Draft 2013 CCSG Guidelines

7/23/2019 Draft 2013 CCSG Guidelines

http://slidepdf.com/reader/full/draft-2013-ccsg-guidelines 1/52

The Office of Cancer Centers of the National Cancer Institute

Policies and Guidelines Relating to the Cancer Center Support Grant

Draft 2013



Table of Contents

I. Cancer Centers Program: Philosophy & Policies

eatures of an NCI!designated Cancer Center"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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The Si# $ssential Characteristics of an NCI!designated Cancer Center """"""""""""""""""""""""""""""""""""""""""

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T%pes of Centers""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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&a'or Research (reas of ( Cancer Center and T%pes of Interactions"""""""""""""""""""""""""""""""""""""""""""""""

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Consortiu) Centers"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

*

+udget and unding Policies"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""" ,""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

II. Instructions and Review Criteria for Application for a P! Cancer Center "upport

#rant

$ligi-ilit% Re.uire)ents """""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

/""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

e% Dates in the Grant (pplication Reie and unding Process """""""""""""""""""""""""""""""""""""""""""""""""

/Pre!application Consultation """""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

/

Instructions for Su-)itting the CCSG (pplication"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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or)atting Instructions and Reie Criteria for Specific Co)ponents of CCSG (pplications """"""

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Page 6i)its""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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6etter of (gree)ent to (ccept the (pplication""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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1" ace Page7"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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2" Description Perfor)ance Sites and e% Personnel 777777777777777



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3" Ta-le of Contents""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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*" Consolidated and Su))ar% +udget Re.uest""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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," Standard Cancer Center Infor)ation""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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8" 9istor% and Description of the Cancer Center Specificall% Descri-ing the Si# $ssential

Characteristics of the Cancer Center""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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/" Descriptions +udgets and Narratie :ustifications for Indiidual CCSGCo)ponents

""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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/"1 Senior 6eadership"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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/"2 6eaders of Scientific Research Progra)s"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

1/

/"3 Planning and $aluation"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

1/

/"* Deelop)ental unds"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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/", Cancer Center (d)inistration 777777777777777777777"

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4" Research Progra)s""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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4"1 Goals"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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4"2 Selection of &e)-ers7"""

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4"3 Characteristics of Progra)s"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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4"* Definition of Peer!Reieed unded Research Pro'ects77777777777"

2*4", or)atting for $ach Progra) Section"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

2*

5" Shared Resources""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

2/

5"1 Goals"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

2/

5"2 +udgets"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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5"3 or)atting for $ach Shared Resource Section"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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5"* Issues Regarding Specific Shared Resources"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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10" Clinical Protocol and Data &anage)ent"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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11" Protocol Reie and &onitoring S%ste) ;PR&S<"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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12" $arl% Stage Clinical Research Support"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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13" Inclusion of &inorities and =o)en in Clinical Trials"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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1*" Inclusion of Children in Clinical Trials 7777777777777777777734

Other Reie Considerations""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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Process for Criterion Scoring



""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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Process for Deter)ining Oerall I)pact>Priorit% Score""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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Duration""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

*1

Oerall +udget Reco))endation""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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(pplication and Reie for Co)prehensieness""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

*1

Peer Re!ealuation of the Protocol Reie and &onitoring S%ste)

""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""*2

ederal Citations Releant to CCSG (pplications""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

*2

(ppendices""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""

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Reie &aterials to -e (aila-le at the ull or 6i)ited Site ?isit 777777777777""

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III. Peer Review of the Application................................................................................................................................................................

$%



Policies and #uidelines Relating to the CancerCenter "upport #rant 'CC"#(

I. Cancer Centers Program: Philosophy & Policies

The National Cancer (ct officiall% esta-lished the Cancer Centers Progra) in 15/1"The legislation as -ased on the report of a congressional co))ittee hich concluded that a for)ali@ed cancer centers

progra) ould proide a unit% of purpose a centrali@ed platfor) for sharing concepts and resourcesand a )anage)ent structure necessar% to achiee progress toard the goal of preenting and curingcancer" The (ct grandfathered in tele e#isting centers that ere alread% receiing support throughdierse NCI grants and contracts and authori@ed the esta-lish)ent of additional centers" It alsoi)ple)ented a standard funding )echanis) ;the P30 Cancer Center Support Grant or CCSG< andguidelines and created an ad)inistratie and organi@ational ho)e for the progra) at the NCI"

+ased on this earl% legislation .ualified applicant institutions receie the CCSG aard andacco)pan%ing NCI designation for successfull% )eeting a spectru) of rigorous co)petitie standardsassociated ith scientific and organi@ational )erit" =hile CCSG re.uire)ents hae eoled oer the%ears the grant continues to support research infrastructure that enhances colla-oratie

transdisciplinar% research productiit%" CCSG grants proide funding for for)ali@ed cancer research progra)s shared research resources scientific and ad)inistratie )anage)ent planning and ealuationactiities deelop)ent of ne scientific opportunities and centrali@ed clinical trial oersight andfunctions"

(lthough the CCSG does not directl% fund the ider range of actiities at cancer centers including patient and ancillar% care serices an NCI!designated Cancer Center linAs state!of!the! art research andcare thus perpetuating the translational continuu)"

To decrease cancer incidence and )ortalit% a)ong populations ithin their catch)ent area including)inorit% and undersered populations NCI!designated Cancer Centers are e#pected to esta-lish partnerships ith other health delier% s%ste)s and state and co))unit% agencies for disse)ination of

eidence!-ased findings"

Oer the past seeral decades the nu)-er of NCI!designated Cancer Centers has gron e#tensiel% Btoda% the% are in a ariet% of organi@ational settings across the nited States" (n NCI!designated Cancer Center is a local regional and national resource directl% sering its co))unit% and through theAnoledge it creates the countr% as a hole"

)eatures of an *CIdesignated Cancer Center

A Policy of Inclusion: (n NCI!designated Cancer Center capitali@es on all institutional cancer researchcapa-ilities integrating cancer related progra)s in -asic la-orator% clinical and preention cancer control and population!-ased science into a single transdisciplinar% cancer center research

enterprise across depart)ental school and institutional -oundaries" ( )a'or test of -othinstitutional co))it)ent and the .ualit% of center leadership is to strengthen and unite all )a'orareas of research present ithin the institution;s< and to har)oni@e research ith educationserice and care"

+,cellence in Cancer Research: (ll NCI!designated Cancer Centers e#cel in cancer research"Successful cancer centers hae scientificall% rigorous research supported -% peer!reieed grants fro)the National Institutes of 9ealth ;NI9< and other sources and organi@ed into for)al colla-oratie

1



cancer!focused Progra)s ;for a definition of Progra) as it relates to the CCSG see Section 4<"

Community -issemination +ducation and Information Activities: Cancer centers interact ithintheir co))unities to ensure that ne Anoledge -enefits patients professionals and the pu-lic" The%are actie participants in state and co))unit% co)prehensie cancer control planning andi)ple)entation efforts" Centers also disse)inate their )edical adances as rapidl% as possi-le ia

professional and pu-lic education and partnerships ith pu-lic health or clinical serice delier%s%ste)s"

The "i, +ssential Characteristics of *CI /designated Cancer Centers

( successful NCI!designated Cancer Center de)onstrates strength in si# essential characteristics"Together these characteristics )a#i)i@e its scientific potential and produce a hole that is greater thanthe su) of its partsE

• )acilities: Ph%sical facilities dedicated to the conduct of cancer focused research and to the

centerFs shared resources and ad)inistration are appropriate and ade.uate for the tasA"

•

0rgani1ational Capabilities: The center taAes )a#i)u) adantage of institutional capa-ilitiesin cancer research" This includes appropriate planning and ealuation of center strategies andactiities integrating education and training of -io)edical researchers and health care professionals including those fro) undersered populations into progra))atic research effortsand in addition to addressing research .uestions of -road applica-ilit% using its aaila-lee#pertise and resources to address cancer pro-le)s ithin the catch)ent area"

• Transdisciplinary Collaboration and Coordination: Su-stantial coordination interaction and

colla-oration -oth a)ong center )e)-ers fro) a ariet% of disciplines and -eteen center)e)-ers and inestigators in other institutions enhance and add alue to the productiit% and.ualit% of research" (s appropriate to the nature of the research centers facilitate transition ofscientific findings through the translational continuu) ia coordination of research across NCI

and other funding )echanis)s and through colla-orations ith other partners"• Cancer )ocus: The center )e)-ersF grants and contracts as ell as the structure and o-'ecties

of its for)al research Progra)s de)onstrate a clearl% defined cancer research focus"

• Institutional Commitment: The center is a for)al organi@ational co)ponent of the institution

ith sufficient space positions and discretionar% resources to ensure its sta-ilit% and fulfill thecenterFs o-'ecties" The center director has authorities appropriate for )anaging the center andfurthering its scientific )ission" The institution recogni@es tea) science in its pro)otion andtenure policies"

• Center -irector: The director is a highl% .ualified scientist and ad)inistrator ith leadership

e#perience and e#pertise appropriate for esta-lishing a ision for the center adancing scientificgoals and )anaging a co)ple# organi@ation" 9e or she is effectie in using institutionall%

designated authorities to )anage the center and adance its scientific o-'ecties"

Types of Centers

Cancer centers hae deeloped in )an% different organi@ational settings reflecting considera-lediersit% in the si@e and co)ple#it% of their research e)phases" =hether organi@ed as a freestandingcenter a center )atri#ed ithin an acade)ic institution or a for)al research!-ased consortiu)under centrali@ed leadership all centers are peer!reieed -% the sa)e scientific organi@ational

2



and ad)inistratie criteria" There are to t%pes of NCI!designated cancer centersE

• Cancer Centers hae a scientific agenda pri)aril% focused on -asic la-orator% clinical and

preention cancer control and population!-ased research or so)e co)-ination of theseco)ponents" (ll areas of research are linAed colla-oratiel%" =hile not all -asic findings re.uire

a translational endpoint -asic la-orator% centers deelop linAages ith other institutions thatill foster application of la-orator% findings for pu-lic -enefit here appropriate"

• Comprehensive Cancer Centers de)onstrate reasona-le depth and -readth of cancer research

actiities in each of three )a'or areasE -asic la-orator% clinical and preention control and population!-ased research" Co)prehensie cancer centers also hae su-stantial transdisciplinar%research that -ridges these scientific areas" The% are effectie in sering their catch)ent area asell as the -roader population through the cancer research the% support" The% integrate trainingand education of -io)edical researchers and co))unit% health care professionals into progra))atic efforts to enhance the scientific )ission and potential of the center"

2a3or Research Areas of Cancer Centers and Types of Interactions

(n NCI!designated cancer center should feature igorous interactions across its research areasfacilitating colla-oration -eteen -asic la-orator% clinical and preention control and population! -ased science inestigators and the for)al research progra)s of hich the% are a part" No particularconfiguration is )andated -ut the centerFs organi@ational approach should sere the science of theinstitution ith reasona-le -readth and depth of cancer!focused scientific facult% and dedicated researchfacilities"

In addition centers should ensure that the% are -oth fostering -asic discoer% and as applica-lefacilitating transition of scientific findings through the translational pipeline ;i.e. -asic to pre!clinicaland earl% clinical deelop)ent then to Phase III trials or other t%pes of definitie studies appropriate to

the nature of the research<" Discoeries )a% -e adanced through NCI and other peer!reieedtranslational science and clinical trial funding )echanis)s ;e.g. grants for SPOR$s progra) pro'ects phase I>II consortia and the NCI National Clinical Trials NetorA or NCTN< and other colla-oratiestrategies including e#ternal partnerships" The for) and e#tent of these actiities )a% ar% -ased on thet%pe of center -ut all centers are encouraged to esta-lish colla-oratie linAs that )a#i)i@e productiit%and result in appropriate application of findings"

Depending on center t%pe the )a'or research areas )a% includeE

• 4asic 5aboratory Research: Centers use their -ase of support to pro)ote -readth and depth in

-asic la-orator% research and transdisciplinar% colla-orations a)ong inestigators in -asicdiscoer% and other research areas -oth ithin the Center and ith other e#ternal partners"

• Clinical Research: Cancer centers engage in a -road spectru) of clinical studies ith dierse

for)s of sponsorship" ( cancer center is a )a'or source of innoatie inestigator!initiatedclinical studies that can -e e#ported to NCIFs NCTN or other appropriate e#ternall% peer!reieed funded )echanis)s" Clinical studies inole releant la-orator% research heneer possi-le" In addition to fostering translation -eteen the la-orator% and clinic and conductingearl% proof!of!principle clinical trials cancer centers lead and>or participate in NCIFs NCTNtrials including studies of rare cancers" Cancer centers also participate in trials initiated -%

3



industr% and other e#ternal partners"

• Prevention Control and Population Research: =hile cancer centers )a% not -e a-le to

conduct research in all aspects of preention cancer control and population science and no onearea is re.uired the% de)onstrate depth in grant support across seeral the)atic areas ;e.g.epide)iolog% pri)ar% preention earl% detection health serices disse)ination palliation and

suriorship<" The% also de)onstrate appropriate colla-oratie linAs to other research areasithin the center and ith e#ternal partners"

Consortium Centers

NCI supports consortiu) centers in hich inestigators fro) distinct scientific institutions partnertogether to contri-ute actiel% to the deelop)ent and actuali@ation of the cancer research agenda thesefor)ali@ed relationships hae the potential to -oth strengthen the science of the center and furthere#tend the -enefits of cancer research" Partnerships -eteen research institutions sering special populations or located in geographic areas not currentl% sered -% an NCI!designated Cancer Center are particularl% encouraged"

Three -asic principles appl% to consortiu) arrange)ents in the conte#t of the NCI designationE

• +ach member institution adds strategic value to the research mission of the cancer center

i.e. to hold a reasonable portfolio of peerreviewed cancer related research grants that

contribute to the center6s scientific goals. The ter)s applied to these research partnerships)a% ar% e.g. so)e centers )a% refer to the arrange)ent as a research affiliation rather than aconsortiu)" Consortiu) centers in the CCSG conte#t are clearl% distinguished fro) other t%pesof partnerships hoeer such as clinical netorAs or affiliations ith co))unit% hospitalsdesigned pri)aril% for the purpose of enhancing clinical trial accrual or e#panding the centerFs patient -ase"

• At the time of application for a CC"# the partnering institutions already function as one

cohesive cancer center. Their research )ust -e integrated ;as eidenced -% a histor% ofcolla-oration including 'oint grants and pu-lications< and )echanis)s e#ist for includinggeographicall% dispersed )e)-ers in progra))atic actiities" Co))on fundraising and a 'ointInternal Reie +oard for ealuation of all cancer research across the partner institutions areencouraged -ut not re.uired"

• A formal written agreement is in place to ensure the stability and integration of the

consortium partnership. The agree)ent should includeE! ( process for resolution of differences at the highest leels of institutional leadership"! ( single Protocol Reie and &onitoring S%ste) and Data and Safet% &onitoring

Institutional Plan goerning cancer clinical trial protocols across all partner institutions"! (n integrated planning and ealuation process for cancer research clinical trials facult%

recruit)ent and other actiities that foster the strategic scientific deelop)ent of the center"! Ongoing tangi-le institutional co))it)ents to the cancer center fro) all consortiu) partners

in proportion to their )e)-ership"! ull eligi-ilit% for )e)-ership in for)al scientific Progra)s and leadership positions in the

center! Reasona-le access to shared resources for all )e)-ers"

*



! Center director oersight of CCSG!supported shared resources including those located in partner institutions"

4udget and )unding Policies

Time 5imitations: CCSG aards are for periods of up to fie %ears"

"ome Restrictions on Allowable 4udgets: Re.uested and>or aarded funds )a% not duplicate or re! place costs nor)all% included in the institutionFs indirect cost -ase or serices and -enefits nor)all% proided -% the institution ;e.g. purchasing personnel and other ancillar% serices< to otherdepart)ents schools or institutes" CCSG funds should not -e used to co)pensate for NI9>NCIad)inistratie reductions of actie aards or to pa% for shortfalls in funded research pro'ects" The%cannot supple)ent or offset an% patient costs een those directl% related to clinical research protocols"

Renewal 'Type 7( Applications "i1e of -irect Cost 4udget Re8uest: Guidelines for this section ill -e finali@ed at a later date"

See unding Policies -elo for infor)ation on aards"

*ew 'Type 9< Applications: +udget re.uests fro) a center ith no current CCSG grant should note#ceed 1000000 direct costs for %ear one ;the -udget in su-se.uent %ears )a% receie cost!of liingad'ust)ents depending on the NCI polic% in effect for the fiscal %ear<" The cap on the -udget re.uest for a first!ti)e application is predicated on the li)ited tracA record of the applicant organi@ation" The NCI)a% consider an e#ception to the cap in cases here a prior CCSG aard as phased out due to a non!funda-le priorit% score"

