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NATIONAL CANCER INSTITUTENATIONAL CLINICAL TRIALS NETWORKPROGRAM GUIDELINESDIVISION OF CANCER TREATMENT AND DIAGNOSISNATIONAL CANCER INSTITUTENATIONAL INSTITUTES OF HEALTHDecember 15, 2012Version 1.1This is an Update to Version 1.0 which was dated July 23, 2012.Please see pages 239-241 for a summary of the updates.Page 1 of 241
NCTN Program GuidelinesTable of ContentsPART 1: OVERVIEW OF THE NCTN PROGRAM . 14I. INTRODUCTION . 14A. Purpose and Content of Guidelines . 14B. Background, Overview, and Purpose of the NCTN Program. 14C. Overall Goal of the NCTN Program . 15D. Anticipated Organization of Key Components of the NCTN Program . 151.2.3.4.5.6.7.Network Group Operations Centers.16Network Group Statistics and Data Management Centers .16Network Group Integrated Translational Science Centers .17Network Lead Academic Participating Sites .17Network Radiotherapy and Imaging Core Services Centers .17Canadian Collaborating Clinical Trials Network .17Interactions with Other NCI-supported Programs .177.1 NCI Clinical Trials Tumor Banks. 177.2 NCI Community Clinical Oncology Programs (CCOPs) & Minority-Based CCOPs (MB-CCOPs). 187.3 NCI Cancer Trials Support Unit (CTSU).187.4 NCI Central Institutional Review Boards (CIRBs). 197.5 NCI Advisory & Scientific Committees .197.5.1 NCI Clinical Trials and Translational Research Advisory Committee (CTAC) .207.5.2 NCI Scientific Steering Committees (SSCs) . 207.5.3 NCI Clinical and Translational Research Operations Committee (CTROC) .20II. GOALS OF NCTN RESEARCH . 22A. Clinical Treatment Trials & Advanced Imaging Trials. 22B. Ancillary Studies . 22C. Cancer Control, Symptom Management, Prevention, and Quality of Life Studies . 22D. Collaborations Among Network Group and with Other Organizations on Clinical Trials . 23E. NCTN Clinical Trials Originating from Outside the Network Groups . 23F. Conduct of NCTN Clinical Research . 23III. GENERAL MANAGEMENT & NETWORK OPERATING AND FUNDING PRINCIPLES . 24A. General Management . 24B. NCTN Leadership Management Committee . 24C. Network Operating Principles . 251.2.3.4.Access to NCTN Trials & Crediting for Patients Accrual to Trials .25Submission of Data and Biospecimens for NCTN Trials .25Use of the NCI Central Institutional Review Board .25Trial Proposals Originating From Outside the Network Groups .26Page 2 of 241
NCTN Program GuidelinesTable of ContentsD. Network Funding Principles . 261. Grant Funding for Key Components of the NCTN Program .262. Funding for Data Collection/Management & Biospecimen Collection on “Per Case” Basis .272.1 Network Lead Academic Participating Sites Funding . 272.2 CCOPs and MB-CCOPs Funding . 272.3 Pediatric Network Group Member Institutions/Sites Funding . 272.4 Adult Network Group Member Institutions/Sites Funding .282.5 Categories of “Per Case Management” Funding . 282.6 Notification of “Per Case Management” Funding for Trials .303. Program Income for Key Components of the NCTN Program.30IV. TERMS & CONDITIONS OF AWARD FOR COOPERATIVE AGREEMENTS FOR NCTN PROGRAM KEY COMPONENTS . 32A. General Terms and Conditions of Award for All Key Components of the NCTN Program . 321.2.3.4.5.General Programmatic Responsibilities .32Program Director(s)/Principal Investigator(s) Primary Responsibility & Program Income Reporting .32NIH Staff Programmatic Responsibility .33Joint Responsibility .34Dispute Resolution .34B. Specific Terms and Conditions of Award for the Key Components of the NCTN Program . 361. Specific Awardee Rights & Responsibilities - Network Group Operations Centers .361.1 Clinical Trial Development Program .361.1.1 Overall Research Strategy . 