COMMUNITY CLINICAL ONCOLOGY PROGRAM

Release Date:  March 13, 2000

RFA:  CA-01-004

National Cancer Institute  

Letter of Intent Receipt Date:  June 9, 2000
Application Receipt Date:       July 14, 2000

PURPOSE

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

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

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

HEALTHY PEOPLE 2010

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

ELIGIBILITY REQUIREMENTS

Applications may be submitted from domestic institutions for cooperative 
agreements to continue the Community Clinical Oncology Program (CCOP).  New 
applicants and currently funded programs are eligible as described below.  
Racial/ethnic minority individuals, women, and persons with disabilities are 
encouraged to apply as Principal Investigators.

A.  CCOP Applicants

1. An applicant may be a hospital, a clinic, a group of practicing physicians, 
a health maintenance organization (HMO), or a consortium of hospitals and/or 
clinics and/or physicians and/or HMOs that agree to work together with a 
principal investigator and a single administrative focus.

2. A university, Veterans Administration hospital, or military treatment 
facility (MTF) may be included in an application as a member of a consortium 
led by a community institution, but may not be the applicant organization or 
the major contributor to accrual.  An unfunded, non-university clinical trials 
cooperative group member is eligible to apply.

3. Funded cooperative group affiliate programs are eligible to apply, but 
should state in the application that support through this mechanism will be 
relinquished if a CCOP award is received.

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

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

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

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

B.  Research Base Applicants

An applicant may be:

1. An NCI-funded clinical trials cooperative oncology group;

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

Cooperative groups 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 
cancer prevention and control research only.

MECHANISM OF SUPPORT

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

The total project period for applications submitted in response to this RFA 
may not exceed 3 years for new applicants, and no more than 5 years for 
applicants currently supported under this program.  Currently supported 
applicants will be funded for 3, 4, or 5 years depending upon priority 
score/percentile, review committee recommendations, and programmatic 
considerations.  The anticipated award date is June 1, 2001.

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 vary also.  Awards 
and level of support depend on receipt of a sufficient number of applications 
of high scientific merit.  Although this program is provided for in the 
financial plans of the NCI, awards pursuant to this RFA are contingent upon 
the availability of funds for this purpose.

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

FUNDS AVAILABLE

It is anticipated that up to $8.7 million in total costs per year for 5 years 
will be committed to specifically fund applications which are submitted in 
response to this RFA.  Approximately eight (8) research base awards and nine 
(9) CCOP awards will be made.  This level of support is dependent on the 
receipt of a sufficient number of applications of high scientific merit. An 
additional $28.3 million in total costs per year for 5 years will be committed 
to specifically fund several large ongoing chemoprevention trials that are 
being implemented through the CCOP network.  Although this program is provided 
for in the financial plans of NCI, awards pursuant to this RFA are contingent 
upon the availability of funds for this purpose.

RESEARCH OBJECTIVES

Background

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

The CCOPs were clearly effective in accruing patients to treatment clinical 
trials.  The second CCOP RFA, issued in 1986, expanded the focus to include 
cancer prevention and control research based on the rationale that the multi-
institutional clinical trials model essential for testing new treatment 
regimens is also central for conducting large-scale cancer prevention and 
control trials.  In 1999, there were programs in 31 states involving over 345 
hospitals and over 3,900 physicians.  Approximately 5,235 patients were 
entered onto treatment trials and 2,435 participants on cancer prevention and 
control trials in 1999.

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 
and symptom management, and other rehabilitation and continuing care 
interventions.  Several large chemoprevention trials have been implemented 
through the CCOP network, including the breast cancer prevention trial with 
tamoxifen (BCPT), ,the prostate cancer prevention trial with finasteride 
(PCPT), and the study of tamoxifen and raloxifene in the prevention of breast 
cancer (STAR).

The CCOPs are a vital resource for conducting NCI cancer prevention and 
control research because they provide access to: 1) a national network for 
cancer prevention and control trials which require large sample sizes for 
completion; 2) geographic areas which include cross sections of the 
population, providing mixes of patients/participants not always available in 
university or urban settings; 3) large populations of cancer patients free of 
disease which provide a unique resource for chemoprevention clinical trials; 
and 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.  Participation in cancer prevention and control research by CCOPs 
also 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 initiative 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, 
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 community programs (CCOPs) will be 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 
relate directly to NCI for assistance and participation in selected cancer 
prevention and control protocols.  CCOP performance will be evaluated on a 
continuing basis by the NCI program director.