Resubmissions: Resu-)ission applications )ust include an introduction addressing the preious peerreie criti.ue ;Su))ar% State)ent<" The ti)e li)it on resu-)ission applications is 3/ )onths fro)the date of the original su-)ission after that ti)e the application )ust -e su-)itted as ne" See the NI9 polic% on resu-)ission ;a)ended< applications ; NOT!OD!05!003 NOT!OD!10!1*0 <"

Competitive Revision Applications: These applications support a significant e#pansion of the scope ofthe P30 CCSG" The parent aard )ust -e actie upon the co)petitie resu-)ission application and no!cost e#tensions here applica-le )ust -e in place" The Principal Inestigator ;PI< )ust -e the sa)e asthat for the parent aard" Co)petitie reision applications for the P30 CCSG are accepted onl% inresponse to targeted NI9 funding opportunit% announce)ents listed in the NI9 guide and )ust undergo peer reie"

Administrative Revision Applications: Depending upon the aaila-ilit% of funds the NCI illconsider ad)inistratie reisions to CCSGs to pursue i)portant short!ter) scientific opportunities thatneed i))ediate attention or could not -e initiated and sustained through the nor)al co)petitie grant

process ;e.g. R01s<" Interested centers should contact the progra) director of their grant to in.uirea-out aaila-ilit% of such funds"

)unding Policies: Peer reie pla%s a )a'or role in assessing the )erit and -udget 'ustification of nereneal resu-)ission and targeted co)petitie reision applications" &an% other factors )a% affectfunding leels for cancer centers hoeer including the scientific priorities of the NCI the iscal Hear -udget it esta-lishes for the Office of Cancer Centers the entr% of )eritorious ne centers into the progra) and opportunities to enhance the research focus on undersered populations"

,

http://grants.nih.gov/grants/guide/notice-files/not-od-09-003.html

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-016.html

http://grants.nih.gov/grants/guide/notice-files/not-od-09-003.html




(pplications not selected for an aard )a% receie no funding ;ne reneal resu-)ission or targetedco)petitie reision applications< or phase!out funding ;reneal applications<" During a period of phase!out funding the center can su-)it a resu-)ission application addressing the concerns of peerreie"

Non!co)peting ;T%pe ,< applications are paid in accordance ith NCI policies esta-lished each fiscal%ear" In %ears of significant -udgetar% constraint funding plans )a% spread the i)pact oer the entire progra) ;non!co)peting as ell as co)peting grants<" If funds -eco)e aaila-le in future %earsrestorations )a% -e considered"

Carryover of nobligated )unds: CCSGs are ad)inistered under the proisions of NI9 Ter)s of(ard ;httpE>>grants"nih"go>grants>polic%>nihgps2011>nihgpsch4"ht)<" Re.uests for carr%oer ofuno-ligated funds ill -e reieed -% NCI to ensure funds are necessar% for co)pletion of the pro'ectadditional infor)ation including a reised -udget )a% -e re.uested fro) the grantee as part of thisreie" If it is deter)ined that so)e or all of the uno-ligated funds are not necessar% to co)plete the pro'ect the NCI )a% taAe one of seeral actionsE 1< use the -alance to reduce or offset funding for asu-se.uent -udget period 2< restrict the granteeFs authorit% to carr% oer future uno-ligated -alances or

3< a co)-ination of ite)s 1 and 2 a-oe" The Federal Financial Report must specify the amount to becarried over. Any amount not specified for carryover may be used to offset the award in a subsequentbudget period.

Rebudgeting: Cancer centers hae fle#i-ilit% to )oe funds -eteen -udget areas in response tochanging needs and opportunities" =ith the e#ception of restricted categories such as deelop)entalfunds the center director )a% increase an% -udget area rated at least e#cellent -% up to 2, percent oerthe peer!approed leel ithout prior NCI approal" Re-udgeting of funds into areas rated less thane#cellent -% peer reie re.uires prior NCI approal" To ensure appropriate peer reie centers )a%esta-lish ne co)ponents ;i.e. research Progra)s shared resources not currentl% supported -% CCSGdeelop)ental funds etc"< onl% at the ti)e of a reneal ;T2< or co)petitie reision application"

*I; Policy Relative to Program Income: Inco)e reali@ed fro) grant!supported actiities ;e.g. fro)CCSG supported shared resources< )ust -e reported in the -udget>financial state)ents acco)pan%ingannual progress reports and on the annual financial status report in accordance ith NI9 Grants Polic%"The Jadditie cost alternatieK ill appl% to the first 2,000 of progra) inco)e" nless approed foruse otherise progra) inco)e in e#cess of 2,000 ill -e deducted fro) the ne#t %earFs aard"

8

http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch8.htm#recipient_reporting_ffata

http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch8.htm#recipient_reporting_ffata



II. Instructions and Review Criteria for Applications

)or a P! Cancer Center "upport #rant

The NCI aards P30 CCSGs to .ualified applicant institutions that hae successfull% )et a series ofco)petitie standards associated ith scientific and organi@ational )erit" The purpose of a CCSG is to

foster )eritorious science and productie interactions ithin institutions that alread% hae a su-stantialcancer!related research -ase" The application and supporting )aterials should -e presented in sufficientdetail to conince peer reieers that all re.uests for resources are 'ustified"

+ligibility Re8uirements

Onl% research institutions in the "S" are eligi-le to appl%"

Onl% one CCSG application per institution )a% -e su-)itted"

(n applicant institution )ust hae a -ase of at least 10000000 in annual direct costs of peer!reieedcancer!related funding" If the cancer center is a consortiu) of institutions the funding -ase of the centerill -e the su) of the funding -ases of all participating institutions"

pdated infor)ation on NCI and NI9 )echanis)s that )a% -e included for deter)ining eligi-ilit% toappl% for a CCSG as ell as those fro) other approed funding organi@ations is aaila-le athttpE>>cancercenters"cancer"go>docu)ents>fundorg"pdf

<ey -ates in the #rant Application Review and )unding Process

Pre!application Consultation Sept!No :an!&ar &a%!:ul

(pplication Receipt Date :anuar% 2, &a% 2, Septe)-er 2,

Site ?isit &a%>:un Sept>Oct :an>e-

Reie Co))ittee &eeting (ug Dec (pr>&a%

NC(+ &eeting Sept>Oct :an>e- &a%>:une

$arliest Start Date Dec" 1 (pr" 1 :ul% 1

Preapplication Consultation

( pre!application consultation ith NCI staff is highl% reco))ended" Pre!application consultations areconducted ia an in!person )eeting or ideoconference" The consultation should -e scheduled ell in

adance of the application receipt date" NCI staff ill respond to .uestions clarif% the intent of theguidelines discuss strategies for preparing a co)petitie application and funding trends and descri-e the peer!reie process"

The folloing infor)ation is helpful for NCI staffE

• +acAground and responsi-ilities of the cancer center director and the Ae% senior leaders of the

center"

/

http://cancercenters.cancer.gov/documents/fundorg.pdf




• Diagra) shoing the reporting progra))atic and adisor% structure of the center its

relationship to the organi@ational structure of the institution as a hole and a list of e#ternal

adisor% -oard )e)-ers"

• 9o the center e#pects to )eet the si# essential characteristics of an NCI!designated cancer

center"

• Proposed scientific Progra)s and their pro'ected leadership"

• 6ist of all actie peer!reieed approed research grants cooperatie agree)ents and contracts

grouped -% the for)al scientific Progra)s that ill for) the total research -ase of the cancer

center prefera-l% in Su))ar% 2 for)at" "

• 6ist of actie clinical research of the center prefera-l% in Su))ar% * for)at"

or )ore infor)ation call or rite toE

Director Office of Cancer Centers National Cancer Institute National Institutes of 9ealth

8118 $#ecutie +ld Suite /00 &SC 43*,+ethesda &ar%land 20452!43*, ;for $#press )ail use RocAille &D

204,2<TelE 301"*58"4,31a#E 301"*02"0141

Instructions for "ubmitting the CC"# Application

=here to "end the Application: Su-)it one original and three copies of the CCSG application to theCenter for Scientific Reie ;CSR< NI9 according to the instructions in the P9S or) 354 ;re"08>05< Ait" or a ne reneal resu-)ission or co)petitie reision application enclose a coer letter

na)ing the NCI staff person ho agreed to accept the application for consideration"

(t the sa)e ti)e %ou su-)it the application to CSR please send to co)plete copies to the NCI at theaddress -elo to facilitate scheduling and deter)ination of hether additional infor)ation is needed forthe reie" The NCI address isE

Referral Officer National Cancer Institute8118 $#ecutie +ld Roo) 400* &SC 4325+ethesda &ar%land 20452 B 4325 ;for $#press )ail use RocAille &D 204,2<TelE 301"*58"3*24a#E 301"*02"02/,

Acceptance of the Application: ( Scientific Reie Officer ;SRO< located in NCIFs Diision of $#!tra)ural (ctiities oersees the peer!reie process" +eteen su-)ission and the co)pletion of the peer reie process direct all co))unication to the SRO responsi-le for the CCSG reie" The SROsuperises the reie process to ensure a technicall% co)petent and un-iased reie" =hile the appli!cation is in reie the SRO )a% consult NCI progra) staff on progra) policies and guidelines"

4



pon receipt of an application the SRO conducts a thorough reie of the su-)itted )aterials ithattention to the folloing ele)entsE

• Conformity with #uidelines: (pplications should e#hi-it the general organi@ational

ad)inistratie and operational structure of cancer centers and re.uest alloa-le and appropriatecosts as per these guidelines"

• )ormat: (pplications should -e prepared in confor)it% ith the P9S or) 354 ;re" 08>05< in!

structions to facilitate reie of the su-)ission"

• Completeness of Re8uired Information: The applicant should ensure that all essential

infor)ation is presented co)pletel% and una)-iguousl% to facilitate the 8uality and

consistenc% of the reie"

If an application is deficient in the ele)ents a-oe depending upon the )agnitude of the pro-le) theresponsi-le NCI staff )a%E

• Defer the application to a later reie c%cle

• Return the application to the applicant ithout reie

2odifications after "ubmission: &inor unaoida-le )odifications of the application are accepted onthe da% of the site isit ; ttpE>>grants"nih"go>grants>guide>notice!files>NOT!OD!10!11,"ht)l<" &a'or)odifications )a% result in deferral -% the SRO to the ne#t round of receipt and reie" Generall% ne)aterial should not represent )a'or changes in the application as ritten and>or presented" =hether toaccept )odifications of the application or additional infor)ation or to defer the application rests entirel%ith the SRO"

Reies ill -e -ased on the )aterial su-)itted at least ! days prior to the site isit" Do not su-)itadditional )aterial after that ti)e unless specificall% re.uested"

In8uiries about the Application after "ubmission: +efore co)pletion of NCI Su-co))ittee!(Reie ;see Part III NCI Su-co))ittee!( Reie< direct in.uiries to the SRO ho is responsi-le forall aspects of the peer reie process"

(fter co)pletion of the NCI reie address .uestions to the responsi-le progra) director in the OCCor for fiscal .uestions the Grants &anage)ent Specialist"

(pplicants )a% not contact an% )e)-er of the site isit or NCI Su-co))itteeB( a-out the reie"

)ormatting Instructions and Review Criteria for "pecific Components of *ew and Competing

Continuation CC"# Applications

These for)atting instructions supple)ent those of the P9S or) 354 ;re" 08>05<" (dherence to theseinstructions ill assist peer reieers in identif%ing sections of the application and in )atching the)ith the corresponding reie criteria"

Page 5imits: These appl% onl% to the narratie parts of each section including descriptions o-'ectiesgoals rationale acco)plish)ents ta-les figures charts etc" The% do not include -udget pages -udget 'ustifications -iographical sAetches references or pu-lication lists ta-les on clinical trial accrual orlists of grants" Page li)its are not )eant to suggest the opti)al length of sections"

5





5etter of Agreement to Accept the Application: (t least thirt% da%s prior to the receipt date contact NCI progra) staff to o-tain prior agree)ent to accept the application for reie" (ll ne and co)petingcontinuation applications inoling -udget re.uests of 1000000 or )ore in direct costs )ust haeritten approal"

The OCC ill notif% the institution -% letter or e)ail if the NCI is illing to accept its application forreie"

Include the letter of agree)ent to accept the application as the coer page of %our su-)ission"

O-tain a ne letter of agree)ent if the application is not su-)itted -% the e#pected date"

9. )ace Page: The JPrincipal InestigatorK is the cancer center director or designee the J(pplicantInstitutionK is the fiscall% responsi-le institution of hich the cancer center is a part"

7. -escription Performance "ites and <ey Personnel: Proide a description li)ited to the space proided on page 2 of the P9S or) 354 ;re"08>05< of the CCSG!related organi@ation and for)alresearch Progra)s of the cancer center and of the re.uest for support through the CCSG" Proide a list

of perfor)ance sites ;including hospitals< and Ae% personnel as per P9S or) 354 ;re" 08>05<instructions"

" Include a Table of Contents for all )a'or sections and su-sections of the application"

$" Prepare a Consolidated and "ummary 4udget Re8uest per P9S or) 354 ;re" 08>05<"

>. "tandard Cancer Center Information '*o page limit(: These Su))aries ;see (ttach)ent forinstructions and for)ats< ite)i@e the centerFs for)al research Progra)s shared resources -ase offunded research pro'ects patient infor)ation clinical research protocols and a co)parison of currentand re.uested -udgets"

•"ummaries 9a b c and d descri-e the CenterFs senior leadership ;e.g. cancer center directordeput% director and associate directors< leadership of the proposed Progra)s and sharedresources and cancer center )e)-ership"

• "ummary 7a lists all actie cancer!related pro'ects co)petitiel% funded -% sources e#ternal to

the fiscall% responsi-le institution of hich the cancer center is a part as of the date of preparation of the su))ar%" Grants are listed alpha-eticall% -% principal inestigator in three parts B actie funded peer reieed research pro'ects actie non!peer reieed research pro'ects and training and career deelop)ent grants"

• "ummary 7b su))ari@es the funding -% categor%" Together ith Su))ar% 2a it descri-es

the si@e and scope of the funded research -ase of the center"

• "ummary proides cancer registr% data regarding the nu)-ers of patients nel%

diagnosed and treated at the cancer center and the nu)-er placed on therapeutic studies -%cancer site during a recent 12!)onth period" ;NoteE Data in Su))aries 3 and * )a% notcorrelate and should not -e cross!referenced"<

• "ummary $ lists clinical research protocols open at the center during a recent 12!)onth

period sorted -% Progra) categor% of research sponsor and principal inestigator" ;NoteEData in Su))aries 3 and * )a% not correlate and should not -e cross!referenced"<

10



• "ummary > co)pares the current ;last full noncompeting %ear< and re.uested CCSG -udgets

in each CCSG -udget categor%" See the section on +udget and unding Policies in Part I forguidance on re.uest li)its"

%. ;istory and -escription of the Cancer Center "pecifically -escribing the "i, +ssential

Characteristics of the Cancer Center: 5imit of thirty pages%.9 -irector6s 0verview

Proide a short histor% and oerie of the cancer center especiall% its research actiities" +riefl%descri-e the )ost i)portant research acco)plish)ents during the last period of support and the isionand general plans for the future scientific deelop)ent of the center" If %ou are presenting a consortiu)center clearl% outline the contri-utions of each institution and the histor% o-'ecties and -enefits of theconsortiu) arrange)ent"

%.7 "i, +ssential Characteristics of Cancer Centers '"ee Part I )eatures of an *CIdesignated

Cancer Center(

Descri-e specificall% the structure of the cancer center ith respect toE

)acilities: Centers are )ore successful in esta-lishing an identit% if the% hae a distinct ph%sicallocation" Not all )e)-ers of the cancer center need -e ph%sicall% located in facilities controllede#clusiel% -% the center hoeer location of )e)-ers across progra) areas ;-asic la-orator%clinical and preention control and population!-ased science< in close ph%sical pro#i)it% enhancesshared use of resources and facilitates scientific interactions" $en if pro#i)it% is i)possi-le centershared resources and other serices should still -e reasona-l% accessi-le to all )e)-ers"

In %our application discuss the si@e and other characteristics of the ph%sical facilities dedicated tocancer research center shared resources and ad)inistration" Proide a )ap that illustrates the )ainlocation of the centerFs research and ad)inistratie actiities and the ph%sical relationship of an%consortiu) institutions to the )ain ca)pus" Indicate ho the center facilitates access to shared resourcesand other serices ;i.e. Clinical Protocol and Data &anage)ent"

The following review criteria apply to this characteristic 'merit descriptor(:

• 9o ade.uate and appropriate are the centerFs space and ph%sical facilities to its identit%

o-'ecties and actiitiesL

• 9o is reasona-le access to shared resources and other serices and resources facilitated for all

