Please create a high-level masters level PowerPoint (12 slides) with speaker notes on each slide for the following 2 questions
Please comment on the following questions:
1. What are some of the challenges in creating and managing grants and contracts for clinical research studies?
2. What strategies might a Clinical Research Manager use to try to facilitate this process?
**Please utilize the following YouTube videos as well as the Attached PDFs, which is requirement of the paper – feel free to utilize other resources if needed but these videos and pdf are part of the requirement**
https://www.youtube.com/watch?v=mFVzBRYhA2w&t=2s
https://www.youtube.com/watch?v=ov7h-WhIv9w
https://www.youtube.com/watch?v=JqwZDG2RJuc
https://www.youtube.com/watch?v=kL2uumPGDs8
https://www.youtube.com/watch?v=YiG_CWxGCVQ
https://www.youtube.com/watch?v=Qok-LNyfXFg
https://www.youtube.com/watch?v=EyPFi0YO32M
someTitle 7 BuildingBudgets Clinical trials cannot be conductedwithout adequate funding.When considering a study, one of the first steps the study manager or appropriate budget staff must take is to determine if it is financially feasible for the site to conduct the study.Studybudgets are complex and require analysis of the protocol, the clinical trial agreement (CTA), the informedconsent,andanunderstandingoftheregulationsoftheAffordableHealthcareAct that impact research costs. In addition, information on the cost of the study procedures, staffsalariesincludingbenefits,contractors,andfacilityandadministrationfees(overhead) is needed. This chapter covers the following budget steps: (1) identifying study costs to determine financial feasibility of the study, (2) budget development, (3) billing, (4) negotiatingthebudget,and(5)thepaymentplan. FINANCIALFEASIBILITY StudyfeasibilitywascoveredinChapter2detailingwhyasiteshouldorshouldnotconduct aproposedstudy.Inthischapter,wecoverfinancialfeasibilityandwhetherthestudysite can afford to conduct a proposed study. The study teammust look at all of the costs of doingastudy,bothdirectand indirectcosts, toanswer thisquestion.Compensationfrom thestudysponsorshouldbeadequatetocoverallcostsaswellasbringinadequaterevenue asdefinedbyorganizationpolicy.Conductingafinancialfeasibilityreviewenablesthesite todetermine thecostper subject, thenumberof subjects required tobreakeven, and the numberneededtomeettherevenueneedsofthesite. Somecostsare simply thecostofdoingbusinessandshouldbeabsorbedby the site. Whilesponsorsarelookingforwaystoreduceorcontainthecostsofconductingstudies, theyaregenerallyattemptingtobefairtothestudysite.Asponsor,however,doesnotlike being“nickeled-and-dimed”todeathanditisimportantthatthestudymanagerunderstands thecostsofdoingbusinessanddoesnotincludetheseinthestudybudget.Costsofdoing businessarethosecoststhatthesitewouldincurwhetherornotitwasconductingthestudy. These includesuch thingsasgeneral space, telephones,copymachines,waitingarea,and business tasks such as signing financial disclosures, submitting Form FDA 1572, confidentialityagreements,andotherdocuments. Financialfeasibilitygoeshandinhandwithbudgetdevelopment.Thestepscoveredin developingabudgetinthischapterwillassistthesitemanagerinidentifyingcostsofthe study.Eachofthestepspresentedinthedevelopmentofthebudgetisanimportantpartin Pfeiffer, JoAnn, and Cris Wells. A Practical Guide to Managing Clinical Trials, Taylor & Francis Group, 2017. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/wfu/detail.action?docID=5477040. Created from wfu on 2022-06-20 19:01:39. C op yr ig ht © 2 01 7. T ay lo r & F ra nc is G ro up . A ll rig ht s re se rv ed . the determination of financial feasibility and the site’s decision of whether or not to conductthestudy(seeFigure7.1forbudgetdevelopmentsteps). FIGURE7.1 Budgetdevelopmentsteps. BUDGETDEVELOPMENT—INTERNALBUDGET The first step in creating a budget is to gather all of the study’s essential documents, includingtheprotocol, informedconsent, labandpharmacymanuals,sponsorbudget,and the CTA. The information needed to create an accurate budget can be found in these documents.Doaninitialreviewof theprotocolandinformedconsent tobecomefamiliar with the study.As you review these documents, identify items that need clarification or questions.Examplesmaybetypeofmonitoringandhowoften,anyspecialreportsrequired, labclarifications,etc.Makesure these itemsareclarifiedbeforeyousignorapprove the studybudget. STUDYPROCEDURESANDSTAFFTIME Study procedures are identified through a thorough review of the protocol. Protocols include all procedures to be performed at each study visit aswell as follow-up visits or situationsthatrequireadditionaltestingorvisits.Figure7.2isanexampleofascheduleof Pfeiffer, JoAnn, and Cris Wells. A Practical Guide to Managing Clinical Trials, Taylor & Francis Group, 2017. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/wfu/detail.action?docID=5477040. Created from wfu on 2022-06-20 19:01:39. C op yr ig ht © 2 01 7. T ay lo r & F ra nc is G ro up . A ll rig ht s re se rv ed . events(SE).Thisissimilartowhatwillbefoundinastudyprotocol.TheSEinFigure7.2 will be used to develop a sample budget for this chapter. In addition to the SE, it is importanttoreviewthedescriptionsofthevisitsandproceduresintheprotocoltoidentify costs/procedures thatmay not be included in the SE.A review of the lab and pharmacy manualsmaybeappropriate to identifyany labprocessesorprocedures requiredon site, specialhandling,andothers.Reviewallsectionsoftheprotocolforanydiscrepancies. FIGURE7.2 Scheduleofevents. Tip:Usesearchandfind—ctrlF—tolookforlabs,shipping,andotherkeywordsthatare relatedtostudycostswhenyouarereviewingthesedocuments. FromtheSE,proceduresforeachvisitcanbeidentified.Onceidentified,applyacostto eachoftheprocedures.Institutionsgenerallyuseeitheraninstitutionchargemasterorafee scheduletoassignacosttoeachprocedure. CHARGEMASTER Refer to the institution’s chargemaster for the current fees for each procedure. Of note here,thecostsofprocedureswillvaryfromonegeographiclocationtoanother.Thecostto do a12-lead electrocardiogram is likely tobemore inSanFrancisco,California, than in Phoenix,Arizona.Itiscriticaltomakesurethatthecostsyouapplyarefairmarketvalue forthegeographiclocation.Figure7.3isamock-upexampleofwhataportionofacharge master might look like, showing the costs and codes for venipunctures and magnetic resonance imaging of the spine.Youwill notice that for the procedures listed, there are multiple types (Figure 7.3). The type of institution will also factor into the cost; for example,medicalcentercoststendtobehigherthanthoseofaclinic.Theprotocolshould Pfeiffer, JoAnn, and Cris Wells. A Practical Guide to Managing Clinical Trials, Taylor & Francis Group, 2017. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/wfu/detail.action?docID=5477040. Created from wfu on 2022-06-20 19:01:39. C op yr ig ht © 2 01 7. T ay lo r & F ra nc is G ro up . A ll rig ht s re se rv ed . specifythespecifictypeofprocedureforthestudy.Ifitisnotclear,contactthesponsorto determinethespecificprocedure.Whenapplyingacostforaprocedure,itisimportantto makesureyouarechargingforthecorrectone.Forexample,achargemastermayinclude 20ormoreX-rayprocedures,40ormorebloodtests,andsoon.Reviewthevisitdetailsand whatisincludedineachassessment/proceduretoensurethatyouhaveidentifiedallcosts fortheprocedure. FIGURE7.3 Samplechargemaster. COSTOFSTUDYVISITS Once the cost of each procedure has been identified in the charge master, add the appropriatecosttotheapplicableprocedureofthestudyvisits(Figure7.4).Thisisastartto buildingthebudget. FIGURE7.4 Studyvisitprocedures. Pfeiffer, JoAnn, and Cris Wells. A Practical Guide to Managing Clinical Trials, Taylor & Francis Group, 2017. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/wfu/detail.action?docID=5477040. Created from wfu on 2022-06-20 19:01:39. C op yr ig ht © 2 01 7. T ay lo r & F ra nc is G ro up . A ll rig ht s re se rv ed . Thenextstepistodeterminethecostsoftheremainingtasks/procedures,includingthe staffrequiredtoperformtheprocedureandtheamountoftimetocompleteeachprocedure. Note that some procedures may require more than one staff member. For example, a physicalexammaybeperformedbyastudynursewithphysicianoversight.Theinformed consentmight be presented by the study coordinatorwith the investigator reviewing the studyandansweringquestionsinthelast15minutes.Refertotheprotocoltodetermineany specific requirementsdetailingwhomust performprocedures. In addition, the sitemight have policies or standard operating procedures that dictate who performs what procedures/activitiesintheconductofclinicaltrials. Staff time includes salary, benefits, and payroll taxes. Benefits might include the following:vacation, sick leave,medical anddental, retirement, life insurance, short-term and long-term disability, and eye care. Payroll taxes include local, state, federal, FICA (Federal Insurance Contributions Act [Social Security and Medicare]), and Workmen’s Compensation.