InstructionsforPatient-Oriented ClinicalResearch PilotProposalsSubmittedApril1,2018–March31,2019

Pleasecarefullyfollowtheinstructionsbelowandusetheformsprovided.Proposalsthatareincompleteorotherwisedonotfollowinstructionswillbereturnedtothe investigatorwithoutreview.

Allpagesofallitemsinyourproposalmust beconsecutivelynumbered,useArial11pointfont,singlespaced, on8.5x11pages,leftjustified, with¾”marginsonallsides.

Cover Page

Completeallelementsofthecoverpage:

  • Traineesandjuniorfacultymustprovidethename,titleandUFIDoftheirmentor.
  • IncludetheIRBprotocolnumberanddateofapproval.Ifyouhavenotyet obtainedIRBapprovalfor yourwork,enter“NA”.
  • Costs:Applicantsmust complete theNIH’sstandard “DetailedBudgetfor Initial BudgetPeriod”form, include aseparatebudget justificationandincludewrittencostestimates from requestedCTSI Services.Foracompletelist ofavailableresources,pleasevisittheCTSI website at: funds available for thisproject fromnon-CTSI sources.Funding for thispilotprojectfrom sourcesoutsideofthe CTSIwillstrengthen theapplication.
  • Thecompletedcoverpageshouldbesignedanddatedbytheprincipalinvestigatorandtheprincipalinvestigator’sdepartment chair.

Page2

  • Abstract(200wordsorless): Providetherationaleforthework,usuallyintheform ofaresearchquestionto beanswered,andadescriptionof theapproachtobetakentoanswer thequestion.
  • TranslationalImpact(200 wordsorless):Describehowtheworkwillimprovehumanhealth.
  • ExternalFundingPlan(200wordsorless): Provideaspecificplanfor obtainingexternalsupport.What agencyandfundingprogramwillbepursuedwiththispilotdata?Theclarityandfeasibilityoftheexternalfundingplanwill beastrongdeterminantoffunding.
  • TraineeMentoringPlan[ifapplicable] (200 wordsorless): Describetheapproachbeing takentomentoringandroleof theproposalinthe developmentof thecareerof thetrainee.

ResearchPlan

Describeyourproposedprojectinaresearchplanofnomorethanfivepages.YoumaysubmitthesameresearchplantotheIRBandtheCTSI.Yourplanshouldincludethefollowingsections:

  • ProjectTimelineincluding currentIRBsubmission status
  • Rationale
  • SpecificAims
  • PreliminaryStudies
  • Design andMethodology. Includeclear justificationforthenumberofparticipantstobe enrolledinthepilotandforthenumberofparticipantsneededforanexternallyfundedstudy.
  • Recruitment Strategy(Feasibility,recruitment,retentionplanning)
  • PlannedEnrollmentTable
  • References(includedinthefive page limit)

RequiredAttachments

  • CoverSheet
  • Page2–Abstract, TranslationalImpact, ExternalFundingPlan, MentoringPlan
  • ResearchPlan
  • KeyPersonnel:Provide a list ofkeypersonnel.Foreachmemberoftheresearch team,includename,title,UFIDandrole ontheproject.
  • NIHBiographical Sketches:NIH-formattedbiosketchesforPI, investigator(s)andmentor(s).TheNIHbiosketchformisavailableat Additionalinstructionsforbiosketches:
  • Eachbiosketchislimitedtofivepages.
  • AllbiosketchesshouldincludeeRACommonsUserNames:
  • PIs:Usethestatement section toexplainwhyyou are wellsuitedfortheroleofPIandhowtheprojectwillcontributetoyourcareer development plan.
  • Mentors:Personal statement shouldincludementor’squalificationsand role in thecareerdevelopmentofthePI.
  • Budget:Submit a detailedbudget using theNIH’sstandard“DetailedBudgetfor Initial BudgetPeriod”form.TheNIH“DetailedBudgetforInitialBudgetPeriod” formcanbedownloadedat
  • Budget JustificationWorksheet: Applicantsmust includeaseparate budgetjustificationfor alllineitems.Includeallcostsassociatedwiththeproject.Indicatethefundingsourceforeachlineitem (i.e. department,Gatorade, CTSI, etc.).
  • Cost Estimates: CTSI servicesrequirecost estimatesinwritingfromCTSIServiceproviders. Foracompletelist ofavailableresources, pleasevisit theCTSI websiteat:
  • Lettersof Support:Trainees and JuniorFacultymust includeletters ofsupportfromtheirmentor(s).

Submitting your proposal

Emailyourcompleteproposal(includingcoversheetand allattachments) as asinglePDFto ications in response tothisRFAwillbe acceptedon arollingbasis untilMarch 31,2019. Proposalsthat do notfollowtheinstructions willnot be ithanyquestions.