)e)-ersL

0rgani1ational Capabilities: ( center should hae an oerall progra))atic structure that effectiel%

pro)otes colla-oratie scientific interactions -oth ithin the institution and ith e#ternal partners" Itshould taAe )a#i)u) adantage of the institutionFs cancer research capa-ilit% ;this is particularl%i)portant to e#plain hen the center includes )ultiple participating institutions in a consortiu)arrange)ent< as ell as an efficient and cost!effectie ad)inistratie organi@ation ith clear lines ofauthorit%" It should sponsor or participate in education and training of -io)edical researchers and healthcare professionals including those fro) undersered populations and integrate these actiities into progra))atic research efforts" In addition to research .uestions of -road applica-ilit% it should use itsaaila-le e#pertise and resources to address cancer pro-le)s ithin the catch)ent area"

11



=hile a for)al ritten strategic plan is not re.uired )ethods used -% the center to o-tain effectieinternal and e#ternal adisor% co))ittee input set priorities )aAe decisions and ealuate center plansand actiities should -e esta-lished and clearl% docu)ented including those for deter)ining andsustaining indiidual )e)-ership in the center"

sing the a-oe description discuss the organi@ational structure capa-ilities and processes of thecenter"

Consortiu) centers should include a discussion of ho differences are resoled a)ong partners and ho planning and ealuation processes are integrated to )eet the strategic goals of the center including thosefor clinical trials facult% recruit)ent and other research actiities" ( cop% of for)al ritten agree)entsdocu)enting specifics of consortiu) arrange)ents and co))it)ents relatie to CCSG re.uire)entsshould -e )ade aaila-le at the site isit"


• 9o effectie is the center in taAing full adantage of institutional capa-ilities in cancer

research and in fostering scientific interactions and 'oint initiaties a)ong progra))aticele)ents and ith e#ternal partnersL

• =hat is the eidence that the center has an efficient and cost effectie ad)inistratie

organi@ation ith clear lines of authorit%L

• 9o effectie are strategic planning and ealuation processes for the conduct of center

actiities including use of e#ternal and internal cancer center adisor% -odiesL

• In addition to addressing research .uestions of -roader applica-ilit% ho does the center appl%

its e#pertise and resources to cancer pro-le)s applica-le to the catch)ent area it seresL

• 9o effectiel% does the center integrate training and education of -io)edical researchers and

health care professionals including )e)-ers of undersered populations ith progra))aticresearch effortsL

• or consortiu) centers ho ade.uate are the )echanis)s in place for ensuringE

- Differences can -e resoled a)ong consortiu) institutionsL

- (n integrated planning and ealuation process to )eet the strategic goals of the center in

research scientific recruit)ent and other actiitiesL

- The partnership is sta-le as eidenced -% a histor% of research integration and the proisions

of for)ali@ed agree)entsL

- (ll )e)-ers hae reasona-le access to shared resources and other serices participate in

scientific Progra)s and )a% assu)e leadership positions in the center een if partnerinstitutions are geographicall% dispersedL

Transdisciplinary Collaboration and Coordination: (n actiel% functioning center pro)otesinnoatie and interactie research opportunities through the for)ation of for)al scientific researchProgra)s co)prised of groups of inestigators ho share co))on scientific interests and goals and participate in co)petitiel% funded research and in pu-lications" +oth inter! and intra!progra))atic

12



colla-oration is i)portant" These actiities )a#i)i@e the potential of the institution hether s)all orlarge to conduct transdisciplinar% and translational research"

&oe)ent of scientific findings through the translational pipeline ;i.e. -asic to pre!clinical and earl%clinical deelop)ent then to Phase III trials or other t%pes of definitie studies appropriate to the natureof the research< is also critical" NCI and other peer!reieed translational science and clinical trialfunding )echanis)s ;e.g. grants for SPOR$s )ulti!inestigator R01s and progra) pro'ects phase I>IIconsortia and the NCI National Clinical Trials NetorA< are i)portant aenues for adancingdiscoeries originating in the center and coordination of research across these )echanis)s is strongl%encouraged" Colla-oratie strategies )a% inole inestigators ithin the cancer center inestigators inother centers industr% or other partners" The for) and e#tent of these actiities )a% ar% -ased on thet%pe of Center -ut all Centers are encouraged to esta-lish colla-oratie linAs that result in appropriateapplication of findings i.e. not all transdisciplinar% research is translational"

In this section su))ari@e the centerFs )a'or scientific strengths its principal research opportunitiesand the transdisciplinar% coordination and colla-oration -eteen cancer center )e)-ers includinginter!and intra!progra))atic colla-orations and those inoling consortiu) institutions" Discuss ho

productiit% and .ualit% of translational research in the center is enhanced -% these colla-orations andthe )echanis)s used -% the center to pro)ote interactie research opportunities" Descri-e strategies thathae pro)oted appropriate )oe)ent of findings through the translational and clinical continuu) -othithin and outside the Center including coordination across NCI and other translational science andclinical funding )echanis)s"

Consortiu) applications also should docu)ent the integration of research Progra)s and actiities acrossthe partner institutions as ell as cross!institutional access to center resources and participation andleadership in Progra)s"


•

9o effectie is the center in pro)oting transdisciplinar% and>or translational colla-orationsa)ong -asic la-orator% clinical and preention cancer control and population science cancercenter )e)-ersL

• To hat e#tent hae colla-orations ithin and a)ong ;intra! and inter!progra))atic< Progra)s

added alue to cancer related scientific actiitiesL

• 9o effectie is the center in )oing scientific findings forard to cancer!related endpoints

appropriate to the nature of the research through internal colla-orations and>or e#ternal partnersL

• or consortiu) centers ho ade.uate are )echanis)s to ensure thatE

- Research is integrated across partner institutions as eidenced -% progra))atic structure ando-'ecties 'oint pu-lications and grants and other transdisciplinar% cross!institutionalactiitiesL

Cancer )ocus: ( clearl% defined scientific focus on cancer research is de)onstrated ia the center)e)-ersF grants and contracts -% the structure and o-'ecties of its for)al Progra)s and thecolla-orations -eteen la-orator% researchers and other inestigators )ore directl% concerned ithapplication of research Anoledge" NCI recogni@es that cancer!relatedness should -e a )atter of fle#i-le

13



interpretation ;e.g. as ith studies of -asic )echanis)s or of conditions or -ehaiors that influence arange of diseases< -ut the center should -e prepared to de)onstrate ho the scientific research itsupports through the CCSG is linAed to cancer"

+ased on the description a-oe discuss ho the pro'ects in the centerFs peer reieed funded research -ase and the colla-orations -eteen center inestigators support the o-'ecties of its cancer researchProgra)s and reflect a scientific cancer focus"

The following review criterion applies to this characteristic 'merit descriptor(:

• =hat are the -readth depth and significance of the cancer!related research -ase as 'udged -%

the structure and o-'ecties of the Progra)s peer!reieed research support colla-oratie pu-lications and other actiities of center )e)-ersL

Institutional Commitment: The NCI designation lends stature to an institution -% attracting patientsindustr% research support and philanthrop%" The NCI su-stantiall% inests in cancer centers and e#pectssi)ilar co))it)ent of the institution;s< to the center" Co))it)ents of parent institutions to the cancercenter generall% include the folloingE

• (n organi@ational status for the cancer center that is co)para-le or superior to that of

depart)ents"

• unding fro) the institution and consortiu) partners"

• Research clinical and ad)inistratie space and positions"

• &easures that ensure other institutional leaders ;deans hospital presidents and depart)ent

chairs< ill proide the long!ter) sta-le support necessar% to acco)plish strategic cancer centero-'ecties"

• :oint control at a )ini)u) ith depart)ent chairs oer facult% recruit)ents to the cancer

center"

• ( ell!defined plan for a change in directorship and for continuing institutional co))it)ent to

support of the cancer center"

• Recognition of participation in tea) science including that of clinical inestigators in

institutional policies related to pro)otion and tenure"

• (uthorit% of the center directorE

- (s co)para-le or superior to that of depart)ent chairs ith appoint)ents to decision )aAing

co))ittees releant to the cancer center and for)all% codified authorities"

- Oer specific research and resource space and e.uip)ent dedicated to the cancer center forthe enhance)ent of center research capa-ilities"

- Oer inpatient and outpatient clinical research facilities and the appoint)ent and ealuation

of indiiduals critical to linAing oncolog% care to clinical research"

- Oer facult% appoint)ents to the cancer center and of their periodic reie for continued

)e)-ership"

1*



- Oer central discretionar% funds ;e.g. philanthropic funds facilities and ad)inistratie

costs and clinical reenues<"

• In consortiu) centers director oersight for integration of scientists in colla-orating institutions

into the research Progra)s of the center and CCSG!supported shared resources"

This section of %our application should discuss the institutional co))it)ent relatie to the a-oedescription"

Include a letter signed -% the Dean and 9ospital President or other appropriate institutional officialsdocu)enting specifics of institutional co))it)ent -oth for the long!ter) future of the center and forthis aard period"

The sta-ilit% of a consortiu) is de)onstrated ia proisions of for)al ritten agree)ents the record oftangi-le contri-utions of each consortiu) institution to the cancer center and the proisions of for)alagree)ents"


• To hat e#tent has the institution ;and consortiu) partners here appropriate< )et prior

co))it)ents and proided resources to insure that the center reaches its full potentialL

• 9o appropriate are resources co))itted to the center -% the institution and an% consortiu)

partners for the ne#t pro'ect period ;e.g. return of indirect costs endo)ent inco)e andclinical inco)e< and the processes for deter)ining ho funds ill -e usedL

• or )atri# centers is there eidence that cancer center status is at least e.uialent to that of an

acade)ic depart)ent and that other institutional leadership ;depart)ent chairs deans etc"< proides support for strategic center o-'ectiesL

• 9o appropriate is the directorFs position ithin the institution and his>her representation on

decision!)aAing co))ittees releant to center o-'ecties appropriateL

• 9o ade.uate is the authorit% of the center director oerE

! (ppoint)ent of ne )e)-ers and discontinuation of e#isting )e)-ersL

! (ppoint)ents of facult% necessar% to enhance the research o-'ecties of the centerL

! Inpatient and outpatient research facilities necessar% to achiee the centerFs clinical researcho-'ecties ;in centers ith clinical research actiities<L

! Philanthrop% clinical reenues or other funding strea)sL

• =hat is the ade.uac% of the institutionFs plan for dealing ith a change in the directorship of the

centerL

• 9o do institutional pro)otion and tenure policies recogni@e tea) scienceL

• or consortiu) centers ho ade.uate are the )echanis)s for ensuring the center director has

authorit% oer integration of inestigators fro) all partner institutions into the scientificProgra)s of the center and oersight oer CCSG!supported shared resources in colla-oratinginstitutionsL

1,



Center -irector: The director should -e a highl% .ualified scientist and ad)inistrator ith theleadership e#perience and e#pertise appropriate for esta-lishing a ision for the center adancingscientific goals and )anaging a co)ple# organi@ation" In a consortiu) the director should pla% a )a'orrole in adancing the integration of the partner institutions into the research and other actiities of thecenter" 9e or she should hae an appropriate ti)e co))it)ent to the directorship role"

In %our application descri-e the scientific and ad)inistratie .ualifications and leadershipe#perience of the center director as ell as his>her ti)e co))it)ent to the center" Discuss actiities ofthe director relatie to oerall )anage)ent of the center and use of authorities and resources to adancethe centerFs research )ission"


• 9o appropriate are the scientific and ad)inistratie .ualifications and e#perience of the

director for the centerFs research actiities and o-'ectiesL

• 9o effectie is the director in esta-lishing a ision for the center and using authorities to

further its scientific o-'ectiesL

• 9o appropriate is the directorFs ti)e co))it)ent to the centerFs scientific and )anage)ent

actiitiesL

• or consortiu) centers ho effectie is the director in adancing integration of the partner

institutionsL

?. -escriptions 4udgets and *arrative @ustifications for Individual CC"# Components

sing the for)s and instructions in the P9S or) 354 ;re" 08>05< for each alloa-le -udget categor%for hich funds are re.uested prepareE

• ( description

• ( -udget for the first 12 )onth +udget Period

• ( su))ar% -udget for the entire Proposed Pro'ect Period

The CCSG proides reasona-le costs for a great ariet% of actiities clearl% related to the research needsof the cancer center" The narratie descri-ing the role and function of re.uested personnel should clearl% 'ustif% the stated percent effort hether or not %ou re.uest salar%"

The )a'or categories of alloa-le costs areE

?.9 "enior 5eadership: No )ore than one page of narratie per senior leader plus fie additional pagesfor narratie discussion of their colla-oratie actiities" Indiiduals in piotal leadership positions in thecenter are eligi-le for salar% support for the ti)e and effort the% deote to its research actiities"Consider the -readth and co)ple#it% of the role of each senior leader to deter)ine the appropriate leelof effort needed to )eet this responsi-ilit% ;i.e. there is no standard leel of effort for all senior leaders<"

Prepare a description and a consolidated -udget of percent efforts for all senior leaders and narratie 'ustifications that carefull% descri-e their roles" ollo each narratie ith a -iographical sAetch ;seeP9S or) 354 re" 08>05<"

18



In a short ,!page description discuss ho the senior leaders hae orAed together toE

• $sta-lish a ision for the center and address oerall center goals policies and operations"

• oster -asic discoer% and as appropriate i)ple)ent strategies that adance earl% scientific

findings ia coordination across NCI and other funding )echanis)s and colla-orations ith

other e#ternal part

• $na-le a focus on cancer pro-le)s applica-le to the catch)ent area sered -% the center"

• Integrate the training of -io)edical scientists and health care professionals including those

fro) )inorit% and other undersered populations into progra))atic research efforts ;e.g.appoint)ent of an (D or center ide co))ittee to focus on coordination>integration efforts)eetings or retreats focused on training education and for)al )entoring progra)s and otheractiities<

The for) and e#tent of these actiities )a% ar% -ased on the t%pe of Center"

The following review criteria apply to this component 'merit descriptor(:

• 9o appropriate are the .ualifications and effectieness of each senior leader in relation to

his>her role in the research actiities of the centerL

• 9o appropriate is the ti)e co))it)ent of each leader to needs and o-'ecties of the center

and to the difficult% and co)ple#it% of his>her specific responsi-ilitiesL

• 9o effectie is the senior leadership tea) inE

- $sta-lishing a future ision for the center and adancing goals and policies releant to the

centerFs progressL

- ostering -asic discoer% and appropriatel% adancing scientific findingsL

- $na-ling a focus on cancer pro-le)s applica-le to the centerFs catch)ent areaL

- Integrating training and education of -io)edical scientists and health care professionals into

progra))atic research effortsL

?.7 5eaders of "cientific Research Programs: 4udget pages only. Proide onl% a single consolidated -udget that lists all Progra) leaders in the center and their percent efforts" This is )erel% a consolidationof the separate -udgets proided and 'ustified in /"0" Do NOT proide an% narraties"

?. Planning and +valuation: 5imit of five pages. Proide an oerall description a consolidated -udget and a narratie 'ustification for each planning and ealuation actiit%" Costs of planning andealuation )ight include support for the e#ternal adisor% co))ittee and ad hoc scientific and technicalconsultants a se)inar series hen the speaAers or inited participants also sere as consultants for thecenterFs scientific or ad)inistratie actiities retreats designed to sti)ulate transdisciplinar% researchopportunities and the regular assess)ent of center goals and actiities -% the senior leadership"

The center should hae a for)al standing $#ternal (disor% Co))ittee ;$(C< appropriatel% -alancedfor -asic la-orator% clinical preention cancer control and population science and ad)inistratie

1/



e#pertise" The $(C should )eet at least once %earl% and proide o-'ectie ealuation and adice in aconsensus report to the center director"

The narratie should su))ari@e ho past CCSG funds ere used hat as acco)plished to i)proeand deelop the cancer center and ho future needs ill -e )et ith the re.uested -udget" Discussreco))endations )ade -% the $(C an% actions taAen in response to those reco))endations orreasons for not responding" Proide a consolidated list of $(C )e)-ers ith titles and affiliations andattach their -iosAetches" Discuss ho internal ealuation processes hae affected center planning andi)ple)entation actiities ;e.g. of shared resources clinical resources and deelop)ental funds< oerthe last pro'ect period" (lthough -udgetar% support for deelop)ent of future scientific Progra)s is notalloa-le in the CCSG plans for deeloping such Progra)s should -e discussed in this section"


• 9o effectie are internal adisor% and ealuation actiities for the deelop)ent of the centerFs

scientific actiitiesL

• 9o effectie is the center in using the adice of the $(C in adancing its scientific o-'ectiesL

