COMMUNITY CLINICAL ONCOLOGY PROGRAM

Release Date:  April 2, 2001

RFA:  RFA-CA-02-003

National Cancer Institute

Letter of Intent Receipt Date:  June 8, 2001
Application Receipt Date:       July 13, 2001

PURPOSE

The Division of Cancer Prevention (DCP), National Cancer Institute (NCI), 
invites domestic institutions to apply for cooperative agreements in response 
to this Community Clinical Oncology Program (CCOP) Request for Applications 
(RFA).  Applicants for new and currently funded Community Clinical Oncology 
Programs (CCOP) and research bases are invited to respond to this RFA.

Using the national resource of highly trained oncologists in community 
practice, the CCOP: 1) provides support for expanding the clinical research 
effort in the community setting; 2) stimulates quality care in the community 
through participation in protocol studies; 3) fosters the growth and 
development of a scientifically viable community cancer network able to work 
closely with NCI-supported clinical cooperative groups and cancer centers; 4) 
supports development of and community participation in cancer prevention and 
control intervention research, which includes chemoprevention, biomarkers and 
early detection, symptom management, quality of life, rehabilitation, and 
continuing care research; 5) involves primary care providers and other 
specialists in cancer prevention and control clinical trials; and 6) increases 
the involvement of minority and underserved populations in clinical research.  
Combining the expertise of community physicians and other health care 
professionals with NCI-approved cancer treatment and prevention and control 
clinical trials provides the opportunity for the transfer of the latest 
research findings to the community level.

The NCI-supported clinical cooperative groups and/or cancer centers serve as 
research bases for the CCOPs.  These research bases design the protocols for 
the clinical trials in cancer treatment, prevention and early detection as 
well as evaluating interventions affecting quality of life, rehabilitation and 
symptom management associated with cancer and it treatment.  In addition, they 
manage and analyze all data collected and they monitor data quality and 
subject accrual.  The research bases seek to define the key unanswered 
questions in cancer and then conduct clinical trials to answer them.  

This reissuance of the CCOP RFA seeks to build on the strength and 
demonstrated success of the CCOP network over the past eighteen years by:  1) 
continuing the program as a vehicle for supporting community participation in 
cancer treatment and prevention and control clinical trials through research 
bases (clinical cooperative groups and cancer centers supported by NCI); 2) 
expanding and strengthening the cancer prevention and control research effort; 
3) utilizing the CCOP network for conducting NCI-assisted cancer prevention 
and control research; and 4) evaluating on a continuing basis CCOP performance 
and its impact in the community.

HEALTHY PEOPLE 2010

The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a PHS-led national 
activity for setting priority areas. This RFA, Community Clinical Oncology 
Program, is related to the priority area of cancer.  Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted from domestic institutions.  New applicants and 
currently funded programs are eligible to apply to be a CCOP or a research 
base.  Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as Principal Investigators.

A.  CCOP Applicants

1. An applicant may be 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 
principal investigator and a single administrative focus.

2. A university, Veterans Administration 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 accrual.  An unfunded, non-university clinical trials 
cooperative group member is eligible to apply.

3. Funded 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 award is received.

4. Institutions not eligible to apply as the CCOP applicant organization 
include:

a. A comprehensive, consortial, or clinical cancer center holding an NCI 
Cancer Center Support (Core) grant;

b. A university hospital that is the major teaching institution for that 
university; or

c. A university hospital clinical trials cooperative group member funded by 
the Division of Cancer Treatment and Diagnosis (DCTD), NCI.

B.  Research Base Applicants

An applicant may be:

1. An NCI-funded Clinical Trials Cooperative Oncology Group (Cooperative 
Group);

2. An NCI-funded clinical center, consortium, or comprehensive cancer center. 

Cooperative Groups as CCOP research bases must participate in both cancer 
treatment and prevention and control clinical trials.  Cancer Centers as CCOP 
research bases may participate in both cancer treatment and prevention and 
control studies or only cancer prevention and control research.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will be 
a cooperative agreement (U10), an "assistance" mechanism (rather than an 
"acquisition" mechanism), in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during performance of 
the activity.  Under the cooperative agreement, the NIH purpose is to support 
and/or stimulate the recipient's activity by involvement in and otherwise 
working jointly with the award recipient in a partner role, but it is not to 
assume direction, prime responsibility, or a dominant role in the activity.  
Consistent with this concept, the dominant role and prime responsibility for 
the activity resides with the awardee(s) for the project as a whole, although 
specific tasks and activities in carrying out the studies will be shared among 
the awardees and the NCI Program Staff. Details of the responsibilities, 
relationships and governance of the study to be funded under cooperative 
agreement(s) are discussed later in this document under the section "Terms and 
Conditions of Award."  

The total project period for applications submitted in response to this RFA 
may not exceed 3 years for new applicants, and no more than 5 years for 
applicants currently supported under this program.  Currently supported 
applicants will be funded for 3, 4, or 5 years depending upon priority 
score/percentile, review committee recommendations, and programmatic 
considerations.  The anticipated award date is June 1, 2002.

Because the nature and scope of the research proposed in response to this RFA 
may vary, it is anticipated that the size of awards will also vary.  Awards 
and level of support depend on receipt of a sufficient number of applications 
of high scientific merit.  Although this program is provided for in the 
financial plans of the NCI, awards pursuant to this RFA are contingent upon 
the availability of funds for this purpose.

NCI has determined that there is a continuing program need for community 
participation in cancer clinical research trials, both cancer treatment and 
prevention and control.  While this RFA is a one-time issuance, it is expected 
that a CCOP RFA will be published in the NIH Guide for Grants and Contracts 
annually in the future provided that funds are available.

FUNDS AVAILABLE

It is anticipated that up to $7.0 million in total costs per year for 5 years 
will be committed to specifically fund applications which are submitted in 
response to this RFA.  Approximately three (3) research base awards and 
thirteen (13 ) CCOP awards will be made.  This level of support is dependent 
on the receipt of a sufficient number of applications of high scientific 
merit. Although this program is provided for in the financial plans of NCI, 
awards pursuant to this RFA are contingent upon the availability of funds for 
this purpose.

RESEARCH OBJECTIVES

Background

The CCOP network (CCOPs and research bases) was initiated in 1983 to bring the 
benefits of clinical research to cancer patients in their own communities by 
providing support for physicians to enter patients onto treatment research 
protocols.  In the first three years, 62 community programs in 34 states were 
funded and accrued 14,000 patients to NCI approved treatment clinical trials.

The CCOPs were clearly effective in accruing patients to treatment clinical 
trials.  The second CCOP RFA, issued in 1986, expanded the focus to include 
cancer prevention and control research based on the rationale that the multi-
institutional clinical trials model essential for testing new treatment 
regimens is also central for conducting large-scale cancer prevention and 
control trials.  In 2000, there were 51 programs in states involving over 355 
hospitals and over 3,500 physicians.  Approximately 5,785 patients were 
entered onto treatment trials and 4,400 participants on cancer prevention and 
control trials in 2000.

Cancer prevention and control research in the CCOPs is aimed at reducing 
cancer incidence, morbidity, and mortality through the identification, 
testing, and evaluation of interventions in controlled clinical trials.  The 
development of cancer prevention and control research in the CCOP network has 
been increasing steadily since funding started in 1987.  Protocols cover the 
full spectrum of cancer prevention and control research, from chemoprevention 
and the validation of biomarkers, screening and early detection, pain control, 
symptom management and quality of life, and other rehabilitation and 
continuing care interventions.  Several large chemoprevention trials have been 
implemented through the CCOP network, including the breast cancer prevention 
trial with tamoxifen (BCPT), the prostate cancer prevention trial with 
finasteride (PCPT), and the study of tamoxifen and raloxifene in the 
prevention of breast cancer (STAR).

The CCOP network is a vital resource for conducting NCI cancer prevention and 
control research because this consortium provides access to: 1) a national 
network for cancer prevention and control trials which require large sample 
sizes for completion; 2) large populations of cancer patients for symptom 
management, supportive care, quality of life, and rehabilitation interventions 
3) large populations of cancer patients free of disease survivors which 
provide a unique resource for chemoprevention clinical trials; 4) cancer 
patients' family members and others who may be at increased risk of developing 
cancer and thus be candidates for prevention and detection studies; and 5) 
geographic areas which include cross sections of the population, providing 
mixes of patients/participants not always available in university or urban 
settings.   Participation in cancer prevention and control research by CCOPs, 
in particular, further expands the network of community physicians, increasing 
the potential for diffusion of state-of-the-art cancer prevention and control 
practices.

Objectives and Scope

The CCOP Network is designed to:

(1) Bring the advantages of state-of-the-art cancer treatment and prevention 
and control research to individuals in their own communities by having 
practicing physicians and their participants enter onto NCI-approved cancer 
treatment and prevention and control clinical trials; (2) Provide a basis for 
involving a wider segment of the community in cancer prevention and control 
research and investigate the impact of cancer therapy and control advances in 
community medical practices; (3) Increase the involvement of primary health 
care providers and other specialists (e.g., surgeons, family practitioners, 
gastroenterologists, urologists, gynecologists) with the CCOP investigators in 
cancer treatment and prevention and control research, providing an opportunity 
for education and exchange of information; (4) Facilitate wider community 
participation, including minorities, women and, other underserved populations, 
in cancer treatment and prevention and control research approved by NCI; and 
(5) Reduce cancer incidence, morbidity, and mortality by accelerating the 
transfer of newly developed cancer prevention, early detection, treatment, 
patient management, rehabilitation, and continuing care technology to 
widespread community application.

