NCI National Clinical Trials Network (NCTN) Program Guidelines
NCI National Clinical Trials Network (NCTN) Program Guidelines NCI National Clinical Trials Network (NCTN) Program Guidelines
D. Trial Operations Part 4: Appendices – IX. Common Budget Outline 1. Protocol Development and Management Salary, fringe, travel and consortium/contractual indirect costs for staff to develop, prepare, revise and manage protocols 2. Regulatory Salary, fringe, travel and consortium/contractual indirect costs for staff to administer IRB and other regulatory paperwork 3. Audits (RESTRICTED FUNDING) Salary, fringe, travel, consortium/contractual indirect and/or consultant costs for staff to conduct and manage audits and associated quality assurance activities SUBTOTAL - TRIAL OPERATIONS E. Statistics & Data Management (Provided by SDMC) 1. Statistical & Data Management Leadership Salary, fringe, travel and consortium/contractual indirect costs for leadership of the entire function (where they are combined) and their support staff 2. Data Operations Salary, fringe and consortium/contractual indirect costs for leadership, data coordinators and support personnel plus supplies and services , including restricted support for creation of public datasets for completed trials with primary results published 3. Biostatistics and Bioinformatics Salary, fringe, travel and consortium/contractual indirect costs for leadership, statistics, bioinformatics and support personnel plus supplies and services 4. Information Systems Salary, fringe and consortium/contractual indirect costs for leadership, applications development, database and IT support staff, equipment, software, etc. SUBTOTAL - STATISTICS & DATA MANAGEMENT F. Scientific Services 1. Clinical Reviews Salary, fringe, travel, consortium/contractual indirect, & consultant costs for pathology, surgery, and any other clinical reviews 2. Tissue Banks Coordination Only (RESTRICTED FUNDING in Ops & SDMC Budgets) Salary, fringe, travel, consortium/contractual indirect, consultant and other costs for coordination with the Tissue Bank(s) for the Network Group 3. RT or Imaging Technical Innovation for Network Group w/ this Specialty Focus Only 4. Scientific Support Services 5. DSMB/DMC (Ops Center & SDMC) (RESTRICTED FUNDING IN Ops & SDMC Budgets 6. Statistical Support for Creating Datasets for Data Sharing Policy (RESTRICTED FUNDING in SDMC Budgets) Salary, fringe, travel, equipment, consortium/contractual indirect, consultant & other costs for services related to technical innovation only. For Group with special expertise need because of specific developmental research strategy in RT and/or Imaging outside Core Services (1 adult and 1 pediatric Group max) Salary, fringe, travel, consortium/contractual indirect and supply or other costs for outcomes, correlative studies or other scientific services Salary, fringe, travel, consortium/contractual indirect and supply or other costs for administration/management of DSMB/DMCs for Network Group Salary, fringe, travel, consortium/contractual indirect and supply or other costs for outcomes, correlative studies or other scientific services Page 234 of 241
Part 4: Appendices – IX. Common Budget Outline G. Per Case Data Management Funding * - RESTRICTED FUNDING (Whether by PSA or Member Subcontracts) 1. Screening on Trial Per Case (No intervention) Only for screening done as part of trial (i.e., consent required on study) for estimated # of patients in project period year 2. Therapeutic Basic Intervention Per Case Based on estimates for # patients randomized and/or placed on study intervention on therapeutic study 3. Advanced Imaging Basic Intervention Per Case Based on estimates for # patients randomized and/or placed on study intervention on advanced imaging study – basic data collection 4. Biospecimen Collections Per Case Based on estimate of # of per patient for trials designated for biospecimen per case payments 5. Special Advanced Imaging Per Case for Network Group with Specialty Focus in this Area 6. For Pediatrics Network Group Only– Provide High-Performance Per Case payments here based on accrual thresholds (Basic Intervention Provided Above) 7. For Pediatrics Network Group Only– Provide Institutional Infrastructure payments here based on accrual thresholds SUBTOTAL -PER CASE REIMBURSEMENTS SUBTOTAL - ACCRUAL COSTs & TOTAL ALL DIRECT COSTS Based on estimates for # patients randomized and/or placed on study intervention on advanced imaging study for advanced credentialing/imaging resources * Please Note: Special Per Case Funding would be based on individual trial needs determined by NCI/DCTD and should not be included in the application budget from the Network Group. Additional “high-performance” per case data management funding would be provided via special program administered by the CTSU, and should not be included in a Network Group Operations Center application budget except for a Pediatric Network Group Page 235 of 241
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Part 4: Appendices – IX. Common Budget Outline<br />
G. Per Case Data Management Funding * - RESTRICTED<br />
FUNDING (Whether by PSA or Member Subcontracts)<br />
1. Screening on Trial Per Case (No intervention) Only for screening done as part of trial (i.e., consent required on study) for estimated # of patients in project period year<br />
2. Therapeutic Basic Intervention Per Case Based on estimates for # patients randomized and/or placed on study intervention on therapeutic study<br />
3. Advanced Imaging Basic Intervention Per Case Based on estimates for # patients randomized and/or placed on study intervention on advanced imaging study – basic data collection<br />
4. Biospecimen Collections Per Case Based on estimate of # of per patient for trials designated for biospecimen per case payments<br />
5. Special Advanced Imaging Per Case for<br />
<strong>Network</strong> Group with Specialty Focus in this Area<br />
6. For Pediatrics <strong>Network</strong> Group Only– Provide<br />
High-Performance Per Case payments here based<br />
on accrual thresholds (Basic Intervention Provided<br />
Above)<br />
7. For Pediatrics <strong>Network</strong> Group Only– Provide<br />
Institutional Infrastructure payments here based<br />
on accrual thresholds<br />
SUBTOTAL -PER CASE REIMBURSEMENTS<br />
SUBTOTAL - ACCRUAL COSTs & TOTAL ALL DIRECT COSTS<br />
Based on estimates for # patients randomized and/or placed on study intervention on advanced imaging study for advanced credentialing/imaging<br />
resources<br />
* Please Note: Special Per Case Funding would be based on individual trial needs determined by <strong>NCI</strong>/DCTD and should not be included in the application budget from the <strong>Network</strong> Group.<br />
Additional “high-performance” per case data management funding would be provided via special program administered by the CTSU, and should not be included in a <strong>Network</strong> Group Operations Center<br />
application budget except for a Pediatric <strong>Network</strong> Group<br />
Page 235 of 241
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