?.$ -evelopmental )unds: 5imit of twelve pages. Deelop)ental unds are the )a'or source of -udgetar% fle#i-ilit% in the CCSG and should -e linAed su-stantiall% to the planning and ealuationactiities of the center" These funds allo centers to taAe risAs and strengthen eaAer scientific areas"The% also proide opportunities for e#ploring innoatie ideas and ne colla-orations and technologiesto center )e)-ers"

The cancer center )ust centrall% )onitor and ealuate the effectieness of all deelop)ental funds"These funds can -e ad)inistered fle#i-l% ! dispensed centrall% -% the director and senior leaders toachiee -road strategic o-'ecties or delegated to indiidual Progra) leaders to target specific scientifico-'ecties" Deelop)ental funds )a% not pa% for training routine e.uip)ent purchases upgrades foresta-lished shared resources or salar% support for Senior or Progra) leaders or shared resource

personnel"

Prepare an oerall description and a co)posite -udget that includes all re.uested deelop)ental fundcategories" $#plain ho funds are linAed to the strategic and progra))atic priorities and scientificopportunities of the center -ased on planning and ealuation actiities" Proide indiidual -udgets -%categor% ith separate narratie 'ustifications" Narraties should su))ari@e ho past CCSGdeelop)ental funds ere used hat as acco)plished ith the) ;e.g. esta-lish)ent of a ne sharedresource nu)-er of recruit)ents and areas of e#pertise and nu)-er of pilot pro'ects resulting in peer!reieed funding< and ho the ne re.uest ill -e used to )eet the centerFs strategic goals" If pilot pro'ects are proposed descri-e ho the pro'ects are reieed for scientific )erit and selected forfunding"

se of deelop)ental funds is restricted to the folloingE

Recruitment of faculty level scientists in areas of strategic need: :udicious recruit)ents strengtheneaA areas of science and enhance the centerFs oerall research strength" $ligi-le inestigators areE ;1<those nel% recruited fro) outside the parent institution ith deelop)ental support -eginning at theti)e of or er% soon after arrial at the grantee institution" ;2< those inside the institution ho hether

14



'unior scientists or ell esta-lished in other scientific areas are entering the field of cancer research asindependent inestigators for the first ti)e"

Deelop)ental funds )a% not -e used to support costs associated ith the recruit)ent process itselftraining or tuition or large e.uip)ent purchases -ut )a% fund recruit)ent pacAages that include thestaff needed ;e.g. technicians graduate students and postdoctoral fellos< to initiate the research progra) of a ne inestigator" The duration of support fro) these funds should not e#ceed 3 %ears" Thiscategor% should proide te)porar% support per)itting a ne cancer inestigator to esta-lish his>herscientific actiities at the ne center and achiee independent funding" Deelop)ental funds cannotsupport esta-lished cancer researchers alread% ithin the institution"

In %our application e#plain ho these deelop)ental funds ere used in the preious 3 to , %ear grant period specif%ing hich inestigators and pro'ects ere supported the rationale for recruiting theseinestigators relatie to the needs of the center and to hat e#tent these inestigators ere su-se.uentl% productie as eidenced -% research grants and pu-lications"

Identif% the Ainds of indiiduals the center plans to recruit as part of its plans for deeloping the center"

Identification of particular indiiduals or research plans is not necessar%"

Interim salary and research support: The center director )a% proide partial support for up to 14)onths to an inestigator ho has a reasona-le pro-a-ilit% of regaining independent research support inthe near future" Interi) salar% and support is independent of an% salar% funded -% the CCSG in the StaffInestigator categor%" Indiiduals ho are haing chronic difficult% ith peer!reieed grant supportand for ho) per)anent institutional funds are not aaila-le are ineligi-le"

Hour application should include a description of the process and the criteria used to select inestigatorsfor interi) support" Peer reie at the ne#t co)petitie ealuation ill e#a)ine the uses of the interi)support categor% and the success that indiiduals supported fro) this categor% hae had in regaining peer!reieed grant support"

To support pilot pro3ects that allow center scientists to pursue innovative highris ideas or

stimulate high priority research areas 'e.g. translational research research on underserved

populations or development of new technologies or methodologies(: Centers are encouraged to )aAethese funds accessi-le to -asic la-orator% clinicalE and preention control -ehaioral and population! -ased research for pro'ects of relatiel% short duration ;i.e. 1!2 %ears<" Pilot pro'ects )a% -e aarded tone or esta-lished inestigators preparator% to the deelop)ent of an application for independent peer!reieed support or to taAe )a#i)u) adantage of a uni.ue research opportunit% nurture aninnoatie idea sti)ulate a high priorit% research area or encourage cross!disciplinar% translationalresearch"

NCI also encourages the deelop)ent of ne technologies that ill adance cancer research;procedures instru)entation anal%tical tools or reagents< e.g. the detection and anal%sis of )olecularsignatures of cancer in itro or in io -io)edical i)aging )odel deelop)ent drug discoer% tu)ortargeting drug delier% sure% deelop)ent and infor)atics"

Hour application should descri-e the processes for eliciting and reieing proposals and list theaardees and their pro'ects for the preceding pro'ect period" Descri-e the outco)e of all pro'ects

15



supported -% the CCSG through the pilot and technolog%>)ethodolog% deelop)ent )echanis)s ;e.g.grant aards pu-lications and patents<"

If CCSG resources are used in partnership ith industrial resources the cancer center )ustassure that applica-le federal la goerns the pu-lic aaila-ilit% of an% final products of the research"

NI9 )ust tracA all pilot pro'ects in this categor% that include foreign co)ponents and if necessar% StateDepart)ent clearance )ust -e o-tained prior to i)ple)entation" OCC staff ill act as the liaison -eteen the Centers and the NI9 ogart% International Center hich is responsi-le for coordinating allclearances"

-evelopment of new shared resources: CCSG funds )a% -e used to help deelop ne sharedresources hen the center recogni@es a need" If the resources are sufficientl% deeloped to -e proposedand reieed as esta-lished resources ;e.g. a tracA record de)onstrating its ia-ilit% as a full%functioning shared resource< the% should -e proposed under the shared resources categor%" The% )a%not -e used for upgrades or routine purchases of e.uip)ent"

Descri-e the planned shared resources including need anticipated scope of the serices and ti)eline for deelop)ent and potential usage ;predicated on )e)-er sure%s or other data<" Report on the outco)esfor funds used for this co)ponent in the prior pro'ect period ;e.g. of a nel% esta-lished sharedresource<"

Purchase of peerreviewed shared services from other *CIdesignated Cancer Centers: Not all NCI!designated Cancer Centers hae access ithin their on institution to high technolog% or otherspeciali@ed shared serices that )a% -e crucial to acco)plish)ent of research goals on either a per)anent or a te)porar% -asis" Since esta-lish)ent of such resources )a% not -e econo)icall% orscientificall% feasi-le in eer% institution sharing of resources across cancer centers is encouraged"Centers )a% use deelop)ental funds to purchase successfull% peer!reieed ;i.e. scoring $#cellent ora-oe< shared serices or e#pertise fro) ithin the esta-lished shared resources of other NCI!

designated Cancer Centers for this purpose"

+ased on the scientific goals of the center %our application should -riefl% descri-e the anticipatedshared resource needs in this categor% and the research areas to -e supported and identif% the NCI!designated Cancer Center shared resource serices and the personnel that ill proide those serices"=here appropriate report on the outco)e of funds used preiousl% for this purpose in the past e.g.successful grant applications co)pletion of pro'ects and pu-lications" unding should -e consistentith CCSG guidelines on shared resources ;e.g. need cost!efficienc% and accessi-ilit%< -ut no specifict%pes of financial arrange)ents are )andated due to ariation in institutional policies and cost structuresand the t%pe and olu)e of the serices that )a% -e re.uired"

"taff Investigators:&e)-ers of the center ho are i)portant contri-utors to the scientific

translational and clinical actiities of the center )a% receie salar% support as a Staff Inestigator fortheir specific roles in the center" To .ualif% indiiduals should pla% a defina-le and special role in eitherhelping the center achiee scientific o-'ecties a-oe and -e%ond their on research ;Research StaffInestigator< facilitating center!ide clinical actiities ;Clinical Staff Inestigator< or furthering center research that focuses on cancer issues for )inorit% and other special or undersered populations ;SpecialPopulations Staff Inestigator<"

20



Research Staff Inestigators )ust -e a Principal or Co!Inestigator on at least one NCI approed peer!reieed and funded research!pro'ect aard and should pla% a special role in helping the center achieescientific o-'ecties -e%ond those of their on indiidual research"

Clinical Staff Inestigators should -e instru)ental in the deelop)ent and i)ple)entation of the

centerFs clinical actiit% including authorship of clinical trials accrual of patients on interentionaltrials and leadership role in NCI National Clinical Trials NetorA studies"

Special Populations Staff Inestigators )ust hae a tracA record of NCI approed peer!reieedresearch focused on )inorit% and other special and undersered populations and should hae a specialrole in adancing center research that focuses on cancer issues for )inorit% and other special orundersered populations"

Prepare an oerall description for the co)ponent and a consolidated -udget" Identif% each StaffInestigator -% na)e and t%pe" There is no li)it on the nu)-er of Staff Inestigators -ut choicesshould -e )ade 'udiciousl% and 'ustified -% the description of duties" The CCSG guidelines do not prohi-it )e)-ers ith other official roles in the Center fro) receiing additional support as a Staff

Inestigator -ut responsi-ilities for each role should -e clearl% distinguished" Proide a separatenarratie 'ustification ith a description of duties and a -iographical sAetch for each Staff Inestigator proposed and clarif% ho %our selection ill ena-le the center to )eet oerarching scientific and>orclinical o-'ecties" (dditional infor)ation ;e.g. for Research Staff Inestigators and SpecialPopulations Staff Inestigators their research tracA record and a list of peer reieed grants on hichthe% sere as Principal or Co!Inestigator for Clinical Staff Inestigators a list of authored trials etc"<should also -e proided"

Su-se.uent applications should proide infor)ation on acco)plish)ents of Staff Inestigators fundedin prior c%cles"

The following review criteria apply to the developmental funds component 'merit descriptor(:

• 9o effectie has the center -een in using deelop)ental funds to strengthen cancer related

science in the prior pro'ect period ia deelop)ent of ne shared resources recruit)ent of neinestigators interi) salar% and research support pilot pro'ects purchase of shared resourceserices or funding of staff inestigatorsL

• 9o effectie has the center -een in using internal and e#ternal adisor% -odies to assist in

identif%ing scientific opportunities and needs appropriate for the inest)ent of deelop)entalfunds ;deelop)ent of ne shared resources and areas of recruit)ent<L

• 9o appropriate are plans for use of funds and are the% tied to adance)ent of center strategic

goalsL

?.> Cancer Center Administration: 5imit of twelve pages. Proide a description -udget and narratie 'ustification" Include the costs necessar% for central ad)inistration of resources and serices re.uired for center research actiities fiscal )anage)ent of the center and reporting actiities" +ecausead)inistratie structures differ fro) center to center carefull% e#plain and 'ustif% re.uested support"

The CCSG central ad)inistratie -udget )a% support an appropriate percentage of the salar% of thechief ad)inistrator secretarial and other staff trael needs of senior leaders and Progra) leaders in the

21



perfor)ance of their center!specific roles and supplies for the ad)inistratie functions of the center"unding for a percentage of salar% for a staff person to support linAs ith state health depart)ents otherstate agencies or the Centers for Disease Control and Preention ;CDC< also is alloa-le" Partial salar%support for a center infor)atics lead to further NCIFs goals of increased interopera-ilit% -oth ithin theCenterFs e#isting infor)atics s%ste)s and orAflos and -eteen those s%ste)s and NCI infor)atics

s%ste)s )a% -e included as ell"

$#a)ples of non!alloa-le costs include non!research educational actiities pu-lic relations fund!raising and general grant application and )anuscript preparation" &atri# centers should notduplicate parent institution responsi-ilities ;i.e." serices nor)all% supported through indirectcosts or proided -% the institution to other co)para-le research units such as acade)icdepart)ents<"

=hile organi@ational structures and functions ar% %our application should descri-e as appropriateE

• Sources of funding for actiities of the ad)inistratie office including the CCSG"

• Mualifications of ad)inistratie staff and their roles in goernance and decision!)aAing

processes at the center"

• Relationship of the center ;e.g. leel of support oerlap of functions and authorities< to other

offices ithin the parent institution such as the central grants office and clinical and other pertinent entities"

• Roles of center ad)inistration in CCSG!related actiities for e#a)pleE

- Oersight and )anage)ent of shared resources hether center or institutionall% )anaged

e.g. prioriti@ation processes prices charge-acAs auditing user satisfaction )easures and.ualit% control"

- acult% recruit)ent retention and tenure>pro)otion actiities"

- &anage)ent of )e)-ership processes"

- Processes for solicitation receipt reie aard and )onitoring of pilot pro'ects"

- Space )anage)ent including policies on assign)ent and retention"

- (rranging and docu)enting center )eetings"

- &anage)ent of philanthropic and other funds"

- +udgeting accounting and e#penditure )onitoring"

- Oersight of actiities releant to the CCSG grant application process"

• or consortiu) centers ho CCSG functions are coordinated across the partner institutions"


• 9o .ualified are ad)inistratie staff )e)-ers for their rolesL

• (s applica-le ho effectie is the ad)inistration inE

- Oersight and )anage)ent of shared resources ;hether center or institutionall% )anaged<L

22



- +udget accounting and e#penditure )onitoring processes including )anage)ent of

philanthropic and other funding strea)sL

- acult% recruit)ent and retention processes including those related to pro)otion and tenureL

- (rranging and docu)enting )eetings organi@ed -% the centerL

- &anage)ent of processes related to pilot pro'ect solicitation reie and aardL

- &anage)ent of )e)-ership processesL

- Representing the center ith institutional offices including the central grants office and

clinical and other pertinent entitiesL

• or consortiu) centers ho effectie are )echanis)s to ensure efficient ad)inistration of

CCSG functions across institutionsL

B. Research Programs: 5imit of ! pages per Program

B.9 #oals: Cancer Centers foster cancer!focused research in part through the creation of for)al

scientific Research Progra)s" In the conte#t of the CCSG a Progra) co)prises the actiities of a groupof inestigators ho share co))on scientific interests and goals and participate in co)petitiel% fundedresearch" Progra)s are highl% interactie and lead to e#change of infor)ation e#peri)ental techni.uesand ideas that enhance the indiidual productiit% of scientists and often result in colla-orations and 'oint pu-lications" lti)atel% the success of Progra)s is )easured -% scientific e#cellence and thee)ergence of productie colla-orations" 9o this is achieed ill ar% ith the center and the needs of particular Progra)s there is no proscri-ed set or -alance of actiities for acco)plishing theseo-'ecties" or)al or infor)al planning )eetings se)inars and retreats deelop)ental funding ofselected pilot pro'ects ne shared resources or Ae% recruit)ents )a% -e effectie a%s of pro)otingincreasing leels of interaction"

B.7 Selection of members of a centerFs Progra)s is one of the )ost critical decisions )ade -%leadership" unctional and productie Progra)s select indiiduals for their scientific e#cellence and 'ustas i)portantl% for their co))it)ent to orA together to further the scientific goals of the cancer center"So)e Progra) )e)-ers )a% not hold peer!reieed grants -ut contri-ute to the research o-'ecties ofthe center in other i)portant a%s ;e.g. deelop)ent and i)ple)entation of centerFs clinical actiit%including authorship of clinical protocols accrual of patients on interentional trials and leadershiproles in NCI National Clinical Trials NetorA studies< and these contri-utions should -e recogni@ed"

&an% Progra)s in cancer centers inole sustained colla-orations ith scientists ho clearl% strengthenand enhance alue!added interactions and the scientific productiit% of the research -ut ho hae nofor)al appoint)ent ithin the institutions that co)prise the cancer center" Colla-orators fro) other

NCI! designated Cancer Centers or research institutions )a% -eco)e center and Progra) )e)-ers"=hile the funded research pro'ects of these )e)-ers cannot count toard the funding -ase of the Pro!gra) these )e)-ers )a% hae full access to shared resources and deelop)ental funds"

B. Characteristics of Programs: Progra)s should -e of ade.uate si@e and scientific .ualit% shoulde#hi-it a high degree of interaction and should -e capa-l% led" ( Progra) )ust hae at least three peer!reieed and funded research pro'ects ;e.g. R01 R21 01 300< fro) a )ini)u) of 3separate independent Principal Inestigators to -e eligi-le hoeer successful progra)s su-stantiall%

23



e#ceed this )ini)u)" Peer!reieed funded research su-!pro'ects of larger grants ;e.g. P01s P,0s< -ut not shared resources )a% -e counted as separate pro'ects"

The interactie attri-utes of a Progra) are docu)ented -% colla-oratie research pro'ects 'oint pu-lications collo.uia 'oint se)inar series and other eidence of )eaningful interchange that ce)entinteractions around related or co))on goals" (gain the t%pe and -alance of actiities ill ar% fro)center to center" In addition effectie scientific leadership ith a histor% of cancer!related fundingappropriate to the nature of the Progra) proides intellectual sti)ulation cohesion focus anddirection"

B.$ -efinition of PeerReviewed )unded Research Pro3ects for Inclusion in Programs and for

-esignation of sers in "hared Resources: Peer reie as e)plo%ed -% the NI9 is the accepta-lestandard for inclusion of a cancer!related research pro'ect ithin a for)al Progra)" $ligi-le peer!reieed grants and contracts including those for)all% aarded to indiidual or )ultiple inestigatorsare as follosE

• Research grants cooperatie agree)ents and research contracts fro) the NCI including all

aards ith the folloing prefi#esE R00 R01 R03 R1, R14 R21 R2* R2, R33 R3/ R*1R*2 R*3 R** R,, R,8 P01and P,0 su-!pro'ects P20 SC1 SC2 01 10 15 ,*,8 N01 research contracts and peer!reieed funded su-contracts of center )e)-ers participating in colla-oratie research" ;NoteE Shared resources of )ulti!co)ponent grants arenot eligi-le for inclusion<

• Co)ponents of NCI National Clinical Trials NetorAs ;e.g. 10s 15s<

• Indiidual research studies inoling protocols approed -% the NCI Cancer Therap% $aluation

Progra) ;CT$P< and funded -% NCI"

• Indiidual research studies inoling preention and control protocols approed -% the NCI

Cancer Control Protocol Reie Co))ittee and funded -% NCI"• (arded cancer!related research grants cooperatie agree)ents and research contracts fro)

other institutes of the NI9 ;sa)e prefi#es as a-oe<"

or descriptions of specific NI9 funding )echanis)s see httpE>>grants"nih"go>grants>funding>acsearchresults"ht)" Peer!reieed cancer!related support fro)a nu)-er of other NCI progra)!approed funding organi@ations can -e included" (n updated list ofapproed organi@ations is aaila-le at httpE>>cancercenters"cancer"go>docu)ents>fundorg"pdf .

