Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI)
Funding Opportunity Title	Community Clinical Oncology Program Groups (U10)
Activity Code	U10 Cooperative Clinical Research Cooperative Agreements
Announcement Type	Reissue of RFA-CA-10-010
Related Notices	June 8, 2012 - This RFA has been reissued as RFA-CA-12-007.
Funding Opportunity Announcement (FOA) Number	RFA-CA-11-006
Companion FOA	U10, RFA-CA-11-007 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 accrual groups for the NCI-supported Community Clinical Oncology Program (CCOP) Network. CCOP was established in 1983 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 mission includes: (1) accelerating development of interventions to prevent and treat cancer and its symptoms by increasing accrual to trials; (2) fostering quality care in the community through adoption of results from clinical trials; and (3) increasing the involvement of minority and underserved patient/participant populations in cancer clinical trials and associated research. The CCOP Network consists of three components each with its own FOA. The components are as follows: CCOP Groups (also referred to as CCOPs, covered by this FOA), Minority Based-CCOPs, and CCOP Research Bases. 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.

Posted Date	May 24, 2011
Letter of Intent Due Date	June 27, 2011
Application Due Date(s)	July 27, 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 28, 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.

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

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 major 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 NCI Cooperative Groups and Cancer Centers that serve as their CCOP Research Bases.

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 (this FOA);
• Minority Based CCOP Groups (see RFA-CA-11-008); and
• CCOP Research Bases (see RFA-CA-11-007).

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 that 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 is typically affiliated with a NCI-designated Cancer Center or an NCI-funded Clinical Cooperative Group. The role of CCOP Research Bases is to design clinical trials for use in the CCOP Network. Research Bases also conduct the clinical trials, manage and analyse the data, and report the results. Cooperative Group-affiliated CCOP Research Bases design and conduct both cancer treatment and cancer prevention and control clinical trials. Cancer Center-affiliated CCOP Research Bases design and conduct only cancer prevention and control clinical trials.

Definition: Cancer prevention/control clinical trials include the 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 or to treat symptoms arising from cancer or toxicities arising from cancer therapy; and ways to improve continuing, palliative, and end-of-life care.

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 chemo-prevention 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, which were located in 28 states and included more than 340 hospitals and more than 3,000 physicians. The CCOPs enrolled approximately 9,225 patients to treatment and prevention and control trials in 2010. 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.

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 $14.3 million for 15-16 awards. Future year amounts will depend on annual appropriations.
Award Budget	Application budgets are not limited, but need to reflect actual needs of the proposed project. Because the nature and scope of the proposed research will vary from application to application, the size of each award will also vary.
Award Project Period	The total project period proposed may not exceed 3 years for new applications and 5 years for renewal applications.

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.

Higher Education Institutions:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For profit Organizations

• For-Profit Organizations (Other than Small Businesses)

Governments

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Native American tribal organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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 CCOP Group applications, the following eligibility provisos apply:

• An application may be submitted by a community institution defined as a hospital, a clinic, a group of practicing physicians, a health maintenance organization (HMO), or a consortium of hospitals and/or clinics and/or physicians and/or HMOs that agree to work together with a PD/PI and a single administrative focus;
• A university, Veterans Administration (VA) hospital, or military treatment facility (MTF) may be included in an application as a member of a consortium led by a community institution, but may not be the applicant organization or the major contributor to patient accrual;
• A non-university clinical trials cooperative group member that is not currently funded by NCI is eligible to apply; and
• Institutions funded as clinical trials cooperative group affiliate programs are eligible to apply, but should state in the application that support through this mechanism will be relinquished if a CCOP cooperative agreement is awarded.

Institutions not eligible to apply for the CCOP Group awards include:

• An NCI-funded Cancer Center;
• A university hospital that is the major teaching institution for that university; and
• A university hospital clinical trials cooperative group member funded by the Division of Cancer Treatment and Diagnosis (DCTD), NCI

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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

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.

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.

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

Only one application per institution is allowed.

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.

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

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.

