NCI National Clinical Trials Network (NCTN) Program Guidelines
NCI National Clinical Trials Network (NCTN) Program Guidelines NCI National Clinical Trials Network (NCTN) Program Guidelines
PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers Any separate, non-NCI/DCTD funding (i.e., funding not provided under the Cooperative Agreements of the NCTN Program) dispensed by a Network Group to cover costs associated with patient enrollment on NCTN trials that it leads must be provided to all qualified institutions/sites that participate in its NCTN trials regardless of which Network Group the enrolling institution belongs to and/or credits with the patient accrual. This principle is considered an essential feature of the NCTN Program and the Terms and Conditions of Award as it is fundamental to ensure fairness for work performed across the Network. 1.4 Program for Collaborations and Participation in Collective Management The Network Group Operations Center is responsible for developing collaborations with other Network Groups as well as other NCI-sponsored programs and investigators (e.g., SPOREs, Cancer Centers, R01/P01 investigators) to augment and enhance the clinical research strategy and research productivity of its portfolio of clinical trials conducted in the NCTN. In addition, the Network Group Operations Center is also responsible for participating in the collective management of the Network including participation in appropriate NCTN Program activities and initiatives (e.g., NCI Scientific Steering Committees, NCI CIRB, etc.) 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. Each Network Group Operations Center is required to have policies to encourage other Network Groups to name co-principal investigators for studies that the Center leads (in disease areas that other Network Groups have scientific research goals and/or scientific research committees) in order to augment accrual via collaboration on its NCTN trials. 1.5 Compliance with Federal Regulations for Clinical Research & Resource Sharing Plans The Network Group Operations Center is responsible for assuring that the Network Group and its member sites are in compliance with all applicable federal regulations concerning the conduct of human subjects research. Policies and guidelines to be addressed include the following: 1.5.1 Office for Human Research Protection (OHRP) Assurances The Network Group Operations Center must assure that each member (this includes all affiliates or participating sites enrolling patients under any of the membership categories for the Network Group) has a current, approved Federalwide Assurance (FWA), on file with OHRP. Information on assurances is available on the OHRP website at: http://www.hhs.gov/ohrp/. In addition, federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. 1.5.2 IRB Review of NCTN Trials by Member Institutions/Sites The Network Group Operations Center must assure that each protocol for an NCTN trial that one of its member institutions/sites credits to the Network Group is reviewed and approved by the appropriate Institutional Review Board (IRB) of the Network Group member prior to patient entry via the Regulatory Support Services (RSS) of the CTSU, and assure that each protocol is reviewed annually by the IRB so long as the protocol is active (it is anticipated that the adult or pediatric NCI CIRB will be the IRB of record in most cases). The Network Group must ensure that each member site of the Group forwards its regulatory documents to RSS, otherwise the site will not be allowed to enroll patients on NCTN trials. 1.5.3 Assurance of Appropriate Informed Consent by Member Institutions/Sites The Network Group Operations Center must have procedures in place to ensure that each member institution/site is trained and understands the policies and procedures relevant to ensuring that patients are enrolled on studies with appropriate informed consent per NCI/NIH policy and federal regulations. The template for the NCI informed consent document must be Page 50 of 241
PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers used for all NCTN trials, with appropriate modifications as approved by NCI/DCTD for specific trials during the protocol development and review process. Information on the NCI informed consent templates is available at: http://cancer.gov/clinicaltrials/patientsafety/simplification-ofinformed-consent-docs/page3. 1.5.4 IRB Review of the Network Group Operations Center Institutional Review Board (IRB) review of the Network Group Operations Center grant is required. The IRB should determine and document that the Network Group Operations Center has sufficient mechanisms in place to ensure that (1) oversight of data management and analysis by the associated Network Group Statistics and Data Management Center and Data and Safety Monitoring systems are adequate, given the nature of the research involved; (2) sample protocols and informed consent documents are developed and distributed to each member institution/site participating in a trial; (3) each member institution/site holds or is covered under an applicable OHRP-approved Federalwide Assurance (FWA); (4) each protocol is reviewed and approved by the IRB covering the member institution/site prior to the enrollment of subjects; (5) any substantive modification by the institutional member/site of sample consent information related to risks or alternative procedures is appropriately justified; and (6) informed consent is obtained from each subject in compliance with DHHS regulations. Information on this requirement for IRB review can be obtained on the OHRP website at: http://www.hhs.gov/ohrp/policy/aplrev.html. 1.5.5 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. Cumulative subject accrual and progress in conducting subset analyses must be reported to NIH in the annual Progress Reports. Note: A Network Group Operations Center should report this data for all patients enrolled on studies it leads regardless of whether it is credited with the patient enrollment or not and this data should be reported in the Network Group Operations Center 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 Groups conducting 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 Page 51 of 241