Participating research bases will be required to continue providing clinical 
treatment and/or cancer prevention and control research protocols, as 
applicable, and as studies progress and findings indicate, to develop new 
protocols.  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 be expected to monitor the quality of protocol conduct, 
follow CCOP accrual, and participate on a continuing basis in program 
evaluation.

SPECIAL REQUIREMENTS

Terms and Conditions of Award

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

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

A.  Terms and Conditions of Award for CCOP Awardees

1. CCOP Awardees Responsibilities

The awardee's programmatic responsibilities for the conduct of the research 
supported by this cooperative agreement are described in the following; the 
INVESTIGATOR'S HANDBOOK, a Manual for Participants in Clinical Trials of 
Investigational Agents Sponsored by the Division of Cancer Treatment and 
Diagnosis, (DCTD), National Cancer Institute and can be found at URL: 
http://ctep.cancer.gov/handbook; the NCI-CTMB 
GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS 
AND CCOP RESEARCH BASES and can be found at URL: 
http://ctep.cancer.gov/monitoring/guidelines.html and any subsequent 
modifications of these documents; and the Intellectual Property Option to 
Collaborator that can be found at the URL address: 
http://ctep.cancer.gov/industry/ipo.html   
These documents are hereby incorporated by reference as terms of award and are 
available at the URLs cited above or from the program staff listed under 
“INQUIRES.”

1.a. Protocols

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

To be eligible to receive credit for accrual to a research base protocol, the 
CCOP must have an affiliation agreement with the research base responsible to 
NCI for that protocol.  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.

1.b. Research Base Affiliation(s)

Each CCOP must affiliate with one national multi-specialty cooperative group 
having a spectrum of cancer treatment and prevention and control clinical 
trials.  Each CCOP can affiliate with a maximum of four additional research 
bases exclusive of the national mult-specialty cooperative groups (exceptions 
may be granted in conjunction with participation in an NCI sponsored "pilot" 
project).

Note:  A list of currently eligible research bases may be obtained from the 
following URL: http://dcp.nci.nih.gov/CORB/ or from the program official 
listed in the Letter of Intent Section.

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 in order to avoid bias in the allocation of patients to competing 
protocols.

Initial affiliations should be maintained for the duration of the funding 
cycle.  When circumstances require changes in research base affiliations, 
prior written approval from the DCP Program Director is required.

1.c. Accrual

Each CCOP is required to accrue a minimum of 50 credits* per year to treatment 
clinical trials that have been approved by the PRC, DCTD, NCI.  (The 50 credit 
minimum requirement may be waived for those applicants whose speciality is 
pediatrics and are able to place a majority of their eligible patients on 
protocols.)  As one measure of performance, it is expected that at least 10 
percent of patients for whom protocols are available will be placed on 
clinical trials by CCOP physicians.  

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 CCOPs ability to meet projected accrual goals to both cancer treatment and 
prevention and control clinical trials will be assessed.  For CCOPs that have 
demonstrated an outstanding record of accrual to cancer prevention and control 
clinical trials, the 50 credit minimum for treatment may be waived.

*  Each protocol approved for CCOP use will be assigned a credit value.  
Credits will be based on the complexity of the intervention, the amount of 
data management required, and the duration of follow-up.  For example, each 
patient accrued to an average Phase II or Phase III treatment protocol will 
count 1 credit; and an NCI-designated high-priority treatment protocol 1.5 
credits. Cancer prevention and control protocols will be assessed for credit 
using a similar approach.  For example, a randomized Phase III chemoprevention 
protocol will be assigned a value of 1 credit per participant entered.  Cancer 
control protocols involving limited interventions will receive credit that is 
commensurate with the amount of data management effort required, usually an 
assignment of 0.3 or 0.5 credit per participant entered.  Follow-up credit for 
chemoprevention protocols may also be assigned.

