GuidelineChangesOutline - OCCWebApp 2.2

GuidelineChangesOutline - OCCWebApp 2.2

Guideline Changes Outline

Outline of 2013 Guideline Changes

Updated November 19, 2013

Summary of 2013 FOA / Guidelines Changes

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Component	Changes
*Director’s Overview and Six Essential Characteristics* Organizational Capabilities Transdisciplinary Collabroation and Coordination Institutional Commitment Center Director	Additions Integration of education and training of biomedical researchers and health care professionals, including those from underserved populations, into programmatic research efforts Focus on cancer research in the catchment area Deletions Overlap with requirements of Planning and Evaluation Component Data on non-aligned members Clarifications Centers may vary in the nature and range of training and education activities they sponsor Additions Movement of findings through the translational pipeline via coordination with NCI and other peer-reviewed funding mechanisms Interactive activities beyond grants and publications are acceptable Encouragement of collaborative links with other centers, institutions, industry Additions Recognition of team science in promotion and tenure policies Additions Management and use of authorities and resources to advance the center’s research mission Deletions Overlap with institutional commitment re director’s authorities
*Consortia*	Additions Ongoing, tangible commitments from all consortium partners to the cancer center Examples of acceptable forms of ‘tangible’ support Deletions Requirement that all clinical trials must be open and available in all partner institutions Clarifications Requirement for each consortium partner to hold a portfolio of peer-reviewed cancer related grants Requirement that consortium operate as one cohesive center at time of application Role of the grantee and consortium partners in joint planning and evaluation processes
*Senior Leadership*	Additions Expanded role for senior leadership in establishing a vision, fostering basic discovery and appropriate translation, enabling a focus on cancer research in the catchment area, and establishing a process for integrating training and education into programmatic research Examples of how the center might document senior leadership involvement in integration of training Examples relevant to enabling a research focus in the catchment area are in
*Administration*	Additions Focus on oversight of activities relevant to the CCSG application process Clarifications Administrative functions and subsequent applicability of review criteria may vary, based on organization’s structure
*Developmental Funds*	Additions Opportunities to share meritorious resources across centers, fund staff investigators (including a new category focused on special populations research), and support global health pilot projects Leadership and participation in clinical trials as evidence of success for new recruits Clarifications Developmental funds are restricted
*Shared Resources*	Additions More emphasis on support of science as opposed to usage metrics Language on institutional resources and those supported by other NIH mechanisms Purchase of small equipment Deletions Usage and capacity tables Clinical Protocol and Data Management as a shared resource
*Clinical Protocol and Data Management*	Additions Broader range of functions eligible for CCSG support, including those focused on speeding the clinical trials process, reporting for CTRP New Review criteria added for CPDM Instructions for DSM plans and budgets Modifications Table on accrual to interventional trials shortened and clarified, based on Data Table 4 Review criteria for DSM shortened
*Inclusion of Women and Minorities*	Additions All centers provide plans for recruitment and retention of women and minorities Accrual of women and minorities to non-interventional studies, per NIH policy Optional inclusion of information on other underserved populations
*Protocol Review and Monitoring System*	Additions Encouragement of 2 stage review (concept then full protocol) Simplified reporting templates One time opportunity for re-evaluation during the project period in cases of conditional- or dis- approval Text on special considerations for accrual to trials involving rare cancers and targeted therapies, along with link to policy/list of rare cancers Clarifications Full scientific review should focus on institutional and industry trials Processes for re-evaluation in cases of conditional- or dis-approval Procedures for review of institutional trials from other centers
*Early Phase Clinical Research Support (formerly Protocol Specific Research Support)*	Additions Expands use of funds to early phase clinical research activities , e.g., imaging scans, pharmacodynamic studies and support for IDE or IND applications Requests for information on studies to be supported and outcomes of former studies
*Supportive Data / Data Tables*	For other changes, consult “Summary of Changes in the 2013 CCSG Data Guide”
*Research Programs*	Opportunity to request program development funds in addition to salary support For basic science, specific language recognizing non-translational endpoints Examples of how scientific findings are advanced For clinical programs, focus on quality of trials, participation/leadership in NCTN, institutional trials that capitalize on center research Focus on how the center addresses cancer research in its catchment area, with examples Broader range of activities to document collaboration Value added by shared resources Stronger language on participation of clinical investigators in program Definition of ‘cancer health disparities’ Instructions on handling PMCID numbers in the application Deletions Requirements for agendas, data on non-aligned members, benchmarks for collaborative publications and clinical trial accrual Modifications Listing only of those publications demonstrating impact/collaborative activity Review criteria addressing accrual issues for trials of rare cancers and targeted therapies Requirement for at least 5 peer-reviewed and funded research projects in a Program Clarifications Definition of ‘cancer-related’ Crediting of collaborative publications across multiple programs
*Comprehensiveness*	Modifications 1-stage review focusing on quality/interactivity of science, effectiveness in serving the catchment area through research, and how the scientific mission of the center is enhanced by integration of training/ education into programmatic research efforts
*Review Process*	Additions Application only option, with new eligibility criteria and review process Deletions Limited site visit option Scoring for ‘Overall Quality of the Programs’ Shared resource logs, minutes for retreats and program meetings Modifications Posters optional, but updated information may be provided in the slide book Review materials to be available (after submission of the application) for reviews with site visits and “Application Only” (i.e., no site visit). Note: For applications being site visited, it will be important to consult with the SRO for additional guidance
*Other / Overall*	Additions Additional guidance on defining ‘catchment area’ in multiple components Request for LOI 2 months in advance of submission Modifications Review criteria presented as questions ‘Competitive Revision Applications to ‘Revisions’; ‘Administrative Revision Applications’ to ‘Administrative Supplements’; ‘Percent Effort’ to ‘Person Months’; ‘Principal Investigator’ to ‘Project Director/Principal Investigator’ Address and telephone numbers for OCC have been changed Deletions $500K/1M letter of agreement to accept the application
*P30 Funding*	Additions Guidance for T2 budgets, with caps at various levels based on current DC award Deletions Elimination of Benchmark Ratio Modifications Eligibility requirement for application raised to $10 M Clarifications Funding policies and factors influencing award levels