(Forthebudgetpresentedinthischapter,afigureof33%isappliedtothe hourlyratetoaccountforbothbenefitsandtaxes.) Toestimatethetimeitwilltakestafftoperformthevariousstudyprocedures,review previous similar studies that the sitehas conducted. If the sitehasnot conducted studies before or has not conducted a similar study, the site might contact other sites or use professionalnetworkstogatherinformation.Figure7.5breaksdownthestaffcostsforeach procedureintothefollowingcategories: Pfeiffer, JoAnn, and Cris Wells. A Practical Guide to Managing Clinical Trials, Taylor & Francis Group, 2017. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/wfu/detail.action?docID=5477040. Created from wfu on 2022-06-20 19:01:39. C op yr ig ht © 2 01 7. T ay lo r & F ra nc is G ro up . A ll rig ht s re se rv ed . FIGURE7.5 Studyprocedure—staffcosts. Staffhourlyrate; Hourlyrateplusbenefitsandtaxes(33%); Estimatedtimerequiredforeachstaffmembertoperformtheprocedure; Staffcostsbasedonamountoftimespent;and Totalstaffcostoftheprocedure. Once staff costs have been calculated, these costs can be added to the study visit procedurestodeterminetotalprocedurecost(Figure7.6).Foraprocedurefeeidentifiedin thechargemaster,staffcostsmustbeaddedfora totalcost.Forexample, thefeefor the blood draw is $50.00. To determine total cost, the staff timemust be added to the fee. (Blooddrawfee=$50+$13.30staffcost,foratotalcostof$63.30.) Pfeiffer, JoAnn, and Cris Wells. A Practical Guide to Managing Clinical Trials, Taylor & Francis Group, 2017. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/wfu/detail.action?docID=5477040. Created from wfu on 2022-06-20 19:01:39. C op yr ig ht © 2 01 7. T ay lo r & F ra nc is G ro up . A ll rig ht s re se rv ed . FIGURE7.6 Totalprocedurecost. Adding the costs of the procedures for a visit provides the total cost to the site to conductthatvisit.Forexample,thetotalcostofthescreeningvisitis$554.85andthetotal costforVisit4is$199.65.Todeterminethecostofallstudyvisitspersubject,simplyadd the totalcosts foreachstudyvisit (screen throughVisit5).Thecost to thesite forstudy visits is $1,853.00per study subject. In addition to the studyvisit cost, to determine the total costper subject for the study, subject compensation for timeand travelneeds tobe added to thevisit costs. If compensation is$25.00pervisit and thereare fivevisits, add $125.00tothevisitcosts,bringingthetotalcosttothesitepersubjectto$1,978.00. Thesponsor’sproposedbudget,sometimesreferredtoastheexternalbudget,generally does not break down the costs to the extent required by the site to determine financial feasibility.Sponsorbudgetstypicallyproposecompensationtothestudysiteinoneofthree ways: 1. Proposedcompensationperstudyvisit; 2. Proposedcompensationpersubject;or 3. Proposecompensationfortotalsubjectstoberecruited. Conducting the financial feasibility allows the site to determine if the sponsor’s proposedcompensation,regardlessofwhichwayitispresented,providescompensationfor the costs to the site. Figure 7.7 shows the costs to the site in the three ways typically presentedbyasponsor. Pfeiffer, JoAnn, and Cris Wells. A Practical Guide to Managing Clinical Trials, Taylor & Francis Group, 2017. