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SLU.EDU/MEDICINE/AHEADGUIDE FOR INVESTIGATORS“At Saint Louis University, research is critical to our mission. Research andscholarship enrich and energize our faculty, trainees, and students whileadvancing knowledge in health and biomedicine.” Christine Jacobs, M.D.Vice President for Medical Affairs Dean of the School of Medicine 2025© 2025 Saint Louis University. All rights reserved. Message

Welcome Investigators!What this guide offers you:Step-by-step guidance throughyour research with AHEADWhat to expectWho to contactHow to prepare for your consultServices and pricingData source descriptionsKey policiesAbout UsThe AHEAD Institute unites investigators across disciplines to improvepatient and population health, advance the quality of care, and reducecosts. When you seek our support, a dedicated faculty or staffmember collaborates with your research team.Our individualized services involve the development of studyprotocols, in-depth statistical analyses, and complex datamanagement. Leslie Hinyard, PhD, MSWExecutive Director, The AHEAD InstituteChair and Professor, Health and Clinical Outcomes Researchleslie.hinyard@health.slu.eduAHEAD transforms your research vision into actionable results.2AHEAD GUIDE FOR INVESTIGATORS

Project PreparationDraft a timeline aligned with your researchcommitments.Confirm funding with your department oraward specialist.Assemble a research team to optimizeworkflow.Task*AssigneeReview the LiteratureInvestigatorDevelop Research Question & HypothesisExplore Available DataSecure & Confirm Project FundingSubmit a Service RequestKey Contact: Joanne Salas, MPHjoanne.salas@health.slu.eduAsk about data sourcesComplete these essential steps prior to submitting a Service Request:ConceptualizeYour StudyDefine your objective, study population,primary exposure, outcome, andcovariates.Ensure your study design effectivelyaddresses your research question.3Summarize relevant PubMed literature intodigestible information.Identify gaps in existing literature.Formulate a research question that ismeaningful, feasible, and novel.Review theLiteratureConsiderLogisticsExploreAvailable Data(pages 9-11)AHEAD GUIDE FOR INVESTIGATORS We understand these tasks can be challenging. If you are struggling, please reach out — we are here to help.

Task*AssigneeSelect Data SourceInvestigator & AHEADDetermine Study Design & MethodsComplimentary ConsultationAttend a 1-hour virtual consultation with AHEAD.Introduce us to your project, clarify research questions,determine data needs, and learn about our process.lizzie.ward@health.slu.eduAsk about funding, scheduling, and logistics.Contact Lizzie at any point in the project, including prior to submitting a Service Request.Zidong (Alex)Zhang, PhDJasonDoherty, PhDRuizhi(Regina)Huang, MSTimChrusciel,MPHMattSimpson,MPH12Key Contact: Lizzie Ward Submit a Service Request AHEAD contacts investigator within 10 business days.Our Process: Step-by-Step4Biostatisticians AHEAD GUIDE FOR INVESTIGATORSInvolve AHEAD early in the grant planning process tocomply with SLU’s funding policies and requirements.

Task*AssigneePrepare Scope of WorkAHEADApprove Scope of WorkInvestigatorProvide Data Use AgreementAHEADSign & Return Data Use AgreementInvestigatorWrite, Submit, & Revise IRB ProtocolInvestigatorObtain IRB Approval or ExemptionInvestigatorSubmit Data RequestVaries by data sourcePull/Cut DataAHEADCollect DataInvestigatorAnalyze DataAHEAD34RoxannKirkwood, MSIrene RyanOur Process: Step-by-StepScope of WorkAHEAD drafts the Scope of Work.Investigator reviews the Scope of Work for accuracy.Investigator signs and returns the Scope of Work toAHEAD.5Project ExecutionInvestigator ensures legal approvals with IRB and Data Use Agreements.AHEAD performs data procurement, analysis, and validation.We make decisions rooted inhonest data brokering andsound statistics.We respond to emails within 48 business hours. Data ManagersAHEAD GUIDE FOR INVESTIGATORS

56Task*AssigneeCreate Output Summary, Tables, & FiguresAHEADWrite Methods AHEADWrite Results Investigator & AHEADObtain AHEAD Approval for PublicationInvestigatorSubmit Abstract & ManuscriptInvestigatorRevise ManuscriptInvestigator & AHEADReport Publications & Presentations to AHEADInvestigatorAttend Final Meeting with Award SpecialistInvestigator & AHEADFinal DeliverablesAHEAD provides results tables, figures, and otherdeliverables.Discuss deliverables to ensure research needs are met.Our Process: Step-by-Step6Scientific OutputsJointly write sections of abstracts and manuscripts.Abide by Publication Policy (page 12). Investigator is responsible for activities and fees directly relatedto submitting works for publication.Investigator agrees to properly include AHEAD biostatisticians as co-authors on publications and presentations involving their methods.AHEAD GUIDE FOR INVESTIGATORS