Participating CCOPs are required to enter patients onto NCI-approved cancer 
treatment and prevention and control clinical trials through the research 
base(s) with which each CCOP is affiliated.  CCOPs may have direct access to 
selected protocols through specific NCI- sponsored programs.

Participating research bases are required to develop clinical treatment and/or 
cancer prevention and control research protocols, and provide them to the 
CCOPs.  Cancer prevention and control research should be intervention-oriented 
and may include such areas as cancer prevention, early detection, symptom 
management, rehabilitation, quality of life, and continuing care.  Research 
bases will monitor the quality of protocol conduct, follow CCOP accrual, and 
participate on a continuing basis in program evaluation.

SPECIAL REQUIREMENTS

Terms and Conditions of Award

The following terms and conditions pertaining to the scope and nature of the 
interaction between NCI and the investigators will be incorporated in the 
Notice of Award.  These terms will be in addition to the customary 
programmatic and financial negotiations which occur in the administration of 
grants.  The terms and conditions described in this section are in addition 
to, and not in lieu of, otherwise applicable OMB administrative guidelines; 
HHS Grant Administration Regulations at 45 CFR part 74; other HHS, PHS, and 
NIH Grant Administration policy statements; and other NCI administrative terms 
of award.

A.  Terms and Conditions of Award for CCOP Awardees

1. CCOP - Awardees Responsibilities

The awardee's programmatic responsibilities for the conduct of the research 
supported by this cooperative agreement are described in the following;  the 
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 and can be found at the URL 
address: http://ctep.cancer.gov/handbook/; the NCI-CTMB 
GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS 
AND CCOP RESEARCH BASES and can be found at the URL address: 
http://ctep.cancer.gov/handbook/ and any subsequent 
modifications of these documents; and the Intellectual Property Option to 
Collaborator that can be found at the URL address: 
http://ctep.cancer.gov/industry/ipo.html   
These documents are hereby incorporated by reference as terms of award and are 
available at the URLs cited above or from the program staff listed 
under “INQUIRES.”

1.a. Protocols

All protocols originating from and/or coordinated by the research bases for 
CCOP use must be reviewed and approved  by the Cancer Prevention and Control 
Protocol Review Committee (CPCPRC), Division of Cancer Prevention (DCP), 
and/or the Protocol Review Committee (PRC), Division of Cancer Treatment and 
Diagnosis (DCTD), NCI, prior to implementation.  Protocols will be assigned 
credit once they are approved by the review committee.

Each research base protocol approved for CCOP use will be assigned a credit 
value.  Credits will be based on the complexity of the intervention, the 
amount of data management required, and the duration of follow-up.  For 
example, each patient accrued to an average Phase II or Phase III treatment 
protocol will count 1 credit; and an NCI-designated high-priority treatment 
protocol 1.5 credits. Cancer prevention and control protocols will be assessed 
for credit using a similar approach.  For example, a randomized Phase III 
chemoprevention protocol will be assigned a value of 1 credit per participant 
entered.  Cancer control protocols involving limited interventions will 
receive credit that is commensurate with the amount of data management effort 
required.  Follow-up credit for chemoprevention protocols may also be 
assigned.

To receive credit for accruals the CCOP must access NCI-approved treatment 
and/or prevention and control protocols through the research bases with which 
it has affiliation agreements.  
The research base is responsible for the development and implementation of 
high quality cancer treatment and prevention and control clinical trials, and 
for evaluation of the results of such studies  The CCOP also may access 
treatment trials from research bases with which it is not affiliated through 
the NCI’s Cancer Trials Support Unit (CTSU).  CCOP accruals to protocols will 
receive credits and not per case reimbursement.  The purpose of the CTSU is to 
broaden access to clinical trials and to streamline and centralize 
administrative, financial and data collection task associated with conducting 
NCI-approved treatment trials.

CCOPs are encouraged to participate in cancer prevention and control research 
that is supported through other federal administrative and funding 
instruments.   This activity is encouraged because the cooperative agreements 
awarded under this RFA primarily support development and conduct of studies 
evaluating an intervention.  Research supported through these other mechanisms 
might include nonintervention research in cancer control (e.g., epidemiology, 
methods development, population-based surveys, etc.).  CCOP participation in 
these studies would advance cancer prevention and control research and improve 
public health outcomes.  This activity will be considered in the evaluation of 
the CCOP’s productivity. 

1.b. Research Base Affiliation(s)

Each CCOP must affiliate with one national multi-specialty cooperative group 
having a spectrum of cancer treatment and prevention and control clinical 
trials.  Each CCOP can affiliate with a maximum of four (4) additional 
research bases exclusive of the national multi-specialty cooperative groups 
(exceptions may be granted in conjunction with participation in NCI-sponsored 
“pilot” projects).  Affiliation with a sixth research base may be considered 
if it is with one of the cancer center CCOP research bases that participates 
in only cancer prevention and control research. 

Note:  A list of eligible research bases may be obtained from the URL address: 
http://dcp.nci.nih.gov/corb/ or by contacting the Community Oncology and 
Prevention Trials Research Group, DCP, NCI at (301) 496-8541.

If participation in the protocols of one group competes with that of another 
group with which the CCOP is affiliated, the CCOP must prioritize the 
protocols to avoid bias in the allocation of patients to competing protocols.

Initial affiliations should be maintained for the duration of the funding 
cycle.  When circumstances require changes in research base affiliations, 
prior written approval from the DCP Program Director is required.  The 
Guidelines for Obtaining Approval of CCOP Organizational Changes may be 
obtained from the following URL address: http://dcp.nci.nih.gov/corb/

1.c. Accrual

Each CCOP is required to accrue a minimum of 50 credits per year to treatment 
clinical trials that have been approved by the PRC, DCTD, NCI.  An additional 
measure of performance is that at least 10 percent of patients for whom 
protocols are available will be placed on clinical trials by CCOP physicians.  

The 50 credit minimum to treatment requirement may be waived for: 1) those 
applicants whose speciality is pediatrics and are able to place a majority of 
their eligible patients on protocols; and 2) for those applicants with an 
outstanding record in accrual to cancer prevention and control protocols.

Each CCOP is required to accrue a minimum of 50 credits per year to cancer 
prevention and control clinical trials that have been approved by the CPCPRC, 
DCP. 

The 50 credit minimum to cancer prevention and control requirement may be 
waived for those applicants whose speciality is pediatrics and are able to 
place a majority of their eligible patients on protocols.

In addition, CCOPs are encouraged to participate in cancer prevention and 
control research that is supported through other federal administrative and 
funding instruments, such as investigator-initiated awards.  Participation in 
such research will be considered in the evaluation of CCOP productivity.

1.d. Quality Control

In accordance with research base guidelines and NCI policies, the CCOP 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 must follow policies developed by the research bases with which they are 
affiliated  and approved by the NCI for auditing the accuracy of scientific 
data submitted to them by the CCOP participants.  A list of the research bases 
can be found at the URL address: http://dcp.nci.nih.gov/corb/.

1.e. Data Management

The CCOP must provide the 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, 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.

1.f. 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 patients must have an active NCI Investigator Number.

1.g. Monitoring

Each CCOP must agree to periodic on-site audits by representatives of its 
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 protocol specifications; quality 
control and accuracy of data recording; and completeness of reporting adverse 
drug reactions.  

Reports of such on-site audits will be reviewed by the Clinical Trials 
Monitoring Branch (CTMB), Cancer Therapy Evaluation Program (CTEP), DCTD, and 
by the DCP Program Director.  In addition, NCI program and grants management 
staff will review protocol accrual, and fiscal and administrative procedures.

CCOP member/affiliate performance sites and/or individual investigators 
participating or collaborating on NCI-supported multi-institutional clinical 
trials must be in compliance with the monitoring standards established by the 
research base.  They should include the following standards: (1) 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-outs on medical records are unacceptable; (2) 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.  Only one line should be placed through the initial entry, 
so that both the original entry and the change are legible; (3) The improper 
modification of important patient records will result in additional 
investigations by the NCI Clinical Trials Monitoring Branch (CTMB) and may 
lead to suspension of accrual and funding.

1.h. 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 protocols requiring radiation therapy, as required by the 
affiliated research base(s).

1.i. Organizational Changes

Certain CCOP organizational changes must have the prior written approval of 
the DCP Program Director.  These include the addition/deletion of a 
participating physician, a health professional other than a physician (who 
actively enters patients to cancer prevention and control trials), an 
affiliate, component, or research base.  The Guidelines for Obtaining Approval 
of CCOP Organizational Changes may be obtained from the URL address: 
http://dcp.nci.nih.gov/corb/

1.j. Reporting Requirements

Annual progress reports must be submitted to DCP.  A suggested format will be 
provided for this purpose.  The format may be found at the URL address: 
http://dcp.nci.nih.gov/corb/.  The inability of a CCOP to meet the performance 
requirements set forth in the Terms and Conditions of Award in the RFA, or 
significant changes in the level of performance, may result in an adjustment 
of funding, withholding of support, suspension or termination of the award.

1.k. Network Participation

CCOPs are part of a national network for conducting cancer treatment and 
prevention and control 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.

1.l. Patient/Participant Log

Each CCOP may be asked to periodically 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.