Cover Sheetfor Patient-OrientedClinicalResearchPilotProjectProposal

PrincipalInvestigatorName
Position/Title
UFID
Email
Fiscal/AdminContact(NameEmail)
Co-investigatorName(if applicable)
Position/Title
UFID
MentorName(ifapplicable)
Position/Title
UFID
IRB/IACUC ProtocolNumber
IRB/IACUCApprovalDate(mm/dd/yy)
Numberofparticipantsto beenrolled
Total costofproposedwork*
Funding amountavailablefromnon-CTSIsources(e.g.,departmentalorOpportunity Fundsupport).
TotalfundsrequestedfromCTSI

*Pleaseuseattached CTSIBudget JustificationWorksheettodocumentcosts.

Signatures

PrincipalInvestigatorDepartmentChairorRepresentative

NameDateNameDate

Page 2 ofClinicalResearch PilotProjectProposalAbstract(200wordsorless)

TranslationalImpact(200 wordsorless)

ExternalFunding Plan(200wordsorless)

MentoringPlan(200wordsorless)

ResearchPlan(nomorethan 5pages)

ProjectTimeline;including proposedIRBsubmissiondate

Rationale

SpecificAims

PreliminaryStudies

DesignMethodology

RecruitmentStrategy

Planned EnrollmentReport

RacialCategories / Ethnic Categories
NotHispanicorLatino / HispanicorLatino / Total
Female / Male / Female / Male
AmericanIndian/AlaskaNative / 0
Asian / 0
NativeHawaiian orOtherPacificIslander / 0
BlackorAfricanAmerican / 0
White / 0
MoreThanOne Race / 0
Total / 0 / 0 / 0 / 0 / 0

PHS398/ PHS2590 (Rev.08/12ApprovedThrough8/31/2015)OMBNo.0925-0001/0002

References

KeyPersonnel

NameofProject Member
Position/Title
UFID
RoleonProject
NameofProject Member
Position/Title
UFID
RoleonProject
NameofProject Member
Position/Title
UFID
RoleonProject
NameofProject Member
Position/Title
UFID
RoleonProject
NameofProject Member
Position/Title
UFID
RoleonProject
NameofProject Member
Position/Title
UFID
RoleonProject
P.I.(Last,First):
ProposalTitle:

PleaserefertotheRFAguidelinesforallowablecosts;somelineitemsfromtheNIHDetailedBudgetforInitialBudgetPeriodformmightnotqualifyforCTSIPatient-OrientedClinicalPilotfunding.Besuretolistfundsavailableforthisprojectfromnon-CTSIsources.FundingforthispilotprojectfromsourcesoutsideoftheCTSIwillstrengthentheapplication.FundsrequestedforuseofCTSIServicesshouldbelistedunder"OtherExpenses."

Personnel(listtheKeyPersonnelincludedinthisstudyi.e.PI,Co-I,Mentor,etc.)
Name / RoleinProject / TotalFundingRequested / Howwillthisbefunded(i.e.CTSI,Dept.,Grant,etc.) / ForOfficeUseOnly
PrincipalInvestigator / $0.00
Consultants(fromNIHDetailedBudgetforInitialBudgetPeriod)
Name / RoleinProject / TotalFundingRequested / Howwillthisbefunded(i.e.CTSI,Dept.,etc.) / ForOfficeUseOnly
Equipment(fromtheNIHDetailedBudgetforInitialBudgetPeriod;refertoRFA) / TotalFundingRequested / Howwillthisbefunded(i.e.CTSI,Dept.,etc.) / ForOfficeUseOnly
Supplies(fromtheNIHDetailedBudgetforInitialBudgetPeriod;refertoRFA) / TotalFundingRequested / Howwillthisbefunded(i.e.CTSI,Dept.,etc.) / ForOfficeUseOnly
Travel(fromtheNIHDetailedBudgetforInitialBudgetPeriod;typicallynotapplicable,refertoRFA) / TotalFundingRequested / Howwillthisbefunded(i.e.CTSI,Dept.,etc.) / ForOfficeUseOnly
InpatientCareCosts(fromtheNIHDetailedBudgetforInitialBudgetPeriod;typicallynotapplicable) / TotalFundingRequested / Howwillthisbefunded(i.e.CTSI,Dept.,etc.) / ForOfficeUseOnly
P.I.(Last,First):
ProposalTitle:
OutpatientCareCosts(fromtheNIHDetailedBudgetforInitialBudgetPeriod;refertoRFA) / TotalFundingRequested / Howwillthisbefunded(i.e.CTSI,Dept.,etc.) / ForOfficeUseOnly
OtherExpenses(ItemizedbyCategory)includerequestedCTSIServicesinthissection;listofavailableresources / TotalFundingRequested / Howwillthisbefunded(i.e.CTSI,Dept.,etc.) / ForOfficeUseOnly