Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Community Clinical Oncology Program Research Bases (U10)

Activity Code

U10 Cooperative Clinical Research – Cooperative Agreements

Announcement Type

Reissue of RFA-CA-10-011

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-CA-11-007

Companion FOA

U10, RFA-CA-11-006 and U10, RFA-CA-11-008

Number of Applications

Only one application per institution is allowed as defined in Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.393, 93.394, 93.395, 93.399  

FOA Purpose

This funding opportunity announcement (FOA) solicits applications from institutions/organizations that propose to serve as Research Bases for the NCI-supported Community Clinical Oncology Program (CCOP) Network. The goal for CCOP is to develop and conduct state-of-the-art cancer prevention, control, and treatment clinical trials with significant involvement of community oncologists and populations they serve. The CCOP Network consists of three components (each with its own FOA), which are: CCOP Groups (also referred to as CCOPs); Minority Based-CCOPs; and CCOP Research Bases (covered by this FOA). A CCOP Group encompasses community oncologists who accrue patients/participants to NCI-approved clinical trials. The Minority Based CCOPs are formed by oncologists in communities with a high proportion of minority patients that accrue patients/participants to NCI-approved clinical trials. These trials are designed and conducted by the CCOP Research Bases, which also manage and analyze the data, and report the results. CCOP Research Bases must be located either at an NCI-supported Clinical Cooperative Group or at an NCI-designated Cancer Center.

Key Dates
Posted Date
Letter of Intent Due Date

June 28, 2011

Application Due Date(s)

July 28, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November/December, 2011

Advisory Council Review

January, 2012

Earliest Start Date(s)

June, 2012

Expiration Date

July 29, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The overall objective of the Community Clinical Oncology Program (CCOP) is to develop and conduct state-of-the-art cancer prevention clinical trials and control and treatment clinical trials with prominent involvement of community oncologists and the populations that they serve. The CCOP, established by the Division of Cancer Prevention, National Cancer Institute (NCI) in 1983, is a community-based clinical trials network that links community physicians, who accrue participants/patients to cancer clinical trials as part of their overall practice, with the “CCOP Research Bases” formed at the awardee institutions of the NCI-sponsored Clinical Trials Cooperative Groups and NCI-designated Cancer Centers.

The CCOP Network is designed to: (1) increase the involvement of community oncologists, other specialists (e.g., surgeons, family practitioners, gastroenterologists, urologists, gynecologists), and their patients in clinical trials designed by NCI Cooperative Groups and Cancer Centers; (2) involve a wider segment of the community in cancer clinical trials, including minorities, women, and other underserved (e.g., rural) populations; and (3) accelerate the transfer of knowledge gained from clinical trials to community oncology practices.

The CCOP Network consists of three types of components:

CCOP Groups (covered by RFA-CA-11-006);

Minority Based CCOPs   (covered by RFA-CA-11-008); and

CCOP Research Bases (this FOA).

A CCOP Group is a consortium of community oncologists from one or more interacting community institutions that accrue patient/participants to clinical trials designed and conducted by the CCOP Research Bases. Each CCOP Group must accrue annually at least 50 patients to treatment clinical trials and at least 50 participants to prevention and control clinical trials. Equally important to accrual, CCOPs also assure the quality of the data collected and the safety of the participants/patients entered on trials.

A Minority Based CCOP Group is a consortium of oncologists from one or more interacting community institutions that have at least 30% minority cancer patients and accrue patients/participants to clinical trials designed and conducted by the CCOP Research Bases. Each MB-CCOP must accrue annually at least 50 patients to treatment clinical trials and at least 50 participants to cancer prevention and control clinical trials. Equally important to accrual, MB-CCOPs also assure the quality of the data collected and the safety of the participants/patients entered on trials.

A CCOP Research Base designs clinical trials for use in the CCOP Network. It also conducts the clinical trials, manages and analyses the data, and reports the results. Cooperative Group CCOP Research Bases design and conduct both cancer treatment and cancer prevention and control clinical trials. Cancer Center CCOP Research Bases design and conduct only cancer prevention and control clinical trials.

Definition: Cancer prevention/control clinical trials include clinical evaluations of: the effectiveness of interventions for the purpose of reducing the risk for developing cancer (including but not limited to chemo-preventive agents, surgical interventions, and lifestyle modifications); methods for early detection of cancer and precancerous lesions; interventions to improve patients’ quality of life and/or to treat symptoms arising from cancer or toxicities arising from cancer therapy; and ways to improve continuing, palliative, and end-of-life care.

The research of applicants applying to this FOA must be focused on cancer prevention and/or control clinical trials. These trials are aimed at reducing cancer incidence, morbidity, mortality, and cancer disparities through the identification, testing, and evaluation of strategies and interventions. Given that some toxicities and symptoms are not well described, the use of observational study designs can be considered responsive with an appropriate justification. The scope of research areas under cancer prevention and control includes: interventions to reduce the incidence of pre-neoplastic lesions and invasive cancer; methods for early detection of cancer and pre-neoplastic lesions; cancer risk reduction and development of risk assessment models; interventions to reduce toxicity from cancer treatment and symptoms from cancer as well as improve quality of life; the clinical validation of markers for early detection, toxicity, and prediction of response; and ways to improve continuing cancer care, palliative care and end of life.