1.m. Federally Mandated Regulatory Requirements

Each CCOP must establish mechanisms to meet DHHS/PHS regulations for the 
protection of human subjects.  At a minimum, these include: (1) methods for 
assuring that each facility at which CCOP investigators are conducting 
clinical trials has a current, approved assurance on file with the Office of 
Human Research Protection (OHRP); that each protocol is reviewed by the 
responsible IRB prior to patient entry; and that each protocol is reviewed 
annually by the IRB so long as the protocol is active; (2) methods for 
assuring or documenting that each patient (or patient's parent/legal guardian) 
gives fully informed written consent to participation in a research protocol 
prior to the initiation of the experimental intervention; (3) a system for 
assuring timely reporting of all serious and unexpected toxicities to the 
Investigational Drug Branch, CTEP, DCTD, according to DCTD guidelines and/or 
to DCP according to DCP guidelines; (4) implementation of DCP/DCTD 
requirements for storage and accounting for investigational agents provided 
under DCP/DCTD sponsorship; and  (5) education on the protection of human 
research participants for all investigators involved in the design or conduct 
of research involving human subjects.

1.n. Publications

Timely publication of major findings is encouraged.  Publication or oral 
presentation of work done under this agreement requires acknowledgment of NCI 
support.

2.  NCI Staff Involvement

2.a. Protocol Review

To be eligible for credit assignment protocols must be reviewed and approved 
by the CPCPRC, DCP , and/or the PRC, DCTD, NCI, prior to implementation.  
Credit will be assigned after the protocol is approved.

NCI will not provide investigational drugs, permit expenditure of NCI funds, 
or allow accrual credit for a protocol that has not been approved, or that has 
been closed (except for patients already on study).

2.b. Monitoring

There will be periodic on-site audits of each CCOP by representatives of its 
research base(s), NCI, or an NCI-designee, such as DCTD's current Clinical 
Trials Monitoring Service contractor.  

The DCP and CTMB/CTEP will review and provide advice regarding mechanisms 
established for study monitoring including the on-site auditing program.  
DCP/CTEP and/or its contractor staff may attend the on-site audits conducted 
by the research base or its NCI designee as observers.

2.c. Data Management

The DCP Program Director will have access to all data generated under this 
award and will periodically review the 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 Food and Drug 
Administration (FDA).

2.d. Investigational Drug Management

The Regulatory Affairs Branch (RAB), Pharmaceutical Management Branch (PMB), 
CTEP, DCTD and the Chemopreventive Agent Development Research Group (CADRG), 
DCP will advise investigators of specific requirements and changes in 
requirements about investigational drug management that the FDA and NCI may 
mandate.

2.e. Organizational Changes

The DCP program director will review requests for certain organizational 
changes and provide written approval.  These changes include the 
addition/deletion of a participating physician or other health professional 
entering patients/participants in cancer prevention and control research in 
the CCOP, an affiliate, component, or research base.  The Guidelines for 
Obtaining Approval of CCOP Organizational Changes may be obtained from the URL 
address: http://dcp.nci.nih.gov/corb/

2.f. Program Review

The DCP program director will provide a suggested format for the CCOP’s annual 
report.  The DCP Program Director will review the progress of each CCOP 
through consideration of the CCOP annual report, program site visits, and 
reports from affiliated research bases.  This review may include, but not be 
limited to, overall accrual credits, percent of available 
patients/participants placed on study, eligibility and evaluability of 
individuals entered on study, and timeliness and quality of data reporting.  
The inability of a CCOP to meet the performance requirements set forth in the 
Terms and Conditions of Award in the RFA, or significant changes in the level 
of performance, may result in an adjustment of funding, withholding of 
support, suspension or termination of the award.

2.g. Strategy Sessions

The DCP Program Director or designee will sponsor strategy sessions when 
indicated, attended by principal investigators from the CCOPs and appropriate 
DCP/DCTD staff.  At these meetings, information relevant to the CCOPs will be 
reviewed and discussed, including such issues as overall CCOP performance and 
the science of current or proposed clinical trials.  Data will be analyzed and 
the outstanding research questions established and prioritized into national 
research goals by CCOP investigators and the DCP/DCTD attendees.  The 
principal investigators will have the primary responsibility for analyzing and 
prioritizing the research questions to be developed into clinical trials.  The 
DCP Program Director will also assist the CCOP investigators in exploring 
mutual interests in cancer prevention and control research.

2.h. Federally Mandated Regulatory Requirements

The DCP Program Director or designee and DCTD staff will 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. 

3. Arbitration Process

The Terms and Conditions of Award require that the DCP Program Director make 
post-award administrative decisions related to program performance, 
programmatic decisions on scientific-technical matters, and funding 
adjustments.  NCI will establish an arbitration process when a mutually 
acceptable agreement cannot be obtained between the awardee and the DCP 
Program Director.  An arbitration panel (with appropriate expertise) composed 
of one member of the recipient group, one NCI nominee, and a third member 
chosen by the other two will be formed to review the NCI decision and 
recommend a course of action to the Director, DCP.  These special arbitration 
procedures in no way affect the awardee's right to appeal an adverse action in 
accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS 
regulations at 45 CFR Part 16.

B.  Terms and Conditions of Award for Research Base Awardees

1.  Research Base Awardees Responsibilities

It is the responsibility of the Research Base 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, and publication of results, interpretations and 
conclusions of studies.  The research base shall designate research base 
investigators to serve as Protocol Chairpersons for each proposed study.  
Protocols will be developed in accordance with the instructions in the 
INVESTIGATOR'S HANDBOOK available at the following URL address: 
http://ctep.cancer.gov/handbook or from the program 
staff listed under INQUIRIES.

1.a. Protocol Development

The research base is responsible for the development and implementation of 
high quality cancer treatment and prevention and control clinical trials, and 
for evaluation of the results of such clinical trials.  The protocol should be 
a document mutually acceptable to the research base and to DCP/DCTD.  
Communication at the various stages of development is encouraged.

1.b. Concept/Protocol Submission
  
All research base protocols utilized by the CCOPs must be reviewed and 
approved for CCOP use by the Cancer Prevention and Control Protocol Review 
Committee, (CPCPRC) DCP, and/or the Protocol Review Committee (PRC), DCTD, 
NCI, prior to implementation.  Treatment and cancer prevention and control 
protocols should be submitted to the Protocol Information Office (PIO), CTEP, 
DCTD for review by the appropriate committee.

All research base cancer prevention and control protocols must be preceded by 
the submission of a concept proposal for review by the DCP Cancer Prevention 
and Control Concept Review Committee (CPCCRC).  The CPCCRC considers 
scientific merit and the feasibility of implementing prospective cancer 
control protocols in the CCOP research network.  Similarly, concept proposals 
for research base cancer treatment protocols may precede protocol development.  
Cancer treatment concepts are reviewed by the CTEP Protocol Review Committee 
(PRC) in the DCTD.  All concept and protocol documents should be submitted to 
the PIO, CTEP, DCTD.  DCTC may also require a letter of intent for new cancer 
treatment trials.

1.c. Accrual

Each research base protocol approved for CCOP use will be assigned a credit 
value.  Credits will be based on the complexity of the intervention, the 
amount of data management required, and the duration of follow-up.  For 
example, each patient accrued to an average Phase II or Phase III treatment 
protocol will count 1 credit; and an NCI-designated high-priority treatment 
protocol 1.5 credits.  Cancer prevention and control protocols will be 
assessed for credit using a similar approach.  For example, a randomized Phase 
III chemoprevention protocol will be assigned a value of 1 credit per 
participant entered.  Follow-up credit for chemoprevention protocols also may 
be assigned. Cancer control protocols involving limited interventions will 
receive credit that is commensurate with the amount of data management effort 
required.

A research base involved in the design of treatment protocols is required to 
accrue a minimum of 50 credits per year from affiliated CCOPs  to treatment 
clinical trials that have been approved by the PRC, DCTD, NCI.  During the 
initial funding period, a research base is required to develop sufficient 
affiliations to accrue 50 cancer treatment credits by the end of the third 
year.

A research base for cancer prevention and control research is required to 
accrue a minimum of 50 credits per year from CCOPs, members and other 
affiliates to cancer prevention and control clinical trials that have been 
approved by the CPCPRC, DCP.  During the initial funding period, a research 
base is required to develop cancer prevention and control protocols to allow 
accrual of 50 cancer control credits by the end of the third year.   

Research bases are encouraged to participate in and/or facilitate CCOP 
participation in cancer prevention and control research that is supported 
through other federal administrative and funding instruments.   This activity 
is encouraged because the cooperative agreements awarded under this RFA 
primarily support development and conduct of studies evaluating an 
intervention.  Research supported through these other mechanisms might include 
nonintervention research in cancer control (e.g., epidemiology, methods 
development, population-based surveys, etc.).  Research base participation 
and/or facilitation of CCOP participation in these studies would advance 
cancer prevention and control research and improve public health outcomes.  
This activity will be considered in the evaluation of the research bases’ 
productivity. 

1.d. Data Management and Analysis

The research base shall establish and implement mechanisms for data management 
and analysis that ensure that data collection and management procedures are:  
(a) adequate for quality control and analysis; (b) as simple as is appropriate 
to encourage maximum participation of physicians entering patients and to 
avoid unnecessary expense; and (c) sufficiently uniform across research bases.  
CCOP member/affiliate performance sites are required to follow procedures for 
data management and analysis.