In addition, CCOPs are encouraged to participate in cancer prevention and 
control research studies supported through other federal administrative and 
funding instruments such as research project grants (R01s) and contracts.  

1.d. Quality Control

The CCOP must establish and follow procedures for the assurance of data 
quality and quality control in accordance with research base guidelines and 
NCI policies.  The CCOP must follow NCI-approved procedures developed by the 
research base for the prevention and/or identification of false or otherwise 
unreliable data and for quality assurance of data collected by the research 
base.

The CCOP must follow policies developed by the research base and approved by 
the NCI for auditing the accuracy of scientific data submitted to them by the 
research base participants.

1.e. Data Management

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

1.f. Investigational Drug Management

Investigators performing trials under cooperative agreements will be expected, 
in cooperation with NCI, to comply with all FDA monitoring and reporting 
requirements for investigational agents. Specifically, all CCOP investigators 
must have an active NCI Investigator Number.

1.g. Organizational Changes

Certain CCOP organizational changes must have the prior written approval of 
the DCP Program Director.  These include the addition/deletion of a 
participating physician, a health professional other than a physician (who 
actively enters patients to cancer prevention and control trials), an 
affiliate, component, or research base.

1.h. Radiotherapy Equipment

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

1.i. 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, fiscal and 
administrative procedures.

CCOP members/affiliate performance sites and/or individual investigators 
participating or collaborating on NCI-supported multi-institutional clinical 
trials must be in compliance with the monitoring standards established by the 
research base.  They should include the following standards: (1) Medical 
records submitted in support of NCI multi-institutional trials must conform to 
usual standards for the maintenance of clear, accurate, and unambiguous 
medical records.  White-outs on medical records are unacceptable; (2) If it is 
the usual and customary practice of a department, laboratory, clinic or office 
to prepare or issue official reports, then only that department, laboratory, 
clinic or office can change the report, and alterations of the medical record 
must be initialed and dated by the person making such alterations.  For 
clinical progress notes, the change must be dated and initialed by the person 
making the change.  Only one line should be placed through the initial entry, 
so that both the original entry and the change are legible; (3) The improper 
modification of important patient records will result in additional 
investigations by the NCI Clinical Trials Monitoring Branch (CTMB) and may 
lead to suspension of accrual and funding.

1.j. Reporting Requirements

Annual progress reports must be submitted to DCP.  A suggested format 
developed by the DCP Program Director for this purpose will be provided.  The 
inability of a CCOP to meet the performance requirements set forth in the 
Terms and Conditions of Award in the RFA, or significant changes in the level 
of performance, may result in an adjustment of funding, withholding of 
support, suspension or termination of the award.

1.k. Network Participation

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

1.l. Patient/Participant Log

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

1.m. Federally Mandated Regulatory Requirements

Each CCOP must establish mechanisms to meet DHHS/PHS regulations for the 
protection of human subjects.  At a minimum, these include: (1) methods for 
assuring that each facility at which CCOP investigators are conducting 
clinical trials has a current, approved assurance on file with the Office for 
Protection from Research Risks (OPRR); 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; and (4) implementation of DCP/DCTD 
requirements for storage and accounting for investigational agents provided 
under DCP/DCTD sponsorship.

1.n. Publications

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

2.  NCI Staff Involvement

2.a. Protocol Review

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

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

2.b. Monitoring

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

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

DCP/CTEP and/or its contractor staff may attend the on-site audits conducted 
by the Research Base or its NCI designee as observers.

2.c. Data Management

The DCP Program Director will have access to all data generated under this 
award and will periodically review the data management procedures of the CCOP. 
 Data must also be available for external monitoring if required by NCI's 
agreement with other federal agencies, such as the Food and Drug 
Administration (FDA).

2.d. Investigational Drug Management

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

2.e. Organizational Changes

The DCP program director will review requests for certain organizational 
changes and provide written approval.  These changes include the 
addition/deletion of a participating physician or other health professional 
entering patients/participants in cancer prevention and control research in 
the CCOP, an affiliate, component, or research base.