Background

The CCOP Network was initiated in 1983 as a mechanism for including community oncologists and their patients in treatment clinical trials designed by NCI Cooperative Groups and Cancer Centers. In 1986, the Network’s focus expanded to include cancer prevention/control clinical trials research aimed at reducing cancer incidence, morbidity, and mortality through the evaluation of interventions in controlled clinical trials. Prevention and control research in the CCOP Network has increased steadily since funding began in 1987.

The CCOP Network is a vital resource for conducting NCI cancer prevention/control clinical trials because the Network provides access to: (1) cancer prevention trials; (2) large populations of cancer patients for symptom management, supportive care, and quality-of-life interventions; (3) large populations of former cancer patients and survivors who may benefit through participation in chemoprevention clinical trials; (4) cancer patients' family members and other classes of individuals who may be at increased risk of developing cancer and thus be candidates for cancer prevention and/or detection studies; and (5) geographic areas inhabited by diverse populations not always available in university or urban settings. Several large chemoprevention trials have been implemented through the CCOP Network, among them the prostate cancer prevention trial with finasteride (PCPT), the study of tamoxifen and raloxifene in the prevention of breast cancer (STAR), and the selenium and vitamin E trial in the prevention of prostate cancer (SELECT).

In 2010, the CCOP Network consisted of 47 CCOP Groups, located in 28 states and comprising more than 340 hospitals and more than 3,000 physicians. The CCOPs enrolled approximately 9,225 patients to NCI cancer treatment and prevention and control clinical trials. The Network also included 12 CCOP Research Bases, which conducted several hundred treatment/prevention/control trials. The MBCCOP Program consisted of 16 MBCCOP Groups, located in 12 states and Puerto Rico with more than 50 hospitals and 470 physicians. MBCCOP Groups enrolled over 1,150 patients to NCI-approved cancer clinical trials.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The National Cancer Institute intends to commit an estimated total of $42.6 million for 8-9 awards in FY 2012. Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed research project. In addition, Cooperative Group CCOP Research applicants may request funding for costs associated with transition and transformation activities that relate to the consolidation and transformation of the Clinical Cooperative Groups into a more integrated network (see Award Project Period below)..

Award Project Period

 The total project period proposed may not exceed 5 years for any application (i.e., Cooperative Group or Cancer Center CCOP Research Base). Because the NCI-funded Clinical Cooperative Groups are in the process of consolidating into 4 adult groups (from the current 9 adult groups) over the next several years, Cooperative Group CCOP Research Base applicants should propose a project period that will align with their Groups’ consolidation /transformation plans. The proposed project period should allow adequate time for integration of the Research Base’s cancer prevention and control research infrastructure into a consolidated or transformed Cooperative Group, time for the Cooperative Group to be peer reviewed and identified for funding, and time for the Research Base to submit a competing application and be notified about the outcome of the peer review.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Foreign (non-U.S.) components of U.S. Organizations are not allowed.

For new and renewal Research Base applications, the following provisos apply:

NOTE: Institutions applying for CCOP Research Base are not eligible to apply for CCOP Group award (under RFA-CA-10-010) or MBCCOP Group award (under RFA-CA-10-012) if they are either: (1) a NCI-funded Cancer Center; or (2) a university hospital clinical trials cooperative group member funded by the Division of Cancer Treatment and Diagnosis (DCTD), NCI.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Each applicant organization may submit only one application in response to this FOA.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Lori Minasian, MD
Division of Cancer Prevention
National Cancer Institute
6130 Executive Boulevard
Executive Plaza North, Room 2017, MSC 7340
Bethesda, MD 20892-7340 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-8541
Email: minasilo@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-496-3428
Email: ncirefof@dea.nci.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed

Include in Section 3 “Research Strategy” of the PHS 398 Research Plan the following sub-sections A–D:

Note: Standardized table templates are available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply. Applicants are strongly encouraged to use templates for Tables 1 through 6 for inclusion.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Section 3. Research Strategy of the PHS 398 Research Plan consist of sub-sections A – D (as defined below) and page limits replaced as indicated below for these new sub-sections.

Other sections of the PHS 398 Research Plan remain unmodified and should be completed following standard instructions.

NOTE: An application from a currently funded CCOP Research Base (renewal application) must include a progress report under Section 3. Research Strategy, sub-section A Program Overview.