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: [email protected]

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: [email protected]

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exception: Section 3. Research Strategy of the PHS 398 Research Plan must consist of the new sub-sections A D with the following individual limits:

• A. Program Overview - 12 pages
• B. Research Program - 12 pages
• C. Leadership - 6 pages
• D. Administrative/Data Management Core - 12 pages

Standardized table templates are available at http://prevention.cancer.gov/programs-resources/programs/ccop/apply. Applicants are strongly encouraged to use templates for Table 1, 2, 3A, 3B, 4 and 5 and 8 for the inclusion as part of the Resources section.

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

Section 3. Research Strategy must consist of the following new sub-sections A D (see details below).

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 Group (renewal application) must include a progress report under Section 3. Research Strategy, sub-section A Program Overview.

A. Program Overview (up to 12 pages)

• Background and Experience. Describe the group’s history and experience in conducting NCI-sponsored clinical trials, in particular, Cooperative Group trials. The application should provide details of experience working together as a group, particularly in implementing cancer prevention/control/treatment clinical trials and related activities.
• Catchment Area. The application must delineate its catchment area. A map of the service area, designating counties or zip codes from which approximately 80 percent of the patients will be drawn, should be provided. Applicants should describe experience serving minority and underserved populations in cancer and related care. In addition, provide an estimate of the oncologists (i.e., percent) in the service that will participate in the CCOP. A description of other cancer care resources in the catchment area (i.e., hospitals, clinics, physicians, cancer centers) that are not part of the application should be included. A description of the study population in the application’s catchment area, with a breakdown by percentage of the gender and minority composition, should be provided.
• Organizational Structure. The application must describe the current and/or planned organizational structure under which it proposes to operate. An organizational chart showing how the group will function must also be included. If the CCOP has more than one component/affiliate institution, describe the relationship of component(s)/affiliate(s) to each other and to the CCOP headquarters. Include a diagram showing the distance between these institutions (including administrative office and shared resources) and location of proposed personnel.

The availability of facilities, including laboratories, inpatient and outpatient resources, cancer registries, etc., must be described. A statement of commitment from each participating institution or organization. Note: Include letters of institutional commitment under Section 14. of Research Plan "Letters of Support" (e.g., Consultants) and/or documentation of consortium arrangements must be provided. Note: Include Letters of Intent to Establish a Consortium under Section 14 of Research Plan "Letters of Support". Applicants, whose applications are considered for funding, will have to provide fully executed consortium agreements as a Just-in-Time requirement). In addition, each application must have a defined space for administrative activities and administrative personnel that will serve as a focus for data management, quality control, and communication. The description of this space may be included under the Resources section or under Organizational Structure.

• Progress (Renewal Applications only). Include a progress report describing the group’s accomplishments relative to participation in NCI-approved cancer clinical trials and contributions to the research agenda of its affiliated Research Bases over the current funding period (i.e., 3-5 years). Include a summary of accrual to NCI-approved cancer prevention/control and treatment trials over the past project period. (Use of template Tables 7A and 7B available at: http://prevention.cancer.gov/programs-resources/programs/ccop/apply is highly recommended). In addition, template Tables 6A and 6B may be used to detail accrual to cancer clinical trials by physicians for the past 3 years.
• Relevant Accomplishments (New Applications only). Describe the group s accomplishments relative to implementing cancer clinical trials in the group s practice setting(s) and provide a detailed summary of the group’s accrual to cancer trials template Tables 6A and 6B are available at: http://prevention.cancer.gov/programs-resources/programs/ccop/apply. In addition, describe the group’s contributions to the research agenda of its affiliated cooperative groups during the past 3 years (if any).

B. Research Program (up to 12 pages)

• Research Plans. The application should describe the group’s plans and approach to implementing and conducting NCI-approved cancer clinical trials in the practice setting(s) of the community it serves. The plans should cover the next 3 years (for new applications) and 5 years (for renewal applications). The plans should include a description of how the CCOP Group will access an adequate selection of cancer prevention/control/treatment clinical trials to meet or exceed accrual requirements and/or planned accrual goals, as well as provide appropriate trials to the participants/patients in the CCOP Group s catchment area. Applications should describe in narrative form the type of treatment trials the CCOP Group expects to activate as well as a detailed listing of the projected cancer prevention/control trials. Table 9 template is available at: http://prevention.cancer.gov/programs-resources/programs/ccop/apply. Trial access must be documented through formal affiliations with Research Bases. The conditions of affiliation must be provided in the CCOP Research Base affiliation agreement(s).