2.f. Program Review

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

2.g. Strategy Sessions

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

2.h. Federally Mandated Regulatory Requirements

The DCP Program Director or designee and DCTD staff will review mechanisms 
established by each CCOP to meet the Department of Health and Human Services 
(DHHS)/Public Health Service (PHS) regulations for the protection of human 
subjects and FDA requirements for the conduct of research using 
investigational agents.

2.i. 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: 
http://ctep.cancer.gov/handbook or from the program 
staff listed under INQUIRES.

1.a. Protocol Development

The research base is responsible for the development and implementation of 
high quality cancer treatment and prevention and control clinical trials, and 
for evaluation of the results of such clinical trials.

The protocol should be a document mutually acceptable to the research base and 
to DCP/DCTD.  Communication at the various stages of development is 
encouraged.

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

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

1.c. Accrual

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

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

*  Each protocol approved for CCOP use will be assigned a credit value.  
Credits will be based on the complexity of the intervention, the amount of 
data management required, and the duration of follow-up.  For example, each 
patient accrued to an average Phase II or Phase III treatment protocol will 
count 1 credit; and an NCI-designated high-priority treatment protocol 1.5 
credits.  Cancer prevention and control protocols will be assessed for credit 
using a similar approach.  For example, a randomized Phase III chemoprevention 
protocol will be assigned a value of 1 credit per participant entered.  An 
additional 0.3 credits may be assigned for chemoprevention trials requiring 
multiple years of follow-up.  Cancer control protocols involving limited 
interventions will receive credit that is commensurate with the amount of data 
management effort required.

In addition, research bases are encouraged to broaden their research efforts 
in cancer prevention and control by participation in studies supported through 
other federal administrative and funding mechanisms such as research project 
grants (R01s) and contracts.   

1.d. Data Management and Analysis

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

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

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

1.e. Quality Control

A DCP/DCTD-funded research base must follow all the policies and procedures 
for quality control established by NCI.  Similar policies and procedures for 
quality control will be expected from cancer centers.

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

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

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

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

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

1.f. Quality Assurance of Data

The research base must develop and follow procedures for the assurance of data 
quality and quality control in accordance with research base guidelines and 
NCI policies.  The research base must follow NCI-approved procedures for the 
prevention and/or identification of false or otherwise unreliable data and for 
quality assurance of data collected.

The research base must develop and implement NCI-approved policies for 
auditing the accuracy of scientific data submitted to them.

In the event that there is a finding through the quality assurance and/or 
quality control programs of any indication of a pattern of non-compliance with 
protocol or regulatory requirements or a finding of possible alteration of 
data, these findings must be reported in accordance with the NCI-CTMB 
GUIDELINES FOR ON-SITE MONITORING OF CLINICAL TRIALS FOR COOPERATIVE GROUPS 
AND CCOP RESEARCH BASES.  Guidelines are available at the following URL: 
http://ctep.cancer.gov/handbook

1.g. Data and Safety Monitoring Committees

The research base must establish and maintain Data and Safety Monitoring 
Committees (DSMCs) for all Phase III clinical trials in accordance with the 
NCI policy for Data Safety and Monitoring of Clinical Trials.  The NCI policy 
may be found at URL: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. 
 The research base must comply with the approved policies and procedures of 
the DSMB.

1.h. Protocol Closure

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

1.i. Protocol Reporting Requirements

Reporting requirements will be in agreement with FDA regulations and NCI 
procedures.  Interim reports of each activated and ongoing study shall appear 
in the minutes of each research base meeting and shall include specific data 
on patient/participant accrual as well as, when appropriate, detailed reports 
of treatment-associated morbidity.  Quarterly accrual reports must be provided 
as appropriate to CTEP for all active studies.  A system for providing such 
information in a timely manner should be in place.

1.j. Annual Progress Report

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

Research base funding is contingent on accrual from affiliated CCOPs/Minority-
Based CCOPs and annual adjustments may be made.  The inability of a research 
base to meet the performance requirements set forth in the Terms and 
Conditions of Award in the RFA or significant changes in the level of 
performance may result in an adjustment of funding, withholding of support, 
suspension or termination of the award.