CreditsSLU SOM faculty.Up to 50 hours per calendar year. Interested faculty must have approval fromdepartment chair or designee before submittinga Service Request.Just-In-TimeAwardsUp to $5,000 to utilize AHEAD services, providedby the Institute of Clinical and TranslationalSciences Just-In-Time program.Up to an additional $5,000 provided by SOMResearch’s Doubling Discovery program.GrantsInternal SLU grants are billed at $150 per hour. External grants are billed at $150 per hour or aspercent effort salary support (≥ 5%) for a specificanalyst.GMEFundingAvailable to residents and fellows.Provided by the Graduate Medical Education-AHEAD Research Training Program. Interested trainees should review the programguidelines and submit an application.Funding ManagementAll projects receive an initial 1-hour complimentary consultation.Funding Mechanisms7Cost estimates may change with scope or dataset adjustments.Investigators must communicate any changes in funding availability.AHEAD GUIDE FOR INVESTIGATORS

Services and Pricing8Pre-Grant Submission ServicesMethod Guidance andProject Planning Services Feasibility and strategysupport for the completion ofa grant application. Sample size and poweranalyses, feasibilityassessments, and researchstrategy writing.Submit service request 3months prior to the grantdeadline.Cost: Offered at no cost forup to 10 hours.Non-analytic services.Protocol development priorto data collection activities(e.g., planning for primarydata collection and Epic pullprotocols for IRB submission). All IRB submissions are theinvestigator’s responsibility.Biostatistical ServicesResearch Electronic DataCapture (REDCap)ServicesData procurement, analysis,validation, and visualization. Writing and revisions for themethods and results sectionsof abstracts and manuscripts.Survey design, build, andimplementation via REDCap.Investigators canindependently collect dataand build surveys, free ofcost. Questions?redcap@health.slu.eduServices are offered at $150 per hour, unless otherwise noted.AHEAD GUIDE FOR INVESTIGATORS

Available Data SourcesLarge research-ready databases and customized datasets.See the following pages for data source descriptions.9De-identified DataDescriptionWhen To Use ItMidwesternElectronic HealthRecords (SLU/SSM VirtualData Warehouse)EHR from SSMHealthcare System 2008 - PresentRegions: IL, MO, OK, WIUse asalternative toidentifiableEpic data Healthcare Cost & UtilizationProjectInpatient & ED EHR fromUS non-federal hospitals1988 - PresentRegions: all 50 statesUnique samplesStudy healthoutcomes overtime atnational, state,& communitylevelsAll of UsEHR from US healthcareorganizations< 10 years of dataRegions: all 50 statesSurveys & genomicsIndependent access forinvestigatorsStudy under-representedpopulations TriNetXEHR from healthcareorganizations across theglobe> 10 years of dataRegions: 30 countriesStudy rareconditionsAdditional Data OptionsInvestigator-supplied data, Epic data pulls, retrospective chartreviews, publicly available databases (e.g. CDC National Center forHealth Statistics). IRB approval or exemption may be required.AHEAD GUIDE FOR INVESTIGATORSThe above data sources require a data use agreement and/or data request.

Midwestern Electronic Health Records (SLU/SSM Virtual Data Warehouse)In-House Data Source DescriptionsHealthcare Cost and Utilization ProjectDe-identified EHR of > 5 million patients fromthe SSM Healthcare System (birth to age > 90years).Ambulatory and inpatient data. 2008 - Present.Ideal alternative to identifiable Epic data.Regions: Illinois, Missouri, Oklahoma,and Wisconsin. 10De-identified inpatient and emergency department EHR from USnon-federal hospitals.The largest collection of longitudinal US hospital care data.Ideal for developing national and regional estimates of inpatientutilization, access, cost, quality, and outcomes.Includes the following:Nationwide Inpatient Sample:1998-2017 (≈7 million hospital stays)Kids’ Inpatient Database:1997-2016 (≈3 million pediatric discharges)Nationwide Emergency DepartmentSample: 2003-2017 (≈33.5 million ED visits)Nationwide Readmissions Database:2016-2019 (≈18 million discharges)Key Contact: Joanne Salas, MPHjoanne.salas@health.slu.eduKey Contact: Tim Chrusciel, MPHtimothy.chrusciel@health.slu.eduAHEAD GUIDE FOR INVESTIGATORSOur in-house data sources are available at no additional cost.