The process the CCOP group uses to select trials and the recruitment and retention plans for the selected trials should be described. The CCOP Groups outreach efforts and methods for engaging the community its serves should be described as well. The CCOP Group’s plan for recruiting women and minority populations must be described and may be included under Section 5.5.7 Inclusion of Women and Minorities.

The application should describe the CCOP Group s interactions with its Institutional Review Board(s) and the processes it has for ensuring compliance with regulations for Institutional Review Board (IRB) approval and informed consent (compliance with 45 CFR 46) related research involving human subjects. The description may be included under Section 5.5.6 Protection of Human Subjects of the application and cross-referenced to this section of the Research Plan.

The research base(s) affiliations should be described in the application. Table 8 is available at: http://prevention.cancer.gov/programs-resources/programs/ccop/apply and may be included in the Resources section of the application. Copies of affiliation agreements should be included under Section 14. Letters of Support. The rationale for choosing these research base affiliations should be discussed. In addition, the application should outline its plans for contributing to the scientific agenda as well as the infrastructure of its affiliated research bases over the next project period. Examples of contributions might include such activities as: participation/membership in research base committees; serving as chair(s) on cancer clinical trials; authorship of joint publications, etc. Information coming from the community via the CCOP Group that informs the research base scientific agenda should also be described.

• Accrual Goals: Each application must include plans for achieving accrual goals to cancer prevention/control trials and treatment trials over the next project period. Plans must list estimated accrual to specified NCI-approved trials by participating physicians (current or proposed). Use of template Table 6A and 6B is recommended and they are available at: http://prevention.cancer.gov/programs-resources/programs/ccop/apply. A narrative explanation of the CCOP group’s projected accrual goals is allowable. Applications must include evidence that the CCOP Group can meet or exceed the required 50 new participants/patients accruals to cancer prevention/control trials and 50 new participants/patients accruals to cancer treatment trials, annually. Exceptions to this requirement are described under Section VI. 2. A. Cooperative Agreement Terms and Conditions of Award, Accrual Requirements for CCOP Awardee. In addition, provide statistics on the numbers of patients on treatment trials who are still being followed per protocol requirements, if applicable.
• Prevention/Control Participation: The application should describe the type of cancer prevention/control trials the CCOP Group plans on implementing during the next project period. In addition, the application must describe implementation plans for at least two NCI-approved cancer prevention/control clinical trials that use an intervention, such as a trial of a chemopreventive agent or a trial to study an intervention/agent for the treatment of a cancer symptom. The application should include specifics on patient/participant recruitment, compliance and follow-up, etc. The clinical trials selected must come from CCOP Research Bases with which the CCOP Group is or proposes to affiliate.

C. Leadership Structure (up to 6 pages)

• Key/Senior Personnel. A designated PD/PI is required. A substitute PD/PI candidate should be identified to assure continuity in the event of resignation of the PD/PI. The qualifications and experience of both persons must be described, specifically documenting their respective abilities to organize and manage a community oncology program that includes cancer prevention/control/ treatment clinical trials and related activities, as well as experience in accruing patients/participants to clinical trials. In addition, the application should describe the strategy used by the PD/PI and Institutional official to delegate leadership responsibility with respect to the trials selected for activation by the CCOP Group and how the responsibility is delegated among key/senior individuals.

As the leader of the CCOP Group, it is expected that the PD/PI will play a leadership role in some capacity to the community served by the Group. The application should describe the leadership role played by PD/PI and other Senior/Key personnel (if applicable) and the impact it has on the success of the CCOP Group as well as on the overall community.

In addition, the application should describe the leadership positions held by the PD/PI with the CCOP Group’s affiliated research bases as well as contributions made in that position along with its impact. Parallel descriptions should be given for other Senior/Key personnel, if applicable.

A mentoring plan or program for leadership succession within the CCOP Group is recommended to ensure a smooth transition of leadership if and when necessary. If such a plan exists or is under development, it should be described in the application.