1.k. Adverse Event Procedures

In order to be in compliance with FDA regulations, all recipients of NCI 
support for clinical trials, including research bases responsible for 
coordinating and monitoring such trials, must promptly report adverse events 
(including adverse drug reactions) to the NCI and any other trial sponsors 
according to directions provided in the adverse event reporting section of the 
INVESTIGATOR'S HANDBOOK available at the following URL: 
http://ctep.cancer.gov/handbook 

The awardee will notify all institutions/investigators participating in this 
project, funded or unfunded, about the above requirement and about the 
institutions'/investigators' responsibility to report adverse events as 
specified in the protocol.  The awardee will also notify the Investigational 
Drug Branch (IDB),CTEP, DCTD Drug Monitor for DCTD-sponsored investigational 
agents and the Program Director for other agents, of serious or life-
threatening events, as specified in the protocol.

1.l. Performance Review

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

1.m. Data Files Available to NCI Upon Request

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

1.n. Investigational Drug Management

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

1.o. Network Participation

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

1.p. Federally Mandated Regulatory Requirements

Each research base must establish mechanisms to meet FDA regulatory 
requirements for clinical trials involving DCP/DCTD-sponsored investigational 
agents and DHHS/PHS regulations for the protection of human subjects.  These 
regulations include but are not limited to Title 21 CFR 50, 56 and 312 and 
Title 45 CFR 46.  At a minimum the research base must be able to: (1) 
demonstrate that each participant has a current approved assurance on file 
with the NIH Office for Protection from Research Risks (OPRR); (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; (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.

1.q. CCOPS/Minority-Based CCOPs

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

1.r. Publications

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

1.s. Procedures in the Event of Scientific Misconduct

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

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

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

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

1.t. Notification of Patients by the Awardee During Patient's Lifetime

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

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

2. NCI Staff Involvement

2.a. Scientific Resource

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

2.b. Protocol Development

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

2.c. Concept/Protocol Review

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

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

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

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

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

2.d. Data Management and Analysis

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

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

2.e. Quality Control and Monitoring

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

2.f. Review of Quality Control and Study Monitoring

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

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

2.g. Data and Safety Monitoring Committees

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

2.h. Investigational Drug Management

The Regulatory Affairs Branch, CTEP, DCTD, and the Chemoprevention Branch, 
CPRP, DCP, staff will advise investigators of specific requirements and 
changes in requirements concerning investigational drug management that the 
FDA may mandate.

2.i. Program Review

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

The DCP program director will make funding recommendations based on accrual 
from affiliated CCOPs/Minority-Based CCOPs and annual adjustments in funding 
may be made.  The inability of a research base to meet the performance 
requirements set forth in the Terms and Conditions of Award in the RFA, or 
significant changes in the level of performance, may result in an adjustment 
of funding, withholding of support, suspension or termination of the award.

2.j. Protocol Closure

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

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

2.k. Federally Mandated Regulatory Requirements

The DCP Program Director and a DCTD representative will review mechanisms 
established by each research base to meet Department of Health and Human 
Services (DHHS)/Public Health Service (PHS) regulations for the protection of 
human subjects and FDA requirements for the conduct of research using 
investigational agents. 

2.l. CCOPs/Minority-Based CCOPs

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

2.m. Arbitration Process

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

STUDY POPULATIONS

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their sub populations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research.  This policy results from the NIH Revitalization Act of 1993.

All investigators proposing research involving human subjects should read the 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which have been published in the Federal Register of March 28, 1994 
(FR 59 14508-14513) and in the NIH Guide For Grants and Contracts, Volume 23, 
Number 11, March 18, 1994.  Internet address is as follows: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.

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

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are clear and compelling scientific and ethical reasons not 
to include them.  This policy applies to all initial (Type 1and Type 2) 
applications submitted for receipt dates after October 1, 1998. 

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.  As part 
of the scientific and technical merit evaluation of the research plan, 
reviewers will be instructed to address the adequacy of plans for including 
children as appropriate for the scientific goals of the research, or 
justification for exclusion.  

Issues related to the implementation of this policy should be referred to the 
Director, OEP, OER (301/435-2768).