361.1.2 Scientific Research and Administrative Committees .361.1.3 Young Investigator Mentoring/Training: . 371.1.4 Communications Support . 371.1.5 Publications .381.1.6 Data Rights .391.2 Member Site Accrual Program . 391.3 Operational Management . 411.3.1 Governance, Organizational Structure, Policies & Procedures, and Membership . 411.3.2 Development of Study Proposals & Protocols for Clinical Trials . 421.3.3 Conduct of Clinical Trials . 431.3.4 Quality Assurance and Onsite Auditing . 471.3.5 Financial Management . 491.4 Program for Collaborations and Participation in Collective Management . 501.5 Compliance with Federal Regulations for Clinical Research & Resource Sharing Plans . 501.5.1 Office for Human Research Protection (OHRP) Assurances . 501.5.2 IRB Review of NCTN Trials by Member Institutions/Sites . 501.5.3 Assurance of Appropriate Informed Consent by Member Institutions/Sites .501.5.4 IRB Review of the Network Group Operations Center .511.5.5 Inclusion of Women, Minorities, and Children in Clinical Research . 511.5.6 Data and Safety Monitoring Policy and Plans . 521.5.7 Resource Sharing Plans . 521.5.8 Education on the Protection of Human Subjects .531.5.9 Other Federal Regulations . 531.6 Conflict of Interest Policy . 531.7 Special Requests for Use of the NCTN Program Infrastructure Services . 53Page 3 of 241
NCTN Program GuidelinesTable of Contents2. Specific Awardee Rights & Responsibilities - Network Group Statistics and Data Management Centers .542.1 Statistical Analysis Program & Collaborative Research and Collective Management . 542.1.1 Statistical Leadership . 542.1.2 Governance, Organizational Structure, and Policies and Procedures . 542.1.3 Facilities and Equipment . 542.1.4 Collaborative Research and Collective Management .552.2 Data Management .552.2.1 Data Management Policies and Use of Standard NCI Tools . 552.2.2 Data Reporting Requirements .562.2.3 Study Monitoring. 572.2.4 Quality Assurance and Onsite Auditing . 572.3 Compliance with Federal Regulations for Clinical Research & Resource Sharing Plans . 582.3.1 IRB Review of Network Group SDMC . 582.3.2 Inclusion of Women, Minorities, and Children in Clinical Research . 582.3.3 Resource Sharing Plans . 592.3.4 Education on the Protection of Human Subjects .592.3.5 Other Federal Regulations . 592.4 Conflict of Interest Policy . 603. Specific Awardee Rights & Responsibilities - Network Group Integrated Translational Science Centers .613.1 Integrated Translational Science Program . 613.1.1 Scientific Team Expertise/Leadership . 613.1.2 Governance, Organizational Structure, & Facilities and Equipment . 613.1.3 Quality Assurance and Onsite Auditing . 613.2 Pilot Studies and Collaborative Projects .623.3 Compliance with Federal Regulations for Clinical Research .623.3.1 IRB Review of the Network Group Integrated Translational Science Center .623.3.2 Inclusion of Women, Minorities, and Children in Clinical Research . 623.3.3 Resource Sharing Plans . 633.3.4 Education on the Protection of Human Subjects .633.3.5 Other Federal Regulations . 633.4 Conflict of Interest Policy. 644. Specific Awardee Rights & Responsibilities – Network Lead Academic Participating Sites .654.1 Clinical Trial Program. 664.1.1 Scientific Leadership & Contribution to NCTN Activities .664.1.2 Young Investigator and Leadership Mentoring/Training .664.1.3 Operational Management (Governance/Organization, Institutional Support, Affiliates) . 664.1.4 NCI Central Institutional Review Board Membership .674.1.5 Clinical Trials Operations – Conduct of Clinical Trials & Data Management.674.1.6 Quality Assurance and Onsite Auditing . 684.2 Site Accrual Program . 684.3 Compliance with Federal Regulations for Clinical Research .684.3.1 IRB Review of the Network Lead Academic Participating Site. 694.3.2 Inclusion of Women, Minorities, and Children in Clinical Research . 694.3.3 Resource Sharing Plans . 704.3.4 Education on the Protection of Human Subjects .704.3.5 Other Federal Regulations . 704.4 Conflict of Interest Policy . 70Page 4 of 241