Data generated are the property of the awardee; however, the research base 
must provide DCP/DCTD with access to all data generated under this award.

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

In addition, the research bases may contract with independent investigators to 
perform data management and analysis for research funded by other federal 
administrative and funding mechanisms.

1.e. Quality Control

A DCP/-funded research base must follow all the policies and procedures for 
quality control established by NCI.

The research bases shall establish mechanisms for quality control of all 
procedures and modalities employed in its trials.  CCOP members/affiliates are 
required to follow research base procedures for quality control.

The research base shall establish mechanisms for study monitoring.  CCOP 
members/affiliates are required to follow the awardee procedures for study 
monitoring.

The research base is responsible for monitoring the progress of each study 
through: (1) tracking and reporting of patient accrual and adherence to 
defined accrual goals; (2) ongoing assessment of case eligibility and 
evaluability; (3) timely medical review and assessment of patient data; (4) 
Medical records used in support of NCI multi-institutional trials must conform 
to usual standard for the maintenance of clear, accurate, and unambiguous 
medical records.  White-outs on medical records are unacceptable; (5) rapid 
reporting of treatment-related morbidity and measures to ensure communication 
of this information to all parties; (6) interim evaluation and consideration 
of measures of outcome as consistent with patient safety and good clinical 
trials practice; (7) timely communication of results of studies; and (8) an 
on-site monitoring program.

The research base is responsible for ensuring that all performance sites have 
routine audits which are reported to the NCI in accordance with the NCI/CTMB 
GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS 
AND CCOP RESEARCH BASES.  Guidelines are available at the URL address: 
http://ctep.cancer.gov/handbook/.    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 protocols at the 
affected performance site shall be suspended immediately upon notice of the 
NCI determination.  The suspension will remain in effect until the awardee 
conducts the required audit and the audit report is accepted by the NCI.

The 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.

1.f. Quality Assurance of Data

The research base must develop and follow procedures for the assurance of data 
quality in accordance with research base guidelines and NCI policies.  The 
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 research base must develop and implement NCI-approved policies for 
auditing the accuracy of scientific data submitted to them.

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 
AND CCOP RESEARCH BASES.  Guidelines are available at the URL address: 
http://ctep.cancer.gov/handbook/

1.g. Data and Safety Monitoring Committees

The 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 which  may be 
found at URL address: 
http://deainfo.nci.nih.gov/grantspolicies/.  The research base 
must comply with the approved policies and procedures of the DSMB.  Further, 
the research base must establish data safety and monitoring plans for all 
phase I and II clinical trials in accordance with NIH policies, which may be 
found at URL address: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. 
A 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.

1.h. Protocol Closure

The research base shall establish a mechanism for interim monitoring of 
results and monitoring protocol progress.  If the 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 protocol 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.

1.i. Protocol Reporting Requirements

Reporting requirements will be in agreement with FDA regulations and NCI 
procedures.  Interim reports of each activated and ongoing study 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 studies through the NCI’s Clinical Data 
Update System (CDUS). Instructions and Guidelines for CDUS are at the URL 
address: http://ctep.cancer.gov/reporting/cdus.html

1.j. Annual Progress Report

Annual progress reports, including an annual performance report on each 
affiliated CCOP must be submitted to DCP.  A suggested format will be provided 
for this purpose.  The DCP Program Director will review the performance of 
each research base.

The annual report will include, at a minimum, information on: overall case 
accrual credits; cancer prevention and control 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.

A research base leading a large-scale prevention trial (e.g., the Study of 
Tamoxifen and Raloxifene, STAR) must submit a list of the participating sites 
as defined by the Clinical Trials Monitoring Branch, CTEP, DCTD, along with 
the audit schedule of these sites in the annual progress report.  

Research base funding is contingent upon: 1) accrual from affiliated 
CCOPs/Minority-Based CCOPs and members/affiliate institutions; and 2) 
development and implementation of prevention and control protocols.  The 
inability of a research base to meet the performance requirements set forth in 
the Terms and Conditions of Award in the RFA or significant changes in the 
level of performance may result in an adjustment of funding, withholding of 
support, suspension or termination of the award.

1.k. Adverse Event Procedures

To be in compliance 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 sponsors according to NCI 
Guidelines: Expedited Adverse Event Reporting Requirements for NCI 
Investigational Agents available at the URL address: 
http://ctep.cancer.gov/reporting/cdus.html

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.  The awardee will also notify the Investigational 
Drug Branch (IDB),CTEP, DCTD Drug Monitor for DCTD-sponsored investigational 
agents and the Program Director, DCP, for other agents, of serious or life-
threatening events, as specified in the protocol.

1.l. Performance Review

The research base shall establish policies and procedures for credentialing 
participating CCOPs and conducting periodic review of the performance and 
membership status of each performance site conducting prevention and control 
clinical trials.  This review should examine scientific contributions, patient 
accrual, data accuracy and timeliness, protocol compliance, and audit results.  

1.m. Data Files Available to NCI Upon Request

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.

1.n. Investigational Drug Management

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.

1.o. Network Participation

Research bases are part of a national network for conducting cancer treatment 
and prevention and control clinical trials.  As such, each 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.

1.p. Federally Mandated Regulatory Requirements

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 research base must be able to: (1) 
demonstrate that each participant has a current approved assurance on file 
with the Office of Human Research Protections (OHRP); (2) demonstrate that 
each protocol and informed consent is approved by the responsible 
Institutional Review Board (IRB) prior to patient entry, that each 
investigator has a current FDA Form 1572 and curriculum vitae on file with the 
Pharmaceutical Management Branch, (PMB), CTEP, DCTD ; (3) demonstrate that 
each patient (or legal representative) gives written informed consent prior to 
entry on study; (4) implement the CTEP requirement for storage and accounting 
for investigational agents provided under DCP/DCTD sponsorship; (5) establish 
an on-site audit program for periodic data verification and review of 
regulatory responsibilities at each CCOP, cooperative group member,  
cooperative group affiliate program, and cancer center affiliate institution; 
(6) provide a method, upon DCP/DCTD request, of summarizing efficacy and 
toxicity data to be included in DCP/DCTD's annual reports to the FDA for each 
investigational agent; (7) establish a method for the timely reporting of all 
serious and unexpected toxicities; (8) verify completion of education on the 
protection of human research participants for all investigators involved in 
the design or conduct of research involving human subjects; and (9) institute 
data and safety monitoring plans for all phase I and II clinical trials and 
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.

1.q. CCOPS/Minority-Based CCOPs

Research bases must agree to affiliate with CCOPs/Minority-Based CCOPs when 
they are funded, according to guidelines established by each research base for 
its affiliates, and as appropriate.

1.r. Prevention Members 

Cooperative group members, affiliate programs and/or cancer center affiliates 
other than CCOPs may be included in an application as “prevention members.”  
Such non-CCOP member institutions would contribute to the goals of the 
research base related to cancer prevention.  Specific activities of 
“prevention members” should include, but are not limited to, one or more of 
the following: 1) accrual to chemoprevention studies; 2) development of 
chemoprevention protocols; 3) membership in research base cancer prevention 
committees; 4) conduct of preclinical studies necessary for development of 
chemoprevention trials; and 5) conducting ancillary research, such as that 
related to mechanisms of action, recruitment strategies, etc.  

1.s. Publications

Timely publication of major findings is encouraged.  Publication or oral 
presentation of work done under this agreement requires acknowledgment of NCI 
support.

1.t. 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 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 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 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.

1.u. Notification of Patients by the Awardee During Patient's Lifetime

In order for there to be an appropriate response in the event the NCI 
determines, either while a protocol is active or (if relevant) during the 
lifetime of the participants following protocol closure, that a medically 
important toxicity or side effect is associated with protocol-directed 
treatment 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: (a) 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 (b) 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 
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 which allows direct notification of the patient by the NCI.

2. NCI Staff Involvement

2.a. Scientific Resource

The Division of Cancer Prevention (DCP) and Division of Cancer Treatment and 
Diagnosis (DCTD) staff will serve as a resource for specific scientific 
information on cancer prevention and control clinical trials, treatment 
regimens, and clinical trial design.  The DCP Program Director will assist the 
research base as appropriate in developing information concerning the 
scientific basis for specific trials and will also be responsible for advising 
the research base of the nature and results of relevant trials being carried 
out nationally or internationally.  The DCP Program Director will sponsor 
strategy sessions when indicated, attended by leading investigators from the 
research bases, other extramural scientists, and appropriate experts to 
discuss specific research initiatives.  The Investigational Drug Branch (IDB), 
Cancer Therapy Evaluation Program (CTEP), DCTD, and the Chemopreventive Agent 
Development Research Group (CADRG), DCP, through the DCP Program Director, 
will provide updated information on the efficacy, toxicity and availability of 
all Investigational New Drugs (INDs) supplied by NCI to the research base.

2.b. Protocol Development

The protocol is a document mutually acceptable to the research base and to 
DCP/DCTD.  Communication at the various stages of development is encouraged.  
DCP/DCTD staff will assist the research base in protocol design as appropriate 
by providing information regarding:  a) the existence and nature of concurrent 
clinical trials in the area of research, with an emphasis on preventing 
duplication of effort; b) relevant pharmacokinetic and pharmacodynamic data on 
investigational agents; c) availability of investigational agents, including 
biologic response modifiers; d) feasibility and appropriateness of the 
research for use by the CCOPs and/or in a community setting; and e) basic 
research in cancer centers and other NCI-funded programs which may be ready 
for clinical trials.  DCP/DCTD will also comment on the scientific rationale, 
programmatic relevance, priority, design, statistical requirements, and 
implementation of the proposed study.