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

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

LETTER OF INTENT

Prospective applicants are asked to submit, by June 9, 2000, a letter of 
intent that includes a descriptive title of the proposed research, the name, 
address, and telephone number of the Principal Investigator, the identities of 
other key personnel and participating institutions, and the number and title 
of the RFA in response to which the application is being submitted.  Although 
a letter of intent is not required, is not binding, and does not enter into 
the review of subsequent applications, the information allows NCI staff to 
estimate the potential review workload and to avoid possible conflict of 
interest in the review.

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

URLS IN NIH GRANT APPLICATIONS OR APPENDICES

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

APPLICATION PROCEDURES

Preparation of Application

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

A suggested format will be sent to all applicants requesting an RFA or 
submitting a letter of intent.  All applicants are encouraged to obtain and 
use the suggested format instructions for organizing the specific information 
concerning the RFA programmatic requirements in the PHS 398.  If tables from 
the "Suggestions for Organizing Information for a CCOP Application" are 
included, those tables should be part of the body of the application, and NOT 
included in the appendix.  Also, responses to the instructions concerning 
"Human Subjects" verification must be included in the application at the time 
of submission.

1. CCOP Applicants

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

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

For ALL Applicants:

1.a. Each applicant must delineate its catchment area.  A map of the service 
area, designating counties or zip codes from which approximately 80 percent of 
the patients will be drawn, should be provided.  A description of other cancer 
care resources in the catchment area (i.e., hospitals, clinics, physicians, 
cancer centers) which are not part of the application should be included.  In 
describing the study population, a breakdown by percentage of the gender and 
minority composition of the study population should be provided.  This 
information may be based on the institutional records and/or prior experience.

1.b. Each applicant must demonstrate the potential and stated commitment to 
accrue a minimum of 50 credits per year to treatment clinical trials (except 
if waived for applicants whose specialty is pediatrics or those with an 
outstanding record in cancer prevention and control accrual).  Documentation 
must include any prior participation in treatment research clinical trials 
with a clear presentation of the total number of patients and credits accrued 
to NCI-approved treatment clinical trials.  

A list of the NCI approved treatment protocols in which the applicant expects 
to participate and the projected accrual to each must be provided.  Plans for 
recruiting women and minority participants must be included.  

1.c. Each applicant must demonstrate the potential and plans for accrual of a 
minimum of 50 credits per year to cancer prevention and control protocols.  
Documentation must include any prior participation in cancer prevention and 
control research clinical trials with a clear presentation of the total number 
of patients and credits accrued to NCI approved cancer prevention and control 
clinical trials.  A list of the NCI approved prevention and control protocols 
in which the applicant expects to participate and the projected accrual must 
be provided.  Plans for recruiting women and minority participants must be 
included.

If applicable, CCOP applicants should describe their participation in cancer 
prevention and control research supported by other federal administrative and 
funding instruments (e.g., research projects grants (R01s), contracts).

For NEW Applicants:

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

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

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

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

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

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

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

Note:  A list of currently eligible research bases may be obtained from the 
following URL: http://dcp.nci.nih.gov/CORB/ or from the program official 
listed in the Letter of Intent Section.

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

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

1.i. The availability of facilities, including laboratories, inpatient and 
outpatient resources, cancer registries, etc., must be described.  A statement 
of commitment from each participating institution or organization and/or 
documentation of consortium arrangements must be provided.  Evidence of 
involvement with community-based voluntary organizations may be submitted.  In 
addition, each applicant must have a defined space for administrative 
activities and administrative personnel which will serve as a focus for data 
management, quality control, and communication.

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

2. RESEARCH BASE Applicants

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

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

Cooperative groups must participate in both cancer treatment and prevention 
and control clinical trials; cancer centers may participate in cancer 
treatment and prevention and control clinical trials or cancer prevention and 
control research only.

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

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

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

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

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

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

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

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

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

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

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

If applicable, CCOP research base applicants should describe their 
participation in cancer prevention and control research studies supported by 
other federal administrative and funding 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 can 
include requests for non-CCOP member institutions to become "prevention 
members." The Research Base applicants must describe the experience and 
contribution of the non-CCOP member institution to the science and accrual to 
cancer chemoprevention clinical trials.  The applicant must indicate the 
participants and their expected level of participation, and describe their 
ability to participate.