B.> )ormatting )or +ach Program "ection: 5imit of ! pages per Program on average e#cludingtitle page -iosAetches -udget -udget 'ustification and lists of funded pro'ects clinical trials and pu-lications" Centers that include )ost or all clinical research in one Progra) )a% e#ceed the page

li)itation for this Progra) onl%" or each Progra) please proide the folloingE

Title page of the Program ith the na)e;s< of the Progra) leader;s< and the Progra) code ;used inSu))aries 1 and 2 of the Standard Cancer Center Infor)ation Su))aries<"

A description of the Program using page 2 of the P9S or) 354 ;re" 08>05< includingE

• The central the)es and scientific goals of the Progra)"

2*

http://grants.nih.gov/grants/funding/ac_search_results.htm







• The nu)-er of Progra) )e)-ers and the nu)-er of depart)ents and schools represented"

• The NCI and other peer reieed cancer!related support for the last -udget %ear"

• The total nu)-er of pu-lications and the percentage of intra!progra))atic and inter!

progra))atic pu-lications in the last grant period"

A budget for the percent effort of the first and future %ears for the Progra) leader;s< using the standard -udget pages proided in the P9S or) 354 ;re" 08>05<" ( leel of effort )ust -e included for eachProgra) leader een if salar% is not re.uested" Indicate if salaries )eet or e#ceed the NI9 salar% cap"Progra)s )a% also re.uest )odest funding for support of scientific actiities directl% releant toProgra) goals such as s)all pilot pro'ects se)inar speaAers etc"

A budget narrative 3ustification descri-ing the specific role of each Progra) leader;s< in facilitatingthe discoer% process and pro)oting transdisciplinar% research i)portant to cancer and an% pro'ecteduse of funds to support other scientific actiities"

4iographical setches of Progra) leaders;s< se the P9S or) 354 ;re" 08>05<"

A list of the e,ternally funded cancerrelated research pro3ects 'no page limit( of the Progra)separated into to categoriesE Jpeer!reieedK and Jnon peer reieedK -% )e)-er pro'ect andfunding source using the for)at descri-ed for Su))ar% 2(" Progra) leaders should e#clude grants fo!cusing on other diseases ;e.g. dia-etes cardiolog% neurological disease< or address their cancerreleance in the progra))atic narratie"

The members of the Program in alpha-etical order ith their depart)ental and institutional af!filiation their acade)ic ranA ;or e.uialent< and their role in the Progra) ;e.g. research deelop)entand i)ple)entation of the centerFs clinical actiit% including authorship of clinical trials accrual of patients to interentional trials and leadership roles in NCI National Clinical Trials NetorA studies<"Infor)ation on the latter is especiall% i)portant for assess)ent of the transdisciplinar% nature of theProgra) integration of )e)-er actiities and contri-ution of )e)-ers to progra))atic goals"

The scientific goals of the Program and a%s in hich the interests e#pertise and research approachof the Progra) )e)-ers facilitate their achiee)ent"

The most significant scientific accomplishments of the Program ithin the last full pro'ect periodthe effect of those acco)plish)ents and the a%s in hich the% ere facilitated -% the Center" ;NoteEColor photos releant to scientific acco)plish)ents should -e included in the appendices"<

As appropriate how the Program addresses cancer research problems in its catchment area inaddition to .uestions of -roader applica-ilit%"

)or clinical and translational Programs:

• Discuss the potential i)portance of the interentional clinical trials in deelop)ent and

actiated including those sponsored -% the National Clinical Trials NetorA ;NCTN< other peer!reieed funding )echanis)s the institution and industr%"

• Descri-e ho research is coordinated across translational and clinical funding )echanis)s fro)

NCI ;e.g. grants for SPOR$s Phase I>II consortia progra) pro'ects and NCTN< and other

2,



sources"

• Discuss colla-oratie arrange)ents ith additional partners such as other institutions or

industr% that facilitate transition of scientific findings deeloped -% Progra) inestigatorsthrough the translational continuu)"

•

Descri-e the feasi-ilit% and earl% phase inestigator initiated trials that capitali@e on thescientific strengths of the Progra) and plans for )oing findings forard to peer!reieed orother )echanis)s here appropriate"

• Descri-e an% leadership roles in NCTN trials appropriate to the Progra)Fs scientific agenda"

• Proide a list of the clinical research of the Progra) using the definitions and for)at specified in

the instructions for Su))ar% *"

"hared resources and other services used -% progra) )e)-ers"

Intra and inter Programmatic activity ;e.g. )eetings se)inars )ulti!inestigator grants and pu-lications retreats and orAing groups< and other significant colla-orations ith inestigators

outside of the center"

The total number of Program publications and the percent that are intra! and inter!progra))aticand>or colla-oratie ith inestigators in other institutions" Report this infor)ation in the Progra)description" Pu-lications should represent the -road diersit% of Progra) )e)-ers"

A selected list of Programrelated publications 'no page limit( fro) the last pro'ect period" Includeonl% those that hae )ade an i)portant scientific contri-ution had a significant effect for patients andthe pu-lic or particularl% illustrate intra! and inter!progra))atic or other )ulti!institutionalcolla-orations"


• =hat is the oerall scientific .ualit% of the Progra)L

• =hat is the e#tent of cancer focus in the peer!reieed research -aseL

• 9o successful is the Progra) in fostering productie transdisciplinar% and>or translational

research colla-oration a)ong its )e)-ers ith )e)-ers of other progra)s and ith othere#ternal partnersL

• =hat is the eidence that the Progra) is appropriatel% addressing cancer scientific issues

applica-le to its catch)ent area ;in addition to research .uestions of -road applica-ilit%<L

• =hat is the alue added -% the Center to progra))atic efforts in ter)s of shared resources and

other sericesL

• 9o appropriate and effectie are the Progra) 6eaders in relation to e#pertise progra)

)anage)ent and ti)e co))it)entL

• or clinical and translational Progra)s

- =hat is the potential i)portance of the portfolio of interentional trials in deelop)ent and

actiatedL28



- =hat is the eidence that research is coordinated across clinical funding )echanis)s of the

NCI and other funding agencies and>or )oed through the translational continuu) iacolla-orations ith industr% or other partnersL

- 9o do feasi-ilit% and other earl% phase trials capitali@e on the scientific strengths of the

Progra) and hat is their potential i)portanceL

- Is the Progra) participating in accrual to and leadership of NCTN trials appropriate to its

scientific agendaL

- 9o reasona-le is oerall accrual to actiated trialsL

• or consortiu) centersE

- =hat is the eidence for integration of )e)-ers fro) all institutions into scientific Progra)s

and leadership positionsL

- =hat is the eidence that research is integrated across all partner institutions representedL

. "hared Resources: 5imit of twelve pages per resource.

.9 #oals: Shared Resources proide access to speciali@ed technologies serices and e#pertise thatenhance scientific interaction and productiit%" The support of centrali@ed shared serices for centerinestigators is intended to ensure greater sta-ilit% relia-ilit% cost!effectieness and .ualit% control"

The pri)ar% -eneficiaries of CCSG!supported shared resources and serices should -e cancer center)e)-ers ith peer!reieed funded pro'ects a standard assuring funds support high!.ualit% research"Support to others is at the discretion of the center director and should -e 'ustified -% contri-utions to theoerall cancer research o-'ecties of the center ;e.g. access -% a 'unior inestigator funded -% a pilot pro'ect<"

.7 4udgets: Cancer centers )a% use CCSG funding to support )e)-erFs access to eitherinstitutionall%! or cancer center!)anaged shared resources including those integrated through )ultiple NI9 funding sources such as Clinical and Translational Science (ards" CCSG funding should not -eused to esta-lish independent center!)anaged shared resources that duplicate institutionall% )anagedresources if the latter proide cost effectie accessi-le and .ualit% serices" It should also not -e usedto support shared resources that are offered free of charge to other inestigators" If proposed or e#istinginstitutional shared resources are not structured to )eet cancer center needs separate shared resources)a% -e supported through the CCSG -ut )ust -e rigorousl% 'ustified" CCSG funding for an% sharedresource should -e proportional to use -% inestigators ithin the cancer center that hae cancer!related peer!reieed funding"

The CCSG proides sta-ilit% for so)e of the operating costs associated ith salar% of Ae% personnel

operating centrali@ed shared resources and serices s)all e.uip)ent )aintenance contracts sericecontracts and )ini)al supplies" Replace)ent of s)all e.uip)ent ;less than 2,000< also is alloa-le"Other Jaria-leK costs associated ith specific research pro'ects should -e supported -% other fundingsources e.g. user fees charge-acAs institutional funds"

No standard approach applies to all shared resources and serices" NCI recogni@es that irtuall% allshared resources derie a portion of their operating costs fro) )ultiple sources" Centers should 'ustif%the proportion of funding alloca-le to the CCSG in the conte#t of this oerall support" The scope of the

2/



-udget re.uest should -e reflectie of use of the shared resource -% cancer center )e)-ers ith peerreieed funding"

The pri)ar% costs of research are supported -% the peer!reieed funded grants and research contractsof the center" Consider the ele)ents listed -elo in deeloping budgets for shared resources and sericesas the% ill -e factors in peer ealuation of the -udgetE

• Need for the resource relatie to current and pro'ected use -% peer!reieed funded center

)e)-ers"

• Cost!efficienc% particularl% in co)parison to other options ;e.g. purchase orders or contracts to

an outside endor<"

• Sta-ilit% of the operation and .ualit% of the serice"

• (ccessi-ilit% of the resource or serice to .ualified )e)-er!inestigators including the critical

consultatie serices perfor)ed -% e#perts ho direct selected shared resources such as -iostatistics and infor)atics"

• Proportion of the total resource operation paid for -% the CCSG relatie to other sources"

. )ormatting for +ach "hared Resource "ection: Prepare a description -udget and narratie 'ustifications for each resource"

Present all shared resources critical to the clinical research needs of the center ;e.g. -iostatistics< first sothe% can -e reieed in se.uence ith the JClinical Protocol and Data &anage)ent OfficeK JProtocolReie and &onitoring S%ste)K and J$arl% Phase Clinical Research Support"K"

In the narratie for each shared resource descri-e theE

• &a'or serices technologies e.uip)ent and e#pertise proided and their i)portance to the

scientific needs and o-'ecties of the center ;i.e. ho the shared resources support the researchof the Progra)s<"

• &anage)ent structure i.e. -% the center institution or other entit%"

• Cost!effectieness of the resource relatie to other options for o-taining the serice such as

outside endors hen applica-le"

• Mualifications of the shared resource director;s< and the co)petence of Ae% technical staff

include a -iosAetch of the resource director;s< and )anager;s<"

• Processes releant to facilit% planning and oersight"

• Current or anticipated use of serices proiding total nu)-er of users total nu)-er and percentof users ho are center )e)-ers ith peer reieed support and total nu)-er and percentithout peer!reieed support" Do not provide a list of users.

• Policies on operation and use of the shared resource e.g. access priorities hours of operation

staffing etc" and charge -acA s%ste)s" or institutionall% )anaged ;as opposed to cancer center )anaged< resources descri-e the centerFs role in planning and oersight of the sharedresource;s<"

24



The re.uested -udget should reflect realistic needs in ter)s of support fro) other sources ;e.g.institutional or cancer center support or recoer% fro) charge-acAs< and an% other specific additionalre.uire)ents" Proide the folloing infor)ation for the )ost current grant %ear and for the proposed period of support"

Inco)e Source CurrentSupport ;< Percent ofCurrent Total+udget

ProposedSupport ! Hear 1 ;< Percent ofProposed Total+udget

CCSG

ee for Serice>Charge-acAs

Other

Total Operating +udget

.$ Issues Regarding "pecific "hared Resources

( center has the fle#i-ilit% to propose the functions that it ishes to hae funded as shared resources"Pri)ar% consideration should -e gien to resources that are critical to a centerFs research )ission"(dditional factors )a% include the needs of past and potential ne users accessi-ilit% to cancer center)e)-ers and the effectieness and fairness of the process for setting scientific priorities for their use"=hile shared resources should neer -e esta-lished for pri)ar% use -% one or to )e)-ers thea-solute nu)-er of users )a% -e of lesser i)portance than the alue of the resource to the science of thecenter" So)e technicall% sophisticated or uni.ue resources ;e.g. #!ra% cr%stallograph% preparation ofclinical grade gene therap% ectors proteo)ics fa)il% ascertain)ent health co))unication tracAingnutrition support< are not ala%s adapta-le to high!olu)e operation or )a% hae onl% a fe er%speciali@ed users or -e used -% onl% one Progra) ;e.g. population science<" Charge-acAs )a% not -ereleant for resources such as -ioinfor)atics -iostatistics and other consultatie serices not t%picall%

charged to grant )echanis)s"

Informatics: In cancer centers infor)atics e#pertise and resources are critical shared resourcefunctions" The CCSG )a% support applications of infor)atics directed toard cancer research ;e.g. theac.uisition )aintenance and integration of data-ase s%ste)s for clinical trials or studies in populationsdata e#traction storage and anal%sis tools for geno)ics proteo)ics or )olecular structure a data-aseannotating a research repositor% inoling hu)an speci)ens and tools that ena-le sharing of data setsith colla-orating inestigators in related areas of research<" Perfor)ance of specific research functionssuch as data entr% for indiidual research pro'ects or clinical trials is e#cluded" (s the interopera-ilit% of independentl% deeloped infor)atics s%ste)s is an i)portant goal of the research co))unit%infor)atics deelop)ent efforts supported -% CCSG funds )ust co)pl% ith eoling standards

articulated -% the NCI the scientific co))unit% and other standard!setting organi@ations in the )edicaland -ioinfor)atics areas"

4iostatistics: +iostatistics is a shared resource central to the )ission of )ost centers particularl% thosethat perfor) clinical or population research" Participation -% statisticians in )an% colla-oratie actiitiesof the cancer center is eligi-le for CCSG support" Salar% support is alloa-le for participation in cancer!center pilot pro'ects assistance to center inestigators in conceptuali@ing and deeloping research pro'ects anal%ses for pu-lication and the deelop)ent of )ethodolog% clearl% and closel% related to the

25



support of specific pro'ects ithin the cancer center" The CCSG is not intended to supportE 1<independent inestigator!initiated research in statistical )ethodolog% for hich statisticians liAe otherscientists should -e supported -% pro'ect!specific grants or 2< a significant colla-oratie role for astatistician on a funded research pro'ect since the this effort ould nor)all% -e supported -% anappropriate ti)e!and!effort allocation as a colla-orator on that grant"

The following review criteria apply to all shared resources presented in this component 'merit

descriptor(:

