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 2. Specific Awardee Rights & Responsibilities - Network Group Statistics and Data Management Centers .................................54 2.1 Statistical Analysis Program & Collaborative Research and Collective Management .............................................................. 54 2.1.1 Statistical Leadership ........................................................................................................................................................ 54 2.1.2 Governance, Organizational Structure, and Policies and Procedures .............................................................................. 54 2.1.3 Facilities and Equipment .................................................................................................................................................. 54 2.1.4 Collaborative Research and Collective Management ....................................................................................................... 55 2.2 Data Management ................................................................................................................................................................... 55 2.2.1 Data Management Policies and Use of Standard NCI Tools ............................................................................................. 55 2.2.2 Data Reporting Requirements .......................................................................................................................................... 56 2.2.3 Study Monitoring.............................................................................................................................................................. 57 2.2.4 Quality Assurance and Onsite Auditing ............................................................................................................................ 57 2.3 Compliance with Federal Regulations for Clinical Research & Resource Sharing Plans ........................................................... 58 2.3.1 IRB Review of Network Group SDMC ............................................................................................................................... 58 2.3.2 Inclusion of Women, Minorities, and Children in Clinical Research ................................................................................. 58 2.3.3 Resource Sharing Plans .................................................................................................................................................... 59 2.3.4 Education on the Protection of Human Subjects ............................................................................................................. 59 2.3.5 Other Federal Regulations ................................................................................................................................................ 59 2.4 Conflict of Interest Policy ........................................................................................................................................................ 60 3. Specific Awardee Rights & Responsibilities - Network Group Integrated Translational Science Centers .................................61 3.1 Integrated Translational Science Program ................................................................................................................................ 61 3.1.1 Scientific Team Expertise/Leadership ............................................................................................................................... 61 3.1.2 Governance, Organizational Structure, & Facilities and Equipment ................................................................................ 61 3.1.3 Quality Assurance and Onsite Auditing ............................................................................................................................ 61 3.2 Pilot Studies and Collaborative Projects ................................................................................................................................... 62 3.3 Compliance with Federal Regulations for Clinical Research ..................................................................................................... 62 3.3.1 IRB Review of the Network Group Integrated Translational Science Center ................................................................... 62 3.3.2 Inclusion of Women, Minorities, and Children in Clinical Research ................................................................................. 62 3.3.3 Resource Sharing Plans .................................................................................................................................................... 63 3.3.4 Education on the Protection of Human Subjects ............................................................................................................. 63 3.3.5 Other Federal Regulations ................................................................................................................................................ 63 3.4 Conflict of Interest Policy .......................................................................................................................................................... 64 4. Specific Awardee Rights & Responsibilities – Network Lead Academic Participating Sites ......................................................65 4.1 Clinical Trial Program............................................................................................................................................................... 66 4.1.1 Scientific Leadership & Contribution to NCTN Activities .................................................................................................. 66 4.1.2 Young Investigator and Leadership Mentoring/Training .................................................................................................. 66 4.1.3 Operational Management (Governance/Organization, Institutional Support, Affiliates) ................................................ 66 4.1.4 NCI Central Institutional Review Board Membership ....................................................................................................... 67 4.1.5 Clinical Trials Operations – Conduct of Clinical Trials & Data Management..................................................................... 67 4.1.6 Quality Assurance and Onsite Auditing ............................................................................................................................ 68 4.2 Site Accrual Program ................................................................................................................................................................ 68 4.3 Compliance with Federal Regulations for Clinical Research ..................................................................................................... 68 4.3.1 IRB Review of the Network Lead Academic Participating Site.......................................................................................... 69 4.3.2 Inclusion of Women, Minorities, and Children in Clinical Research ................................................................................. 69 4.3.3 Resource Sharing Plans .................................................................................................................................................... 70 4.3.4 Education on the Protection of Human Subjects ............................................................................................................. 70 4.3.5 Other Federal Regulations ................................................................................................................................................ 70 4.4 Conflict of Interest Policy ......................................................................................................................................................... 70 Page 4 of 241
