NCI National Clinical Trials Network (NCTN) Program Guidelines
NCI National Clinical Trials Network (NCTN) Program Guidelines NCI National Clinical Trials Network (NCTN) Program Guidelines
NCTN Program Guidelines Table of Contents PART 1: OVERVIEW OF THE NCTN PROGRAM ...................................................................................................................... 14 I. INTRODUCTION ................................................................................................................................................................ 14 A. Purpose and Content of Guidelines ......................................................................................................................... 14 B. Background, Overview, and Purpose of the NCTN Program.................................................................................... 14 C. Overall Goal of the NCTN Program ......................................................................................................................... 15 D. Anticipated Organization of Key Components of the NCTN Program ...................................................................... 15 1. Network Group Operations Centers .......................................................................................................................................16 2. Network Group Statistics and Data Management Centers .....................................................................................................16 3. Network Group Integrated Translational Science Centers ......................................................................................................17 4. Network Lead Academic Participating Sites ...........................................................................................................................17 5. Network Radiotherapy and Imaging Core Services Centers ....................................................................................................17 6. Canadian Collaborating Clinical Trials Network ......................................................................................................................17 7. Interactions with Other NCI-supported Programs ..................................................................................................................17 7.1 NCI Clinical Trials Tumor Banks................................................................................................................................................. 17 7.2 NCI Community Clinical Oncology Programs (CCOPs) & Minority-Based CCOPs (MB-CCOPs).................................................. 18 7.3 NCI Cancer Trials Support Unit (CTSU) ...................................................................................................................................... 18 7.4 NCI Central Institutional Review Boards (CIRBs) ....................................................................................................................... 19 7.5 NCI Advisory & Scientific Committees ...................................................................................................................................... 19 7.5.1 NCI Clinical Trials and Translational Research Advisory Committee (CTAC) ..................................................................... 20 7.5.2 NCI Scientific Steering Committees (SSCs) ....................................................................................................................... 20 7.5.3 NCI Clinical and Translational Research Operations Committee (CTROC) ........................................................................ 20 II. GOALS OF NCTN RESEARCH ............................................................................................................................................... 22 A. Clinical Treatment Trials & Advanced Imaging Trials .............................................................................................. 22 B. Ancillary Studies ..................................................................................................................................................... 22 C. Cancer Control, Symptom Management, Prevention, and Quality of Life Studies ................................................... 22 D. Collaborations Among Network Group and with Other Organizations on Clinical Trials ......................................... 23 E. NCTN Clinical Trials Originating from Outside the Network Groups ........................................................................ 23 F. Conduct of NCTN Clinical Research ......................................................................................................................... 23 III. GENERAL MANAGEMENT & NETWORK OPERATING AND FUNDING PRINCIPLES .............................................................................. 24 A. General Management ............................................................................................................................................ 24 B. NCTN Leadership Management Committee ............................................................................................................ 24 C. Network Operating Principles ................................................................................................................................ 25 1. Access to NCTN Trials & Crediting for Patients Accrual to Trials .............................................................................................25 2. Submission of Data and Biospecimens for NCTN Trials ...........................................................................................................25 3. Use of the NCI Central Institutional Review Board .................................................................................................................25 4. Trial Proposals Originating From Outside the Network Groups ..............................................................................................26 Page 2 of 241
NCTN Program Guidelines Table of Contents D. Network Funding Principles .................................................................................................................................... 26 1. Grant Funding for Key Components of the NCTN Program .....................................................................................................26 2. Funding for Data Collection/Management & Biospecimen Collection on “Per Case” Basis .....................................................27 2.1 Network Lead Academic Participating Sites Funding .............................................................................................................. 27 2.2 CCOPs and MB-CCOPs Funding ............................................................................................................................................... 27 2.3 Pediatric Network Group Member Institutions/Sites Funding ................................................................................................ 27 2.4 Adult Network Group Member Institutions/Sites Funding ..................................................................................................... 28 2.5 Categories of “Per Case Management” Funding ..................................................................................................................... 