A. Program Overview (up to 12 pages)

·       Leadership Team

Describe qualifications and experience of a designated PD/PI (or multiple PDs/PIs if this option is used). The PD/PI may be the Chair of the Cooperative Group (for those applicants). In addition, describe the qualifications and experience of an individual designated to coordinate cancer prevention and control research. This individual must be qualified in the field of cancer prevention/control and have experience within the Research Base. Describe also the involvement of professionals with the appropriate expertise to design and implement the proposed treatment and/or cancer prevention/control clinical trials. Medical, surgical, radiation, and other oncology specialists, nurse oncologists, epidemiologists, statisticians, health educators, and/or other public health professionals and basic scientists may be included.

Define the proposed prevention and/or control committee(s) (or equivalents) and describe the committee(s) role in development of the Research Base’s scientific research agenda. In addition, if applicable, a description should outline how the committees' composition and functions as well as the relationship to other clinical trial committees. For the committees that are not yet formed, outline the type of expertise sought. However, do not provide names of any potential external candidates and do not contact them, in order not to compromise the selection of potential reviewers.

·       Cooperative Group Consolidation and Transformation Plans (Cooperative Group CCOP Research Base applications only)

NCI is in the process of consolidating the NCI-funded Clinical Cooperative Groups (Groups) and transforming the NCI’s clinical trials program into a more integrated network. These changes will require Cooperative Group CCOP Research Bases to undergo a similar transformation. Consequently, all Cooperative Group CCOP Research Base applicants must describe the current status of their transformation and/or how the more integrated network will influence their CCOP Research Base operations and scientific research agenda. In addition, the application must outline plans for the next 12 months pertinent to transformation and/or network integration. Updates on transformation/network integration progress will be required in the Cooperative Group CCOP Research Base annual progress reports.

NOTE: The proposed project period for CCOP Research Base applicants may not exceed 5 years. Because the Groups’ consolidation and integration will be completed within the next several years, Cooperative Group CCOP Research Base applicants may have a new organizational structure before the end of 5 years. Therefore, these Research Base applicants should propose a project period that will provide funding until their newly consolidated and/or integrated Cooperative Group exists. In addition, the proposed project period should include time for submission of the next competing Cooperative Group CCOP Research Base application and notification of a funding decision. Applicants must describe the rationale for the requested project period in relation to their transition plans and transformation into the more integrated network.

a)         A summary of CCOP Research Base activities and major accomplishments focusing on prevention/control trials opened during the past funding period (i.e., 5 years), with an emphasis on the scientific contributions and clinical significance of the completed trials.

b)         Status and relevant publications for active, closed, and completed cancer prevention and control clinical trials conducted in the past funding period (i.e., 5 years).

c)         Accrual to each NCI approved cancer prevention and control clinical trial during the past year to be broken down by CCOPs and MB-CCOPs and Member and Affiliates (see Table 2 under standardized template tables available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply);

d)         Accrual to each NCI approved cancer treatment clinical trial during the past year (see Table 1 under standardized template tables available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply);

e)         Include the patient accrual to prevention and/or control and treatment clinical trial (if applicable) by gender and ethnicity/race composition. (Use the Inclusion Enrollment Report tables. Include in section 5.5.4 Inclusion Enrollment Report.)

f)          Renewal applications with currently funded “prevention member(s)” must describe how the “prevention member(s)” has contributed to the CCOP Research Base’s cancer prevention and control research focus.

g)         Describe contributions of each funded prevention member (if applicable) including, but not limited to, preclinical studies in the development towards chemoprevention protocol(s), chemoprevention protocols, ancillary studies to prevention trials and other research activity relevant to the Research Base’s cancer prevention program. Include data on accruals to chemoprevention trials developed by the Research Base applicant, if applicable.

B. Cancer Prevention and Control Research Program (up to 12 pages)

·       Research Agenda

Applicants should articulate their vision of the prevention and/or control scientific agenda for the proposed Research Base (for the duration of the project period, i.e., 5 years). The cancer prevention and control research agenda should be compatible with the scientific interests of the group and the expertise within the group.

The research plan should provide information on the prevention and/or control clinical trials proposed for the next project period that reflect the Research Bases overarching research agenda. Provide the underlying study hypothesis, study design, and implementation plan for each of the proposed studies.

Provide the long-term plans for the recruitment and retention of participants or patients to cancer clinical trials, including programs or plans for the recruitment and retention of minorities. For any specific programs, describe ongoing evaluations of the efforts to recruit patients/participants from underserved populations.

The CCOP Research Base applicants should demonstrate their ability to provide the CCOPs, Minority Based CCOPs and their member and affiliates with a selection of cancer prevention and control clinical trials of high scientific merit.

For existing CCOP Research Bases (renewal applications), describe how the clinical trials build upon previous trials and their results to further the overall goal of the cancer prevention and control research focus of the Research Base.

As a recommended format of information summary, applicants are strongly encouraged to use Tables 3, 4, and 5 available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply and provide a concise description of the prevention/control clinical trials currently under development (approved concepts, protocols under development), approved and active protocols and concepts in development.