• To hat e#tent is the resource strategic to the scientific goals of the center and its research

Progra)sL

• =hat is the .ualit% of the science that the resource supportsL

• =hat is the .ualit% accessi-ilit% and cost efficienc% of the serice proided for all )e)-ersL

• =here releant does the resource co)pl% ith NCI national or international standardsL

• If an institutional shared resource to hat e#tent does the cancer center participate in planning

and oersightL

• 9o appropriate are the .ualifications of staff and their ti)e co))it)entL

9!. Clinical Protocol and -ata 2anagement 'CP-2( DClinical Trials 0ffice 'not a shared

resource(:5imit of twelve pages

Proide a description -udget and narratie 'ustification" This co)ponent proides central )anage)entand oersight functions for coordinating facilitating and reporting on the cancer clinical trials of theinstitution;s< that define the center hateer the stud% origin ;local industrial NCI National ClinicalTrials NetorA or other<" (s a tool for )anage)ent of a centerFs clinical research progra) itco)ple)ents the Protocol Reie and &onitoring S%ste)" It also proides a central location for cancer

protocols a centrali@ed data-ase of protocol!specific data an updated list of currentl% actie protocolsfor use -% center inestigators and status reports of protocols" Mualit% control functions )ight includecentrali@ed education and training serices for data )anagers and nurses and data auditing for trialco)pliance data and safet% )onitoring data accurac% and accrual tracAing"

In addition this co)ponent also )a% supportE

• Staff to assist in anal%sis and reengineering of protocol preparation and reision and trial

actiation processes"

• Trial deelop)ent )anagers hose pri)ar% responsi-ilit% is tracAing and )anaging of protocols

in deelop)ent to assure ti)el% co)pletion of all re.uired actiities"

• Ph%sician protocol officers ith pri)ar% responsi-ilit% for asse)-ling scientific and clinical

protocol content and coordination and resolution of unresoled scientific and clinical issues in protocol reision"

• Other staff positions that speed protocol preparation reision and actiation including those

that focus on acceleration>facilitation of colla-oratie clinical trial actiities crossing )ultiple

30



cancer centers or NCI!funded )echanis)s ;e.g. SPOR$s National Clinical Trials NetorAetc"<"

• ( partial staff position in the uniersit% legal and>or contracting office ith the funded ti)e to

-e deoted e#clusiel% to negotiating Cancer Center clinical trial agree)ents"

• Staff ith responsi-ilities releant to data su-)issions for the NCI Clinical Trials ReportingProgra)"

The CCSG allos funding for oersight and .ualit% control for the centerFs entire clinical trials effortbut does not include tasks involved in the actual direct conduct of individual trials (such as data entry"Therefore the CCSG re.uest for this resource should not duplicate replace or )aAe up for reductionsin funding proided through the indiidual grants and contracts supporting the studies"

Proide an oerie of accrual to interentional clinical trials oer the fie!%ear pro'ect period preceding the co)peting reneal application" ;This is a su))ar% of Standard Cancer Center Su))ar%* data and the definitions and reporting %ears used in Su))ar% * appl% to the data in this ta-le"< (sa)ple te)plate is -eloE

Accrual to InterventionalE Therapeutic and 0ther Interventional Clinical

Protocols 4y Reporting Fear 'mmDyyyy(E

Reporting Hear ;specif%<

National Group

$#ternal Peer Reie

Institutional ;inestigator initiated<

Industr%

Total (ccrual to InterentionalClinical Protocols

ECenters )a% proide data on accrual to non!interentional clinical studies in a si)ilar for)at if desired"

In addition to the a-oe Data and Safet% &onitoring ;DS&< should -e addressed in this section" DS& isre.uired for all t%pes of clinical trials including ph%siologic to#icit% and dose!finding studies ;Phase I<efficac% studies ;Phase II< efficac% effectieness and co)paratie trials ;Phase III<" &onitoring should -e co))ensurate ith risA" The esta-lish)ent of data and safet% )onitoring -oards ;DS&+s< isre.uired for )ulti!site clinical trials inoling interentions that entail potential risAs to the participants;JNI9 Polic% for Data and Safet% &onitoringK !"# $uide for $rants and %ontractshttpE>>grants"nih"go>grants>guide>notice!files>not54!04*"ht)l<"

DS& functions are distinct and should not -e the direct responsi-ilit% of the Protocol Reie and

&onitoring S%ste) ;PR&S< hich oersees scientific aspects of cancer clinical trials" Do not )ergethese actiities and co))ittees"

+% NI9 reie criteria the peer reieers ill -e responsi-le for deter)ining hether the DS& plan isaccepta-le or unaccepta-le" Peers are e#pected to define the eaAnesses of an unaccepta-le DS& planand to reflect an% eaAnesses in the i)pact>priorit% score" The final approal of a DS& plan in itsoriginal for) or later )odified for) is the responsi-ilit% of the staff of the OCC"

31

http://grants.nih.gov/grants/guide/notice-files/not98-084.html

http://grants.nih.gov/grants/guide/notice-files/not98-084.html



Proide a er% -rief su))ar% of the CenterFs DS& plan" Do not include the entire plan ithin the te#t -ut proide a cop% at the site isit"

NoteE Reie of the DS& plan -% peers is an NI9 re.uire)ent separate fro) and unrelated to theseparate reie and approal of the plan -% NCI progra) staff"

If funding is re.uested for staffing related to DS& actiities proide a separate -udget and 'ustification pages and include in the narratie a su))ar% description ofE

• The DS& process and orAload releant to inestigator!initiated studies and studies supported

on co)petitie grants including ealuation auditing and )onitoring of patient safet% -ased on phase leel of risA or other pertinent factors" Do not include DS& actiities directl% supportedon other grants and contracts"

• The co))ittees inoled in DS& processes and the -iographical sAetches of the )e)-ers of

these co))ittees"

( sche)atic diagra) illustrating the relationship -eteen the CPD& and the DS& and PR&S

co))ittees )a% -e helpful to clarif% their roles and functions"

The following review criteria apply to the CP-2 'merit descriptor(

• 9o effectie is CPD& in centrali@ing )anaging and reporting on the cancer clinical trials of

the centerL

• To hat e#tent does CPD& help to assure ti)el% initiation and co)pletion of clinical trial

actiitiesL

• 9o effectie are the .ualit% control functions and training serices offered -% the CPD&L

• 9o reasona-le is oerall accrual -ased on the nature>t%pe of the indiidual trials supportedL

The following review criteria apply to the -"2 'acceptableDunacceptable(:

• 9o ade.uate is the DS& plan in defining the oerall structure of the )onitoring entit% and the

)echanis)s for reporting aderse eentsL

• or centers re.uesting funds for i)ple)entation of DS& functionsE

- 9o appropriate oerall are DS& processes and orAload in relation to actiities associated

ith the ealuation auditing and )onitoring of different t%pes clinical research studies ;notthe specific ealuation of a particular stud% or stud% audit<L

- 9o ade.uate is the e#pertise of indiiduals sering on Ae% co))ittees that perfor) DS&

functionsL

• or consortiu) centers is there a single DS& plan goerning all cancer clinical trials across

partner institutionsL

99. Protocol Review & 2onitoring "ystem 'PR2"(E 5imit of ten pages e,clusive of protocol listing.

Proide a description -udget and narratie 'ustification" ( particularl% i)portant function for centersinoled in clinical research is a )echanis) for assuring ade.uate internal oersight of the scientificaspects of all the cancer clinical trials in the institution or institutions that for)all% co)prise the center

32



;i.e. consortiu) centers should docu)ent that all protocols are reieed through a central PR&S<" Thisfunction is co)ple)entar% to that of an Institutional Reie +oard ;IR+< hich focuses on the protection of hu)an su-'ects"

The PR&S is not intended to duplicate or oerlap ith the responsi-ilities of the IR+" (uditing for.ualit% control or safet% reasons is not a function of the PR&S" DS& co))ittee functions and PR&Sco))ittee functions are separate and distinct fro) one another and should not oerlap" The focus of thePR&S is on scientific merit& priorities& and progress of the clinical protocol research of the center" ThePR&S should hae the authorit% to open protocols that )eet the scientific )erit and scientific prioritiesof the center and to close protocols that do not de)onstrate scientific progress ;an e#ception )a% -etrials of rare diseases hich often do not accrue rapidl%<" PR&S ealuations do not include .ualit%control concerns unless the pro-le) is so serious as to )aAe the results of the protocols )eaningless"

The PR&S scientificall% ealuates and prioriti@es all cancer center trials deried and supported fro)institutional sources or fro) industr%" 9oeer the PR&SE

• Should not duplicate traditional peer reie hich includes peer!reieed protocols supported

-% the arious NI9 )echanis)s ;e.g. R0ls 0ls 10s P0ls and P,0s etc"< other approedfunding agencies ;httpE>>cancercenters"cancer"go>docu)ents>fundorg"pdf < and clinical research protocols approed -% the NCIFs Cancer Therap% $aluation Progra) or the Cancer ControlProtocol Reie Co))ittee" These protocols receie an e#pedited ad)inistratie reie for the purpose of prioriti@ation onl%"

• Is not re.uired to ealuate or prioriti@e studies dealing ith health% hu)an su-'ects and the

population sciences e.g. o-serational and epide)iologic studies"

(ll trials approed -% the PR&S for )erit hether ia full or ad)inistratie reie hae access toCCSG!supported centrali@ed resources such as infor)atics -iostatistics and clinical protocol and data)anage)ent"

The PR&S )a% elect to perfor) a 2!stage reie in hich institutional concepts ithout a full protocol are first reieed for scientific )erit" Concepts approed in this stage are then sent forardfor full protocol deelop)ent" Reie of the protocol itself ould occur as the second stage" The ai)sof this 2!stage reie are to reduce staff effort in deeloping protocols of lesser scientific )erit and theti)efra)e fro) concept approal to protocol actiation"

4udget and @ustification" The -udget )a% include appropriate personnel ad)inistratie supporte.uip)ent appropriate to the tasA and supplies"

-escribe the criteria for selection of the membership of the committee. 6ist the )e)-ers of theco))ittee and their e#pertise" The -iographical sAetches of these indiiduals should -e included at the

end of this section" Scientific e#pertise fro) -asic la-orator%E clinicalE preentionE cancer control and population!-ased science should -e represented on the PR&S co))ittee" =hile there )a% -e )ini)aloerlap co))ittee representation should not duplicate that of the DS& Co))ittee and the sa)eindiidual should not chair or hae superisor% responsi-ilit% oer -oth co))ittees"

-escribe the procedures for scientific review and scientific monitoring of cancer clinical trial protocols including the criteria and process for su-)ission of institutional clinical trial protocols to theco))ittee for reie and approal the process for reie of all cancer clinical research protocols of the

33





institution the reie criteria that are used to assess scientific rationale stud% design e#pected accrualrates -iostatistical input and feasi-ilit% for co)pletion ithin a reasona-le ti)e period and the criteriaused for )onitoring ongoing institutional protocol research to ealuate scientific progress includingaccrual rates to ensure that the scientific ai)s of the stud% can -e co)pleted"

-escribe the process and criteria used for prioriti1ing the actiation of cancer clinical trial protocolsat the institution ith respect to scientific )erit and patient aaila-ilit%" Descri-e the input if an% ofdisease focused groups to the prioriti@ation process" Clarif% hether a one or to stage reie ;e.g. protocol onl% or concept then protocol< is conducted at the PR&S leel and proide a prioriti@ationsche)a"

-iscuss the metrics used by the committee to assess the efficiency and timeliness of their activities "

-escribe the process criteria and authority for terminating a clinical protocol " Discuss hether theco))ittee has ter)inated an% protocols and for hat reason"

-escribe PR2" operations relative to the IR4 approal process ith e)phasis on theco)ple)entaril% of the to entities and a-sence of oerlap or duplication"

If a consortium center discuss how the PR2" process is governed across the partner institutions.

Provide a subset of data from "ummary $ Clinical Research Protocol Information that includes all

institutional protocols ;i.e. studies that hae not receied e#ternal reie< reieed -% the PR&S forscientific )erit or actiel% )onitored for scientific progress in a recent 12!)onth period ;Grant %ear:anuar% to Dece)-er Qpreferred for)at or :ul% through :une<" (dd a colu)n to the ta-le to indicatehich protocols hae -een approed and actiated approed -ut not %et actiated deferred for reisiondisapproed or closed" ;or the last colu)n %ou )a% use a coding s%ste) e.g. 1 for approed andactiated 2 for approed -ut not %et actiated 3 for deferred * for disapproed and , for closed<

NoteE In a consortiu) center the ta-le should include protocols fro) all partner institutions"

NCI ill re.uest a sa)ple fro) the list for detailed reie prior to the site isit" Do not include orappend protocols to the CCSG application"

In addition proide infor)ation for the )ost recent 3 %ear period ;Grant %ear :anuar% to Dece)-erQpreferred for)at or :ul% through :une< on the nu)-er of trials reieed or prioriti@ed -% sponsor"

( sa)ple te)plate is -eloE

Total *umber of Protocols Reviewed or Prioriti1ed by "ponsor

3*



'for most recent years of activity(

Hear ;Specif% ))>%%%%!

))>%%%%<

National Group Total

$#ternall% Peer!Reieed Total

Institutional Total

Industr% Total

Total Total Total Total

In cases of conditional approal or disapproal of the PR&S the peer reieers ill clarif% in the

Su))ar% State)ent hat steps or changes are needed for full approal along ith an% reco))enda!tions on ti)ing of re!ealuation -% peers"

The following review criteria apply to this component 'approve conditionally approve or

disapprove(:

• 9o appropriate are the co)position of the co))ittee and the .ualifications of its )e)-ers for

ensuring the -readth of e#pertise necessar% to conduct a critical and fair scientific reie of allinstitutional clinical cancer protocolsL

• 9o appropriate are PR&S authorities and processes for initiating )onitoring and ter)inating

all cancer clinical research protocols in the institution;s< co)prising the centerL

• 9o appropriate are the criteria and processes for scientific reie taAing into account the

rationale and stud% design potential duplication of studies elsehere ade.uac% of -iostatisticalinput and feasi-ilit% for co)pletion ithin a reasona-le ti)eL

• 9o appropriate are processes for ensuring prioriti@ation of co)peting protocols fro) all

sources and opti)al use of the centerFs scientific resourcesL

• 9o ade.uate are the criteria for )onitoring trials to ensure the% are )aAing sufficient scientific

progressL

• (re the criteria and process for ter)inating trials that do not )eet scientific goals ;trials

inoling rare diseases are e#cluded< ade.uate and used appropriatel%L

• 9o ade.uate are )etrics for )oing trials forard through the PR&S s%ste) in a ti)el%

fashionL

• If a consortiu) center is there a single PR&S goerning all cancer clinical trial protocols across

the partner institutionsL

97. +arly Phase Clinical Research "upport '+PCR" formerly Protocol "pecific Research

"upport(: 5imit of $ pages. Proide a description -udget and narratie 'ustification" This CCSG

3,



co)ponent proides support for short ter) pilot and phase I clinical research studies originating fro)scientific inestigators ithin the cancer center" Preli)inar% data generated fro) these studies hichhistoricall% hae -een rarel% funded through other )echanis)s can -e used as the -asis for applicationfor support of later phase studies through co)petitie grants or industr%" Support is not )eant for allearl% phase trials for later phase trials or for studies that do that do not inole testing of an agent or

deice" Center leadership )ust prioriti@e studies for support and oersee these funds" $ligi-ilit% criteriaare as follosE

• These should -e high priorit% innoatie pilot and phase 0 or I institutional clinical studies

focusing on initial earl% phase testing of a candidate agent or deice for the diagnosis preentiondetection or treat)ent of cancer"

• Studies )ust -e conceptuali@ed>designed -% )e)-ers of the centerFs research Progra)s"

• Studies should t%picall% -e of short duration ;e.g. 1!2 %ears<"

• Studies receiing support through other peer!reieed research grants cooperatie agree)ents

or contracts are ineligi-le for support through this )echanis)" Studies )a% receie partial

support fro) industr% assu)ing all other criteria are )et"

• The centerFs PR&S )ust -e approed or conditionall% approed -% peer reie for funding of

studies supported through this co)ponent"

• Supported studies )ust -e approed -% the PR&S"

unding in these pilot and phase I clinical studies is li)ited to support ofE

• Nurses and data )anagers for a pilot ;pre!phase I< or phase I clinical trial

• Costs associated ith generation of preli)inar% data through other earl% phase clinicall% related

actiities for e#a)ple

- Purchase of i)aging ti)e for scans related to earl% phase clinical research

- Support for IND or ID$ applications

- Phar)acod%na)ic studies e.g. use of se.uential or pre! and post! -iopsies or assa%s of

actiit% in peripheral tissues to identif% inestigational agents desering full clinicaldeelop)ent clinical ealuation of structurall% si)ilar analogues directed at the sa)e)olecular target deter)ination of a dosing regi)en for an agent to -e used in co)-inationtherap% or deelop)ent of noel i)aging pro-es that esta-lish )echanis) of action in patient sa)ples or proide functional and )eta-olic infor)ation a-out the effect of a drug onits target"

unds in this co)ponent )a% not -e used for an% superisor% functions"