The application should propose a committed group of multidisciplinary professionals appropriate for its expected clinical trials participation. This team should include medical oncologists, surgeons, radiation oncologists, pathologists, oncology nurses, data managers, health educators, and personnel representing other apropriate disciplines (e.g., gynecology, urology, gastroenterology, pediatrics, internal medicine, family practice), as appropriate. A description of the team, how they operate and interact, and how they lend their expertise to achieve the goals of the CCOP Group should be provided.

D. Administrative/Data Management Core (up to 12 pages)

• Operations. The application should describe the CCOP Groups standard operating procedures and how the workflow is implemented for choosing trials to activate, accruing and following participants/patients, and collecting and managing the data associated with the trials and trial accrual. Describe the hierarchy the Group has in place to oversee the day to day operations for conducting clinical trials. In addition, describe the plans for communication among physicians and component/affiliate institutions and incentives for participation in clinical trial accrual. The qualifications, experience, and proposed duties of all proposed support personnel should be described.
• Data Management & Quality Assurance. The internal quality assurance plan and procedures of the CCOP Group must be described in detail. Assurance of quality is the joint responsibility of the CCOP Group and its affiliated Research Bases. Procedures for data management and investigational drug monitoring must be described in the application. For data management procedures, include details on who is responsible for data management overall; what is the source of records (e.g., hospital, office, clinic, registry); who will register patients on trials; how will the information flow (provide flow chart); who will enter data on primary patient records and study forms (e.g., nurses, physicians, data managers, secretaries); who will collect and send patient materials (e.g., pathology slides, port films, etc.) to the Research Bases if required; what records (study flow sheets, reminder slips) will be included on patient charts; how will data be transmitted (e.g., batch mode or as real-time); and are mechanisms are in place for electronic data transfer. In addition, describe data management operations within and between components/affiliates and the central CCOP office, if applicable. Describe how NCI and Food and Drug Administration (FDA) requirements for investigational drug management are handled.

The summary audit report(s) of CCOP Group performance by affiliated CCOP Research Base(s) should be provided. These reports may be included under Section 5.5.6 Protection of Human Subjects. A brief description of the overall summary audit(s) results should be included in this Administrative & Data Management sub-section of the Research Plan and cross referenced to the actual summary audits reports.

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:

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

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.

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.

This initiative is not subject to intergovernmental review.

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.

Budget requests may include the following allowable items:

• Partial support for the PD/PI(s) and Associate PD/PI salary but ONLY for time spent on CCOP Group organizational/administrative tasks.
• Salary support for full or part-time research nurses, administrative personnel, data managers, and study assistants;
• Supplies and services directly related to study activities (e.g., processing and sending material for pathology review, processing and sending port films for radiation therapy quality control);
• Handling of investigational drugs related to NCI-approved protocols;
• Travel to meetings directly related to study activities (e.g., research base meetings, NCI-sponsored strategy sessions/workshops, local travel); and
• Special personnel resources needed to support the recruitment and retention of eligible minority patients on clinical trials.

The following items are NOT allowed in the budget requests:

• Costs of clinical care provided to patients (e.g., for patient care reimbursement, transportation costs);
• Salary support for clinical support personnel (e.g., physicist, clinical psychologist, and dosimetrist); and
• Physician compensation (other than specified above for PD/PIs and associate PD/PI for their CCOP-related administrative activities)

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 the NCI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

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 award.

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

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.

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).

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 program 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 program?

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 program 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 program proposed? Will the program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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

• Background and Experience. How adequate is the experience of the applicants team in conducting NCI cancer clinical trials and working together as a group in implementing clinical trials? Is the overall team of professionals participating in the CCOP Group appropriate and adequate to achieve the goals and aim of the program?
• Catchment Area. How nearly complete is the information provided on the catchment area (including geography, population, location, and number of components, presence of cancer care resources that are not part of the application)? Given these data, is the patient population large enough and do the physicians affiliated with the proposed CCOP Group see enough of these patients to ensure that the CCOP Group will be able to meet or exceed the accrual requirements?
• Organizational Structure. How appropriate is the planned organizational structure to accomplish the proposed research activities?
• Institutional Commitment. Does the structure appear realistic and is there adequate institutional commitment? How convincing are the supporting documents from participating institutions? Are the available facilities, including laboratories, in-patient and outpatient resources, cancer registries, and space for administrative activities adequate to support the proposed research activities?
• Progress (Renewal Applications). How significant was the involvement and/or contributions of the CCOP Group to its affiliated research bases in the current funding period (relative to its size and capacity)? How successful was the CCOP Group in meeting or exceeding the minimum annual accrual goals (for cancer prevention/control and treatment trials)?
• Relevant Accomplishments (New Applications). How relevant are the group’s accomplishments in implementing cancer clinical trials in the group s practice setting(s) to the goals and requirements for CCOP Groups?