2.c. Concept/Protocol Review

All research base protocols utilized by the CCOPs must be reviewed and 
approved by the Cancer Prevention and Control Protocol Review Committee, 
(CPCPRC) DCP, NCI and/or the Protocol Review Committee (PRC), DCTD, NCI, prior 
to implementation.

The major considerations in protocol review by DCP or DCTD include;  a) 
strength of the scientific rationale supporting the study; b) importance of 
the question being proposed; c) avoidance of undesirable duplication with 
ongoing clinical trials; d) appropriateness and feasibility of study design; 
e) satisfactory projected accrual rate and follow-up period; f) 
patient/participant safety; g) compliance with NIH and the federal regulatory 
requirements; h) adequacy of data management; and i) appropriateness of 
patient/participant selection, evaluation, assessment of toxicity, response to 
intervention, and follow-up.

The DCP/DCTD review committee chairperson will provide the research base with 
a consensus review that describes recommended modifications and other 
suggestions as appropriate.  If a protocol is disapproved, reasons will be 
communicated to the research base principal investigator as a consensus review 
within a reasonable time.

The DCP Program Director will work with the research base, where appropriate, 
to develop a mutually acceptable protocol compatible with the research 
interests, abilities, and needs of the base, its affiliates, and NCI.  Credit 
will be assigned following final approval of the protocol.

NCI will not provide investigational drugs, permit expenditure of NCI funds, 
or allow accrual credit for a protocol that has not been approved.

2.d. Data Management and Analysis

The awardees will retain custody of and primary rights to their data; however, 
DCP/DCTD will have access to all data generated under this award.  The DCP 
Program Director or a DCTD representative may review data management and 
analysis procedures of the research base, under mutually agreeable 
circumstances, for consistency with policies and procedures established by 
DCP/DCTD for awardees conducting cancer treatment and prevention and control 
clinical trials.  

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

2.e. Quality Control and Monitoring

The Clinical Trials Monitoring Branch (CTMB), CTEP, DCTD/DCP Program Director 
may review quality control and monitoring procedures of the research base 
including the on-site auditing program for consistency with policies and 
procedures established by DCTD/DCP for awardees conducting cancer treatment 
and prevention and control clinical trials.

2.f. Review of Quality Control and Study Monitoring

The DCP and CTMB, CTEP will review and provide advice regarding mechanisms 
established for study monitoring including the on-site auditing program.

DCP/CTEP and/or its contractor staff may attend as observers, the on-site 
audits conducted by the Research Base or its NCI designee.  The frequency of 
participation by an NCI representative as observer will be determined by the 
NCI.

2.g. Data and Safety Monitoring Committees

The NCI Staff will assess the research base compliance with NCI established 
policies on Data and Safety Monitoring Plans for Phase I and II trials and 
Data and Safety Monitoring Committees for Phase III trials.  One or more 
DCP/STEP staff will serve as non-voting members on the DSMC.

2.h. Investigational Drug Management

The Regulatory Affairs Branch, CTEP, DCTD, and the Chemopreventive Agent 
Development Research Group (CADRG), DCP, staff will advise investigators of 
specific requirements and changes in requirements concerning investigational 
drug management that the FDA may mandate.

2.i. Program Review

Annual progress reports, including an annual performance report on each 
affiliated CCOP, must be submitted to DCP.  DCP staff will provide a suggested 
format for this purpose.  The DCP Program Director will review the progress of 
each research base through consideration of the research base quarterly 
accrual reports, annual report and program site visits.

The DCP program director will make funding recommendations based on accrual 
from affiliated CCOPs/Minority-Based CCOPs, and other members and affiliates 
as well as the development and implementation of cancer prevention and control 
protocols in the CCOP network.  The inability of a research base to meet the 
performance requirements set forth in the Terms and Conditions of Award in the 
RFA, or significant changes in the level of performance, may result in an 
adjustment of funding, withholding of support, suspension or termination of 
the award.

2.j. Protocol Closure

DCP/DCTD will review research base mechanisms for interim monitoring of 
results and will monitor protocol progress.  DCP/DCTD may request that a 
protocol study be closed for reasons including:  a) insufficient accrual rate; 
b) accrual goal met; c) poor protocol performance; d) patient/participant 
safety; e) already conclusive study results; and f) emergence of new 
information which diminishes the scientific importance of the study question.

NCI will not provide investigational drugs, permit expenditure of NCI funds, 
or allow accrual credit for a study after requesting closure (except for 
patients already on study).

2.k. Federally Mandated Regulatory Requirements

The DCP Program Director and a DCTD representative will review mechanisms 
established by each research base to meet 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. 

2.l. CCOPs/Minority-Based CCOPs

The DCP Program Director will notify research bases when CCOPs/Minority-Based 
CCOPs are funded.

3. Arbitration Process

The Terms and Conditions of Award require that the DCP Program Director make 
post-award decisions related to protocol review, program performance and 
adjustments in funding.  NCI will establish an arbitration process when a 
mutually acceptable agreement cannot be obtained between the awardee and NCI 
staff.  An arbitration panel (with appropriate expertise) composed of one 
member of the recipient group, one NCI nominee, and a third member chosen by 
the other two will be formed to review the NCI decision and recommend an 
appropriate course of action to the Director, DCP.  These special arbitration 
procedures in no way affect the awardee's right to appeal an adverse action in 
accordance with PHS regulations 42 CFR Part 50, Subpart D, and DHHS 
regulations 45 CFR Part 16.

STUDY POPULATIONS

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
 
It is the policy of the NIH that women and members of minority groups and 
their sub- populations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided indicating that inclusion 
is inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43). 

All investigators proposing research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000  
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to provide a description of plans 
to conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups, if applicable; and b) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS.

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are clear and compelling scientific and ethical reasons not 
to include them.  This policy applies to all initial (Type 1) applications 
submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
“NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects” that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/noticefiles/not98-024.html.

Investigators may also obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

Note:  Applicants for National Cancer Institute funding who propose clinical 
research for adults with cancer may use language similar to the following for 
the “Participation of Children” section of their application:

This CCOP project does not include children because the number of children 
with cancer is limited and because the majority are already accessed by a 
nationwide pediatric cancer research network.  This exemption is based on 
Exclusion 4b of the NIH Policy and Guidelines on the Inclusion of Children as 
Participants in Research Involving Human Subjects.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should read the 
policy that was published in the NIH Guide for Grants and Contracts, June 5, 
2000 (Revised August 25, 2000), available at the following URL address 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

LETTER OF INTENT

Prospective applicants are asked to submit, by June 8, 2001, a letter of 
intent that includes a descriptive title of the proposed research, the name, 
address, and telephone number of the Principal Investigator, the identities of 
other key personnel and participating institutions, and the number and title 
of the RFA in response to which the application is being submitted.  Although 
a letter of intent is not required, is not binding, and does not enter into 
the review of subsequent applications, the information allows NCI staff to 
estimate the potential review workload and to plan the review.

The letter of intent should be sent to the program staff listed under 
INQUIRIES.

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

APPLICATION PROCEDURES

Preparation of Application

The research grant application form PHS-398 (rev. 4/98) is to be used in 
applying for cooperative agreements.  Application kits are available at most 
institutional offices of sponsored research and may be obtained from the 
Division of Extramural Outreach and Information Resources, National Institutes 
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD, 20892-7910, telephone 
number (301) 435-0714, e-mail: grantsinfo@nih.gov.  For those applicants with 
internet access, the 398 kit may be found at 
http://grants.nih.gov/grants/forms.htm.

A suggested format will be available at the URL address: 
http://dcp.nci.nih.gov/corb/   All applicants are encouraged to obtain and use 
the suggested format instructions for organizing the specific information 
concerning the RFA programmatic requirements in the PHS 398.  If tables from 
the “Suggestions for Organizing Information for a CCOP Application” are 
included, those tables should be part of the body of the application, and NOT 
included in the appendix.  Also, responses to the instructions concerning 
"Human Subjects" verification must be included in the application at the time 
of submission.

1. CCOP Applicants

Because the Terms and Conditions of Award (discussed in the SPECIAL 
REQUIREMENTS Section above) will be included in all awards issued as a result 
of this RFA, it is critical that each applicant include specific plans for 
responding to these terms.  Plans must describe how the applicant will comply 
with NCI staff involvement as well as how all the responsibilities of awardees 
will be fulfilled.

An application from a currently funded program will be a competing 
continuation and must include a progress report, which at a minimum consists 
of: (1) a summary of prior CCOP activities/accomplishments, including a clear 
presentation of annual accrual over the funding period.  Accrual tables from 
previous annual progress reports should be included.  A summary of accrual to 
all cancer treatment and a summary of accrual to all cancer prevention and 
control protocols by gender and ethnicity must be provided; progress in 
meeting DCP's established accrual goals must be presented;  (2) a plan for 
continuing to meet prevention and control accrual requirements including plans 
for follow-up of participants from the large prevention trials as well as 
plans for implementation of additional cancer control protocols; (3) tables of 
the current budget and FTEs with a justification for any request for 
additional resources; (4) an evaluation of CCOP performance by affiliated 
research base(s); and (5) a complete description of how the applicant has met 
the special cooperative agreement terms and conditions of the award.

