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 � Central Review and Correlative Science/Translational Research Committees: Committees should be established for conducting central review of the following major elements that affect the outcome of specific clinical or provide integral/integrated translational science associated with specific trials, including the following: � Integral or Integrated Correlative Science and/or Translational Research Committees: integral and/or integrated correlative science or translational science studies included in Network Group trials that address specific and important scientific hypotheses (or are integral to the primary study design) should be appropriately designed. Funding for these studies is not provided directly by the NCTN award but may be applied for via BIQSFP funding or through other sources, including administrative supplements from NCI/DCTD in certain cases for specific trials. � Pathology: Pathology review may be either by a committee within the Network Group or by an external reference panel. Prospective central verification of pathologic diagnosis may be required for specific trials in which it is integral or essential to the study design (i.e., cases in which known variability in the accuracy of histologic (or other) diagnosis is a potentially serious problem and in which pathology data is integral to appropriate study design and analysis). Funding for this central review, whether retrospective or prospective, is not provided by the NCTN award; however, it can be provided via BIQSFP funding or through other sources. � Radiation therapy: When relevant, central review (either concurrent or retrospective) of treatment-planning studies and compliance with protocol-specified doses for individual patients may be required and should be provided via coordination with the Network Radiotherapy and Imaging Core Services Centers. � Imaging support including diagnostic imaging: When relevant, central review (either prospective or retrospective) of imaging in NCTN trials may be required for evaluating response, establishing a diagnosis, and/or screening of patients and should be provided via coordination with the Network Radiotherapy and Imaging Core Services Centers. � Systemic Therapies (Chemotherapy, Immune Therapy or other Biologic Therapies): Central review may be performed by the Network Group study team for the trial to determine protocol compliance with dose administration and dosage modification. � Surgery: When relevant, adequacy of protocol-specified surgical procedures may be assessed (e.g., through review of operative notes, study-specific surgical forms, and pathology reports) by the Network Group study team for the trial. Onsite Auditing: Both the Network Group’s Operations Center and its associated Statistics and Data Management Center have responsibilities with respect to onsite auditing, and the Network Group’s SOPs should clearly delineate how these responsibilities are apportioned between the two Centers. In particular, Network Group’s Operations Center and its associated Statistics and Data Management Center should ensure that policies and procedures are in place to ensure that auditors participating in the onsite auditing program maintain confidentiality of all patient materials. The Network Information on the requirements for onsite auditing is provided by Guidelines from the Clinical Trials Monitoring Branch (CTMB) of NCI/DCTD/CTEP available at: http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm In order for the NCI to review the Network Group’s compliance with this requirement, each Network Group should provide annually an accounting of audit activities for all its members (see the Suggested Format for Reporting Onsite Auditing Activities in Part 4 – Appendices – Section II.A.9). CTMB also provides direct oversight of each Network Group’s auditing program. The purpose of an audit is to document the accuracy of data submitted to the Network Groups and to verify investigator compliance with protocol and regulatory requirements. In addition, the monitoring Page 48 of 241
PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers program provides an opportunity for the audit team to share with the staff at the Participating Site information concerning data quality, data management, and other aspects of quality assurance. The main objective of the audit program used by the Network Groups is to verify study data that could affect the interpretation of primary study endpoints. This is done through independent verification of study data with source documents. The Network Group Operations Center is responsible for oversight of all its members enrolling patients on NCTN studies that any member credits to the Network Group regardless of whether the Network Group is leading the trial or not. This includes ultimate oversight responsibility for CCOP and MB-CCOP members as well as Lead Academic Participating Sites and their affiliates when accrual for an enrollment in an NCTN trial is credited to the Network Group. The Network Operations Center should be aware of all affiliate sites participating in its trials under the aegis of an institutional member, CCOP, MB-CCOP, or Lead Academic Participating Site via its consolidated roster. Any members of a Network Group found not to be in compliance with the NCI Guidelines for Onsite Monitoring by the CTMB may be suspended from participating in any NCTN trials until a corrective action plan is submitted by the institution/site to the Network Group and is reviewed and approved by the Network Group and CTMB/CTEP. Additional information on quality assurance required of Network Groups with respect to trial data (including Operations Center responsibilities) and, in particular, procedures a Network Group is required to follow in the event any data irregularities are identified through the audit program or other quality control procedures are explained in detail in these Terms and Conditions of Award. Please see Part 1 - Section IV.D.4 of these Guidelines on Quality Assurance regarding reporting of audit issues and potential cases of scientific misconduct. 