B. Research Program

• Research Plans. Are the CCOP group’s plans for implementing NCI-approved cancer clinical trials well thought out and appropriate for the Group s structure and capacity? What is the likelihood that the applicant team will have access to the appropriate and adequate numbers of clinical trials to achieve their proposed objectives?

Does the existing CCOP Group (or new Group applicants) have in place an appropriate process for selecting clinical trials that fits their structure? Does the process include appropriate CCOP Group team members?

Are the recruitment/retention plans and outreach plans described likely to be effective?

How effective is the existing CCOP Group (or new Group applicants) in engaging the community served? How relevant are these activities to the goals and roles of CCOP Groups?

Are the affiliations of the CCOP Group with Research Base(s) appropriate and consistent with the rationale provided in the application?

• Accrual Goals. Are the proposed participant accrual plans matching the history of accrual by the applicant team, the overall size of the proposed Group, and the catchment area served? What is the likelihood that the applicants will be able to achieve the required minimal numbers of 50 participants per year recruited into prevention/control trials and 50 participants per year recruited into treatment clinical trials annually, over the proposed project period? Are they capable of achieving significantly higher levels of accrual?
• Prevention/Control Participation. How well do the implementation plans for the prevention/control trials address issues relevant for clinical trial management and study specific requirements? How knowledgeable is the CCOP Group applicant team with respect to good clinical practices related to regulatory requirements, data collection and data management?

C. Leadership

• Key/Senior Personnel. Are the qualifications, training, and experience of the PD/PI /associate PD/PI appropriate for organizing and managing a community oncology clinical research program that includes accrual to NCI approved treatment and prevention/control clinical trials as well as related activities?

Has the PD/PI demonstrated effective leadership abilities in the community served by the CCOP Group and/or to the affiliated research bases of the Group? Have other Key/Senior personnel taken on leadership roles that contribute to the success of the CCOP Group and/or the research agenda of the affiliated research bases?

D. Administrative/Data Management

• Operations. Are the management structure, standard operating procedures, and workflow processes for conducting clinical trials clear and adequate for the proposed program goals? Are the personnel and their duties appropriately matched?

Is the quality assurance plan/program for data management and investigational drug monitoring described with sufficient detail to assess it completeness? Does the plan/program appear to be robust enough to accomplish its objectives?

Do the audit report evaluations reflect that the CCOP Group (new or renewal) is in good standing overall or do they reflect problems that are of concern?

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 program 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 program.

Renewals

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

Revisions

Not Applicable

As applicable for the program 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.

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:

• Will receive a written critique.

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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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.

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.

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 program 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 Group Awardees

Throughout these Terms and Conditions of Award, CCOP awardee 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, including those designated as affiliates and CCOP components, all of whom agree to collaborate on research goals of the NCI Community Clinical Oncology Program.

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:

• INVESTIGATOR'S HANDBOOK, a Manual for Participants in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatment and Diagnosis, (DCTD), National Cancer Institute (http://ctep.cancer.gov/investigatorResources/investigators_handbook.htm);
• 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); and
• Intellectual Property Option to Collaborator (http://cancer.gov/industry/ipo.html).

