COMMUNITY CLINICAL ONCOLOGY PROGRAM

RELEASE DATE:  April 23, 2004

RFA NUMBER:  RFA-CA-05-014  (Reissued as RFA-CA-07-025)

EXPIRATION DATE:  July 15, 2004

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENT OF PARTICIPATING ORGANIZATION:
National Cancer Institute (NCI) 
 (http://www.nci.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.399

LETTER OF INTENT RECEIPT DATE:  June 14, 2004
APPLICATION RECEIPT DATE:  July 14, 2004

This RFA is a reissuance of RFA-CA-04-008, which was published in the NIH 
Guide on May 19, 2003.

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

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 (cooperative groups and cancer centers that 
design the protocols for clinical trials, collect and analyze study data, and 
monitor the data quality and patient accrual performance of CCOPs and other 
institutional members) 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, 
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 efforts and expertise of community physicians and other health 
care professionals with those of the NCI-funded cancer treatment and 
prevention and control clinical trials groups provides opportunities for 
transfers 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 its treatment.  In addition, 
research bases manage and analyze all data collected and 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 these 
questions.  

This reissuance of the CCOP RFA seeks to build on the strength and 
demonstrated success of the CCOP network over the past 20 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.

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 3 years, 62 community programs in 34 states were 
funded and accrued 14,000 patients to NCI-funded 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 2003, there were 50 programs in states involving over 375 
hospitals and over 3,075 physicians.  Approximately 5,700 patients were 
entered onto treatment trials and 7,000 participants on cancer prevention and 
control trials in 2003. 

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 prostate cancer prevention 
trial with finasteride (PCPT), the study of tamoxifen and raloxifene in the 
prevention of breast cancer (STAR) and the selenium and vitamin E trial 
(SELECT) in the prevention of prostate cancer.

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 and 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 as well as to the research bases’ member/affiliate institutions.  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 accrual, and participate on a 
continuing basis in program evaluation.

MECHANISM OF SUPPORT

This RFA will use the NIH U10 award mechanism.  The NIH U10 is a cooperative 
agreement award mechanism in which the Principal Investigator retains the 
primary responsibility and dominant role for planning, directing, and 
executing the proposed project, with NIH staff being substantially involved as 
a partner with the Principal Investigator, as described under the section 
"Cooperative Agreement Terms and Conditions of Award.”

This RFA uses just-in-time concepts.  It uses the non-modular budgeting 
formats so follow the instructions for non-modular research grant 
applications.  This program does not require cost sharing as defined in the 
current NIH Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.    

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, 
review committee recommendations, and programmatic considerations.  The 
anticipated award date is June 1, 2005.

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 on 
an annual basis, provided that funds are available.

FUNDS AVAILABLE

The NCI intends to commit approximately $18.5 million in total costs FY 2005 
to fund seventeen to twenty-one new and/or competitive continuation grants in 
response to this RFA. The $18.5 million in total costs per year for 5 years is 
to specifically fund applications that are submitted in response to this RFA.  
Approximately four research base awards and seventeen CCOP awards will be 
made. 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 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.

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution meets any of the 
following characteristics: 
	
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, hospitals and health 
maintenance organizations
o Domestic institutions/organizations  
o Foreign institutions are not eligible to apply
o Faith-based or community organizations

A.  For CCOP applicants, the following provisos apply.

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 patient 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.  For research base applicants, the following provisos apply.

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.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to develop 
an application for support.  Individuals from underrepresented racial and 
ethnic groups as well as individuals with disabilities are always encouraged 
to apply for NIH programs.   

SPECIAL REQUIREMENTS

Cooperative Agreement Terms and Conditions of Award

The administrative and funding instrument used for this program is a 
cooperative agreement (U10), which involves anticipated assistance to awardees 
from the NCI Program Staff. 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 partnership 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, as described 
below.

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 that 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 
documents: 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  
(http://ctep.cancer.gov/handbook/);  GUIDELINES FOR ON-SITE MONITORING OF 
CLINICAL TRIALS FOR COOPERATIVE GROUPS AND CCOP RESEARCH BASES 
(http://ctep.cancer.gov/monitoring/guidelines.html); and the Intellectual 
Property Option to Collaborator (http://ctep.cancer.gov/industry/ipo.html).  
These documents (and any subsequent modifications of them) are hereby 
incorporated by reference as terms of award and are available at the URLs 
cited above or from the program staff listed under “INQUIRIES.”

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 upon approval 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.  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 CTSU 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 tasks associated with conducting NCI-approved treatment trials.