1.3.5 Financial Management The Network Group Operations Center is responsible for the financial management of the Center, including appropriate funding for all Center activities and provision of appropriate NCI/DCTD approved total cost for various categories of “per case management” funding to member institutions/sites through purchase service agreements or subcontracts as well as funding for other important scientific and administrative services needed for Center functions such as support for Study Chairs and Scientific Research Committee Chairs. In addition, the Network Group Operations Center should have policies and procedures in place with their member institutions/sites and related affiliates to ensure that “per case management” funding provided to these members by the Network Group is dispersed to the site in the total cost amount required by NCI/DCTD for the particular category of “per case management” funding (see Part 4 – Appendices – Section IV.A. for information on the anticipated total cost figures for the various categories of “per case management” funding anticipated for the initial project period under the NCTN Program. The Network Group Operations Office should also ensure that the funding is allocated at the site so that investigators and clinical research staff from different departments and disciplines at the institution that participate in NCTN trials are appropriately represented in the disbursement of funding. For example, the Principal Investigator(s) at an institution/member site, with which a Network Group has a subcontract or purchase service agreement (PSA) for work related to enrollment of patients and conduct of trials in the NCTN Program, may be a member of the Medical Oncology department at the institution, yet work under the subcontract or PSA is performed across multiple departments at the institution (e.g., surgery, pathology, radiation oncology). The Network Group should strive to ensure that all member institutions/sites distribute funding to all departments involved in support of NCTN clinical trials in a manner that reflects the work performed by the various members of the clinical research team. Page 49 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 />
program provides an opportunity for the audit team to share with the staff at the Participating<br />
Site information concerning data quality, data management, and other aspects of quality<br />
assurance. The main objective of the audit program used by the <strong>Network</strong> Groups is to verify<br />
study data that could affect the interpretation of primary study endpoints. This is done through<br />
independent verification of study data with source documents.<br />
The <strong>Network</strong> Group Operations Center is responsible for oversight of all its members enrolling<br />
patients on <strong>NCTN</strong> studies that any member credits to the <strong>Network</strong> Group regardless of whether<br />
the <strong>Network</strong> Group is leading the trial or not. This includes ultimate oversight responsibility for<br />
CCOP and MB-CCOP members as well as Lead Academic Participating Sites and their affiliates<br />
when accrual for an enrollment in an <strong>NCTN</strong> trial is credited to the <strong>Network</strong> Group. The <strong>Network</strong><br />
Operations Center should be aware of all affiliate sites participating in its trials under the aegis of<br />
an institutional member, CCOP, MB-CCOP, or Lead Academic Participating Site via its<br />
consolidated roster. Any members of a <strong>Network</strong> Group found not to be in compliance with the<br />
<strong>NCI</strong> <strong>Guidelines</strong> for Onsite Monitoring by the CTMB may be suspended from participating in any<br />
<strong>NCTN</strong> trials until a corrective action plan is submitted by the institution/site to the <strong>Network</strong><br />
Group and is reviewed and approved by the <strong>Network</strong> Group and CTMB/CTEP.<br />
Additional information on quality assurance required of <strong>Network</strong> Groups with respect to trial<br />
data (including Operations Center responsibilities) and, in particular, procedures a <strong>Network</strong><br />
Group is required to follow in the event any data irregularities are identified through the audit<br />
program or other quality control procedures are explained in detail in these Terms and<br />
Conditions of Award. Please see Part 1 - Section IV.D.4 of these <strong>Guidelines</strong> on Quality<br />
Assurance regarding reporting of audit issues and potential cases of scientific misconduct.<br />
1.3.5 Financial Management<br />
The <strong>Network</strong> Group Operations Center is responsible for the financial management of the<br />
Center, including appropriate funding for all Center activities and provision of appropriate<br />
<strong>NCI</strong>/DCTD approved total cost for various categories of “per case management” funding to<br />
member institutions/sites through purchase service agreements or subcontracts as well as<br />
funding for other important scientific and administrative services needed for Center functions<br />
such as support for Study Chairs and Scientific Research Committee Chairs.<br />
In addition, the <strong>Network</strong> Group Operations Center should have policies and procedures in place<br />
with their member institutions/sites and related affiliates to ensure that “per case management”<br />
funding provided to these members by the <strong>Network</strong> Group is dispersed to the site in the total<br />
cost amount required by <strong>NCI</strong>/DCTD for the particular category of “per case management”<br />
funding (see Part 4 – Appendices – Section IV.A. for information on the anticipated total cost<br />
figures for the various categories of “per case management” funding anticipated for the initial<br />
project period under the <strong>NCTN</strong> <strong>Program</strong>.<br />
The <strong>Network</strong> Group Operations Office should also ensure that the funding is allocated at the site<br />
so that investigators and clinical research staff from different departments and disciplines at the<br />
institution that participate in <strong>NCTN</strong> trials are appropriately represented in the disbursement of<br />
funding. For example, the Principal Investigator(s) at an institution/member site, with which a<br />
<strong>Network</strong> Group has a subcontract or purchase service agreement (PSA) for work related to<br />
enrollment of patients and conduct of trials in the <strong>NCTN</strong> <strong>Program</strong>, may be a member of the<br />
Medical Oncology department at the institution, yet work under the subcontract or PSA is<br />
performed across multiple departments at the institution (e.g., surgery, pathology, radiation<br />
oncology). The <strong>Network</strong> Group should strive to ensure that all member institutions/sites<br />
distribute funding to all departments involved in support of <strong>NCTN</strong> clinical trials in a manner that<br />
reflects the work performed by the various members of the clinical research team.<br />
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