All of UsTriNetXThird-Party Data Source DescriptionsDe-identified EHR of > 507,000 patients from US healthcareorganizations.Focused on underrepresented minorities (e.g., POC, LGBTQIA).Includes surveys, physical measurements, and digital health data.All investigators with a health.slu.edu email address canindependently access data snapshots. Register here. 11Key Contact: Joanne Salas, MPHjoanne.salas@health.slu.eduKey Contact: Ruizhi (Regina) Huang, MSruizhi.huang@health.slu.eduNew registrants receive an initial $300 credit tokickstart their projects. Once the credits areexhausted, users can resume analysis by adding theirown Google Billing Account. If you require our dataanalysis services, please submit a Service Request.De-identified EHR of > 120 million patients from healthcareorganizations around the globe (> 90% from US).Free of charge to unfunded investigators at contributinghealthcare organizations.Nominal fee required for grant-funded projects.AHEAD serves as the liaison between TriNetX and investigators forthe data request process.AHEAD GUIDE FOR INVESTIGATORSFees for third-party data sources may vary.

Publication Policy: To ensure the integrity andaccuracy of methodology, it is essential to includeAHEAD biostatisticians as co-authors on publicationsand presentations involving their data sciencemethods. All publications and presentations utilizingAHEAD resources must be submitted to AHEADpersonnel included as co-authors for final review andapproval. AHEAD personnel reserve 10 business daysto review all materials prior to submission to journalsor scientific conferences. All such materials mustinclude the following acknowledgment: "This work issupported by resources from the Saint LouisUniversity AHEAD Institute.”Data Storage Policy: Project data will be archived in azipped folder for 24-months following projectcompletion, or for a duration specified by the termsof a funding award. Investigators are responsible fornotifying the AHEAD personnel of the need to storeproject data beyond the standard 24-month periodand may also be responsible for the cost of extendeddata storage. Communication and Response Policy:The investigator’s failure to respond to the initialemail for consultation and subsequent emails for1 month will result in the project’s closure.AHEAD personnel will contact investigators within10 business days of receiving the service request.Throughout the project, AHEAD personnel willrespond to emails within 48 business hours duringregular working days.AHEAD personnel are not expected to workduring university holidays and campus closures.If AHEAD personnel are on vacation, they willrespond to emails upon their return.12Key TakeawaysInvestigators agreeto properly includeAHEADbiostatisticians asco-authors onpublications andpresentationsinvolving theirmethods.Investigators areresponsible fornotifying AHEADpersonnel of theneed to store projectdata beyond thestandard 24-monthperiod. The investigator’sfailure to respond tothe initial email forconsultation andsubsequent emailsfor 1 month willresult in theproject’s closure.AHEAD GUIDE FOR INVESTIGATORSPolicies

Ready to Start aNew Project?Questions? ahead@health.slu.eduService Request© 2025 Saint Louis University. All rights reserved.13Click below!

14Project StageTask*AssigneePre-InitialConsultationLiterature ReviewInvestigatorResearch Question & HypothesisInvestigatorData Source ExplorationInvestigatorSecure & Confirm Project FundingInvestigatorService RequestInvestigatorInitial ConsultationDiscussionData Source SelectionInvestigator & AHEADDetermine Study Design & MethodsInvestigator & AHEADRegulatory &CompliancePrepare Scope of WorkAHEADApprove Scope of WorkInvestigatorProvide Data Use AgreementAHEADSign & Return Data Use AgreementInvestigatorWrite, Submit, & Revise IRB ProtocolInvestigatorObtain IRB Approval or ExemptionInvestigatorSubmit Data RequestVaries by data sourceProject ExecutionData Pull/CutAHEADData CollectionInvestigatorData AnalysisAHEADOutput Summary, Tables, & FiguresAHEADMethods WritingAHEADResults WritingInvestigator & AHEADObtain AHEAD Approval forPublicationInvestigatorAbstract & Manuscript SubmissionInvestigatorManuscript RevisionsInvestigator & AHEADNotify AHEAD of All Publications & Conference PresentationsInvestigatorKey Project Responsibilities*Not all tasks are required for every project. Required tasks will be clarified during the initial consultation.AHEAD GUIDE FOR INVESTIGATORS