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PART 1: Overview of <strong>NCTN</strong> <strong>Program</strong> Section IV – Terms/Conditions of Award – <strong>Network</strong> Group Ops Centers<br />
used for all <strong>NCTN</strong> trials, with appropriate modifications as approved by <strong>NCI</strong>/DCTD for specific<br />
trials during the protocol development and review process. Information on the <strong>NCI</strong> informed<br />
consent templates is available at: http://cancer.gov/clinicaltrials/patientsafety/simplification-ofinformed-consent-docs/page3.<br />
1.5.4 IRB Review of the <strong>Network</strong> Group Operations Center<br />
Institutional Review Board (IRB) review of the <strong>Network</strong> Group Operations Center grant is<br />
required. The IRB should determine and document that the <strong>Network</strong> Group Operations Center<br />
has sufficient mechanisms in place to ensure that (1) oversight of data management and analysis<br />
by the associated <strong>Network</strong> Group Statistics and Data Management Center and Data and Safety<br />
Monitoring systems are adequate, given the nature of the research involved; (2) sample<br />
protocols and informed consent documents are developed and distributed to each member<br />
institution/site participating in a trial; (3) each member institution/site holds or is covered under<br />
an applicable OHRP-approved Federalwide Assurance (FWA); (4) each protocol is reviewed and<br />
approved by the IRB covering the member institution/site prior to the enrollment of subjects; (5)<br />
any substantive modification by the institutional member/site of sample consent information<br />
related to risks or alternative procedures is appropriately justified; and (6) informed consent is<br />
obtained from each subject in compliance with DHHS regulations. Information on this<br />
requirement for IRB review can be obtained on the OHRP website at:<br />
http://www.hhs.gov/ohrp/policy/aplrev.html.<br />
1.5.5 Inclusion of Women, Minorities, and Children in <strong>Clinical</strong> Research<br />
NIH policy requires that women and members of minority groups and ethnic subgroups be<br />
included in all NIH-supported biomedical and behavioral clinical research projects involving<br />
human subjects at: http://grants.nih.gov/grants/funding/women_min/women_min.htm.<br />
Compliance with this policy requires appropriate study designs, targets for total protocol accrual<br />
with distribution by ethnic/racial categories and by sex/gender, as well as reporting of accrual by<br />
ethnic/racial categories and by sex/gender. Since <strong>Network</strong> Groups conduct multiple phase 3<br />
clinical trials, the amended NIH Policy on inclusion of women and minorities in research also<br />
applies (see NIH Guide Notice on NIH <strong>Guidelines</strong> on the Inclusion of Women and Minorities as<br />
Subjects in <strong>Clinical</strong> Research – Amended October 2001 at:<br />
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html, with a complete copy of<br />
the updated <strong>Guidelines</strong> available at:<br />
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. A<br />
description of plans to conduct analyses, as appropriate, by sex/gender and/or ethnic/racial<br />
groups must be included in clinical trial protocols. Cumulative subject accrual and progress in<br />
conducting subset analyses must be reported to NIH in the annual Progress Reports.<br />
Note: A <strong>Network</strong> Group Operations Center should report this data for all patients enrolled on<br />
studies it leads regardless of whether it is credited with the patient enrollment or not and this<br />
data should be reported in the <strong>Network</strong> Group Operations Center annual progress reports. Final<br />
analyses of sex/gender and ethnic/racial differences must be reported in the required Final<br />
Progress Report or any future competitive renewal applications.<br />
NIH policy requires that children (i.e., individuals under 21 years of age) must be included in all<br />
human subjects research, conducted or supported by the NIH, unless there are clear and<br />
compelling reasons not to include them as described at:<br />
http://grants.nih.gov/grants/funding/children/children.htm. For cancer clinical research,<br />
<strong>Network</strong> Groups conducting research in adult cancers can provide a rationale for not including<br />
children because the majority of children with cancer in the United States are already accessed<br />
by a <strong>Network</strong> Group devoted to pediatric cancer research, so that requiring inclusion of children<br />
in the proposed adult study would be both difficult and unnecessary (since the research question<br />
is already being addressed in children by the pediatric network) as well as potentially<br />
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