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

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

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

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

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

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

Method of Applying

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

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

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

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

Photocopies must be clear and single-sided.  At the time of submission, two 
(2) additional copies of the application must also be sent to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8062, MSC-8239

Rockville, Maryland  20852 (for courier service)
Bethesda, Maryland 20892-8239

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

Applications must be received by July 14, 2000.  If an application is received 
after that date, it will be returned to the applicant without review.  The 
Center for Scientific Review (CSR) will not accept any application in response 
to this RFA that is essentially the same as one currently pending initial 
review, unless the applicant withdraws the pending application.  The CSR will 
not accept any application that is essentially the same as one already 
reviewed.  This does not preclude the submission of substantial revisions of 
applications already reviewed, but such an application must follow the 
guidance in the PHS Form 398 application instructions for the preparation of 
revised applications, including an introduction addressing the previous 
critique.

REVIEW CONSIDERATIONS

A. REVIEW PROCEDURES

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by the NCI staff.  Incomplete and/or non-responsive 
applications will be returned to the applicant without further consideration. 
 
Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NCI in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will receive a written critique and 
undergo a process in which only those applications deemed to have the highest 
scientific merit, generally the top half of the applications under review, 
will be discussed, assigned a priority score, and receive a second level 
review by the National Cancer Advisory Board.

B. REVIEW CRITERIA

1.  CCOP Applicants

All applicants will be evaluated on the following criteria:

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

1.b. Ability to accrue a minimum of 50 credits per year to treatment clinical 
trials and a minimum of 50 credits per year to cancer prevention and control 
clinical trials.  Established CCOPs will be funded at a yearly accrual goal 
that may be higher than 50 credits for treatment clinical trials and 50 
credits for cancer prevention and control clinical trials.  These established 
CCOPs will be evaluated for their past performance in meeting these accrual 
goals.  The minimum treatment accrual requirement may be waived for applicants 
whose specialty is pediatrics, or for applicants with an outstanding record in 
prevention and control.  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, participation in cancer prevention and control research studies 
supported through other federal and administrative funding instruments such as 
research project grants (R01s) and contracts will be evaluated. 

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

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

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

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

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

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

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

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

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

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

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

2.  Research Base Applicants

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

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

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

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

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

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

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

In addition, research base applicants= participation in and accrual to cancer 
prevention and control studies supported through other federal administrative 
and funding instruments such as research projects grants (R01s) and contracts 
will be reviewed and evaluated.

Documentation must include CCOP-research base affiliation agreements.

2.e. 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.

2.f. 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.  
The qualifications and contribution to the science and accrual of cancer 
chemoprevention clinical trials will be assessed in the evaluation of the 
Research Base's request for the non-CCOP member institutions that apply for 
the designation of "prevention member".

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

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

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

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

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

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

AWARD CRITERIA

The anticipated date of award is June 1, 2001.  Applications recommended by 
the National Cancer Advisory Board will be considered by NCI staff for award 
based upon (a) scientific and technical merit; (b) demographic and geographic 
distribution of applicants to assure inclusion of minority and underserved 
population; (c) availability of funds.  Multiple CCOP applicants for funding 
who are competing for the same patient population will be considered, but all 
may not be awarded unless warranted by the population density.

SCHEDULE

Letter of Intent Receipt:       June 9, 2000
Application Receipt Date:       July 14, 2000
Review by NCAB Advisory Board:  February 2001
Anticipated Award Date:         June 1, 2001

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Joseph Kelaghan, MD
Acting Chief, Community Oncology and Prevention Trials Research Group
Division of Cancer Prevention, NCI
Executive Plaza North - Room 300
6130 Executive Boulevard, MSC-7340
Bethesda, Maryland  20892-7340
Telephone:  (301) 496-8541
Fax: (301) 496-8667
E-mail address: jk85i@nih.gov

Direct inquiries regarding review issues to:

Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8062, MSC-8239
Rockville, Maryland  20852 (for courier service)
Bethesda, Maryland 20892-8239
Telephone: (301) 496-3428
Fax: (301) 496-0275
Email address: tf12w@nih.gov 

Direct inquiries regarding fiscal matters to:

Ms. Crystal Wolfrey
Grants Administration Branch

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

AUTHORITY AND REGULATIONS

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

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


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