Mentored Research Training Program (TL1)

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Mentred Research Training Prgram (TL1) The TL1 award supprts trainees seeking a practical intrductin t clinical and translatinal research. The TL1 award prvides full-time research training supprt fr predctral candidates and cmbined health-prfessinal dctrate-master s candidates and t pstdctral fellws seeking additinal training in clinical research. The verall gal f the TL1 prgram is t increase the number f well-trained clinician-scientists wh can lead the design and versight f future clinical investigatins critical t transfrming the translatinal prcess s that new treatments and cures fr disease can be delivered t patients faster. Fr this award cycle, applicatins are being accepted fr: Up t tw predctral awardees cnducting clinical and translatinal research Or up t ne pstdctral awardee cnducting clinical and translatinal research The OSU CCTS TL1 training prgram is part f the NIH Ruth L. Kirschstein Natinal Research Service Award (NRSA) prgram, the gal f which is t help ensure that a diverse pl f highly trained scientists is available in apprpriate scientific disciplines t address the Natin's bimedical, behaviral, and clinical research needs. It is funded thrugh a grant frm the Natinal Center fr Clinical and Translatinal Science (NCATS). All TL1 awardees will receive: Stipend supprt awarded at the NIH allwed annual maximum; Up t $4,000 t defray the cst f the research prgram and travel t natinal meetings; Access t the CCTS prfessinal services and staff including bistatistics, subject recruitment, and human subjects apprval; and Access t a training curriculum in clinical and translatinal research methdlgy and specialized training seminars. Predctral awardees will als receive tuitin supprt. If yu have any additinal questins abut this pprtunity, please cntact Stuart Hbbs at 614-685-5972 r via e-mail at stuart.hbbs@sumc.edu Applicant Eligibility Requirements Befre yu apply, please nte the fllwing infrmatin. Eligibility criteria fr TL1 applicants (established by ur funding surce, the Natinal Institutes f Health) are as fllws: 1. Citizenship Status: At the time f appintment t the training prgram, individuals selected t participate in the training prgram must be citizens r nn-citizen natinals f the United States, r have been lawfully admitted t the United States fr permanent residence and have in their pssessin an Alien Registratin Receipt Card (I-151 r I-551) r ther legal verificatin f admissin fr permanent residence. Nn-citizen natinals are persns brn in lands that are nt States but are under U.S. svereignty, jurisdictin, r administratin (e.g., American Sama). Individuals n temprary r student visas are nt eligible fr NRSA supprt. 2. Predctral Trainees: Pre-dctral trainees must have received a baccalaureate degree by the beginning date f their NRSA trainee appintment and must be training at a pst-baccalaureate level and enrlled in a prgram leading t a PhD in a clinical research-related dctral degree prgram, r a cmbined dctral level prfessinal degree plus a clinical research-related advanced degree, such as a MD, DDS, DO, DNP, PharmD / MS r MD, DDS, DO, DNP, PharmD / PhD. Students wh are fficially enrlled in a qualifying health-prfessinal dctral prgram and wish t pstpne their prfessinal studies fr ne year t gain research experience may be appinted t the Rev. 10/03/2017

TL1 RFA 2017 2 TL1 research training grant fr that perid, prvided that NRSA eligibility requirements are met. NRSA supprt is nt prvided fr study leading t a MD, DO, DDS, DNP, PharmD r ther similar prfessinal clinical degrees, r a master's degree that is nt pursued in a cmbined prgram with a prfessinal level dctrate. Individuals currently supprted by ther Federal funds are nt eligible fr trainee supprt frm the TL1 prgram at the same time. 3. Pst-dctral Trainees. Pstdctral trainees must have received, as f the beginning date f the NRSA appintment, a PhD, MD, DDS, r cmparable dctral degree frm an accredited dmestic r freign institutin. Eligible dctral degrees include, but are nt limited t the fllwing: DMD, DC, DO, DVM, OD, DPM, ScD, EngD, AuD, DPT, DPH, DNSc, PharmD, ND (Dctr f Naturpathy), DSW, PsyD as well as a dctral degree in nursing research r practice. Pstdctral appintees can be paid up t $51,120 per year. Any stipend due them abve that amunt will have t be cvered by the applicant s department r cllege, and an acknwledgement f this supprt frm the Department Chair shuld be included. Fr NIH established pstdc stipend levels see http://grants.nih.gv/grants/plicy/nihgps/html5/sectin_11/11.1_general.htm 4. Effrt: Trainees must be able t cmmit full-time effrt in the prgram at the time f appintment. 