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/wfu/detail.action?docID=5477040. Created from wfu on 2022-06-20 19:01:39. C op yr ig ht © 2 01 7. T ay lo r & F ra nc is G ro up . A ll rig ht s re se rv ed . FIGURE7.7 Studysubjectcosts. OTHERSTUDYCOSTS Visit costs are only one part of the cost of doing the study. There aremany other costs associatedwithconductingastudy. ReviewingtheSEisagoodplacetostart.However,itisimportanttoreviewtheentire protocolforhiddenitemsandservices.Itemssuchassubjectcompensation;extraservices for certain lab results,which could include follow-up tests; and local labs as opposed to central labs are generally not found in the SE. Reviewing the inclusion and exclusion criteriaisimportant.Somecriteriamayrequireadditionaltestingthatdoesnotshowupin theSE,forexample,HIVtestingorreviewofrheumatoidarthritisfactors.Payattentionto footnotes.Does the footnote affectbudgetingandbilling?For example, aproceduremay include timing the results at multiple intervals, such as during a five-hour intravenous infusionrequiringanursetocheckvitalsevery30minutes,increasingstafftime. Somestudycostsarepaidbythesponsoruponreceiptofaninvoicefromthestudysite. Thesearecoststhatdonotoccuronaregularbasisandaretypicallyreferredtoas“pass- through”costs.Manyofthesecostsmayormaynotoccurduringtheconductofthestudy. Examples of costs to be invoicedmight include items such as subcontractor fees, record storage, subject travel and parking, subject meals for lengthy visits, screen failures, adjudication of serious adverse events (SAEs), and shipping and handling of biological specimens.These itemsaregenerally invoiced to the sponsorwhen theyoccur.Although thesecostsmightnotoccur,asetfeeshouldbedeterminedandincludedinthebudgetasan invoiceditemwhenpossible.Forexample,thecostofadjudicatinganSAEmightbesetat $500perSAEandscreenfailureswouldbesetat thecostof thescreeningvisit,whichis $547.55. Additionalcosts toconsidermight includeitemssuchasdataentry,management/data verification/queries, institutional review board (IRB) amendments and reports, reconsenting, room fees (cost—for example, patient in room 8 hours; hospital overnight stays and travel and lodging, for subjects who travel a long distance, etc.), remote monitoring fee (coordinator time to prepare records, be available, follow-up, etc.), and Pfeiffer, JoAnn, and Cris Wells. A Practical Guide to Managing Clinical Trials, Taylor & Francis Group, 2017. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/wfu/detail.action?docID=5477040. Created from wfu on 2022-06-20 19:01:39. C op yr ig ht © 2 01 7. T ay lo r & F ra nc is G ro up . A ll rig ht s re se rv ed . additional testing/procedures for adverse events.Only a thorough review of the protocol willassistintheidentificationofallofthecostsassociatedwiththeconductofthestudy. STUDYSTART-UPCOSTS Preparing thesite toconduct thestudy involvescosts to thesite.Thesearecosts that the sitewouldnotincurifnotdoingthestudy.Thesecostsshouldbecoveredbythesponsoras aone-timenonrefundablefee.ThesecostsincludeIRBfeesforthesubmissionandapproval oftheinformedconsentandotherstudydocumentsandadministrativefeesforbudgetand contract review and negotiation, protocol review, study-specific training, investigator meetings,siteset-up,chartreviewsforrecruitment,andsourcedocumentationpreparation. Dependingonthetypeofstudy,theremayalsobespecialtyfeessuchasspecialequipment needed, set-up fees, radiology, pharmacy, laboratory, pathology, etc. Once the site has determinedthecoststostartthestudy,thisshouldbeincludedinthebudgetasaone-time nonrefundable fee.This cost should be nonrefundable because,whether or not the site is abletoenrollsubjectsintothestudy,thesitestillincursthecosts. RECRUITMENT Recruiting subjects, whether doing so through chart reviews, social media, or other advertising avenues, is also a study expense.Most sponsors provide recruitingmaterials and a set amount for recruiting. Site personnel need to determinewhether the sponsor’s proposedbudgetwillcovertherecruitmentactivitiesneededtorecruitthenumberofstudy subjectstomeetthesite’srecruitmentgoal. ShippingandHandling Inmultisite clinical studies, sponsorsmaycontractwith a central lab toprocess samples collectedfromthesubject.Shippingbiologicmaterialsrequiresspecialhandlingaswellas training.Shippingandhandlingcostsshouldbecoveredbythestudysponsorandincluded inthebudget. SAERESOLUTION When an SAE occurs, the site is responsible for following the event through resolution. This includes obtaining all necessary records from all parties whowere involved in the SAE, which might include physician records, hospital records, and death certificates. Followingtheeventtoresolutioncantakemonthsandsometimesevenyearsuntilthefinal outcomeisknown.Trackingandobtainingrecordsareoneroustasksandtakeperseverance Pfeiffer, JoAnn, and Cris Wells. A Practical Guide to Managing Clinical Trials