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
5.4.1 IRB Review of the Network Radiotherapy & Imaging Core Services Centers
Institutional Review Board (IRB) review of the Network Radiotherapy & Imaging Core Services
Centers grant is required. The IRB should determine and document that the Centers have
sufficient mechanisms in place to ensure appropriate data management and analysis of
radiotherapy and imaging data for quality assurance and credentialing with respect to ensuring
the protection of the confidentiality of patient data, given the nature of the research involved.
Information on this requirement for IRB review can be obtained on the OHRP website at:
http://www.hhs.gov/ohrp/policy/aplrev.html.
5.4.2 Inclusion of Women, Minorities, and Children in Clinical Research
NIH policy requires that women and members of minority groups and ethnic subgroups be
included in all NIH-supported biomedical and behavioral clinical research projects involving
human subjects at: http://grants.nih.gov/grants/funding/women_min/women_min.htm.
Compliance with this policy requires appropriate study designs, targets for total protocol accrual
with distribution by ethnic/racial categories and by sex/gender, as well as reporting of accrual by
ethnic/racial categories and by sex/gender. Since Network Groups conduct multiple phase 3
clinical trials, the amended NIH Policy on inclusion of women and minorities in research also
applies (see NIH Guide Notice on NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research – Amended October 2001 at:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html, with a complete copy of
the updated Guidelines available at:
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. A
description of plans to conduct analyses, as appropriate, by sex/gender and/or ethnic/racial
groups must be included in clinical trial protocols and the Network Group SDMC should ensure
that it has appropriate procedures in place to address this requirement. Cumulative subject
accrual and progress in conducting subset analyses must be reported to NIH in the annual
Progress Reports. Final analyses of sex/gender and ethnic/racial differences must be reported in
the required Final Progress Report or any future competitive renewal applications. The Network
Radiotherapy & Imaging Core Services Centers should ensure that, when appropriate, data
collected in support of NCTN trials by the Centers are incorporated into these reporting
requirements by the Network Group Operations Centers and associated Network Group
Statistics and Data Management Centers and have a policy in place to address this requirement.
NIH policy requires that children (i.e., individuals under 21 years of age) must be included in all
human subjects research, conducted or supported by the NIH, unless there are clear and
compelling reasons not to include them as described at:
http://grants.nih.gov/grants/funding/children/children.htm. Since the Network Radiotherapy &
Imaging Core Services Centers may support any applicable trial conducted under the NCTN
Program, the Centers will collect data to support clinical trial research in children via their
association with the pediatric Network Group Operations Center and associated SDMC.
5.4.3 Resource Sharing Plans
Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms if applicable,
and GWAS Sharing Plan) are expected for this FOA. Since it is expected that the Network
Radiotherapy and Imaging Core Services Centers will follow the Resource Sharing Plans of the
associated Network Groups' Operations Centers, the Network Radiotherapy and Imaging Core
Services Centers should submit a Resource Sharing Plan in its application that indicates that it
understands and is bound by these plans. An example of a Data Sharing Plan for Network Group
Operations Centers and associated Network Group Statistics and Data Management Centers for
the NCTN Program is provided in Part 4 - Appendices - Section VII in the Guidelines document for
the NCTN Program.
Network Group Operations Centers should also have plans in place regarding the following types
of resources, as appropriate for the clinical research it conducts: Sharing Model Organisms and
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