NCTN Program Guidelines Table of Contents 5. Specific Awardee Rights & Responsibilities - Network Radiotherapy and Imaging Core Services Centers ...............................71 5.1 General Features and Overview ............................................................................................................................................... 71 5.1.1 Governance, Organizational Structure, Policies & Procedures, & Facilities and Equipment ............................................. 71 5.1.2 Quality Assurance/Onsite Auditing .................................................................................................................................. 71 5.2 Radiotherapy and Imaging Core Services Centers .................................................................................................................... 72 5.2.1 Scientific and Technical Expertise ..................................................................................................................................... 72 5.2.2 Credentialing of Institutions and Services ......................................................................................................................... 72 5.3 Program for Collaborations and Participation in Collective Management ............................................................................... 72 5.4 Compliance with Federal Regulations for Clinical Research ..................................................................................................... 72 5.4.1 IRB Review of the Network Radiotherapy & Imaging Core Services Centers ................................................................... 73 5.4.2 Inclusion of Women, Minorities, and Children in Clinical Research ................................................................................. 73 5.4.3 Resource Sharing Plans .................................................................................................................................................... 73 5.4.4 Education on the Protection of Human Subjects ............................................................................................................. 74 5.4.5 Other Federal Regulations ................................................................................................................................................ 74 5.5 Conflict of Interest Policy .......................................................................................................................................................... 74 6. Specific Awardee Rights & Responsibilities - Canadian Collaborating Clinical Trials Network .................................................75 6.1 Overall Rights and Responsibilities ........................................................................................................................................... 75 6.2 Regulatory Oversight ................................................................................................................................................................ 75 6.3 Biospecimen Collection and Tumor Banking ............................................................................................................................ 75 C. NCI/DCTD Staff Responsibilities .............................................................................................................................. 76 1. Coordination of National Priorities ........................................................................................................................................76 2. Scientific Resource and Liaison Activities ...............................................................................................................................76 2.1 Scientific Resource for NCTN Clinical Investigations ........................................................................................................... 76 2.2 Scientific and Administrative Program Directors & Liaison Activities.................................................................................. 76 2.3 NCI/DCTD Attendance at Meetings of the Key Components of the NCTN Program ........................................................... 77 2.4 Coordination of Resources to Enhance Accrual/Completion of NCTN Trials ....................................................................... 77 3. Study/Trial Proposal Review & Protocol Development and Review Process ...........................................................................77 3.1 Proposal Review .................................................................................................................................................................. 78 3.2 Protocol Development Review/Approval and Amendment Review/Approval .................................................................... 81 3.3 Study/Trial Closure .............................................................................................................................................................. 82 3.4 Data and Safety Monitoring Boards (Data Monitoring Committees) .................................................................................. 82 4. Quality Assurance and Onsite Auditing ..................................................................................................................................82 5. Data Management and Analysis Review & Use of Standard NCTN Tools and Services ............................................................84 6. Investigational Agent Development and Regulations .............................................................................................................84 7. Compliance with Federal Regulatory Requirements Review ..................................................................................................85 8. Budget Levels for Per Case Management Funding & Budget Adjustments for the NCTN Program ..........................................85 9. Changes in Principal Investigator(s) for Any Key Component of the NCTN Program ...............................................................85 10. Changes in Awardee Institution for Any Key Component of the NCTN Program .....................................................................85 D. Joint Responsibilities (Key Components of the NCTN Program and NCI/DCTD) ....................................................... 87 1. General Study Development and Conduct .............................................................................................................................87 2. Data and Safety Monitoring Boards (Data Monitoring Committees) ......................................................................................87 3. Development of Collaborative Trials and International Trials.................................................................................................87 4. Collective Management of the Network ................................................................................................................................88 5. Network-Wide Common Services, Tools, and Resources ........................................................................................................89 6. Legacy Studies .......................................................................................................................................................................90 Page 5 of 241
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<strong>NCTN</strong> <strong>Program</strong> <strong>Guidelines</strong> Table of Contents<br />
5. Specific Awardee Rights & Responsibilities - <strong>Network</strong> Radiotherapy and Imaging Core Services Centers ...............................71<br />
5.1 General Features and Overview ............................................................................................................................................... 71<br />