28 2.6 Notification of “Per Case Management” Funding for Trials .................................................................................................... 30 3. Program Income for Key Components of the NCTN Program..................................................................................................30 IV. TERMS & CONDITIONS OF AWARD FOR COOPERATIVE AGREEMENTS FOR NCTN PROGRAM KEY COMPONENTS .................................... 32 A. General Terms and Conditions of Award for All Key Components of the NCTN Program ........................................ 32 1. General Programmatic Responsibilities .................................................................................................................................32 2. Program Director(s)/Principal Investigator(s) Primary Responsibility & Program Income Reporting ......................................32 3. NIH Staff Programmatic Responsibility ..................................................................................................................................33 4. Joint Responsibility ................................................................................................................................................................34 5. Dispute Resolution ................................................................................................................................................................34 B. Specific Terms and Conditions of Award for the Key Components of the NCTN Program ........................................ 36 1. Specific Awardee Rights & Responsibilities - Network Group Operations Centers ..................................................................36 1.1 Clinical Trial Development Program ......................................................................................................................................... 36 1.1.1 Overall Research Strategy ................................................................................................................................................ 36 1.1.2 Scientific Research and Administrative Committees ........................................................................................................ 36 1.1.3 Young Investigator Mentoring/Training: .......................................................................................................................... 37 1.1.4 Communications Support ................................................................................................................................................. 37 1.1.5 Publications ...................................................................................................................................................................... 38 1.1.6 Data Rights ....................................................................................................................................................................... 39 1.2 Member Site Accrual Program ................................................................................................................................................. 39 1.3 Operational Management ........................................................................................................................................................ 41 1.3.1 Governance, Organizational Structure, Policies & Procedures, and Membership ............................................................ 41 1.3.2 Development of Study Proposals & Protocols for Clinical Trials ...................................................................................... 42 1.3.3 Conduct of Clinical Trials ................................................................................................................................................. 43 1.3.4 Quality Assurance and Onsite Auditing ........................................................................................................................... 47 1.3.5 Financial Management .................................................................................................................................................... 49 1.4 Program for Collaborations and Participation in Collective Management .............................................................................. 50 1.5 Compliance with Federal Regulations for Clinical Research & Resource Sharing Plans .......................................................... 50 1.5.1 Office for Human Research Protection (OHRP) Assurances ............................................................................................. 50 1.5.2 IRB Review of NCTN Trials by Member Institutions/Sites ................................................................................................ 50 1.5.3 Assurance of Appropriate Informed Consent by Member Institutions/Sites ................................................................... 50 1.5.4 IRB Review of the Network Group Operations Center ..................................................................................................... 51 1.5.5 Inclusion of Women, Minorities, and Children in Clinical Research ................................................................................. 51 1.5.6 Data and Safety Monitoring Policy and Plans ................................................................................................................... 52 1.5.7 Resource Sharing Plans .................................................................................................................................................... 52 1.5.8 Education on the Protection of Human Subjects ............................................................................................................. 53 1.5.9 Other Federal Regulations ................................................................................................................................................ 53 1.6 Conflict of Interest Policy ........................................................................................................................................................ 53 1.7 Special Requests for Use of the NCTN Program Infrastructure Services ................................................................................. 53 Page 3 of 241
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<strong>NCTN</strong> <strong>Program</strong> <strong>Guidelines</strong> Table of Contents<br />
D. <strong>Network</strong> Funding Principles .................................................................................................................................... 26<br />
1. Grant Funding for Key Components of the <strong>NCTN</strong> <strong>Program</strong> .....................................................................................................26<br />
2. Funding for Data Collection/Management & Biospecimen Collection on “Per Case” Basis .....................................................27<br />
2.1 <strong>Network</strong> Lead Academic Participating Sites Funding .............................................................................................................. 27<br />
2.2 CCOPs and MB-CCOPs Funding ............................................................................................................................................... 27<br />
2.3 Pediatric <strong>Network</strong> Group Member Institutions/Sites Funding ................................................................................................ 27<br />