NCTN Program GuidelinesTable of Contents5. Specific Awardee Rights & Responsibilities - Network Radiotherapy and Imaging Core Services Centers .715.1 General Features and Overview . 715.1.1 Governance, Organizational Structure, Policies & Procedures, & Facilities and Equipment .715.1.2 Quality Assurance/Onsite Auditing .715.2 Radiotherapy and Imaging Core Services Centers . 725.2.1 Scientific and Technical Expertise .725.2.2 Credentialing of Institutions and Services . 725.3 Program for Collaborations and Participation in Collective Management . 725.4 Compliance with Federal Regulations for Clinical Research .725.4.1 IRB Review of the Network Radiotherapy & Imaging Core Services Centers .735.4.2 Inclusion of Women, Minorities, and Children in Clinical Research . 735.4.3 Resource Sharing Plans . 735.4.4 Education on the Protection of Human Subjects .745.4.5 Other Federal Regulations . 745.5 Conflict of Interest Policy. 746. Specific Awardee Rights & Responsibilities - Canadian Collaborating Clinical Trials Network .756.1 Overall Rights and Responsibilities .756.2 Regulatory Oversight . 756.3 Biospecimen Collection and Tumor Banking . 75C. NCI/DCTD Staff Responsibilities . 761. Coordination of National Priorities .762. Scientific Resource and Liaison Activities .762.1 Scientific Resource for NCTN Clinical Investigations .762.2 Scientific and Administrative Program Directors & Liaison Activities. 762.3 NCI/DCTD Attendance at Meetings of the Key Components of the NCTN Program . 772.4 Coordination of Resources to Enhance Accrual/Completion of NCTN Trials .773. Study/Trial Proposal Review & Protocol Development and Review Process .773.1 Proposal Review .783.2 Protocol Development Review/Approval and Amendment Review/Approval .813.3 Study/Trial Closure . 823.4 Data and Safety Monitoring Boards (Data Monitoring Committees) . 824. Quality Assurance and Onsite Auditing .825. Data Management and Analysis Review & Use of Standard NCTN Tools and Services .846. Investigational Agent Development and Regulations .847. Compliance with Federal Regulatory Requirements Review .858. Budget Levels for Per Case Management Funding & Budget Adjustments for the NCTN Program .859. Changes in Principal Investigator(s) for Any Key Component of the NCTN Program .8510. Changes in Awardee Institution for Any Key Component of the NCTN Program .85D. Joint Responsibilities (Key Components of the NCTN Program and NCI/DCTD) . 871.2.3.4.5.6.General Study Development and Conduct .87Data and Safety Monitoring Boards (Data Monitoring Committees) .87Development of Collaborative Trials and International Trials.87Collective Management of the Network .88Network-Wide Common Services, Tools, and Resources .89Legacy Studies .90Page 5 of 241
NCTN Program GuidelinesTable of ContentsE. Appeals Process for Decisions Regarding Study Proposals & Types of Studies Performed by NCTN Program . 911. Decisions on Study Proposals.912. Decisions on Types of Studies Funded Under the NCTN Program .91V. OTHER NCI ADMINISTRATIVE CONSIDERATIONS. 93A. Program Staff Administration of the NCTN Program . 93B. Senior Program Specialist for the NCTN Program . 93C. NCI Office of Grants Adminis
page 1 of 241 national cancer institute national clinical trials network program guidelines division of cancer treatment and diagnosis national cancer institute
