INTRODUCTION
PART
I: DESCRIPTION OF THE PROGRAM AND ITS POLICIES
1.0
History of the NCI Cancer Centers
2.0
Cancer Center Versus Cancer Research Center
3.0
Institutional Variety and the Cancer Center
4.0
The Essential Characteristics of an NCI Cancer Center
4.1 Cancer Focus
4.2 Institutional Commitment
4.3 Center Director
4.4 Organizational Capabilities
4.5 Facilities
4.6 Interdisciplinary Coordination and Collaboration
5.0
Cancer Center Designations
6.0
Major Research Areas of a Center
6.1 Basic Laboratory Research
6.2 Clinical Research
6.3 Prevention, Control, and Population Research
6.4 Multidisciplinary and Translational Interactions Between Basic, Clinical and Prevention/Control/Population Research
7.0
Community Outreach, Education and Dissemination Activities of Cancer Centers
8.0
Research Programs
8.1 Goals
8.2 Selection of Members
8.3 Characteristics of Programs
9.0
Cancer Centers and the CCSG
9.1 Relation of CCSG to the Cancer Center as a Whole
9.2 Sources of Budget Flexibility in a CCSG
9.3 Shared Resources and Services
9.3.1 Biostatistics
9.3.2 Clinical Protocol and Data Management Shared Resource
9.3.2.1 Data and Safety Monitoring
9.3.3 Informatics
9.4 The Protocol Review and Monitoring System (PRMS)
9.5 Interactions with Private Industry
10.0
Overview of the Process for Application and Review of the CCSG
11.0
Peer Review
12.0
Major Policies on Budget
12.1 Competing Continuation Applications (Type 2) - Size of Total Request
12.2 Competing Continuation Applications (Type 2) - Increases
12.3 First-Time Applications (Type 1)
12.4 Supplemental Applications
12.4.1 Competing Supplemental Applications
12.4.2 Administrative Supplements
13.0
Funding Policies
14.0
The Relationship of Centers to Each Other and to the NCI
PART
II: GUIDELINES FOR SUBMISSION AND REVIEW OF NEW AND COMPETING CONTINUATION APPLICATIONS FOR THE CANCER-CENTER SUPPORT GRANT
1.0
General Information
2.0
Submission, Acceptance, and Review of Competing Application
2.1.1 Research Institutions in the US
2.1.2 Not More than One CCSG Per Institution
2.1.3.1 Sources of support that may be included
2.1.3.2 Sources of support that may not be included
2.1.3 Research Base
2.2
Limitations and Dollar Caps on CCSG Applications
2.2.1 Time
Limitations
2.2.2 Dollar
Ceilings on New (Type 1) Applications
2.2.3 Dollar
Ceiling (Cap) on Renewal (Type 2) and Supplemental (Type 3) Applications
2.2.4 Page
Limitations
2.3
Submitting the Application
2.3.1 Agreement
to Accept an Application
2.3.2 Preapplication
Consultation
2.3.3 Evaluation of Comprehensiveness
2.3.4 Key Dates in the Grant Review and Funding Process
2.3.5 Where to Send the Application
2.3.6 Modifications After Submission
2.4
Acceptance of the Application
2.4.1 Conformity with Guidelines
2.4.2 Format
2.4.3 Completeness of Required Information
2.5
Review of the Application
2.5.1 Site
Visit
2.5.2 Parent
Committee
2.5.3 Ad
Hoc Review
2.5.4 National
Cancer Advisory Board (NCAB)
2.6
Inquiries About the Application
2.6.1 Before
Completion of NCIIRG Review
2.6.2 After
Completion of NCIIRG Review
3.0
Programs, Budgets, and Allowable Costs
3.1
Programs
3.1.1 Definition of Peer-Reviewed,
Funded Research Projects for Inclusion in Programs
3.2
Allowable Budget Items
3.2.1 Level
of Effort for Senior Leaders and Program Leaders
3.2.2 Level
of Effort for Saff Investigators
3.2.3 Planning
and Evaluation
3.2.4 Developmental
Funds
3.2.4.1 Newly Recruited Investigators
3.2.4.2 Interim Salary and Research Support
3.2.4.3 Pilot Projects
3.2.4.4 Technology/Methodology Development Projects
3.2.4.5 Development of New Shared Resources
3.2.5 Center
Administration
3.2.6 Shared
Resources and Services
3.2.6.1 Users of Shared Resources and Services
3.2.6.2 Operational Costs to the CCSG
3.2.6.3 Peer Review of Shared Services
3.2.6.4 National Institutes of Health (NIH) Policy Relative to Program Income
3.2.7 Protocol
Review and Monitoring System (PRMS)
3.2.7.1 Elements
3.2.7.2 Application
3.2.7.3 Review
3.2.7.4 Recommendations
3.2.7.5 Budget
3.2.8 Protocol-Specific
Research
3.2.8.1 Application
3.2.8.2 Review
3.2.8.3 Relation to Industry Support
3.2.9 Some
Restrictions on Allowable Budgets
4.0
NIH Policies Governing Conduct of Clinical Trials
4.1 Inclusion
of Women and Minorities in Clinical Trials (NIH Policy)
4.2 Inclusion
of Children in Clinical Trials (NIH Policy)
4.3 Data and Safety Monitoring Plan
4.4 Data Sharing
4.5 Health Insurance Portability and Accountability Act
5.0
Peer Review Criteria for Competing CCSG Applications
5.1
General Guidance
5.2
Specific Issues for Review
5.2.1 Scientific
Quality of Each Program
5.2.2 Overall
Quality of the Program
5.2.3 Essential
Characteristics of the Center
5.2.3.1 Cancer Focus
5.2.3.2 Institutional Commitment
5.2.3.3 Center Director
5.2.3.4 Organizational Capability
5.2.3.5 Facilities
5.2.3.6 Interdisciplinary Coordination and Collaboration
5.2.4 Senior
Leadership
5.2.5 Planning
and Evaluation
5.2.6 Developmental
Funds
5.2.7 Protocol
Review and Monitoring System
5.2.8 Protocol
Specific Research
5.2.9 Shared
Resources and Services
5.2.9.1 Biostatistics
5.2.9.2 Clinical Protocol and Data Management Shared Resource
5.2.9.3 Informatics
5.2.10 Administration
5.2.11 Staff
Investigators
5.2.12 Minority and Gender Representation
5.2.13 Inclusion
of Children in Clinical Trials (NIH Policy)
5.2.14 Data and Safety Monitoring Plan
5.2.15 Overall
Merit Rating of the Cancer Center
5.2.16 Overall
Budget Recommendation
6.0
Comprehensiveness
6.1
One-time Opportunity to Reapply for Comprehensiveness
6.2
Retaining the Comprehensive Designation
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