Proide a listing of all studies supported ith $PCRS funds oer the last pro'ect period ithinestigator na)e pro'ect na)e phase anato)ic site ;if applica-le< duration and outco)e or i)pact;e.g. led to peer!reieed funding for a later phase trial etc"<" Discuss the process used for prioriti@ingstudies for support" Descri-e proposed uses of $PCRS funds for the co)ing pro'ect period ;e.g. areas to -e supported and e#a)ples<" +ase the -udget re.uest on the centerFs actual and pro'ected clinical stud%actiities as ell as on co)ple#it% of these studies"

38



The following review criteria apply to this component:

• 9o ell do the proposed studies co)pl% ith criteria for support outlined a-oeL

• =hat is the .ualit% and innoation of studies proposed for the co)ing pro'ect periodL

• 9o effectie has past CCSG support for this co)ponent -een in ter)s of outco)eL

• 9o appropriate is the prioriti@ation and selection process for use of funds in this co)ponentL

9. Inclusion of 2inorities and =omen in Clinical Trials '*I; Policy(: No )ore than 8 pages intotal ith Inclusion of Children" It is the polic% of the NI9 ;NI9 Reitali@ation (ct of 1553!Section*52+ of Pu-lic 6a 103!*3<that o)en and )e)-ers of )inorit% groups and their su-!populations)ust -e included in all NI9!supported clinical research pro'ects unless a clear and co)pelling 'ustification is proided indicating that inclusion is inappropriate ith respect to the health of thesu-'ects or the purpose of the research" (ll inestigators proposing clinical research should read theNI9 Guidelines for Inclusion of =o)en and &inorities as Su-'ects in Clinical ResearchK;httpE>>grants"nih"go>grants>guide>notice!files>NOT!OD!02!001"ht)l< a co)plete cop% of the updated

Guidelines is aaila-le athttpE>>grants"nih"go>grants>funding>o)en)in>guidelinesa)ended102001"ht)"

In %our application proide clear docu)entation on the accrual of o)en and )inorities into interven'

tional clinical trials" If this section of the application is not approed a grant aard cannot -e issueduntil a correctie plan and ade.uate response to the criti.ue is su-)itted and approed -% NCI"

Reieers ealuating the section of the application on the inclusion of o)en and )inorities in clinicalresearch ill consider separatel% hether the accrual of o)en and )inorities to therapeutic and non!therapeutic trials is proportionate to the cancer patient population in the cancer centers pri)ar%catch)ent area" Thus separate ta-les for accrual in therapeutic and nontherapeutic studies should -eincluded ;accrual to epide)iologic outco)e o-serational and other non!interentional studies should

not -e included in these ta-les<" Reieers ill assess the total picture taAing both therapeutic and non!therapeutic interentional clinical trial accrual into account in relation to approal>disapproal of genderand )inorit% accrual per the current reie criteria in the CCSG Guidelines"

=hen o)en or )inorities are su-stantiall% under!represented the ade.uac% of the institutions policiesspecific actiities and a correctie plan -eco)e especiall% critical in conincing peer reieers that theinstitution is serious a-out addressing the pro-le) and is inesting the appropriate effort to correctunder!accrual" In addition if the population of the catch)ent area of the cancer center has li)ited ethnicdiersit% proide a discussion of the institutionFs efforts to -roaden the ethnic diersit% of its clinicaltrial accrual"

Include the folloing infor)ation in this sectionE

-emographics" Proide su))ar% infor)ation shoing the de)ographics of the pri)ar% geographiccatch)ent area of the center -% ethnic categories and su-categories and -% gender as ell as for thecancer patient population treated at the cancer center" The catch)ent area is defined -% the center -asedon the geographic areas ;cities counties states< fro) here its patient population is dran"

Accrual. Co)plete Parts ( and + of the JInclusion $nroll)ent Report Ta-leK found in the P9S or);re 08>05<" Proide su))ar% accrual infor)ation fro) the )ost recent 12!)onth period -% ethnic

3/


http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm


http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm



categories and su-categories and -% gender in the folloing to areasE ;a< the therapeutic clinical trialsconducted at the cancer center and ;-< the non!therapeutic trials conducted at the cancer center" Relatethis infor)ation to the de)ographic infor)ation proided a-oe"

In addition the reised P9S or) 354 instructions ;re" 08>05< re.uire applicants to proide data on theco)position of proposed stud% populations in ter)s of gender and racial>ethnic groups" For %%$applications& this requirement is limited to pro)ected accrual to phase """ studies that utili*e %%$ re'

sources and are not funded by any other +# grant mechanism. See the P9S or) 354 ;re" 08>05< forta-le for)ats for -oth targeted>planned enroll)ent and actual enroll)ent" Please indicate if %ou hae no phase III trials that )eet this criterion"

Plans for Accrual of =omen and 2inorities: In this section include a description ofE

• (n% general policies of the parent institution designed to help ith recruit)ent and retention of

o)en and )inorities"

• naoida-le circu)stances that i)pede accrual of o)en and )inorities ;e.g. a high proportion

of non!eligi-le patients<"

•(ctions planned or -eing taAen -% the center -ased on careful anal%ses of the population hichde)onstrate a clear effort to recruit o)en and )inorities and correct deficiencies that are potentiall% aoida-le"

The following review criteria apply to this component 'approvalDdisapproval(:

• 9o proportional is the accrual of o)en and )inorities to -oth therapeutic and non!

therapeutic clinical trials -ased on de)ographic and accrual data proidedL

• 9o appropriate are plans and processes for )onitoring and i)proing recruit)entL

9$.! Inclusion of Children in Clinical Trials: Included in % page limit for 2inorities and women

above( The NI9 )aintains a polic% that children ;i.e. indiiduals under the age of 21< )ust -e included

in all clinical research conducted or supported -% the NI9 unless there are scientific and ethical reasonsnot to include the)"

(ll inestigators proposing research inoling hu)an su-'ects should read the NI9 Polic% and Guide!lines on the inclusion of children as participants in research inoling hu)an su-'ects;httpE>>grants"nih"go>grants>funding>children>children"ht)<"

(s part of the scientific and technical )erit ealuation of the research plan reieers ill -e instructedto address the ade.uac% of plans for including children ;as appropriate for the scientific goals of theresearch< or 'ustification for e#clusion"

The folloing criterion applies to this co)ponent ;accepta-le>unaccepta-le<E

• 9o appropriate is the plan for including children in clinical trials or ho accepta-le is the

'ustification for e#cluding children in clinical trialsL

34

http://grants.nih.gov/grants/funding/children/children.htm

http://grants.nih.gov/grants/funding/children/children.htm



0ther Review Considerations

Reviewing "cience in the CC"#: Science not process is the pri)ar% focus of the reie" $en hen process is to -e specificall% ealuated such as ith planning and ealuation or use of deelop)entalfunds the criteria for success are the scientific 'udg)ent -ehind or conse.uences of particular actionsor decisions" In a CCSG reie assess)ent of scientific .ualit% differs i)portantl% fro) the peer reieof indiidual grants" It is not the role of peer reie to re!ealuate indiidual pro'ects that hae alread%receied funda-le i)pact>priorit% scores" Rather scientific reie of a CCSG should seeA to ealuate the)a'or issues listed under Oerall I)pact> Priorit% Score of the Cancer Center and indiidual co)ponentreie criteria"

Assessing 2erit -espite Institutional -iversity: The peer!reie process ill ealuate scientific )eritand the alue!added -% the center across a ariet% of institutions" NCI encourages peer reie torecogni@e and reard scientific e#cellence and the diersit% of organi@ational for)s" S)all institutionsco)pete directl% ith large ones centers organi@ed onl% recentl% co)pete against distinguished cancer!research organi@ations that hae e#isted for decades" The center )a% -e co)prised of a consortiu) ofscientific institutions" Scientific excellence is not synonymous with large size; s)aller institutions )a%

deelop a li)ited nu)-er of scientific Progra)s that capitali@e on their specific scientific strengths orspecial populations" The pri)ar% consideration is the )erit of the Progra)s presented not their nu)-eror si@e"

Process for Criterion "coring

Prior to the site isit assigned reieers ill su-)it to the SRO their criterion scores for the oerallapplication on the fie standard reie criteriaE Significance Inestigator;s< Innoation (pproach and$niron)ent" These scores ill -e included in the Draft Site ?isit Report and Su))ar% State)ent under the heading Oerall I)pact> Priorit% Score -ut in Aeeping ith NI9 polic% ill not -e discussed as partof the reie process"

Process for -etermining 0verall Impact DPriority "core

(s part of the ealuation and ritten criti.ue on the Oerall I)pact> Priorit% Score of the Centerreieers ill discuss and descri-e the e#tent to hich the oerall application )eets the fie standardreie criteria as delineated under the NI9 enhanced peer reie process" The ealuation of the fiestandard reie criteria ;listed -elo< ill -e addressed for the application as a hole along ithealuating additional specific reie for the co)ponents of the CCSG application" In the OerallCriti.ue under a su-heading Oerall I)pact> Priorit% Score the Chairperson ill proide a su))ar%that includes an ealuation of the $ssential Characteristics and the Oerall I)pact> Priorit% Score reiecriteria that address the , criteriaE Significance Inestigator;s< Innoation (pproach and $niron)ent"

0verall ImpactDPriority "core of the Cancer Center 'merit descriptorG overall( which includes theelements listed below:

Reieers ill proide an oerall i)pact>priorit% score to reflect their assess)ent of the liAelihood forthe pro'ect to e#ert a sustained poerful influence on the research field;s< inoled in consideration ofthe folloing fie scored reie criteria and additional reie criteria ;as applica-le for the pro'ect proposed<"

"cored Review Criteria

35



Reieers ill consider each of the fie reie criteria -elo in the deter)ination of oeralli)pact>priorit% score" (n application does not need to -e strong in all categories to -e 'udged liAel% tohae )a'or scientific i)pact" or e#a)ple a pro'ect that -% its nature is not innoatie )a% -e essentialto adance a field"

"ignificance . Does the pro'ect address an i)portant pro-le) or a critical -arrier to progress in thefieldL If the ai)s of the pro'ect are achieed ho ill scientific Anoledge technical capa-ilit% and>or clinical practice -e i)proedL 9o ill successful co)pletion of the ai)s change the concepts)ethods technologies treat)ents serices or preentatie interentions that drie this fieldL =hat isthe oerall .ualit% of the science in the centerL =hat has the center contri-uted to the deelop)ent of)ore effectie preention diagnosis and treat)ent for cancer ;here appropriate<L

;NoteE in the conte#t of a P30 Cancer Center Support Grant reie the ter) Upro'ectF refers to theCenter application and Upro'ect ai)sF refers to the CenterFs strategic goals"<

Investigator's( . (re the PD>PIs colla-orators and other researchers ell suited to the pro'ectL If $arl%Stage Inestigators or Ne Inestigators or in the earl% stages of independent careers do the% hae

appropriate e#perience and trainingL If esta-lished hae the% de)onstrated an ongoing record ofacco)plish)ents that hae adanced their field;s<L If the pro'ect is colla-oratie or )ulti!PD>PI do theinestigators hae co)ple)entar% and integrated e#pertise are their leadership approach goernanceand organi@ational structure appropriate for the pro'ectL

Innovation. Does the application challenge and seeA to shift current research or clinical practice paradig)s -% utili@ing noel theoretical concepts approaches or )ethodologies instru)entation orinterentionsL (re the concepts approaches or )ethodologies instru)entation or interentions noelto one field of research or noel in a -road senseL Is a refine)ent i)proe)ent or ne application oftheoretical concepts approaches or )ethodologies instru)entation or interentions proposedL

Approach. (re the oerall strateg% )ethodolog% and anal%ses ell!reasoned and appropriate to

acco)plish the specific ai)s of the pro'ectL (re potential pro-le)s alternatie strategies and -ench)arAs for success presentedL If the pro'ect is in the earl% stages of deelop)ent ill the strateg%esta-lish feasi-ilit% and ill particularl% risA% aspects -e )anagedL If the pro'ect inoles clinicalresearch are the plans for 1< protection of hu)an su-'ects fro) research risAs and 2< inclusion of)inorities and )e)-ers of -oth se#es>genders as ell as the inclusion of children 'ustified in ter)s ofthe scientific goals and research strateg% proposedL Does the cancer center add alue oer and a-oe theseparatel% funded research efforts the)selesL 9ae thoughtful coherent scientific Progra)s -eenasse)-led and Progra) )e)-ers selected to )a#i)i@e the cancer!related interactie science in the parent institution as a holeL 9o do the different cancer!related scientific the)es in the parentinstitution fit together in the centerL

+nvironment. =ill the scientific eniron)ent in hich the orA ill -e done contri-ute to the pro-a-ilit% of successL (re the institutional support e.uip)ent and other ph%sical resources aaila-leto the inestigators ade.uate for the pro'ect proposedL =ill the pro'ect -enefit fro) uni.ue features ofthe scientific eniron)ent su-'ect populations or colla-oratie arrange)entsL =hat i)pact has thecenter itself had ;or is liAel% to hae< on the .ualit% of the science the productiit% of the scientists andthe transdisciplinar% actiities of the institution relating to cancerL 9ae the choices for center)e)-ership )ade -% its leaders resulted in a group of e#cellent cancer!focused scientists ho are alsoco))itted to productie interactions ith one anotherL

*0



lti)atel% the application should reflect ho the CCSG has influenced Center acco)plish)ents i.e. ifthe Center ould hae reported si)ilar achiee)ents ithout the -enefit of the CCSG the Ualue!addedF ould -e )ini)al and should -e reflected in the oerall i)pact>priorit% score along ith anassess)ent of the liAelihood for the CCSG to e#ert a sustained and poerful influence on the cancerresearch fields highlighted in the CenterFs application"

The nu)erical oerall i)pact>priorit% score for the application ill -e deter)ined -% calculating the)ean score fro) all eligi-le reieers at the NCI!( )eeting and )ultipl%ing the aerage -% 10 thisoerall score ranging fro) 10 B 50 ill -e reported on the Su))ar% State)ent"

-uration

• =hat is the reco))ended nu)-er of %ears of supportL

0verall 4udget Recommendation:

• Is the direct cost -udget re.uest consistent ith guidelines!reco))ended leels or 'ustified -%

special circu)stances as outlined in the guidelinesL

Application and Review for Comprehensiveness

The deter)ination of hether a cancer center ill -e designated as Jco)prehensieK ;see page * fordefinition< -% the NCI is deter)ined -% hether the center fulfils the -road scientific and otherre.uire)ents for co)prehensieness as descri-ed elsehere in the application" nless a center adisesthe SRO in adance of the reie that the% choose not to -e considered for co)prehensieness the NCISu-co))ittee!( ;see Part III NCI Su-co))ittee!( Reie< ill ealuate co)prehensieness as anintegral part of the oerall reie of the Cancer Center Support Grant application"

In consortiu) centers a co)prehensie designation )a% -e -ased on research in the pri)ar% institution

alone or on supple)ental strengths of the research in all consortiu) institutions" Grants of the partnerinstitutions )a% -e counted toard Progra) eligi-ilit% and calculation of the CCSG>NCI funding ratio pending a successful peer reie"

The following review criteria apply for determination of comprehensiveness 'approveDdisapprove(:

• 9o ade.uate is the depth and -readth of science in each of the three )a'or areas of -asic

la-orator% clinical and preention control and population sciencesL

• =hat is the degree of eidence for strong transdisciplinar% research -ridging these sciencesL

• 9o effectiel% has the center defined the cancer pro-le)s releant to its catch)ent area and

sered its catch)ent area as ell as the -roader population ia the research it supportsL

• 9o is the scientific )ission of the cancer center ena-led -% training and education of

-io)edicalscientists and health care professionalsL

0netime 0pportunity to Reapply for Comprehensiveness: ( funded grantee that fails to receie theco)prehensie designation at the ti)e of NCI Su-co))ittee!( reie )a% re!appl% once during thegrant pro'ect period" The re!application hich should address reieer concerns ill -e ealuated -%

*1



the NCI Su-co))ittee!(" Centers interested in re!application should contact NCI progra) staff forfurther infor)ation"

Retaining the Comprehensive -esignation: If an NCI!designated Co)prehensie Cancer CenterFsco)peting reneal application )eets the scientific standards for co)prehensie recognition fro) the