5. Training Supprt: N individual trainee may receive mre than 5 years f aggregate NRSA supprt at the pre-dctral level, including any cmbinatin f supprt frm institutinal training and individual fellwship awards Educatinal Requirements Nte: These requirements shuld be reflected in yur Career Develpment plan, as apprpriate. All pre-dctral trainees wh are nt enrlled in an apprved Clinical and Translatinal academic prgrams (such as MPH in Clinical Translatinal Science, the Bimedical Sciences Graduate Prgram with a clinical r translatinal emphasis, r the Graduate Interdisciplinary Specializatin in Bimedical Clinical and Translatinal Science [GISBCTS],) will be required t enrll in the GISBCTS. All trainees (pre- and pst- dctral) will take PUBHEPI 6412 - Basic Principles in Clinical and Translatinal Science and PUBHEPI 6413: Cnducting & Cmmunicating Research in Clinical & Translatinal Science. All curses taken thrugh the graduate schl, with the exceptin f curses taken under the audit ptin, cunt tward minimum hurs requirement fr dctral students. Predctral trainees are respnsible fr ensuring they are enrlled in the prper number f hurs fr Fall, Spring, and Summer semesters. Failure t meet any f these cnditins may result in the immediate cancellatin f the Graduate Schl Tuitin and Fee Award. Students are respnsible fr the payment f any special fees such as the COTA fee, recreatin fee, student activity fee, learning technlgy fee, etc. Predctral TL1 Trainees must remain in gd academic standing, which requires a minimum quarterly cumulative grade pint average f 3.00 while making reasnable prgress tward the graduate degree. All trainees are expected t attend the Translatinal Science Cnference spnsred by the Assciatin fr Clinical and Translatinal Science. All trainees will cmplete the CITI Gd Clinical Practice training if they have nt already dne s.

TL1 RFA 2017 3 Scientific Mentrship Team Applicants will put tgether a three-persn mentring team. Primary Mentr. It is expected that the applicant will identify a mentr in their area f clinical r translatinal research wh is likely t be a member f the faculty in the applicant s unit. Under guidance frm the mentr, the applicant will further develp their prpsal that describes the clinical research prject t be undertaken. Yur mentr is respnsible fr: Guiding and encuraging the design and executin f an riginal, high quality, clinical research prject. Supervising the preparatin f a final reprt. Prviding career develpment and cunseling. Attending CCTS Mentr training Yur mentr shuld meet with yu regularly at least mnthly and attend ccasinal meetings/trainings fr TL1 trainees and mentrs rganized by the CCTS. Additinal members f the mentrship team (at least 2 additinal): The mentrship team prvides additinal expertise in the scientific area f research chsen fr the prject. In rder fr the team t be cmplementary t the interests f the primary mentr, the threepersn team shuld have the fllwing characteristics: 1. One mentr must be frm a different department than the applicant. The chice f this mentr shuld reflect a skill-building purpse that is discussed in the career develpment and mentring plans. 2. The mentring team must include at least ne clinician and ne lab-based researcher. Mentring teams that crss health science clleges are encuraged, but nt required. Yur mentrship team may include a University faculty member wh is nt a regular member f the graduate faculty (e.g., an adjunct prfessr), a University staff member, r a qualified individual utside the University wh can prvide expertise in yur discipline. It is imprtant that yu cnsider and discuss what yu wuld d differently if yu receive this award cmpared t yur training withut the award. Additinal infrmatin A Study Sectin will make recmmendatins t the CCTS Executive Cmmittee fr funding Reviewers will evaluate the applicatins by reviewing: the Trainee, the Training Plan, the Mentrs, and the Research. All applicants will receive reviewer cmments n their applicatins. Appinted TL1 Trainees are nt allwed t simultaneusly hld anther appintment r psitin. Trainees must be appinted as a full-time fellw in the PepleSft system and must maintain that appintment during the entire award perid. The student may nt be required t perfrm any service fr the fellwship stipend beynd that nrmally required fr cursewrk and/r research activities, and may nt hld any ther type f emplyment r appintment. Graduate Fellws and Pstdctral Fellws receive stipends related t their academic prgrams. They d nt render services fr pay, and therefre are nt cnsidered emplyees and are nt eligible t pay int the state retirement system, OPERS, nr will they accrue vacatin, r service credits fr the length f the award perid. Mnthly stipends fr fellwships are subject t federal, state and lcal taxes. Depending n a fellw s residency

TL1 RFA 2017 4 status, their taxes may r may nt be withheld frm their stipend. Questins regarding taxes n fellwships shuld be directed t the Office f the Cntrller, Payrll Services Tax Infrmatin, 614-292-2311, r < cntrller.su.edu/pay/pay-hme.shtm > Mre infrmatin can als be fund n the Pstdc pages f the Cllege f Medicine website: Additinal Infrmatin Befre yu apply, please nte the fllwing infrmatin. CLINICAL RESEARCH AND CLINICAL TRIALS Per regulatins, Ruth L. Kirschstein TL1 awards fund clinical research, per the fllwing definitins. Clinical Research 1 : Research with human subjects that is: 1) Patient-riented research. Research cnducted with human subjects (r n material f human rigin such as tissues, specimens, and cgnitive phenmena) fr which an investigatr (r clleague) directly interacts with human subjects. Excluded frm this definitin are in vitr studies that utilize human tissues that cannt be linked t a living individual. It includes: (a) mechanisms f human disease, (b), therapeutic interventins, (c) clinical trials, r (d) develpment f new technlgies. 2) Epidemilgical and behaviral studies. 3) Outcmes research and health services research. Clinical Trial 2 : A research study in which ne r mre human subjects are prspectively assigned t ne r mre interventins (which may include placeb r ther cntrl) t evaluate the effects f thse interventins n healthrelated bimedical r behaviral utcmes. Types f Clinical Trials: Diagnstic trials determine better tests r prcedures fr diagnsing a particular disease r cnditin. Natural histry studies prvide valuable infrmatin abut hw disease and health prgress. Preventin trials lk fr better ways t prevent a disease in peple wh have never had the disease r t prevent the disease frm returning. Quality f life trials (r supprtive care trials) explre and measure ways t imprve the cmfrt and quality f life f peple with a chrnic illness. Screening trials test the best way t detect certain diseases r health cnditins. Treatment trials test new treatments, new cmbinatins f drugs, r new appraches t surgery r radiatin therapy. Phases f Clinical Trials: Clinical trials are cnducted in phases. The trials at each phase have a different purpse and help researchers answer different questins. The OSU TL1 prgram is funded by the NIH s Natinal Center fr Advancing Translatinal Science (NCATS). The authrizatin fr NCATS limits specific supprt fr clinical trials nly thrugh the end f Phase IIA 3. Therefre, if yur research prject is a clinical trial, it shuld fit ne f the fllwing descriptins: Phase I trials Tests a new bimedical interventin in a small grup f peple (e.g. 20-80) fr the first time t determine efficacy and evaluate safety (e.g., determine a safe dsage range and identify side effects). Phase II trials Study the bimedical r behaviral interventin in a larger, but still limited, grup f peple (up t several hundred) t determine efficacy and further evaluate safety. Phase II trials are further divided: 4 1 http://grants.nih.gv/grants/plicy/nihgps/html5/sectin_1/1.2_definitin_f_terms.htm accessed February 2016. 2 http://grants.nih.gv/grants/plicy/nihgps/html5/sectin_1/1.2_definitin_f_terms.htm accessed February 2016. 3 http://ncats.nih.gv/files/phs-act.pdf accessed February 2016. 4 http://www.virginia.edu/vpr/irb/hsr_dcs/clinical_trials_phases.pdf accessed February 2016.

