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
5. Specific Awardee Rights & Responsibilities - Network Radiotherapy and Imaging Core Services Centers
Throughout these Terms and Conditions of Award, “Network Group Radiotherapy and Imaging Core
Services Centers Center” refers to the organizational structure which is composed of the key personnel
(including the scientific and administrative leaders of the Centers) responsible for implementing support for
applicable NCTN trials related to quality assurance, credentialing, and image data management for
radiotherapy and imaging as well as other support functions.
5.1 General Features and Overview
5.1.1 Governance, Organizational Structure, Policies & Procedures, & Facilities and Equipment
Governance & Organizational Structure: The Network Radiotherapy & Imaging Core Services
Centers are under the leadership of one or more Principal Investigators, who coordinate all the
service support for NCTN trials and related activities as well as coordination with the Network
Groups. The Multiple Principal Investigator (PI) option is encouraged for the Network
Radiotherapy & Imaging Core Services Centers award(s) given the team science approach of the
research support effort. Information on the Multiple PI Option is available at
http://grants.nih.gov/grants/multi_pi/index.htm. If this option is used, a “Contact PI” should be
designated from among the multiple PIs. The Principal Investigator (or Contact Principal
Investigator under the Multiple PI option) or designee is also responsible for all grant-related
activities related to this award and for communication about these activities with the
appropriate NCI/DCTD staff.
Network Radiotherapy & Imaging Core Services Centers are responsible for development and
maintenance of a governance and organizational structure for coordinating NCTN support for
applicable NCTN trials led by any of the Network Groups. The governance structure should
clearly describe how activities of the Centers will be coordinated between each other and with
the Network Groups, including the Information Technology (IT) systems for data and image
transfer. To facilitate this coordination, the senior leadership team of each Center should
include representatives from the Network Groups. The organization structure should have clear
and appropriate staff roles and reporting responsibilities, especially with respect to the role and
reporting responsibilities of the multiple PIs.
Standard Operating Procedures: The Network Radiotherapy & Imaging Core Services Centers are
also responsible for the preparation and maintenance of Standard Operating Procedures (SOPs)
that cover all aspects of the Centers’ activities, including the process for prioritizing services
provided to the Network Groups for their clinical trials approved for conduct in the NCTN.
Facilities & Equipment: The Network Radiotherapy & Imaging Core Services Centers’ facilities
(i.e., their physical plant and equipment) should provide all the necessary components to
provide the applicable Core services to Network Group trials, especially with respect to
information technology. This includes the ability to collect, distribute, analyze, and store/archive
all appropriate imaging and radiotherapy treatment delivery data for applicable NCTN trials. The
Centers should ensure basic interoperability between the radiotherapy and imaging core service
components as well as with other key components of the NCTN, including electronic exchange of
digital planning data and images and web-based software tools to facilitate trial-specific digital
data review by Study Chairs. The Centers should also have basic interoperability with the
common data management system (CDMS) used by the Network Groups to collect clinical trial
data as well as the Regulatory Support System (RSS) and the Oncology Patient Enrollment
Network (OPEN) used by the Network Groups for support of patient enrollment.
5.1.2 Quality Assurance/Onsite Auditing
The Core Services Centers should have policies and procedures in place to assure quality
assurance and control of the data services provided for NCTN trials and any auditing the Centers
Page 71 of 241