CCOPs are encouraged to participate in cancer prevention and control research 
that is supported through other federally funded mechanisms such as 
investigator-initiated awards.  Collaborations between CCOPs and independent 
investigators may facilitate the implementation of a wide variety of 
nonintervention research in cancer control such as descriptive, qualitative, 
survey, methods development or epidemiology that will contribute to improving 
public health outcomes.  Participation in such research will be considered in 
the evaluation of the CCOP’s productivity.

b. RESEARCH BASE AFFILIATIONS

Each CCOP must affiliate with one national multi-specialty cooperative group 
having a spectrum of cancer treatment and prevention and control clinical 
trials.  Exceptions to affiliation with more than one multi-specialty group 
may be granted in conjunction with participation in NCI-sponsored “pilot” 
projects.  In addition, each CCOP may affiliate with as many other research 
bases, exclusive of the multi-specialty groups, as the CCOP deems appropriate.  
In deciding on the optimum number of other research bases to affiliate with, 
the CCOP should consider the administrative burden and the membership 
requirements that will result from increased numbers of research base 
affiliations.  The resources of the CCOP should also be factored into this 
decision.

The CCOP must justify the reasons for multiple other research base 
affiliations, either existing or planned in terms of the scope and breadth of 
research that the CCOP anticipates undertaking in its new or competing 
continuation application.  

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.

NOTE:  A list of eligible research bases may be obtained from the URL address: 
http://www3.nci.nih.gov/prevention/ccop/rbccop.html or by contacting the 
Community Oncology and Prevention Trials Research Group, DCP, NCI at (301) 
496-8541.

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 is available 
at http://cancer.gov/prevention/ccop/guidelines.html.  

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 specialty 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 specialty 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 federally funded mechanisms, 
such as investigator-initiated awards.  Participation in such research will be 
considered in the evaluation of CCOP productivity.

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 
is available at the URL address: 
http://www3.nci.nih.gov/prevention/ccop/rbccop.html.   

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.

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 FDA Form 1572 on file with the 
Pharmaceutical Management Branch, CTEP, DCTD, NCI.

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.  The sites 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.

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).

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, a component, or a research base.  The Guidelines for Obtaining 
Approval of CCOP Organizational Changes is available at the URL address: 
http://cancer.gov/prevention/ccop/guidelines.html.

j. REPORTING REQUIREMENTS

Annual progress reports must be submitted to DCP.  A suggested format will be 
provided for this purpose.  The format is available at the URL address: 
http://cancer.gov/prevention/ccop/.  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.

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.

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.

m. FEDERALLY MANDATED 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.

NIH requires that CCOP studies meet the NIH policy requirements for inclusion 
of women and minorities in clinical research and inclusion of children as 
participants in research involving human subjects. 

The NIH expects investigators supported by NIH funding to make their research 
data available to the scientific community for subsequent analysis based on a 
data sharing plan approved as part of the award; see the NIH Data Sharing 
Policy website at http://grants.nih.gov/grants/policy/data_sharing/ and CCOP 
guidance at http://cancer.gov/prevention/ccop. This requirement on data 
sharing is an extension to NIH policy regarding sharing research resources, 
which expects that recipients of NIH support will provide prompt and effective 
access to research tools.  

n. PUBLICATIONS

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

2.  NCI STAFF INVOLVEMENT

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).

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.

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).

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.

e. ORGANIZATIONAL CHANGES

The DCP program director will review requests for certain organizational 
changes and provide written approval.  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 is available at: 
http://cancer.gov/prevention/ccop/guidelines.html

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.

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.

h. FEDERALLY MANDATED 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/ from the program staff listed under 
INQUIRIES.

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.

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

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.  All documents for cancer 
prevention and control concepts and/or protocols should be submitted to the 
DCP Protocol Information Office (PIO), NCI, 
http://www3.cancer.gov/prevention/pio

Similarly, concept proposals for research base cancer treatment protocols may 
precede protocol development.  The CTEP Protocol Review Committee (PRC) in the 
DCTD, NCI is responsible for review of all cancer treatment concepts and 
protocols.  All documents for treatment concepts and/or protocols should be 
submitted to the CTEP Protocol Information Office (PIO), DCTD, NCI 
(http://ctep.cancer.gov/about/pio.html). DCTD may also require a letter of 
intent for new cancer treatment trials.  

c. ACCRUAL
 
Each research base protocol approved for CCOP and/or research base 
member/affiliate institution 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.  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 designed by the research base applicant and approved by the 
PRC, DCTD, NCI.  During its initial competitive segment (project period), a 
new research base applicant is expected to develop a menu of treatment 
protocols that will allow the research base to meet the credit minimums per 
year in its subsequent competing segments.