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

• Overseeing the implementation of the Clinical Trials across the CCOP awardee investigators;
• Assuring that all Human Subjects Requirements are met by all accruing physicians;
• Ensuring appropriate Quality Assurance/Quality Control is in place for complete and accurate data collection;
• Submitting 6, 9 and 12 month accrual reports in a standard format as described at http://prevention.cancer.gov/programsresources/programs/ccop/resource;
• Submitting annual Progress Report PHS 2590 to the NCI Program Official;
• Attending periodic NCI strategy meetings and meetings of affiliated CCOP Research Bases;
• Reporting any findings of suspicious or suggestions of intentional misrepresentations of data to the NCI Program official and the Research Base PD/PI; and
• Overseeing all other activities and specific responsibilities of CCOP Research Group defined below.

Appropriate Clinical Trials for Accrual Requirements

To receive credit for accruals the CCOP awardee must access NCI-approved treatment and prevention/control clinical trials through the CCOP Research Bases with which CCOP awardee has affiliation agreements. The CCOP awardee also may access treatment trials from Research Bases with which it is not affiliated through the NCI’s Cancer Trials Support Unit (CTSU). Accruals by CCOP awardees to CTSU protocols will receive credits (towards the required accrual quotas) and not per case reimbursement.

All clinical trials originating at the CCOP Research Bases must be reviewed and approved by the Protocol Review Committee of the Division of Cancer Prevention (DCP) or the Division of Cancer Treatment and Diagnosis (DCTD), NCI, prior to implementation.

Research Base Affiliations

Each CCOP awardee must affiliate with one national multi-specialty cooperative group having a spectrum of cancer treatment and prevention/control clinical trials. As an exception, CCOP awardees may be granted permission to affiliate with more than one multi-specialty group, if the CCOP awardee participates in NCI-sponsored pilot projects. In addition, each CCOP awardee may affiliate with as many other Research Bases (exclusive of the multi-specialty groups) as the CCOP deems appropriate.

Typically, an established CCOP Group is expected to affiliate with approximately four to six CCOP Research Bases (in addition to its affiliation with multi-specialty cooperative group). Through these affiliations, the CCOP awardee must ensure an access to an adequate selection of clinical trials for its patient population and to meet/or exceed the minimum accrual requirements.

If participation of the CCOP awardee in the clinical trials of one CCOP Research Base competes with that of another CCOP Research Base with which the CCOP awardee is affiliated, the CCOP must prioritize the protocols to avoid bias in the allocation of participants/patients to competing protocols.

Note: A list of eligible Research Bases may be obtained from the CCOP Web pages at http://prevention.cancer.gov/programs-resources/programs/ccop/rbccop or by contacting the Community Oncology and Prevention Trials Research Group (COPTRG), DCP, NCI, at (301) 496-8541.

When circumstances require changes in Research Base affiliations, prior written approval from the DCP Program Director is required. The Guidelines for Approval of CCOP Organizational Changes is available at http://prevention.cancer.gov/programs-resources/programs/ccop/resource

Accrual Requirements

Each CCOP awardee must accrue a minimum of 50 participants/patients per year to cancer prevention/control clinical trials.

• The quotas of newly accrued participants may be, in part, fulfilled by listing active follow-up of participants previously accrued to multi-year chemoprevention trials. For purposes of meeting accrual targets, however, ten participants in active follow-up are needed to substitute for three participants enrolled in cancer prevention/control trials.
• The minimum for cancer prevention/control accruals may be waived for applicants whose specialty is pediatrics and who are able to enroll a majority of their eligible participants/ patients on cancer prevention/control trials.

Each CCOP awardee must accrue a minimum of 50 participants/patients per year to treatment clinical trials. The minimum of 50 treatment participants/patients may be waived in case of:

• CCOP awardees that participate only in pediatric cancer clinical trials and able to place the majority of their eligible participants/patients on treatment trials; and/or
• CCOP awardees with outstanding records in accrual to cancer prevention/control trials.

Quality Control Guidelines

In accordance with CCOP Research Base guidelines and NCI policies, the CCOP awardee must establish and follow procedures for the assurance of data quality and for the prevention and/or identification of false or otherwise unreliable data. The CCOP awardee must follow policies developed by the CCOP Research Bases with which they are affiliated. Any data irregularities identified through quality control procedures or through the audit program that raise the suspicion of intentional misrepresentation of data must be reported to the NCI DCP Program Director within 24 hours. COPTRG must be notified by telephone (301-496-8541) of any findings suspicious or suggestive of intentional misrepresentation of data and/or disregard of regulatory safeguards for any of the three components (regulatory, pharmacy, and patient care) within an audit. It should be emphasized that a reasonable level of suspicion is sufficient to warrant notification to NCI of irregularity and/or misrepresentation.