Both new and currently funded applicants should address the following:

1.a. Each applicant 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.  A description of other cancer 
care resources in the catchment area (i.e., hospitals, clinics, physicians, 
cancer centers) which are not part of the application should be included.  In 
describing the study population, a breakdown by percentage of the gender and 
minority composition of the study population should be provided.  This 
information may be based on the institutional records and/or prior experience.

1.b. Each applicant must demonstrate the potential and stated commitment to 
accrue a minimum of 50 credits per year to treatment clinical trials (except 
if waived for applicants whose specialty is pediatrics and are able to place a 
majority of their eligible patients on protocols or those applicants with an 
outstanding record in cancer prevention and control accrual).  Documentation 
must include any prior participation in treatment research clinical trials 
with a clear presentation of the total number of patients and credits accrued 
to NCI-approved treatment clinical trials.  A list of the NCI approved 
treatment protocols in which the applicant expects to participate and the 
projected accrual to each must be provided.  Plans for recruiting women and 
minority participants must be included.  

1.c. Each applicant must demonstrate the potential and plans for accrual of a 
minimum of 50 credits per year to cancer prevention and control protocols 
(except if waived for applicants whose specialty is pediatrics and are able to 
place a majority of their eligible patients on protocols) .  Documentation 
must include any prior participation in cancer prevention and control research 
clinical trials with a clear presentation of the total number of patients and 
credits accrued to NCI approved cancer prevention and control clinical trials.  
A list of the NCI approved prevention and control protocols in which the 
applicant expects to participate and the projected accrual must be provided.  
Plans for recruiting women and minority participants must be included.

If applicable, CCOP applicants should describe their participation in cancer 
prevention and control research supported by other federal administrative and 
funding instruments (e.g., research projects grants (R01s), contracts).  
Participation in such research will be considered in the evaluation of CCOP 
productivity.

NEW Applicants must provide implementation plans for at least two examples of 
NCI-approved cancer prevention and control protocols that utilize an 
intervention.  The applicant should describe their plan for implementation, 
including specifics on patient/participant recruitment, compliance and follow-
up.  These studies must come from research bases with which they propose to 
affiliate.

The CCOP applicant must document the ability to access the appropriate 
physicians and patient/participant populations, and adequate facilities to 
participate in the proposed clinical trials.

1.d. A designated Principal Investigator is required.  An associate principal 
investigator also should be named to assure continuity in the event of 
resignation of the principal investigator.  The qualifications and experience 
of both, in terms of ability to organize and manage a community oncology 
program that includes cancer treatment and prevention and control research and 
related activities, as well as experience in accruing patients/participants to 
treatment and cancer prevention and control clinical trials must be described.

1.e. Each applicant is expected to have a committed multidisciplinary 
professional group appropriate for its expected protocol participation.  This 
team may include medical oncologists, surgeons, radiation oncologists, 
pathologists, oncology nurses, data managers, health educators, and other 
disciplines (e.g., gynecology, urology, gastroenterology, pediatrics, internal 
medicine, family practice) as appropriate.  The training and experience of 
participating physicians must be provided, along with a description of working 
relationships. Any experience working together as a group, particularly in 
implementing clinical cancer treatment and prevention and control research and 
related activities, should be included.  An organizational chart showing how 
the group will function must also be included.

1.f. Each applicant must provide the qualifications and experience of all 
proposed support personnel as well as a description of the proposed duties for 
each position.

1.g. Through formal affiliations with only one multi-specialty cooperative 
group (exceptions may be granted in conjunction with participation in an NCI 
sponsored “pilot” project) and up to 4 additional research bases, each 
applicant must demonstrate access to both cancer treatment and prevention and 
control research protocols. Affiliation with a sixth research base may be 
considered if it is with one of the cancer center CCOP research bases that 
participates in only cancer prevention and control research.  Evidence must be 
provided that an affiliation has been established with one NCI-approved multi-
specialty cooperative group.  In addition, affiliations with research bases 
offering only cancer prevention and control protocols are appropriate.  The 
conditions of affiliation must be provided in the CCOP-research base 
affiliation agreement(s).  Initial affiliations should be maintained during 
the funding cycle.

Multiple research base affiliations are permitted, as described above,  
provided they are not conflicting.  The affiliation agreements must state 
specifically how the problem of competing protocols will be resolved.

Note:  A list of currently eligible research bases may be obtained from the 
URL address: http://dcp.nci.nih.gov/corb/ or from the Community Oncology and 
Prevention Trials Research Group, DCP, NCI at (301) 496-8541.

1.h. Quality control procedures must be described in detail.  Assurance of 
quality is the joint responsibility of the CCOP and its research base(s).  
Quality control procedures of the research base will be applied to the CCOPs 
and should be specified in the CCOP-research base affiliation agreement.

Procedures for investigational drug monitoring and data management must also 
be described.

1.i. 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 and/or 
documentation of consortium arrangements must be provided.  Evidence of 
involvement with community-based voluntary organizations may be submitted.  In 
addition, each applicant must have a defined space for administrative 
activities and administrative personnel which will serve as a focus for data 
management, quality control, and communication.

1.j. Allocation of funds to support community costs for receipt, handling, and 
quality control of patient data must be specified.  Allowable items in the 
budget are requests for full or part-time administrative personnel, clinical 
research associates, 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); and appropriate travel to meetings directly related 
to study activities (e.g., research base meetings, NCI-sponsored strategy 
sessions/workshops, local travel).  Funding is not allowed for clinical care 
provided to patients (e.g., reimbursement of patient care expenses; 
transportation costs).  Funding is not allowed for clinical support personnel 
(e.g. pharmacist, physicist, clinical psychologist, dosimetrist).  Physician 
compensation is only an allowable cost for the Principal Investigator (PI) and 
Co-PI, specifically for time spent on CCOP organizational/administrative 
tasks.  Justification must be provided for personnel time, effort and funds 
requested.

2. RESEARCH BASE Applicants

Because the Terms and Conditions of Award (discussed in the Special 
Requirements Section above) will be included in all awards issued as a result 
of this RFA, it is critical that each applicant include specific plans for 
responding to these terms.  Plans must describe how the applicant will comply 
with NCI staff involvement as well as how all the responsibilities of awardees 
will be fulfilled.

An application from a currently funded research base will be a competing 
continuation and must include a progress report, which at a minimum consists 
of: (1) a summary of prior research base activities/accomplishments, including 
a clear presentation of annual accrual to cancer treatment and annual accrual 
to cancer prevention and control protocols (gender and racial/ethnic minority 
composition) from affiliated CCOPs over the funding period; (2) progress in 
developing and implementing a cancer prevention and control research program.  
Include the process and organizational structure for protocol development and 
implementation, selection and evaluation (auditing) of performance sites, data 
management, quality control, statistical analysis, and study safety 
monitoring; (3) a clear presentation of annual accrual to each NCI-approved 
prevention and control clinical trial for CCOPs, and research base members and 
affiliates; (4) status of concepts and protocols under development; (5) a 
description of how the applicant has met the special cooperative agreement 
terms and conditions of the award.

Cooperative Groups as research bases must participate in both cancer treatment 
and prevention and control clinical trials.   Cancer Centers as research bases 
may participate in both cancer treatment and prevention and control clinical 
trials or only cancer prevention and control research.

Research bases are encouraged to participate in and/or facilitate CCOP 
participation in cancer prevention and control research that is supported 
through other federal administrative and funding instruments. Research 
supported through these other mechanisms might include nonintervention 
research in cancer control (epidemiology, methods development, population-
based surveys, etc.).  Expanding access to and involvement of the CCOP network 
in investigator initiated research will be considered in the evaluation of  
the research bases’ productivity. 

In describing the study population, it is required that a description of the 
gender and minority population and subpopulation served be provided, as well 
as an outreach plan.  This information may be based on the institutional 
records and/or prior experience.

2.a. Each applicant must demonstrate the ability to design and implement 
multi-institutional treatment clinical trials (if applicable).

A list of treatment protocols available for CCOP participation must be 
provided.

2.b. Each applicant must demonstrate the ability to design and implement 
multi-institutional cancer prevention and control clinical trials.

A list of cancer prevention and control protocols available for CCOP 
participation must be provided.

New research base applicants must also provide at least two examples of active 
or proposed cancer prevention and control intervention clinical trials and 
describe plans for study design, intervention(s), and statistical 
considerations; access to potential patients/participants to be studied; and 
procedures for data management, quality control, and follow-up.  The 
availability of appropriate expertise to design, implement, and analyze the 
results of the proposed clinical trials must be documented.

2.c. Each applicant must have an organizational structure for involving 
appropriate personnel in the design and implementation of treatment and/or 
cancer prevention and control research.  An organizational chart and a 
description of the research base operations showing the relationship(s) 
between the scientific and administrative functional units of the research 
base, vis-a-vis the conduct of treatment and/or cancer prevention and control 
clinical trials, must be provided.

The organizational focus within the research base for cancer prevention and 
control research must be described, including the composition and activities 
of the research base cancer prevention and control committee, or equivalent, 
and its relationship to other clinical trial committees and activities.

2.d. Collaboration with affiliated CCOPs/Minority-Based CCOPs in treatment 
and/or cancer prevention and control research, as applicable, is required. 
CCOP-research base affiliation agreements must be included in the application.

