
recommendations to NCI for modifications to the Program as well as to standard NCTN common tools
and services.
5.4 Compliance with Federal Regulations for Clinical Research
The Network Radiotherapy & Imaging Core Services Centers awardee should have policies and
procedures for ensuring that any work performed is in compliance with federal regulations regarding
the protection of human subjects in clinical trials. In particular, policies and procedures related to
confidentiality, integrity, and security of patient data should be in compliance with the Health
Insurance Portability and Accountability Act (HIPAA). There should also be adequate safe-guards to
ensure the technical integrity of quality assurance programs in support of NCTN clinical trial research.
Policies and guidelines to be addressed include the following:
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