Data Management

The CCOP awardee must provide the NCI DCP Program Director with access to all data generated under this award for periodic review of data management procedures of the CCOP. Data must also be available for external monitoring if required by NCI's agreement with other federal agencies, such as the FDA, OHRP, and with NCI's agreements with pharmaceutical companies for the co-development of investigational agents. The awardees will retain custody of and primary rights to their data.

Investigational Drug Management

Investigators performing trials under cooperative agreements will be expected, in cooperation with NCI, to comply with all FDA monitoring and reporting requirements for investigational agents. Specifically, all CCOP investigators accruing participants/patients must have an active FDA Form 1572 on file with the Pharmaceutical Management Branch, Clinical Trials Evaluation Program (CTEP), DCTD, NCI.

Monitoring Activity Requirements

Each CCOP awardee must agree to periodic on-site audits by representatives of its CCOP Research Base(s), NCI, or an NCI-designee. Such on-site audits may include review of the following:

• use of investigational drugs;
• compliance with regulations for Institutional Review Board (IRB) approval and informed consent (compliance with 45 CFR 46);
• compliance with clinical trial specifications;
• quality control and accuracy of data recording; and/or
• completeness of reporting adverse drug reactions.

The performance sites designated as affiliates and CCOP components and the individual accruing investigators participating or collaborating with the CCOP awardee must be in compliance with the monitoring standards established by the CCOP Research Base(s) and stated in the NCI 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).

Sites found not to be in compliance with the NCI monitoring guidelines may be suspended from participating in Research Base trials until compliance can be confirmed by NCI/CTMB.

Specifically, the institutions/organizations representing performance sites must adhere to the following standards:

• Medical records submitted in support of NCI multi-institutional trials must conform to usual standards for the maintenance of clear, accurate, and unambiguous medical records. White-out corrections on medical records are unacceptable;
• If it is the usual and customary practice of a department, laboratory, clinic, or office to prepare or issue official reports, then only that department, laboratory, clinic, or office can change the report, and alterations of the medical record must be initialed and dated by the person making such alterations (for clinical progress notes, the change must be dated and initialed by the person making the change, and only one line should be placed through the initial entry, so that both the original entry and the change are legible); and
• Improper modification of important participant/patient records will result in additional investigations by the NCI DCTD Clinical Trials Monitoring Branch (CTMB) and may lead to suspension of accrual and funding.

CCOP Radiotherapy Equipment

Radiotherapy equipment must have its calibration verified according to standards set by the Radiologic Physics Center (RPC) in order for institutions to participate in clinical trials requiring radiation therapy, as required by the affiliated Research Base(s).

Organizational Changes in a CCOP

Certain organizational changes in the structure of a CCOP awardee must have the prior written approval of the DCP Program Director. These changes include the addition/deletion of a participating physician, a health professional other than a physician (who is active in enrolling participants/patients to cancer treatment, prevention and control trials), an affiliate, a component, or a Research Base affiliation. The Guidelines for Approval of CCOP Organizational Changes is available at http://prevention.cancer.gov/programs-resources/programs/ccop/resource

CCOP Network Participation

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

Logging Patients/Participants

Each CCOP awardee may be asked to maintain a new patient/participant log or minimal registry to include as applicable age, sex, race, insurance status, risk factors, primary site of cancer, stage of disease, and disposition for the potentially eligible patient/participant pool seen by the CCOP investigators.