For treatment research, each applicant must demonstrate the ability to accrue 
a minimum of 50 credits per year from affiliated CCOPs/Minority-Based CCOPs to 
treatment clinical trials. During the initial funding period a research base 
must demonstrate that they have developed sufficient CCOP affiliations to 
accrue a minimum of 50 cancer treatment credits by the end of the third year.

For cancer prevention and control research, each applicant must demonstrate 
the ability to accrue a minimum of 50 credits per year from affiliated 
CCOPs/Minority-Based CCOPs, members and other affiliates to cancer prevention 
and control clinical trials.  During the initial funding period a research 
base must develop cancer prevention and control protocols to allow accrual of 
a minimum of 50 cancer prevention and control credits by the end of the third 
year. 

If applicable, CCOP research base applicants should describe their 
participation in and/or facilitation of CCOP participation in cancer 
prevention and control research studies supported by other federal 
administrative and funding instruments such as research project grants (R01s ) 
and contracts. 

It is expected that selected cooperative group members, affiliate programs 
and/or cancer center affiliates other than the CCOPs will participate in 
cancer prevention and control research.  Research base applications may 
include requests for these non-CCOP member institutions to become "prevention 
members."  Such non-CCOP member institutions would contribute to the goals of 
the research base related to cancer prevention.  Specific activities of 
“prevention members” should include, but are not limited to, one or more of 
the following: 1) accrual to chemoprevention studies; 2) development of 
chemoprevention protocols; 3) membership in research base cancer prevention 
committees; 4) conduct of preclinical studies necessary for development of 
chemoprevention trials; and 5) conducting ancillary research, such as that 
related to mechanisms of action, recruitment strategies, etc.  The research 
base applicants must describe the experience of the proposed non-CCOP member 
institution and how this “prevention member” will contribute to the goals and 
objectives of the application.  In addition, the research base applicant 
should describe the nature and scope of work proposed for each “prevention 
member.” included in the application and a detailed budget.  

2.e. A designated Principal Investigator is required and his/her 
qualifications and experience must be described.  An individual must be 
designated to coordinate cancer prevention and control research.  His or her 
qualifications and experience within the research base structure should also 
be described.  Each applicant must also demonstrate the ability to access 
professionals with the appropriate expertise to design and implement the 
proposed treatment and/or cancer prevention and control clinical trials.  
Basic scientists, medical, surgical, radiation and other oncology specialists, 
nurse oncologists, epidemiologists, health educators and/or other public 
health professionals may be included.

2.f. Each applicant's ability to manage the data from multi-institutional 
treatment and/or cancer prevention and control clinical trials must be 
described.  Data management includes development of data collection forms, 
procedures for data transmittal, procedures for data entry, data editing, 
compilation, and analysis, as well as procedures for quality control and 
verification of submitted data.  Standards should exist for determining 
eligibility and evaluability of patients/participants entered on protocols.  
Statistical capability must exist to develop protocol statistical parameters, 
analyze the data, and report results.

2.g. Each applicant must demonstrate the ability to initiate procedures for 
training and maintaining the proficiency of personnel from affiliated 
CCOPs/Minority-Based CCOPs on techniques for successful management of 
treatment and/or cancer prevention and control clinical trials research.  
Depending on the clinical trials initiated and the interventions involved, 
this will include training for data managers/nurses and any other individuals 
responsible for data collection, monitoring, or carrying out the 
intervention(s).

2.h. Each applicant's ability to provide mechanisms for periodic review of the 
performance of affiliated CCOPs/Minority-Based CCOPs, including on-site 
monitoring (auditing) and written procedures and criteria for continued 
affiliations, must be described.  Similar measures must be described for other 
member/affiliates participating in cancer prevention and control research.

2.i. Each applicant must describe its plan for independent data and safety 
monitoring for all prevention and control clinical trials.

2.j. Requests for funds must reflect operations/statistical costs for quality 
control and data management costs for CCOP participation in protocols.  This 
estimate is based on the expected accrual credits of affiliated 
CCOPs/Minority-Based CCOPs and for member/affiliate accrual credits in cancer 
prevention and control.  CCOP-research base affiliation agreements must be 
included.  Each applicant 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 for the research base), 
and funds can also be requested for appropriate travel to meetings directly 
related to study activities (such as NCI-sponsored strategy 
sessions/workshops).  In addition, the research bases may request funding for 
specific non-CCOP member institutions that apply to become "prevention 
members."  A detailed budget for each prevention member must be included in 
the application.  Specific justification for all requested funds must also be 
included in the application.

Method of Applying

The RFA label available in the PHS-398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application. Type the RFA number 
on the label. Failure to use this label could result in delayed processing of 
the application such that it may not reach the review committee in time for 
review.  In addition, the RFA title and number must be typed on line 2 of the 
face page of the application form and the YES box must be marked.

The sample RFA label available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change. Please note this is in pdf format.

Submit a signed, typewritten original of the application, including the 
Checklist, and three (3) signed photocopies, in one package to:

Center for Scientific Review 
National Institutes of Health
6701 Rockledge Drive
Room 1040 - MSC 7710
Bethesda, Maryland  20892-7710
(20817 for courier service)

At the time of submission, two (2) additional copies of the application must 
also be sent to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8109, MSC-8239
Rockville, Maryland  20852 (express courier)
Bethesda, Maryland 20892-8239

It is important to send these copies at the same time that the original and 
three copies are sent to CSR; otherwise, the NCI cannot guarantee that the 
applications will be reviewed in competition with other applications received 
on or before the designated receipt date. 

Applications must be received by July 13, 2001.  If an application is received 
after that date, it will be returned to the applicant without review.  The 
Center for Scientific Review (CSR) will not accept any application in response 
to this RFA that is essentially the same as one currently pending initial 
review, unless the applicant withdraws the pending application.  The CSR will 
not accept any application that is essentially the same as one already 
reviewed.  This does not preclude the submission of substantial revisions of 
applications already reviewed, but such an application must follow the 
guidance in the PHS Form 398 application instructions for the preparation of 
revised applications, including an introduction addressing the previous 
critique.

REVIEW CONSIDERATIONS

A. REVIEW PROCEDURES

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by the NCI staff.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration.  

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NCI in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will receive a written critique and 
undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, 
will be discussed, assigned a priority score, and receive a second level 
review by the National Cancer Advisory Board.

B. REVIEW CRITERIA

1.  CCOP Applicants

All applicants will be evaluated on the following criteria:

1.a. Adequacy of plans to include both genders and minorities and their 
subgroups.  Plans for the recruitment and retention of participants will also 
be evaluated.  In describing the study population, it is required that a 
description of the gender and minority population and subpopulation served be 
provided, as well as an outreach plan.  This information may be based on the 
institutional records and/or prior experience.

1.b.  Ability to accrue a minimum of 50 credits per year to treatment clinical 
trials and a minimum of 50 credits per year to cancer prevention and control 
clinical trials.  Established CCOPs will be funded at a yearly accrual goal 
that may be higher than 50 credits for treatment clinical trials and 50 
credits for cancer prevention and control clinical trials.  These established 
CCOPs will be evaluated for their past performance in meeting these accrual 
goals.  The minimum accrual to treatment requirements may be waived for: 1) 
applicants whose specialty is pediatrics and are able to place a majority of 
their eligible patients on protocol; and 2)  for applicants with an 
outstanding record in accrual to prevention and control protocols.  Each 
applicant's ability to access the appropriate populations, professional 
disciplines, and facilities to participate with affiliated research bases in 
NCI-approved cancer prevention and control intervention protocols will be 
appraised.  Any prior participation in cancer treatment and prevention and 
control research will be considered.  For new CCOP applicants, the plans for 
implementing at least two NCI-approved protocols will be assessed for 
feasibility and practicality.

In addition, CCOP participation in cancer prevention and control research 
studies supported through other federal and administrative funding instruments 
such as research project grants (R01s) and contracts will be considered in the 
evaluation of the CCOP’s productivity. 

1.c. Qualifications and experience of the principal investigator/associate 
principal investigator, in terms of ability to organize and manage a community 
oncology program that includes both cancer treatment and prevention and 
control research as well as accrual to such protocols, and related activities.

1.d. Training, experience, and commitment of participating physicians for 
accruing individuals to protocols in which the applicant has agreed to 
participate.  The experience of proposed investigators in the entry and 
treatment of cancer patients on research trials (gained from residency, 
fellowships, postdoctoral training and/or subsequent practice) will be 
appraised.  For multidisciplinary studies, evidence of the availability of 
appropriate professional resources (e.g., radiotherapy, pediatrics, surgery, 
gynecology, urology, gastroenterology, pathology, internal medicine, family 
practice, nursing, and nutrition) will be required.  Experience or special 
skills in cancer prevention and control research and related activities will 
be considered, together with availability of other community resources and 
personnel for such clinical trials.

1.e. Stability of the functional unit or group applying to become a CCOP.  
Preexisting organizational affiliations of at least a core of the group 
applying, and evidence of stable working relationships, will be appraised.  
Examples of established consortium arrangements, and committee structure which 
demonstrates the participation of appropriate physicians and administrators, 
may be submitted.  Evidence of previous success as a group in implementing 
clinical cancer treatment and prevention and control research and related 
activities will be considered.

1.f. Qualifications and experience of all proposed support personnel relative 
to their position descriptions.  The relevant credentials and expected 
contributions to the program of personnel resources not fiscally supported by 
the award will be considered.