In addition, a new CCOP Research Base application must provide at least two examples of active or proposed cancer prevention/control clinical trials and describe plans for study design, intervention(s), and statistical considerations; access to potential study patients/participants; and procedures for data management, quality control, and follow-up. The availability of the appropriate expertise to design, implement, and analyze the results of the proposed clinical trials must be documented.

A new application must demonstrate that the proposed Research Base can develop a portfolio of treatment clinical trials (if applicable) and cancer prevention/control clinical trials to meet the accrual minimums by the end of the first competing project period. The applicant should use Tables 1 and 2 available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply to provide evidence of capability related to its previous history in accruing to cancer treatment and/or prevention and control trials.

Examples of significant contributions might include:

Establishing community networks of non-oncology medical specialties that participate in Research Base cancer prevention protocols either by accruing to the Research Bases studies or actively developing clinical trials for that Research Base;

Member institutions that accrue large numbers of participants to the Research Base’s large-scale prevention trials and/or support disease-specific multidisciplinary prevention working group(s) that develop the relevant research agenda(s);

Conducting pilot and/or early phase I/II trials pertinent to chemo-preventive agent(s) development;

Research focused on the mechanism(s) of action of chemo-preventive agents;

Correlative studies addressing specific questions that emerge from the conduct of prevention trials; and/or

Research pertinent to recruitment and retention strategies that are relevant to prevention trials.

C. Large-scale Cancer Prevention Trials (only if applicable - up to 6 pages)

Succinctly describe the past experience with large-scale cancer prevention trials. The summary should include information regarding the successful conduct of ongoing or complete cancer prevention trials with an emphasis on the scientific contributions of the trial(s). If the clinical trials are completed, describe research results, the clinical significance, and the availability of resources (e.g., specimen repository) to the extramural research community. If the clinical trials are ongoing, the applicants should include a summary that outlines the major milestones during the past funding period. In addition, provide information as outlined in Table 6 available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply regarding the on-site activities associated with the trial(s).

D. Administrative Core (up to 12 pages)

Appropriate personnel must be included to assure the timely design, development, conduct, analysis, and reporting of cancer prevention/control clinical trials. Include an organizational chart and a description of the Research Base operations showing the relationship(s) between the scientific and administrative units of Research Base organization in conducting clinical trials.

Operations (Data Management and Quality Assurance)

Describe the infrastructure that exists to develop the statistical parameters for clinical trials, analyze the data, and report study results. Include the relevant Standard Operating Procedures used by the Research Base to perform the activities cited above in the Resources section of the application.

Describe the process for managing the data, assuring quality control of the data, monitoring the conduct of the clinical trials, and assuring the safety of participants through the monitoring of the trials. In addition, outline how the independent data and safety monitoring for all prevention/ control clinical trials will be implemented by the Research Base.

The applicant must describe its ability to train and maintain proficiency of personnel from affiliated CCOP and/or Minority-Based CCOP Groups on research techniques required in the successful management of treatment (if applicable) and cancer prevention/control clinical trials. Training activities should include data managers/nurses and any other individuals responsible for data collection, monitoring, and/or carrying out the intervention(s).

Provide the methods used for on-site auditing or monitoring for data verification and assurance of compliance with regulations for the protection of human subjects (e.g., Institutional Review Board approval and informed consent) and investigational drug accountability. In addition, describe the applicant’s ability to conduct periodic performance review(s) of affiliated CCOP and/or Minority-Based CCOP Groups, including on-site monitoring (auditing) and written procedures and criteria for continued affiliations. Periodic reviews of other Research Base member/affiliates institutions participating in cancer prevention/control clinical trials must be described as well.

The applicants should address their compliance with the data sharing policy. See Section IV. 6. Other Submission Requirements. Include the procedures that will be used and a timeline for making the data available. In addition, discuss how the rights and confidentiality of participants are protected.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, with the following modification:

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

NOTE: Requests for funds should reflect costs associated with the design and development of cancer prevention/control clinical trials. The request should also reflect operations/statistical costs for quality control and data management costs for CCOP participation in clinical trials based on the expected accruals from affiliated CCOP/Minority-Based CCOP Groups and for member/affiliate accruals in cancer prevention and control. CCOP-Research Base affiliation agreements must be included. Each application should include a budget for monitoring and auditing activities. Funding can be requested for scientific development and pilot testing of new cancer prevention and control research initiatives (including support of a cancer prevention and control committee(s) for the Research Base), and for appropriate travel to meetings directly related to study activities (such as NCI-sponsored strategy sessions/workshops).

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NCI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI. "Award Administration Information."

NOTE: The applicant should review the Cooperative Agreement Terms and Conditions of Award prior to preparing the application as these terms include information and clarifications needed by the applicant to understanding the complete requirements of a CCOP Research Base award.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the Program to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Program proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a program that by its nature is not innovative may be essential to advance a field.