A research base for cancer prevention and control research is required to 
accrue a minimum of 50 credits per year from CCOPs, and other research base 
member/affiliate institutions to cancer prevention and control clinical trials 
led by the research base applicant and approved by the CPCPRC, DCP.  A new 
research base applicant is expected, during its initial competitive segment 
(project period), to develop a menu of cancer prevention and control protocols 
that will allow the research base to meet the credit minimums per year in its 
subsequent competing segments.

Research bases are encouraged to participate in and/or facilitate CCOP 
participation in cancer prevention and control research that is supported 
through other federally funded mechanisms.  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 will be considered in the 
evaluation of the research bases’ productivity. 

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.  In 
addition, the research bases must have a data-sharing plan as required by the 
extension of NIH policy regarding sharing research resources (See NIH Grants 
Policy, Part II Subpart A, Availability of Research Results).  See also the 
“Suggestions for Organizing Information for a CCOP Research Base Application,” 
for guidance on the application of this policy to research base cooperative 
agreements at http://cancer.gov/prevention/ccop.  

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

The research bases may contract with independent investigators to perform data 
management and analysis for research supported by other federally funded 
mechanisms.

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 and research base 
members/affiliates are required to follow research base procedures for quality 
control.

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

The research base is responsible for monitoring the progress of each study 
following good clinical practices 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.  Quality control procedures 
must be in place for incoming data for quality control and quality assurance. 
(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 that 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 
http://ctep.cancer.gov/monitoring/guidelines.html 
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.

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 
http://ctep.cancer.gov/monitoring/guidelines.html.  

g. MONITORING PLAN AND DATA SAFETY AND MONITORING BOARDS

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

The research base must establish and maintain Data and Safety Monitoring 
Committees (DSMCs) for allPhase III clinical trials in accordance with the 
NCI’s policy for Data Safety and Monitoring of Clinical Trials at 
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.  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 at 
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.  Information concerning essential elements of data safety 
monitoring plans for clinical trials funded by the NCI is available at 
http://www.cancer.gov/clinical_trials.  These monitoring activities are 
distinct from the requirement for study review and approval by an 
Institutional Review Board (IRB).  

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.

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 
http://ctep.cancer.gov/reporting/cdus.html.

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 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 clinical trials.  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.

k. ADVERSE EVENT REPORTING 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 sponsor(s) according to NCI 
Guidelines.  For treatment trials utilizing CTEP investigational agents 
guidelines are listed at http://ctep.cancer.gov/reporting/adeers.html.  For 
cancer prevention and control trials utilizing DCP investigational agents 
guidelines are listed at http://www3.cancer.gov/prevention/pio/index.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.

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.  

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.

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.

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.

p. FEDERALLY MANDATED 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.

NIH requires that research base studies meet the NIH policy requirements for 
inclusion of women and minorities in clinical research and inclusion of 
children as participants in research involving human subjects. 

The NIH expects investigators supported by NIH funding to make their research 
data available to the scientific community for subsequent analysis based on a 
data sharing plan approved as part of the award; see the NIH Data Sharing 
Policy website at http://grants.nih.gov/grants/policy/data_sharing/ and CCOP 
guidance at http://cancer.gov/prevention/ccop. This requirement on data 
sharing is an extension to NIH policy regarding sharing research resources, 
which expects that recipients of NIH support will provide prompt and effective 
access to research tools.  

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.

r. PREVENTION MEMBERS

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

s. PUBLICATIONS

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

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.

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 that allows direct notification of the patient by the NCI.

2. NCI STAFF INVOLVEMENT

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.

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.

c. CONCEPT/PROTOCOL REVIEW

All research base protocols utilized by the CCOPs and research base 
member/affiliate institutions 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 research 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.

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.

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.

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.

g. DATA SAFETY AND MONITORING COMMITTEE

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/CTEP staff will serve as non-voting members on the DSMC.

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.

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 progress 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.

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).

k. FEDERALLY MANDATED 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. 

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.

WHERE TO SEND INQUIRIES  

Written and telephone inquiries concerning this RFA are encouraged.  The 
opportunity to clarify any issues or questions from potential applicants is 
welcome. Inquiries may fall into three areas:  scientific/programmatic, peer 
review, and financial or grants management issues:

o Direct your questions about programmatic issues to:

Lori Minasian, MD, FACP
Chief, Community Oncology and Prevention Trials Research Group
Division of Cancer Prevention, NCI
6130 Executive Boulevard, EPN Room 2017, MSC-7340
Bethesda, MD  20892-7340
Rockville, MD 20852 (for courier/express service)
Telephone:  (301) 496-8541
Fax: (301) 496-8667
E-mail address:  lm145a@nih.gov

o Direct your questions about peer review issues to:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for courier/express service)
Telephone: (301) 496-3428
FAX: (301) 402-0275 
Email:  ncirefof@dea.nci.nih.gov

o Direct your questions about financial or grants management matters to:

Ms. Jane Paull
Grants Administration Branch
Office of the Director, NCI
6120 Executive Boulevard. EPS Room 243
Bethesda, MD  20892
Rockville, MD 20852 (for courier/express service)
Telephone:  (301) 496-2182
Fax: (301) 496-8601
E-mail: jp97x@nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows NCI staff to estimate the potential review workload and plan 
the review.
 