5.1.1 Governance, Organizational Structure, Policies & Procedures, & Facilities and Equipment ............................................. 71<br />
5.1.2 Quality Assurance/Onsite Auditing .................................................................................................................................. 71<br />
5.2 Radiotherapy and Imaging Core Services Centers .................................................................................................................... 72<br />
5.2.1 Scientific and Technical Expertise ..................................................................................................................................... 72<br />
5.2.2 Credentialing of Institutions and Services ......................................................................................................................... 72<br />
5.3 <strong>Program</strong> for Collaborations and Participation in Collective Management ............................................................................... 72<br />
5.4 Compliance with Federal Regulations for <strong>Clinical</strong> Research ..................................................................................................... 72<br />
5.4.1 IRB Review of the <strong>Network</strong> Radiotherapy & Imaging Core Services Centers ................................................................... 73<br />
5.4.2 Inclusion of Women, Minorities, and Children in <strong>Clinical</strong> Research ................................................................................. 73<br />
5.4.3 Resource Sharing Plans .................................................................................................................................................... 73<br />
5.4.4 Education on the Protection of Human Subjects ............................................................................................................. 74<br />
5.4.5 Other Federal Regulations ................................................................................................................................................ 74<br />
5.5 Conflict of Interest Policy .......................................................................................................................................................... 74<br />
6. Specific Awardee Rights & Responsibilities - Canadian Collaborating <strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong> .................................................75<br />
6.1 Overall Rights and Responsibilities ........................................................................................................................................... 75<br />
6.2 Regulatory Oversight ................................................................................................................................................................ 75<br />
6.3 Biospecimen Collection and Tumor Banking ............................................................................................................................ 75<br />
C. <strong>NCI</strong>/DCTD Staff Responsibilities .............................................................................................................................. 76<br />
1. Coordination of <strong>National</strong> Priorities ........................................................................................................................................76<br />
2. Scientific Resource and Liaison Activities ...............................................................................................................................76<br />
2.1 Scientific Resource for <strong>NCTN</strong> <strong>Clinical</strong> Investigations ........................................................................................................... 76<br />
2.2 Scientific and Administrative <strong>Program</strong> Directors & Liaison Activities.................................................................................. 76<br />
2.3 <strong>NCI</strong>/DCTD Attendance at Meetings of the Key Components of the <strong>NCTN</strong> <strong>Program</strong> ........................................................... 77<br />
2.4 Coordination of Resources to Enhance Accrual/Completion of <strong>NCTN</strong> <strong>Trials</strong> ....................................................................... 77<br />
3. Study/Trial Proposal Review & Protocol Development and Review Process ...........................................................................77<br />
3.1 Proposal Review .................................................................................................................................................................. 78<br />
3.2 Protocol Development Review/Approval and Amendment Review/Approval .................................................................... 81<br />
3.3 Study/Trial Closure .............................................................................................................................................................. 82<br />
3.4 Data and Safety Monitoring Boards (Data Monitoring Committees) .................................................................................. 82<br />
4. Quality Assurance and Onsite Auditing ..................................................................................................................................82<br />
5. Data Management and Analysis Review & Use of Standard <strong>NCTN</strong> Tools and Services ............................................................84<br />
6. Investigational Agent Development and Regulations .............................................................................................................84<br />
7. Compliance with Federal Regulatory Requirements Review ..................................................................................................85<br />
8. Budget Levels for Per Case Management Funding & Budget Adjustments for the <strong>NCTN</strong> <strong>Program</strong> ..........................................85<br />
9. Changes in Principal Investigator(s) for Any Key Component of the <strong>NCTN</strong> <strong>Program</strong> ...............................................................85<br />
10. Changes in Awardee Institution for Any Key Component of the <strong>NCTN</strong> <strong>Program</strong> .....................................................................85<br />
D. Joint Responsibilities (Key Components of the <strong>NCTN</strong> <strong>Program</strong> and <strong>NCI</strong>/DCTD) ....................................................... 87<br />
1. General Study Development and Conduct .............................................................................................................................87<br />
2. Data and Safety Monitoring Boards (Data Monitoring Committees) ......................................................................................87<br />
3. Development of Collaborative <strong>Trials</strong> and International <strong>Trials</strong>.................................................................................................87<br />
4. Collective Management of the <strong>Network</strong> ................................................................................................................................88<br />
5. <strong>Network</strong>-Wide Common Services, Tools, and Resources ........................................................................................................89<br />
6. Legacy Studies .......................................................................................................................................................................90<br />
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