Significance

Does the Program address an important problem or a critical barrier to progress in the field? If the aims of the Program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the Program? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Program? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the Program involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria - Overall

As applicable for the Program proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

A. Program Overview

·         Leadership Team. Are the qualifications and experience of the PD/PI(s) and the individual(s) directly responsible for cancer prevention/control clinical trials adequate and appropriate for their positions within the Research Base? Are there sufficient and appropriately experienced multidisciplinary health professionals and allied professionals with the skills needed to develop, conduct, and analyze prevention/control clinical trials and treatment trials (if applicable)? Are the relevant prevention/control committees represented and configured with the appropriate expertise? Are the committees well integrated with the Research Base in terms of contributing to the scientific research agenda as well as with other disease committees (if relevant)? What is the likelihood that these committees will be efficient and productive?

Cooperative Group Consolidation and Transformation Plans (Cooperative Group CCOP Research Base applications only). Does the application give a clear picture of of how the CCOP Research Base is transforming operations and integrating its scientific research agenda into one of the consolidated Cooperative Group structure and/or into the more integrated network of Cooperative Groups? Do the plans appear feasible within the timeframe outlined?

If applicable, how sufficient and how significant were the contributions of the prevention members to the activities of the Research Base?

For an application that describes a completed large-scale prevention trial(s), are the research results and/or clinical outcomes significant? What will be the impact of the trial results on prevention of cancer? If the trial(s) is still ongoing, has the study achieved expected milestones per the study design based on when the trial was activated during the past project period?

B. Cancer Prevention and Control Research Program

C. Large-scale Cancer Prevention Trials (if applicable)

How well is the applicant’s team positioned to conduct large-scale clinical trials?

D. Administrative Core

Has the application demonstrated experience in successfully working with community oncologists and orienting their clinical research staff to the study specific requirements?

Will the proposed Research Base have adequate processes and procedures in place for collecting, quality controlling and analyzing the data from multi-institutional clinical trials? Is there adequate data management staff to perform the proposed scope of work? Are the monitoring and auditing plans for study conduct adequate to ensure patient safety and compliance with human subject protections regulations? Are there appropriate and adequate mechanisms for the periodic review of the elements cited above, including the procedures for the data safety and monitoring committees and on-site auditing programs?

Are there adequate plans (and qualified staff) to train CCOP and Minority-Based CCOP Groups on research techniques pertinent to successful management of cancer clinical trials? Will the proposed Research Base have a standard process for a periodic performance review of CCOP, MBCCOP, and member affiliate sites? Is the planned process appropriate to ensure that the performance review is informative and constructive for the participating institutions?

Is the infrastructure for statistical support within the Research Base robust enough to develop the parameters for clinical trials, analyze the study data, and report the research results in a timely fashion?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable.

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Cancer Institute  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board . The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. . More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

Responsibilities of CCOP Research Base Awardees

Throughout these Terms and Conditions of Award, “CCOP Research Base” refers to the organizational structure which is composed of the key personnel (including the designated accruing physicians) and the institutions/organizations of the performance sites, which implement the clinical trials and agree to collaborate on research goals of the NCI Community Clinical Oncology Program and/or Minority Based Community Clinical Oncology Program. In addition, throughout these Terms of Conditions of Award, “Research Base,” refers to all of its member institutions no matter how the membership is defined by a particular Research Base.

The following three documents (and any subsequent modification to them) are hereby incorporated by reference as terms of award. These documents describe the programmatic responsibilities for the conduct of the research supported by this cooperative agreement. The documents are as follows:

It is the responsibility of the Research Base awardee, in accordance with its constitution, bylaws, policies, and procedures, to develop the details of the research design, including definition of objectives and approaches, planning, implementation, analysis, publication of results, interpretations, and conclusions of the clinical trials. The Research Base shall designate Research Base investigators to serve as Study Chairpersons for each proposed clinical trial. All clinical trials will be developed in accordance with the instructions in the INVESTIGATOR'S HANDBOOK (http://ctep.cancer.gov/investigatorResources/investigators_handbook.htm).

The PDs/PIs of the CCOP Research Bases will have the primary responsibility for:

Clinical Trials Development by a CCOP Research Base

The awarded CCOP Research Base is responsible for the development and conduct of high quality cancer prevention/ control clinical trials and treatment trials, if applicable, and for evaluation of the results of such clinical trials. The document that describes the clinical trial (referred to as a protocol) must be reviewed and approved by the Protocol Review Committee for either NCI DCP or NCI DCTD prior to implementation.

The process for submission includes:

A complete description of the submission and review process may be found at http://prevention.cancer.gov/programs-resources/programs/ccop/protodev.

Accrual Requirements for a CCOP Research Base

A CCOP Research Base must meet the following minimal requirements for accrual to clinical trials that a given Research Base has designed and developed:

A new application must develop a portfolio of treatment clinical trials (if applicable) and cancer prevention/control clinical trials to meet the accrual minimums, referenced above, by the end of the first competing project period.

Data Management and Analysis by CCOP Research Base

Data management includes development of: data collection forms; procedures for data transmittal, entry, editing, compilation, analysis, and quality control; and verification of submitted data. Standards should exist for determining eligibility and evaluability of patients/participants entered on clinical trials.