The letter of intent is to be sent by the date listed at the beginning of this 
document.  The letter of intent should be sent to:

Lori Minasian, MD, FACP
Chief, Community Oncology and Prevention Trials Research Group
Division of Cancer Prevention, NCI
6130 Executive Boulevard, EPN Room 2017, MSC-7340
Bethesda, MD 20892-7340
Rockville, MD 20852 (for courier/express service)
Telephone:  (301) 496-8541
Fax: (301) 496-8667
E-mail address: lm145a@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 
document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance, contact GrantsInfo, Telephone: (301) 435-0714, 
Email: GrantsInfo@nih.gov.
 
SUPPLEMENTARY INSTRUCTIONS

A suggested format (“Suggestions for Organizing Information for a CCOP or CCOP 
Research Base Application,”) is available at 
http://cancer.gov/prevention/ccop/.  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 suggested format are included, those tables should be part of 
the body of the application, and NOT included in the appendix.  These tables 
should be included in the application as part of the Resources, Progress 
Report and/or Human Subjects Research sections, as appropriate.  Also, 
responses to the instructions concerning "Human Subjects" verification must be 
included in the application at the time of submission.  Applications submitted 
in response to this RFA may use up to 75 pages to describe the research plan, 
sections a through d.  Applicants are encouraged to use the minimum number of 
pages necessary to clearly and succinctly describe the research plan.  The 75 
page limit may be increased for those applications that include supplements 
for support of large-scale prevention trials and/or with a substantial number 
of proposed “prevention members.”  These applicants should contact the 
Community Oncology and Prevention Trials Research Group, DCP, NCI at (301) 
496-8541.

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:

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) that 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.

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.  

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 federally funded mechanisms 
(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.

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.

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.

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.

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 with as many other research bases (excluding 
the multi-specialty groups) as the CCOP deems appropriate, each applicant must 
demonstrate access to both cancer treatment and prevention and control 
research protocols. The CCOP must justify the reasons for multiple other 
research base affiliations, either existing or planned, in terms of the scope 
and breadth of research that the CCOP anticipates undertaking in its new or 
competing continuation application. Evidence must be provided that an 
affiliation has been established with one NCI-approved multi-specialty 
cooperative group. 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 at: 
http://cancer.gov/prevention/ccop or from the Community Oncology and 
Prevention Trials Research Group, DCP, NCI at (301) 496-8541.

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.

i. The CCOP must describe how it plans to share data.  The procedures to be 
used and a timeline for making the data available should be included in the 
description of the plan.  The CCOP also should discuss how the rights and 
confidentiality of participants are protected.

j. 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 that will serve as a focus for data 
management, quality control, and communication.

k. 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 protocols (if 
applicable) (gender and racial/ethnic minority composition) from affiliated 
CCOPs; annual accrual to cancer prevention and control protocols (gender and 
racial/ethnic minority composition) from affiliated CCOPs and research base 
member and affiliates over the funding period; (NOTE:  An applicant submitting 
the first competing continuation application must demonstrate that the 
research base has generated a sufficient number of NCI approved protocols to 
meet the credit minimums during the ensuing project period.  The research 
base’s menu of NCI-approved concepts or concepts in development is another 
measure of the applicant’s viability as a research base.) (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 federally funded mechanisms. 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.

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.

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 and 
research base member/affiliate institution 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.

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.

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 developed by the research base applicant.  A new 
research base applicant is expected, during its initial competitive segment 
(project period), to develop a menu of treatment protocols that will allow the 
research base to meet the credit minimums per year in its subsequent competing 
segments.

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 led by the research base applicant.  A new 
research base applicant is expected, during its initial competitive segment 
(project period), to develop a menu of cancer prevention and control protocols 
that will allow the research base to meet the credit minimums per year in its 
subsequent competing segments.