NCI Su-co))ittee!( -ut is oted an i)pact>priorit% score that does not )erit funding the center )a%retain the NCI co)prehensie designation onl% for as long as the NCI )aintains the JactieK status ofthe CCSG through ad)inistratie actions"

Peer Re+valuation of the Protocol Review and 2onitoring "ystem

If the PR&S is conditionall% approed or disapproed staff of the OCC ill contact the PIappro#i)atel% four )onths in adance of the reie date reco))ended -% peer reieers to discuss thecenterFs readiness for re!ealuation" If the center is read% staff ill forard a re.uest for an applicationfor re!ealuation of the PR&S -% the NCI IRG Su-co))ittee ( ;see Section III < ith acco)pan%inginstructions" ( funded grantee )a% undergo re!ealuation of the PR&S onl% once during the grant pro'ect period" Peer reieers )a% approe or disapproe the PR&S at the ti)e of re!ealuation i.e.

there is no option for conditional approal"

If the PR&S is disapproed institutional protocols that hae not -een peer!reieed -% approedfunding agencies or )echanis)s )a% not use CCSG!supported shared resources the Clinical Protocoland Data &anage)ent co)ponent or $arl% Phase Clinical Research Support funds" (dditionall% theCenter )a% not use CCSG funding for $arl% Phase Clinical Research Support until the PR&S has -eenre!ealuated and approed" The PR&S )ust continue to operate under institutional funds untilapproal is o-tained"

)ederal Citations Relevant to CC"# Applications '7 pages(

se of Animals in Research: Recipients of P9S support for actiities inoling lie erte-rate ani)als)ust co)pl% ith P9S Polic% on 9u)ane Care and se of 6a-orator% (ni)als;httpE>>grants"nih"go>grants>ola>references>P9SPolic%6a-(ni)als"pdf < as )andated -% the 9ealthResearch $#tension (ct of 154, ;httpE>>grants"nih"go>grants>ola>references>hrea154,"ht)< and theSD( (ni)al =elfare Regulations ;httpE>>"nal"usda"go>aic>legislat>usdaleg1"ht)< as applica-le"

;uman "ub3ects Protection: ederal regulations ;*, CR *8< re.uire that applications and proposalsinoling hu)an su-'ects )ust -e ealuated ith reference to the risAs to the su-'ects the ade.uac% of protection against these risAs the potential -enefits of the research to the su-'ects and others and thei)portance of the Anoledge gained or to -e gained;httpE>>"hhs"go>ohrp>hu)ansu-'ects>guidance>*,cfr*8"ht)l<"

"haring Research -ata: Inestigators su-)itting an NI9 application seeAing ,00000 or )ore indirect costs in an% single %ear are e#pected to include a plan for data sharing or state h% this is not possi-le ;httpE>>grants"nih"go>grants>polic%>datasharing<"

Hou )ust su-)it a plan for data sharing if the CCSG proides direct support for the generation or stor!age of research data ;e.g. pilot pro'ects supported through deelop)ental funds earl% phase clinicaltrials conducted ith funds fro) Protocol Specific Research Support< or funds shared resources thatsere as the final repositor% of data ;e.g. a high throughput DN( arra% anal%sis resource fa)il% regis!

*2

http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf

http://grants.nih.gov/grants/olaw/references/hrea1985.htm

http://www.nal.usda.gov/awic/legislat/usdaleg1.htm

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

http://grants.nih.gov/grants/policy/data_sharing

http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf

http://grants.nih.gov/grants/olaw/references/hrea1985.htm

http://www.nal.usda.gov/awic/legislat/usdaleg1.htm

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

http://grants.nih.gov/grants/policy/data_sharing



tries<" If %ou are re.uesting a -udget for data!sharing actiities ;e.g. data archiing< include the -udgetand 'ustification ith this section"

Reieers assess the ade.uac% of the proposed data sharing plan -ut do not factor it into thedeter)ination of scientific )erit or i)pact>priorit% score"

Policy for #enome=ide Association "tudies '#=A"(: NI9 is interested in adancing geno)e!ideassociation studies ;G=(S< to identif% co))on genetic factors that influence health and diseasethrough a centrali@ed G=(S data repositor%" or the purposes of this polic% a geno)e!ide associationstud% is defined as an% stud% of genetic ariation across the entire hu)an geno)e that is designed toidentif% genetic associations ith o-sera-le traits ;such as -lood pressure or eight< or the presence or a-sence of a disease or condition" (ll applications regardless of the a)ount re.uested proposing ageno)e!ide association stud% are e#pected to proide a plan for su-)ission of G=(S data to the NI9!designated G=(S data repositor% or proide an appropriate e#planation h% su-)ission to therepositor% is not possi-le" Data repositor% )anage)ent ;su-)ission and access< is goerned -% thePolic% for Sharing of Data O-tained in NI9 Supported or Conducted Geno)e!=ide (ssociation Stud!ies NI9 Guide NOT!OD!0/!044" or additional infor)ation see httpE>>grants"nih"go>grants>gas>"

Peer reieers ill assess the ade.uac% of the proposed G=(S plan -ut do not include it in their finali)pact>priorit% score" Concerns regarding G=(S data sharing plans )ust -e resoled -% progra) staff prior to )aAing aards"

"haring of 2odel 0rganisms: NI9 is co))itted to support efforts that encourage sharing of i)portantresearch resources including the sharing of )odel organis)s for -io)edical research ;seehttpE>>grants"nih"go>grants>polic%>)odelorganis)>inde#"ht)<" (t the sa)e ti)e the NI9 recogni@esthe rights of grantees and contractors to elect and retain title to su-'ect inentions deeloped ith ed!eral funding pursuant to the +a%h!Dole (ct ;see the !"# $rants +olicy tatement&

httpE>>grants"nih"go>grants>polic%>nihgps2011> " +eginning Octo-er 1 200* all inestigatorssu-)itting an NI9 application or contract proposal are e#pected to include in the application>proposal adescription of a specific plan for sharing and distri-uting uni.ue )odel organis) research resourcesgenerated using NI9 funding or state h% such sharing is restricted or not possi-le" This ill per)itother researchers to -enefit fro) the resources deeloped ith pu-lic funding" The inclusion of a )odelorganis) sharing plan is not su-'ect to a cost threshold in an% %ear and is e#pected to -e included in allapplications here the deelop)ent of )odel organis)s is anticipated"

Proide a short description of the centerFs institutional approach for adhering to the )odel!sharing pol!ic% as ell as specific )odel sharing plans for an% research conducted directl% ith CCSG funds ;i.e. pilot pro'ects conducted ith deelop)ental funds< or co)ponents sering as research resources ;e.g.)ouse )odel and transgenic )ouse shared resources etc"<" The ade.uac% of plans for sharing )odelorganis)s ill -e considered -% reieers hen a co)peting application is ealuated" (n assess)ent

of the plan ill -e proided in an ad)inistratie note -ut the oerall i)pact>priorit% score ill not -eaffected" If %ou are re.uesting a -udget for )odel!sharing actiities include the -udget and 'ustificationith this section"

5ins to 0ther )ederal Citations:

(ccess to Research Data through the reedo) of Infor)ation (ctEhttpE>>grants"nih"go>grants>polic%>nihgps2003>NI9GPSPart,"ht)

*3

http://grants.nih.gov/grants/gwas/


http://grants.nih.gov/grants/policy/model_organism/index.htm

http://grants.nih.gov/grants/policy/nihgps_2011/

http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part5.htm


http://grants.nih.gov/grants/policy/model_organism/index.htm

http://grants.nih.gov/grants/policy/nihgps_2011/

http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part5.htm



Re.uired $ducation on the Protection of 9u)an Su-'ect ParticipantsEhttpE>>grants"nih"go>grants>guide>notice!files>NOT!OD!00!035"ht)l

NI9 Pu-lic (ccess Polic% Re.uire)entE httpE>>"pu-)edcentral"nih"go>httpE>>grants"nih"go>grants>guide>notice!files>NOT!OD!04!033"ht)l httpE>>pu-licaccess"nih"go>

Standards for Priac% of Indiiduall% Identifia-le 9ealth Infor)ationE httpE>>"hhs"go>ocr>httpE>>grants"nih"go>grants>guide>notice!files>NOT!OD!03!02,"ht)l

(uthorit% and RegulationsE httpE>>"cfda"go>

9ealth% People 2020E httpE>>"health"go>health%people

6oan Repa%)ent Progra)sE httpE>>"lrp"nih"go>

9u)an $)-r%onic Ste) Cells ;h$SC<E httpE>>ste)cells"nih"go>inde#"asphttpE>>grants"nih"go>grants>guide>notice!files>NOT!OD!02!00,"ht)l httpE>>escr"nih"go

Appendices '>! pages(

(t the ti)e of su-)ission to additional copies of the application and all copies of the appendi#

)aterials )ust -e sent to the address -elo"

Referral Officer Diision of $#tra)ural (ctiities National Cancer Institute8118 $#ecutie +ouleard Roo) 40*1 &SC 4325+ethesda &D 20452!4325 ;for "S" postal Serice e#press or regular )ail<RocAille &D 204,2 ;for non!SPS delier%<

TelephoneE ;301< *58!3*24a#E ;301< *02!02/,$!)ailE ncirefofVdea"nci"nih"go

Review 2aterials to be Available at the "ite Hisit

• +iographical sAetches of all cancer center )e)-ers" ( co)plete set of -iographical sAetches

facilitates the reie particularl% if it is aaila-le for use during the presentations"

• (n updated Su))ar% 2 (ctie unded Pro'ects fro) the Standard Cancer Center Infor)ation

Su))aries and in the sa)e for)at a separate list of grants and contracts pending peer reieapproal and funding sorted -% Progra) ;or listed as WH if applica-le<"

• (n updated Su))ar% * 6ist of Clinical Research Studies -% Scientific Progra) ;here

applica-le< using the definitions and sort order specified in the Su))ar% * instructions"

• Copies of the data to -e presented in the posters" Data presented in the posters and proided as

part of the site isit docu)entation should -e updated fro) that presented in the application tothe e#tent possi-le please indicate the calendar date of the update" Posters for deelop)ental

**


http://www.pubmedcentral.nih.gov/


http://publicaccess.nih.gov/

http://www.hhs.gov/ocr/



http://www.cfda.gov/

http://www.health.gov/healthypeople

http://www.lrp.nih.gov/

http://stemcells.nih.gov/index.asp



http://escr.nih.gov/

mailto:[email protected]


http://www.pubmedcentral.nih.gov/


http://publicaccess.nih.gov/



http://www.cfda.gov/

http://www.health.gov/healthypeople

http://www.lrp.nih.gov/



http://escr.nih.gov/

mailto:[email protected]



resources )a% -e presented -ut are not re.uired" Other infor)ation ;e.g. user feed-acA>sure%sshared resource reies or ealuations< )a% -e included"

• Institutional protocols reieed -% the centerFs Protocol Reie and &onitoring S%ste)"

• Copies of the )inutes or reports of e#ternal and internal adisor% co))ittees ;e.g. the centerFs

$#ecutie Co))ittee< retreats and other )eetings releant to the planning and ealuation process for the center"

• The co)plete institutional Data and Safet% &onitoring Plan"

*,



III Peer Review of the Application

0verview: Cancer centers )a% hae a nu)-er of appropriate )issionsXresearch education and care" Neertheless the CCSG predo)inantl% supports the research )ission of the center" The role of peerreie is to assess the e#tent to hich the center has pro)oted or is liAel% to pro)ote e#cellence in

research that )a% lead to a reduction in the incidence )or-idit% and )ortalit% attri-uta-le to cancer to persons ithin their catch)ent area and -e%ond" Reieers also ealuate ho ell the centerFs leader!ship organi@ation and processes for deelop)ent and ealuation facilitate scientific productiit%strengthen the institutionFs research capa-ilities and ena-le its inestigators to taAe adantage of scien!tific opportunities -e%ond hat ould hae liAel% occurred at the institution ithout the CCSG"

Successful cancer centersE

• 9ae a strong peer!reieed research -ase in cancer!related science"

• (dd tangi-le alue to the research -ase alread% in place ithin the institution"

• &eet all si# essential characteristics of an NCI!designated Cancer Center"

Types of Review: (ll CCSG applications undergo peer reie under the authorit% and responsi-ilit% of

the Scientific Reie Officer ;SRO<" (pplications )a% undergo a site isit the site isit co))itteesgather infor)ation for final ealuation -% the NCI Initial Reie Group Su-co))ittee!( ;NCISu-co))ittee!( or NCI!( i.e. parent co))ittee<" ;Criteria for Peer Reie of Indiidual Co)ponentsand Oerall I)pact>Priorit% Score of the Cancer Center are presented in Part II ith the instructions forapplication"<

Site isits )a% -e re.uested -% an% center director -ut are re.uired for ne applicants for centersseeAing an increase in funding of greater than 10 co)pared to the final %ear of their prior aard or achange in designation or for centers ith a ne director or other significant changes" The SRO contactsthe center director in adance of the site isit date to decide on the appropriate length of ti)e for the siteisit discuss the proposed agenda and coordinate other site isit logistics"

In so)e circu)stances a grantee )a% elect not to hae a site isit in this case the reie ill -e -asedonl% on the infor)ation in the application ;i.e. JpaperK reie or (pplication Onl% Reie<"(pplication onl% reies are aaila-le to funded centers that hae had no change in director since thelast reie are re.uesting a -udget increase of less than 10 and hae no other significant changes in!cluding a re.uest for a change in designation" Center directors should consult ith OCC staff -eforere.uesting an application onl% reie to ensure that the% understand the i)plications of this decision"

Proper reie of a center hether at site isits or at the deli-erations of the NCI Su-co))ittee!(re.uires ealuation -% peersE scientists ith su-stantial e#perience a -road perspectie on cancerresearch and scientific organi@ational and ad)inistratie sophistication" Peers )a% -e dran fro)cancer centers or institutions ithout centers" Reieers ho hae not sered on at least one center siteisit in the last 3 %ears ill undergo an orientation"

"ite Hisit Reviews: ( reie tea) ill isit the center to seeA clarification and update of the applicationthrough presentations and tour;s<" The separate ad)inistratie reie during the site isit ill -e asshort as possi-le -ased on the co)pleteness of the application to per)it center ad)inistration to attendthe site isit presentations" Site isits usuall% e#tend a )a#i)u) of 8 hours at the center depending onthe si@e and co)ple#it% of the application and center" Centers are encouraged to present for)al scientificProgra)s in groups rather than indiiduall% to allo )ore ti)e for discussion and )ust present shared

*8



resources in a poster session for)at so reieers can focus )ore ti)e on the CenterFs scientificProgra)s" ( ritten report of the site isit is proided to the applicant ho )a% su-)it factualcorrections prior to the applicationFs final ealuation -% the NCI Su-co))ittee!("

Application 0nly Reviews: our eeAs prior to the reie )eeting reieers )a% su-)it .uestions

generated fro) reie of the application for clarification to the SRO these ill -e forarded to theapplicant" To eeAs prior to the reie )eeting the cancer center ill proide ritten responses tothe su-)itted .uestions" (t the reie )eeting the center director and ad)inistrator ;or center directordesignee< )a% each gie a presentation of no )ore than 10 )inutes ith each presentation folloed -%a 10!)inute .uestion>anser session" The reieers ill discuss and ealuate the co)ponents of theapplication" ( ritten report of this reie is proided to the Principal Inestigator as the Su))ar%State)ent"

*CI "ubcommitteeA Review: The NCI Su-co))ittee!( is a chartered reie co))ittee of the NI9"(fter considering the ritten report of the site isit co))ittee ;here applica-le< the discussion -% the NCI Su-co))ittee!( )e)-ers ho participated in the site isit the deli-erations of the full co))itteeand the response of the applicant to the site isit report ;here applica-le< the NCI Su-co))ittee!( proides a final )erit ealuation and a -udget reco))endation for the CCSG application in a Su))ar%State)ent hich is proided to the Principal Inestigator"

The NCI Su-co))ittee!( also deter)ines if the criteria for co)prehensieness are )et ;hereapplica-le< and co)pletes Peer Re!$aluation of PR&S here re.uired"

Ad hoc Review: =heneer conflict of interest e#ists ithin the usual peer reie process of site isitand NCI Su-co))ittee!( ;e.g. an application su-)itted fro) the institution of a NCI Su-co))ittee!( )e)-er ho is the institutionFs Cancer Center Director< the SRO ill conduct a single step ad hocreie"

*ational Cancer Advisory 4oard '*CA4(: The NC(+ is the final step in the peer reie process" The

NC(+ )a% concur ith all peer reie reco))endations asA for re!reie or )aAe so)e otherreco))endations" NC(+ approal )ust precede funding"

inal funding decisions are )ade in accordance ith the NCIFs -udgets for the OCC during each fiscal%ear"

Documents

Draft 2013 CCSG Guidelines