The awarded CCOP Research Base shall establish and implement mechanisms for data management and analysis that ensure:

Data generated are the property of the awardee; however, the CCOP Research Base must provide DCP/DCTD with access to all data generated under this award. In addition, the Research Bases must have a data-sharing plan as required by the extension of NIH policy regarding sharing research resources (see NIH Grants Policy, Part II Subpart A, Availability of Research Results). See also “Applying to Become a CCOP, MBCCOP, or Research Base,” for guidance on the application of this policy to Research Base cooperative agreements at http://prevention.cancer.gov/programs-resources/programs/ccop/apply.

Data must also be available for external monitoring if required by NCI's agreement with other Federal agencies, such as the FDA, OHRP and by NCI's agreements with pharmaceutical companies for the co-development of investigational agents.

Quality Control by CCOP Research Base

Each awarded CCOP Research Base must follow all the policies and procedures for quality control established by NCI.

The CCOP Research Base is responsible for monitoring the progress of each clinical trial following good clinical practices through:

The CCOP Research Base is responsible for ensuring that all performance sites have routine audits that are reported to the NCI in accordance with the NCI/CTMB GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS, CCOP RESEARCH BASES, and THE CANCER TRIALS SUPPORT UNIT (CTSU) http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm. In the event that the NCI determines that the awardee failed to comply with these guidelines, the accrual of new patients/participants to the Research Base's clinical trials at the affected performance site shall be suspended immediately upon notice from the NCI. The suspension will remain in effect until the awardee conducts the required audit and the audit report is accepted by the NCI.

The CCOP Research Base will be responsible for notifying any affected performance site of the suspension. During the suspension period, no funds from this award may be provided to the performance site for new accruals, and no changes to the award for new accruals will be permitted. The NCI will also notify an institution that is the direct recipient of a cooperative agreement from the NCI if it is necessary to suspend accrual at that institution.

Quality Assurance of Data Guidelines for CCOP Research Base

The CCOP Research Base must develop and follow procedures for the assurance of data quality in accordance with Research Base guidelines and NCI policies. The CCOP Research Base must follow NCI-approved procedures for the prevention and/or identification of false or otherwise unreliable data and for quality assurance of data collected. The CCOP Research Base must develop and implement NCI-approved policies for auditing the accuracy of scientific data submitted to them.

Any data irregularities identified through quality control procedures or through the audit program that raise any suspicion of intentional misrepresentation of data must be immediately reported to CTMB/CTEP/NCI. “The CTMB must be notified immediately by telephone [301-496-0510] of any findings suspicious and/or suggestive of intentional misrepresentation of data and or disregard for regulatory safeguards for any of the three (regulatory, pharmacy, and patient care) components of an audit. Similarly, any data irregularities identified through other quality control procedures suspicious and/or suggestive of intentional misrepresentation of data must be immediately reported to CTMB. It is the responsibility of the CCOP Research Base to immediately notify CTMB when they learn of any significant irregularities or allegations related to scientific misconduct by a staff member or institution participating in their research program. It should be emphasized that the irregularity/misrepresentation does not need to be proven; a reasonable level of suspicion suffices for CTMB/CTEP notification. It is also essential that involved individual(s) and/or institutions follow their own institutional misconduct procedures in these matters.

In the event that there is a finding through the quality assurance and/or quality control programs of any indication of a pattern of non-compliance with protocol or regulatory requirements or a finding of possible alteration of data, these findings must be reported in accordance with the NCI-CTMB GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS, CCOP RESEARCH BASES, and THE CANCER TRIALS SUPPORT UNIT (CTSU) http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm

Monitoring Plan and Data Safety and Monitoring Boards for CCOP Research Base

NIH policy requires that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (see the NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998, at http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

The CCOP Research Base must establish and maintain Data and Safety Monitoring Committees (DSMCs) for all Phase III clinical trials in accordance with the NCI’s policy for Data Safety and Monitoring of Clinical Trials at http://grants.nih.gov/grants/policy/hs/data_safety.htm. The CCOP Research Base must comply with the approved policies and procedures of the DSMB. Further, the CCOP Research Base must establish data safety and monitoring plans for all phase I and II clinical trials in accordance with NIH policies at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. A CCOP Research Base may develop standard monitoring plans for Phase I and II trials; however, these plans should be evaluated for appropriateness to each particular clinical trial. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available at http://cancer.gov/clinical_trials. These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB).

Clinical Trial Closure by CCOP Research Base

The CCOP Research Base shall establish a mechanism for interim monitoring of progress and results of the clinical trials. If the CCOP Research Base wishes to close accrual to a study prior to meeting the initially established accrual goal, the interim results and other documentation should be made available to NCI staff for review and concurrence prior to closure. It is recommended that statistical guidelines for early closure be presented as explicitly as possible in the clinical trial document in order to facilitate these decisions. In the event that the DSMC has recommended early closure, DSMC procedures regarding notification of DCP must be followed.