2.4 Adult <strong>Network</strong> Group Member Institutions/Sites Funding ..................................................................................................... 28<br />
2.5 Categories of “Per Case Management” Funding ..................................................................................................................... 28<br />
2.6 Notification of “Per Case Management” Funding for <strong>Trials</strong> .................................................................................................... 30<br />
3. <strong>Program</strong> Income for Key Components of the <strong>NCTN</strong> <strong>Program</strong>..................................................................................................30<br />
IV. TERMS & CONDITIONS OF AWARD FOR COOPERATIVE AGREEMENTS FOR <strong>NCTN</strong> PROGRAM KEY COMPONENTS .................................... 32<br />
A. General Terms and Conditions of Award for All Key Components of the <strong>NCTN</strong> <strong>Program</strong> ........................................ 32<br />
1. General <strong>Program</strong>matic Responsibilities .................................................................................................................................32<br />
2. <strong>Program</strong> Director(s)/Principal Investigator(s) Primary Responsibility & <strong>Program</strong> Income Reporting ......................................32<br />
3. NIH Staff <strong>Program</strong>matic Responsibility ..................................................................................................................................33<br />
4. Joint Responsibility ................................................................................................................................................................34<br />
5. Dispute Resolution ................................................................................................................................................................34<br />
B. Specific Terms and Conditions of Award for the Key Components of the <strong>NCTN</strong> <strong>Program</strong> ........................................ 36<br />
1. Specific Awardee Rights & Responsibilities - <strong>Network</strong> Group Operations Centers ..................................................................36<br />
1.1 <strong>Clinical</strong> Trial Development <strong>Program</strong> ......................................................................................................................................... 36<br />
1.1.1 Overall Research Strategy ................................................................................................................................................ 36<br />
1.1.2 Scientific Research and Administrative Committees ........................................................................................................ 36<br />
1.1.3 Young Investigator Mentoring/Training: .......................................................................................................................... 37<br />
1.1.4 Communications Support ................................................................................................................................................. 37<br />
1.1.5 Publications ...................................................................................................................................................................... 38<br />
1.1.6 Data Rights ....................................................................................................................................................................... 39<br />
1.2 Member Site Accrual <strong>Program</strong> ................................................................................................................................................. 39<br />
1.3 Operational Management ........................................................................................................................................................ 41<br />
1.3.1 Governance, Organizational Structure, Policies & Procedures, and Membership ............................................................ 41<br />
1.3.2 Development of Study Proposals & Protocols for <strong>Clinical</strong> <strong>Trials</strong> ...................................................................................... 42<br />
1.3.3 Conduct of <strong>Clinical</strong> <strong>Trials</strong> ................................................................................................................................................. 43<br />
1.3.4 Quality Assurance and Onsite Auditing ........................................................................................................................... 47<br />
1.3.5 Financial Management .................................................................................................................................................... 49<br />
1.4 <strong>Program</strong> for Collaborations and Participation in Collective Management .............................................................................. 50<br />
1.5 Compliance with Federal Regulations for <strong>Clinical</strong> Research & Resource Sharing Plans .......................................................... 50<br />
1.5.1 Office for Human Research Protection (OHRP) Assurances ............................................................................................. 50<br />
1.5.2 IRB Review of <strong>NCTN</strong> <strong>Trials</strong> by Member Institutions/Sites ................................................................................................ 50<br />
1.5.3 Assurance of Appropriate Informed Consent by Member Institutions/Sites ................................................................... 50<br />
1.5.4 IRB Review of the <strong>Network</strong> Group Operations Center ..................................................................................................... 51<br />
1.5.5 Inclusion of Women, Minorities, and Children in <strong>Clinical</strong> Research ................................................................................. 51<br />
1.5.6 Data and Safety Monitoring Policy and Plans ................................................................................................................... 52<br />
1.5.7 Resource Sharing Plans .................................................................................................................................................... 52<br />
1.5.8 Education on the Protection of Human Subjects ............................................................................................................. 53<br />
1.5.9 Other Federal Regulations ................................................................................................................................................ 53<br />
1.6 Conflict of Interest Policy ........................................................................................................................................................ 53<br />
1.7 Special Requests for Use of the <strong>NCTN</strong> <strong>Program</strong> Infrastructure Services ................................................................................. 53<br />
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