NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group
Statistics and Data Management Centers (SDMCs)
Section IV.2.2.2 of these Guidelines. The SDMC responsibilities for onsite auditing include data
reporting as describe in Part 1. Section IV.B.2.2.2 as well as other support necessary for the
Network Group’s onsite auditing program to maintain compliance with the NCI-CTMB Guidelines
for Monitoring of Clinical Trials for Cooperative Groups, CCOP Research Bases, and the Cancer
Trials Support Unit (CTSU) at:
http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm.
2.3 Compliance with Federal Regulations for Clinical Research & Resource Sharing Plans
The Network Group Statistics and Data Management Center is responsible for assuring that it is in
compliance with all applicable federal regulations related to human subjects protection including the
confidentiality of patient data (e.g., the Health Insurance Portability and Accountability Act - HIPAA)
and ensuring the technical integrity and security of its data management systems. Policies and
guidelines to be addressed include the following:
2.3.1 IRB Review of Network Group SDMC
Institutional Review Board (IRB) review of the Network Group SDMC grant is required. The IRB
should determine and document that the Network Group SDMC has sufficient mechanisms in
place to ensure that data management and analysis and that Data and Safety Monitoring
systems are adequate, especially with respect to protecting 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.
2.3.2 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.
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. For cancer clinical research,
Network Group SDMCs supporting research in adult cancers can provide a rationale for not
including children because the majority of children with cancer in the United States are already
accessed by a Network Group devoted to pediatric cancer research, so that requiring inclusion of
children in the proposed adult study would be both difficult and unnecessary (since the research
question is already being addressed in children by the pediatric network) as well as potentially
counterproductive since fewer children would be available for the pediatric Network study if
other studies were required to recruit and include children.
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