Performance Review by CCOP Research Base

The CCOP Research Base shall establish policies and procedures for credentialing participating CCOP awardees and Minority Based-CCOP awardees and conducting periodic review of the performance and membership status of each performance site conducting prevention/control clinical trials. This review should examine scientific contributions, participant/patient accrual, data accuracy and timeliness, protocol compliance, and audit results.

In addition, procedures for selecting institutions as “Prevention Members” of the CCOP Research Base should be established, if applicable, as well as evaluation criteria for these members’ progress.

Access to CCOP Research Base Data Files by NCI

Upon the request of the Grants Management Officer, NCI, copies of data files and supporting documentation for all NCI-supported protocols that have a major impact on patterns of care, as determined by the NCI, shall be made available to the NCI in a timely manner.

Investigational Drug Management by CCOP Research Base

Investigators performing trials under cooperative agreements will be expected, in cooperation with DCP/DCTD, to comply with all FDA distribution, monitoring, and reporting requirements for investigational agents.

Network Participation of CCOP Research Bases

NCI-funded CCOP Research Bases are part of a national network for conducting cancer treatment and prevention/control clinical trials. As such, each CCOP Research Base may be asked to participate in strategy sessions or workshops and the continuing evaluation of the program and its impact in the community.

Federally Mandated Requirements as Pertinent to CCOP Research Base

Each Research Base must establish mechanisms to meet FDA regulatory requirements for clinical trials involving DCP/DCTD-sponsored investigational agents and DHHS/PHS regulations for the protection of human subjects. These regulations include, but are not limited to, Title 21 CFR 50, 56 and 312 and Title 45 CFR 46.

At a minimum, the CCOP Research Base must be able to:

Affiliations of CCOP Research Bases with CCOP and/or Minority-Based CCOP awardees

CCOP Research Bases must establish guidelines for CCOP and MBCCOP awardees to affiliate (i.e., become members). The awarded CCOP Research Bases must fulfill their promises to affiliate with proposed CCOPs/Minority-Based CCOPs when these groups are actually funded.

Publications by CCOP Research Base

Timely publication of major findings is encouraged. Publication or oral presentation of work done under this agreement requires proper acknowledgment of NCI support. See the NIH Access Policy for specific requirements.

Procedures in the Event of Scientific Misconduct

If a duly authorized governmental or institutional body issues a final determination that scientific misconduct has occurred or if the awardee determines that other events have occurred which have significantly affected the quality or integrity of the Group data or participant/patient safety, the awardee is responsible for notifying the Group Data and Safety Monitoring Committee (DSMC), the CTMB, the collaborating investigators, the appropriate Institutional Review Boards (IRBs), and other sponsors of the affected work.

The awardee is also responsible, if the events described above have occurred, for ensuring that submitted but unpublished abstracts and manuscripts are corrected, if possible. If publication deadlines have passed or if abstracts and/or manuscripts containing the affected data have already been published, the awardee is responsible, within 90 days after learning of the event(s) significantly affecting the quality of the Group data or participant/patient safety, for submitting to NCI a re-analysis of the results deleting the false or otherwise unreliable data, and disclosing within the text the reason(s) for the re-analysis. The awardee must submit the re-analysis for publication. The NCI may disseminate information about the re-analysis as broadly as it deems necessary.

The awardee must use its best efforts to notify all scientists, research laboratories, and other organizations to which the awardee has sent research materials affected by false or otherwise unreliable data.

True copies of data files and other supporting documentation from studies affected by scientific misconduct or other findings affecting the quality or integrity of data or participant/patient safety shall be made available to the NCI in a timely manner upon the request of the Grants Management Officer, NCI. The NCI reserves the right to re-analyze, to publish, or to distribute its analyses of these data when it is in the interest of public health. Prior to release, publication or distribution of such analyses, the NCI will provide such analyses to the awardee.

Notification of Participants/patients by the Awardee during Participants/patient’s Lifetime

In order for there to be an appropriate response in the event the NCI determines, either while a clinical trial is active or (if relevant) during the lifetime of the participants following the trial’s closure, that a medically important toxicity or side effect is associated with the study intervention or that the medical care of one or more participants may have been compromised by scientific misconduct or other finding affecting the integrity of the data or patient safety at the awardee institution or at a third-party institution, funded or unfunded, the awardee shall assure that the institution(s) responsible for these participant(s') accrual, whether funded or unfunded, will have procedures in place to: (1) contact each participant individually at his or her last known address on file with the institution and give each participant contacted appropriate information and the right to communicate with an appropriate institutional representative and, in the event of misconduct, to meet with a physician not connected with the clinical trial or study in which the participant has participated; and (2) encourage participants to notify the institution of any changes of address. The procedure must provide for informing the participants fully of the consequences of the toxicity or misconduct for their care and well-being, if any, and the availability of follow-up; and their opportunity to examine any portion of their medical records relevant to the potential effect of the toxicity or side effect upon them or that may be affected by scientific misconduct or other findings affecting the quality or integrity of the data or participant/patient safety.

