NCI National Clinical Trials Network (NCTN) Program Guidelines

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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. Page 58 of 241
PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Statistics and Data Management Centers (SDMCs) 2.3.3 Resource Sharing Plans Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms if applicable, and GWAS Sharing Plan) are required for all key components of the NCTN Program. However, since it is expected that the Network Group SDMC will follow the Resource Sharing Plans of the associated Network Group Operations Center, the SDMC is required to follow these Resource Sharing Plans for all NCTN trials its supports. The Network Group Operations Center data sharing plan should comply with the NCTN Program Data Sharing Plan template as described in Part 4 - Appendices - Section VII for Network Group Operations Centers in these Guidelines. Requests for data from clinical trials, conducted under a binding collaborative agreement between NCI CTEP and a pharmaceutical/biotechnology company, that are not under DSMB monitoring but are not yet subject to the Data Sharing Policy (e.g., because the primary study analyses have not yet been published) must be in compliance with the terms of the binding collaborative agreement and must be approved by NCI/DCTD/CTEP (i.e., the Lead NCTN Program Director in conjunction with the NCI/DCTD/CTEP Regulatory Affairs Branch). Release of data may also be subject to the terms of any contracts the Network Group Operations Center has with other entities which cover any of the requested data. Biospecimen Sharing Policy: The Network Group Operations Center is required to follow the NCI/DCTD policy regarding review of requests for use of banked biospecimens collected in association with NCTN trials that it leads by CTEP’s Protocol Review Committee or an NCI/DCTDapproved NCTN Correlative Science Committee as described in Part 1 – Section IV.C.3. Network Group Operations Centers are also required to have a plan/policy in place to describe how information on its inventory of biospecimens will be made available to the public that is submitted to and approved by the Lead NCTN Program Director, Associate Director Cancer Diagnosis Program, and Program Director of the Tumor Banking Program for the Network Groups. This inventory should be consistent with standards established by the Network Tumor Banking Committee for the NCTN Program. The SDMC is required to follow and support these policies for the trials led by its associated Network Group Operations Center. 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 Genome Wide Association Studies (GWAS). The Network Group SDMC is required to follow and support these policies for the trials led by its associated Network Group Operations Center. 2.3.4 Education on the Protection of Human Subjects NIH policy requires education on the protection of human subject for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. This policy is available on the NIH website at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 2.3.5 Other Federal Regulations The NIH Public Access Policy ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. To help advance science and improve human health, the Policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication. More information about this policy or the submission process is available on the NIH Public Access Policy website at: http://publicaccess.nih.gov/. Information on other federal regulations (and their associated citations/URLs) that may be applicable to the SDMC’s activities is provided in Part 4: Appendices – Section IV.B. Page 59 of 241
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NCI National Clinical Trials Network (NCTN) Program Guidelines

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