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 federally funded 
mechanisms 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 
its base’s cancer prevention research agenda.  Specific activities of 
“prevention members” should include, but are not limited to, one or more of 
the following: 1) significant accrual to chemoprevention studies developed by 
the research base applicant; 2) development of chemoprevention protocols; 3) 
membership in the research base applicant’s cancer prevention committees; 4) 
conduct of pre-clinical 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 its investigators and how this “prevention member” will 
contribute to the goals 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.

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.

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.  The research base must describe its 
data-sharing plan.  The procedures to be used and a timeline for making the 
data available should be included in the description of the plan.  A 
discussion on how the rights and confidentiality of participants are protected 
should be included.

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).

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.

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

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(s) 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.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
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 RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/labels.pdf. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and three signed, photocopies, in 
one package to:
 
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application and all 
five copies of the appendix material must be sent to:
 
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD  20852 (for express/courier service)

Appendices should be comprised of unbound materials, with separators 
between documents.

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE 
WILL NO LONGER BE ACCEPTED.  This policy does not apply to courier deliveries 
(i.e., FEDEX, UPS, DHL, etc.) 
(See http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html).  
This policy is similar to and consistent with the 
policy for applications addressed to Centers for Scientific Review as 
published in the NIH Guide Notice (See 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.)

APPLICATION PROCESSING: Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is received 
after that date, it will be returned to the applicant without review.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.
 
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. 
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application.  That is the application for the 
RFA must not include an Introduction describing the changes and improvements 
made, and the text must not be marked to indicate the changes from the 
previous unfunded version of the application.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
for responsiveness by the NCI program staff.  Incomplete and/or non-responsive 
applications will not be reviewed.  

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 Division of Extramural Activities (DEA) at NCI in accordance with the 
review criteria stated below.  As part of the initial merit review, all 
applications will:

o  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 and assigned a priority score
o  Receive a written critique
o  Receive a second level review by the NCI’s National Cancer Advisory Board.

REVIEW CRITERIA

1.  CCOP APPLICANTS

All applicants will be evaluated on the following criteria:

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.

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 federally funded mechanisms such as research 
project grants (R01s) and contracts will be considered in the evaluation of 
the CCOP’s productivity. 

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.

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.

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.

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.

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.

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

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.

j. Adequacy of the data-sharing plan. 

k. 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.

OTHER REVIEW CRITERIA

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:

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.

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.

c. Quality and availability of cancer treatment and/or prevention and control 
protocols, as applicable, which are appropriate for CCOP and other cooperative 
group members/affiliates 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.

d. The ability to accrue a minimum of 50 credits per year from affiliated 
CCOPs/Minority-Based CCOPs to treatment clinical trials developed by the 
research base applicant. For new research base applicants, the ability to 
develop a menu of treatment protocols that will allow the research base to 
meet the credit minimum in subsequent competitive segments.

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 led by the research base applicant.  Experience as 
well as the potential for developing future clinical trials will be 
considered.  For new research base applicants, the ability to develop a menu 
of cancer prevention and control protocols that will allow the research base 
to meet the minimum of 50 credits in subsequent competitive segments.

Documentation must include CCOP-research base affiliation agreements.

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

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”. 

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.

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 inter-group clinical trials.

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. 

j. The adequacy of the data-sharing plan.

k. 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 research base 
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.  

For applicants submitting their initial competing continuation application, 
adequacy of progress must be demonstrated, in implementing a cancer prevention 
and control clinical trials program, including development of an adequate menu 
of NCI approved protocols, which will result in attainment of accrual goals 
and other requirements for a CCOP research base in the next and subsequent 
competitive segments.

l. 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 research base 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.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:
 
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section 
on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans 
to include subjects from both genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, 
below).

ADDITIONAL REVIEW CONSIDERATIONS

SHARING RESEARCH DATA

Applicants requesting more than $500,000 in direct costs in any year of the 
proposed research must include a data sharing plan in their application. The 
reasonableness of the data sharing plan or the rationale for not sharing 
research data will be assessed by the reviewers. However, reviewers will not 
factor the proposed data sharing plan into the determination of scientific 
merit or priority score. See the NIH Data Sharing Policy website at 
http://grants.nih.gov/grants/policy/data_sharing.

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt: June 14, 2004
Application Receipt Date: July 14, 2004
Peer Review Date: October/November 2004
Review by NCAB Advisory Board: February 2005
Anticipated Award Date: June 1, 2005

AWARD CRITERIA

Applications recommended by the National Cancer Advisory Board will be 
considered by NCI program staff for award based upon: 

o  Scientific and technical merit (as determined by peer review);
o  Availability of funds;
o  Programmatic priorities; and
o  Demographic and geographic distribution of applicants to assure inclusion 
of minority and underserved populations.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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Research (OER)
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Bethesda, Maryland 20892
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and Human Services (HHS)
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