It is understood that under regulations at 45 CFR Section 74.53, NCI has a right of access to research records pertinent to the NCI funding. In exceptional circumstances, such as a public health emergency, the institutions will be required to provide participant names and treatments to the NCI in a format that allows direct notification of the participant/patient by the NCI.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

A National Cancer Institute (NCI) Division of Cancer Prevention (DCP) Program staff member(s) will have substantial programmatic involvement acting as a Project Scientist(s) or Project Coordinator(s). Additional NCI staff members may be designated to have substantial involvement (e.g., in the role of Project Coordinators). The NCI Project Scientist(s)/Coordinator(s) will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is deemed essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.

Additionally, an NCI Program Director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Some Program Officials may also have substantial programmatic involvement (as Project Scientists/Coordinators). In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications or will seek NCI waiver as stated above.

The main NCI responsibilities pertinent to CCOP Research Group awards include the following activities:

Review of Clinical Trials in CCOP Network

Monitoring, Investigational Drug and Data Management

Approval of CCOP Organizational Changes

The NCI Program staff members will review organizational change request and provide a written response. Organizational changes requiring NCI approval are outlined in “Guidelines for Approval of CCOP Organizational Changes,” available at http://prevention.cancer.gov/programs-resources/programs/ccop/resource.

Program Review and Federally Mandated Requirements

The main NCI responsibilities pertinent to CCOP Research Base awards include the following activities:

Scientific Resource

NCI DCP Project Scientist(s) and/or Project Coordinator(s) will:

Clinical Trial Development, Review, and Closure

DCP/NCI Project Scientist(s) and/or Project Coordinator(s) will:

Communicate, as appropriate, with the Research Base during all stages of clinical trial development;

Data Management and Analysis

Quality Control, Data Monitoring, and Investigational Drug Management

Program Review, Strategy Sessions and Federally Mandated Requirements

Areas of Joint Responsibility include:

Execution of this program will require collaboration among the PDs/PIs of the CCOP Groups and CCOP Research Bases, the DCP Project Scientists(s) and staff as well as NCI DCTD CTEP Program officials and staff, and/or its designees/contractors as described above.
 
Dispute Resolution:

Any disagreement(s) that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as decribed in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Additional Reporting Requirements for Research Base awardees

A suggested format for Research Base specific information relative to the progress summary section of the Form PHS 2590 will be provided. The format is available at https://ccop.nci.nih.gov/. An update on clinical trials, in development, and clinical trials that were approved, activated, closed and/or completed during the relevant budget period should be discussed in the progress summary. Plans pertaining to clinical trial activities for the next budget period should be addressed as well. An annual performance report on each affiliated CCOP must be included. The performance report will include, at a minimum, information on: overall case accrual; cancer prevention/control clinical trials research, existing or planned; eligibility and evaluability of patients/participants entered on study; timeliness and quality of data reporting; and results of quality control review and audits if performed during that year.

Consolidation/Transformation Updates.

Coopeative Group CCOP Research Base applications will need to include updates on the transformation/network integration progress in the annual progress reports.

A Research Base must submit a list of the participating sites as defined by the NCI DCTD CTEP Clinical Trials Monitoring Branch along with the audit schedule of these sites in the annual progress report.

Clinical Trials Reporting Requirements

Reporting requirements will be in agreement with FDA regulations and NCI procedures. Interim reports of each activated and ongoing clinical trial shall appear in the minutes of each Research Base meeting and shall include specific data on patient/participant accrual as well as, when appropriate, detailed reports of treatment-associated morbidity. Quarterly accrual reports must be provided as appropriate to CTEP for all active trials through the NCI’s Clinical Data Update System (CDUS). Instructions and Guidelines for CDUS are at http://cancer.gov/reporting/cdus.html.

Adverse Event Reporting Procedures

To comply with FDA regulations, all recipients of NCI support for clinical trials, including Research Bases responsible for coordinating and monitoring such trials, must promptly report adverse events (including adverse drug reactions) to the NCI and any other trial sponsor(s) according to NCI Guidelines. For treatment trials utilizing CTEP investigational agents, guidelines are listed at http://ctep.cancer.gov/reporting/adeers.html. For cancer prevention and control trials utilizing DCP investigational agents, guidelines are listed at http://prevention.cancer.gov/clinicaltrials/management/pio.

The awardee will notify all institutions/investigators participating in this project, funded or unfunded, about the above requirement and about the institutions'/investigators' responsibility to report adverse events as specified in the protocol.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Lori Minasian, MD
National Cancer Institute (NCI)
Telephone: 301-496-8541
Email: minasilo@mail.nih.gov

Peer Review Contact(s)

Referral Officer
Division of Extramural Activities
National Cancer Institute (NCI)
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Sean Hine
National Cancer Institute (NCI)
Telephone: 301-496-2182
Email: hines@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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