1.g. Adequacy of quality assurance mechanisms for both cancer treatment and 
prevention and control interventions, and adequacy of procedures for 
investigational drug monitoring and data management and identification of 
false or otherwise unreliable data.

1.h. Adequacy of available facilities, including laboratories, in-patient and 
outpatient resources, cancer registries, etc., and adequacy of space for 
administrative activities and personnel.

1.i. Appropriateness of research base affiliations and of the cancer treatment 
and prevention and control research protocols chosen.  Affiliation agreements 
must be provided in the application.

The review group will critically examine the submitted budget and will 
recommend an appropriate budget and period of support for each favorably 
recommended application.  

Allowable items in the budget are requests for full or part-time 
administrative personnel, clinical research associates, 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); and appropriate 
travel to meetings directly related to study activities (e.g., research base 
meetings, NCI-sponsored strategy sessions/workshops, local travel).  Funding 
is not allowed for clinical care provided to patients (e.g., patient care 
reimbursement, transportation costs).  Funding is not allowed for clinical 
support personnel (e.g. pharmacist, physicist, clinical psychologist, 
dosimetrist).  Physician compensation is only an allowable cost for the 
Principal Investigator (PI) and Co-PI, specifically for time spent on CCOP 
organizational/administrative tasks.  Justification must be provided for 
personnel time and effort and funds requested.

The initial review group will also examine: the appropriateness of proposed 
project budget and duration; the adequacy of plans to include both genders and 
minorities and their subgroups and plans for the recruitment and retention of 
subjects; the provisions for the protection of human and animal subjects; and 
the safety of the research environment.

For competing continuations, the review group will critically examine the 
adequacy of progress during the funding period, including ability to meet the 
accrual goals in cancer treatment and prevention and control, progress made as 
a CCOP, and evaluation of CCOP performance by affiliated research bases(s).  
Consideration will be given to previous accrual and the ability to meet the 
previous accrual projections for which the CCOP was funded.  The research base 
evaluation report(s) must be provided in the application.  Plans for continued 
accrual and follow-up of participants on protocols will be evaluated.

2.  Research Base Applicants

All research base applicants will be evaluated on the following criteria:

2.a. Adequacy of plans to include both genders and minorities and their 
subgroups as appropriate for the scientific goals of the research.  Plans for 
the recruitment and retention of participants will also be evaluated.  In 
describing the study population, it is required that a description of the 
gender and minority population and subpopulation served be provided, as well 
as an outreach plan.  This information may be based on the institutional 
records and/or prior experience.

2.b. Experience in conducting multi-institutional clinical trials; 
demonstrated ability to develop such studies and act as a coordinating and 
statistical center; adequate facilities to conduct the clinical trials; 
adequate procedures to collect, monitor, and analyze the data and assure the 
safety of patients/participants.

2.c. Quality and availability of cancer treatment and/or prevention and 
control protocols, as applicable, which are appropriate for CCOP 
participation, or the potential for developing such clinical trials.  For new 
applications, a detailed description of at least two examples of actual or 
planned cancer prevention and control protocols, with professional expertise 
to assure the quality of the proposed intervention clinical trial will be 
evaluated.

2.d.. The ability to accrue a minimum of 50 credits per year from affiliated 
CCOPs/Minority-Based CCOPs to treatment clinical trials.

The ability to accrue a minimum of 50 credits per year from affiliated 
CCOPs/Minority-Based CCOPs, members and other affiliates to cancer prevention 
and control clinical trials.  Experience as well as the potential for 
developing future clinical trials will be considered.   

Documentation must include CCOP-research base affiliation agreements.

Note:  The minimum of 50 credits per year may be waived for a research base 
that expands the use of the CCOP network to cancer prevention and control 
research supported through other federal administrative and funding 
instruments.  These studies must have been approved by the CPCPRC, DCP for 
CCOP use.  Because the data management for such research is supported by 
another federal funding source, the research base is not eligible to claim 
credit for accruals through the CCOPs/Minority-Based CCOPs, members and other 
affiliates.

Research base applicants’ participation in and/or facilitation of CCOP 
participation in cancer prevention and control studies supported through other 
federal administrative and funding instruments such as research projects 
grants (R01s) and contracts will be considered in the evaluation of the 
research base’s productivity.

2.f. Organizational structure for involving appropriate personnel in the 
design and implementation of treatment and/or cancer prevention and control 
research.  The organizational focus within the research base for cancer 
prevention and control research, including the composition and activities of 
the cancer prevention and control committee, and the designation of protocol 
chairpersons and its relationship to other clinical trial committees and 
activities will be assessed.  The qualifications and contribution to the 
science of and accrual to cancer chemoprevention clinical trials will be 
assessed in the evaluation of the research base's request for the non-CCOP 
member institutions that apply for the designation of "prevention member.” 

2.g. Qualifications and experience of the principal investigator and/or the 
individual responsible for directly relating to the CCOPs.  The availability 
and experience of multidisciplinary health professionals and allied 
professionals with skills needed to develop, utilize, and analyze treatment 
and/or cancer prevention and control clinical trials will also be evaluated.

2.h. Experience in working with community oncologists, orienting community 
data management personnel to protocol requirements, organizing scientific and 
educational meetings for those participating in the clinical trials, and 
participating in intergroup clinical trials.

2.i. Ability to establish quality control, quality assurance, and data 
management procedures.  Experience in data management and analysis of multi-
institutional clinical trials and adequacy of data management staff will be 
appraised.  The use of mechanisms for periodic review of quality control, 
quality assurance, and data management procedures, safety monitoring, 
including procedures for data safety and monitoring committee and on-site 
auditing program will be assessed.

2.j. For competitive continuations, adequacy of progress in implementing a 
prevention and control clinical trials program including cancer prevention and 
control protocol development and implementation, accrual, data management, 
evaluation of performance sites; current status of each protocol and progress 
towards meeting planned accrual goals from CCOPs and members/affiliates; 
summary of prior activities with a clear presentation of annual accrual; 
completion of clinical trials, interim analyses, publication of findings, or 
other dissemination of trial findings throughout the research base; and other 
progress in meeting the requirements for a CCOP research base.  During the 
initial funding period, a research base must demonstrate the adequacy of 
progress in implementing a cancer prevention and control clinical trials 
program that will result in attainment of accrual goals by the end of the 
third year.

The review group will critically examine the submitted budget and will 
recommend an appropriate budget and period of support for each favorably 
recommended application.

Requests for funds must reflect operations/statistical costs for quality 
control and data management costs for CCOP participation in protocols.  This 
estimate is based on the expected accrual credits of affiliated 
CCOPs/Minority-Based CCOPs and for member/affiliate accrual credits in cancer 
prevention and control.  Research bases should include a budget for monitoring 
and auditing costs.  Funding may be requested for scientific development and 
pilot testing of new cancer prevention and control research initiatives, other 
costs related to implementation of specific cancer prevention and control 
protocols (including support of a cancer prevention and control committee for 
the research base), or for appropriate travel to meetings directly related to 
study activities (such as NCI-sponsored strategy sessions/workshops). 
Additionally, funding may be requested to provide infrastructure support for 
non-CCOP member institutions of the Research Bases that can show significant 
contribution to the science and/or accrual for chemoprevention trials. 
Specific justification must be provided.

The initial review group will also examine: the appropriateness of proposed 
project budget and duration; the adequacy of plans to include both genders and 
minorities and their subgroups as appropriate for the scientific goals of the 
research and plans for the recruitment and retention of subjects; the 
provisions for the protection of human and animal subjects; and the safety of 
the research environment.

AWARD CRITERIA

The anticipated date of award is June 1, 2002.  Applications recommended by 
the National Cancer Advisory Board will be considered by NCI staff for award 
based upon (a) scientific and technical merit; (b) demographic and geographic 
distribution of applicants to assure inclusion of minority and underserved 
population; (c) availability of funds.  Multiple CCOP applicants for funding 
who are competing for the same patient population will be considered, but all 
may not be awarded unless warranted by the population density.

SCHEDULE

Letter of Intent Receipt:       June 8, 2001
Application Receipt Date:       July 13, 2001
Review by NCAB Advisory Board:  February 2002
Anticipated Award Date:         June 1, 2002

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.  The 
opportunity to clarify any issues or questions from potential applicants is 
welcome.

Direct inquiries regarding programmatic issues to:

Lori Minasian, MD, FACP
Chief, Community Oncology and Prevention Trials Research Group
Division of Cancer Prevention, NCI
Executive Plaza North - Room 300
6130 Executive Boulevard, MSC-7340
Bethesda, Maryland  20892-7340
Telephone:  (301) 496-8541
Fax: (301) 496-8667
E-mail address: lm145a@nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8109, MSC-8239
Rockville, Maryland  20852 (for courier service)
Bethesda, Maryland 20892-8239
Telephone: (301) 496-3428
Fax: (301) 496-0275
Email address: tf12w@nih.gov 

Direct inquiries regarding fiscal matters to:

Ms. Crystal Wolfrey
Grants Administration Branch
Office of the Director, NCI
Executive Plaza South - Room 243
6120 Executive Boulevard
Bethesda, Maryland  20892
Telephone:  (301) 496-7800
Fax: (301) 496-8601
E-mail: crystal.wolfrey@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.399, Cancer Control.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grant policies and Federal Regulations 42 CFR Part 52 
and 45 CFR Parts 74 and 92.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


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