Federally Mandated Requirements

Each CCOP awardee must establish mechanisms to meet DHHS/PHS regulations for the protection of human subjects. Appropriate documentation must be available for review. At a minimum, these requirements include the following:

• Current and approved Federal Wide Assurance (FWA) is on file with the Office of Human Research Protection (OHRP) for each facility in which CCOP investigators are conducting clinical trials;
• Each and every clinical trial is reviewed by the responsible IRB prior to participant/patient entry;
• Each and every clinical trial is reviewed annually by the IRB as long as the protocol is active;
• Every participant/patient (or participants/patient's parent/legal guardian) gives fully informed written consent to participation in a clinical trial prior to the initiation of the experimental intervention;
• Timely reporting of all serious and unexpected toxicities to the appropriate sponsor to include Investigational Drug Branch, CTEP, DCTD, according to DCTD guidelines and/or to DCP according to DCP guidelines;
• Implementation of DCP/DCTD requirements for storage and accounting for investigational agents provided under DCP/DCTD sponsorship; and
• Education on the protection of human research participants for all investigators involved in the design or conduct of research involving human subjects.

For other Federally mandated requirements see the following Federal citations:

• Human Subjects Protection (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm);
• Data and Safety Monitoring Plan (http://grants.nih.gov/grants/guide/notice-files/not98-084.html);
• Sharing Research Data (http://grants.nih.gov/grants/policy/data_sharing);
• Access to Research Data through the Freedom of Information Act (http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm;
• Inclusion of Women And Minorities in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html) and http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm;
• Inclusion of Children as Participants in Clinical Research (http://grants.nih.gov/grants/funding/children/children.htm). ;
• Required Education on the Protection of Human Subject Participants http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html);
• NIH Public Access Policy (http://www.nihms.nih.gov/ and http://publicaccess.nih.gov/
• Standards for Privacy of Individually Identifiable Health Information (http://www.hhs.gov/ocr/ and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html)
• Authority and Regulations (http://www.cfda.gov/ and http://grants.nih.gov/grants/policy/policy.htm).
  
  

Publications

Timely publication of major findings is encouraged. Publications or oral presentations of work conducted under this cooperative agreement require proper acknowledgment of NCI support. See the NIH Public Access Policy for specific requirements.

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) acting as a Project Scientist(s) or Project Coordinator(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. 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 include the following activities:

Review of Clinical Trials in CCOP Network

• DCP and/or DCTD must review and approve any clinical trial for which a CCOP may claim credit.

Monitoring, Investigational Drug and Data Management

• NCI or an NCI-designated entity will conduct periodic on-site audits;
• DCP and/or CTMB/CTEP will review and advise on mechanisms for monitoring, including the on-site auditing program;
• DCP/CTEP representatives (or a designee) may attend the on-site audits conducted by the Research Base;
• The DCP Project Scientist(s) and Project Coordinator(s) will have access to all data generated under this award and will periodically review the data management procedures of the CCOP; and
• RAB/PMB/CTEP/DCTD and COPTRG/CADRG/DCP will advise investigators of specific requirements and updates in requirements about investigational drug management that the FDA and NCI may mandate.

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 NCI Program staff members will provide a suggested format for the CCOP’s initial and renewal application as well as the annual report (PHS 2590).
• The review of each CCOP awardee by the DCP/NCI Program staff members will include the following:
  • An analysis of the CCOP awardee annual report, follow up of problems noted, and recommendations for improvement;
  • Periodic site visits;
  • Review of CCOP Research Base evaluations;
  • Adjust funding annually based on planned scope of work and availability of funding;
  • The NCI Program may adjust funding, withhold support, suspend or terminate the award, if the CCOP fails to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, the level of performance changes dramatically; and
  • NCI DCP and DCTD staff members review mechanisms established by each CCOP to meet the Department of Health and Human Services (DHHS)/Public Health Service (PHS) regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents.

Areas of Joint Responsibility include:

Execution of this program will require collaboration among the PD/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.

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.

Additional Reporting by CCOP Group Awardees:

CCOP group awardees will report their cumulative accrual to NCI-approved clinical trials at 6 months, 9 months (included in the annual progress report), and 12 months for each budget period.

A suggested format for CCOP-specific information relative to the progress summary section of the PHS Form 2590 will be provided. The format is available at https://ccop.nci.nih.gov/.

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.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described 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.

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

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: [email protected]

Lori Minasian, MD
National Cancer Institute (NCI)
Telephone: 301-496-8541
Email: [email protected]

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
FAX: (301) 402-0275
Email: [email protected]

Sean Hine
National Cancer Institute (NCI)
Telephone: 301-496-2182
Email: [email protected]

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.

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.