TL1 RFA 2017 5 Phase IIa: Pilt clinical trials t evaluate efficacy ( and safety) in selected ppulatins f patients with the disease r cnditin t be treated, diagnsed, r prevented. Objectives may fcus n dse-respnse, type f patient, frequency f dsing, r numerus ther characteristics f safety and efficacy. Phase IIb (Nt funded by this award): Well cntrlled trials t evaluate efficacy ( and safety) in patients with the disease r cnditin t be treated, diagnsed, r prevented. These clinical trials usually represent the mst rigrus demnstratin f a medicine's efficacy. Smetimes referred t as pivtal trials. NCATS prvides the additinal fllwing distinctin: Phase IIA trials prvide data fr expsure-respnse in patients, while Phase IIB trials [nt funded by this award] prvide data fr dse-ranging in patients. http://ncats.nih.gv/clinical 5 Phase III trials Nt funded by this award. Study t determine efficacy f the bimedical r behaviral interventin in large grups f peple (frm several hundred t several thusand) by cmparing the interventin t ther standard r experimental interventins as well as t mnitr adverse effects, and t cllect infrmatin that will allw the interventins t be used safely. Phase IV trials Nt funded by this award. Studies cnducted after the interventin has been marketed. These studies are designed t mnitr the effectiveness f the apprved interventin in the general ppulatin and t cllect infrmatin abut any adverse effects assciated with widespread use. THE SPECTRUM OF TRANSLATIONAL HEALTH RESEARCH 6 Per regulatins, Ruth L. Kirschstein TL1 awards fund translatinal research that ccupies a particular space n the Clinical & Translatinal research spectrum: T1 t T4 (excluding clinical trials frm Phase IIB t Phase IV). The applicatin has a sectin where yu will place yur research n the spectrum and prvide a tw t 4 sentence justificatin fr that placement. Belw are definitins and mre infrmatin. Translatinal research invlves mving knwledge gained frm the basic sciences t its applicatin in clinical and cmmunity settings. This cncept is ften summarized by the phrases bench-t-bedside and bedside-tcmmunity research. As the cncept f translatinal health research has evlved with practice and time, it is clear that translatinal research encmpasses a bidirectinal cntinuum. Fr didactic purpses, translatinal research has ften been described in phases f translatin, r T-phases. T0 refers t basic scientific discvery (Nt funded by this award). T0 is characterized by the identificatin f pprtunities and appraches t health prblems. T1 seeks t mve basic discvery int a candidate health applicatin. Research examples include: human pysilgy, first in humans (healthy vlunteers), prf f cncept, Phase 1 Clinical Trials. T2 assesses the value f applicatin fr health practice leading t the develpment f evidence-based guidelines. Research examples include: Phase 2 and Phase 3 Clinical Trials. Clincial trials IIB and fllwing are nt funded by this award. T3 attempts t mve evidence-based guidelines int health practice, thrugh delivery, disseminatin, and diffusin research. Research examples include health services research related t desseminatin, cmmunicatin, and implementatin; and clinical utcmes research. Phase 4 Clinical Trials are als part f T3, but are nt funded by this award. T4 seeks t evaluate the real wrld health utcmes f ppulatin health practice. Research examples include: ppulatin level utcme studies; studies f the scial determinatns f health. THE SPECTRUM OF TRANSLATIONAL HEALTH RESEARCH (T0 TO T4) 5 http://ncats.nih.gv/clinical accessed February 2016. 6 Adapted frm T-Phases f Translatinal Health Research at https://www.iths.rg/investigatrs/definitins/translatinal-research/, and Harvard Catalyst at http://catalyst.harvard.edu/pathfinder/ accessed June 2015.

TL1 RFA 2017 6 Surce: http://catalyst.harvard.edu/pathfinder/ accessed June 2015 Cre Cmpetencies fr Clinical and Translatinal Investigatr Training The task f CTSA educatin prgrams is t prepare the next generatin f investigatrs t cnduct clinical and translatinal research that will address the health care challenges faced in the United States. Creating a recgnizable discipline centered n clinical and translatinal science will help build this wrkfrce. T help establish the discipline, the CTSA Educatin and Career Develpment Key Functin Cmmittee has drafted natinal standards fr cre cmpetencies in clinical and translatinal science. The thematic cmpetencies identify cmmn, basic elements that shuld shape the training experiences f junir investigatrs by defining skills, attitudes and behavirs that can be shared acrss multidisciplinary teams f clinician-scientists. The verall gal is t create a cmpetency-based educatin fr training clinician-scientists that will define the discipline f clinical and translatinal science. Research Methds Identify majr clinical/public health prblems and relevant translatinal research questins Identify, interpret, and critique literature and assess the state f knwledge regarding a prblem Knw hw t design a study prtcl fr clinical and translatinal research Understand study methds, design and implementatin Use apprpriate labratry, clinical, and ppulatin research methds Understand the principles f the cnduct f respnsible research Analysis, Statistics, and Infrmatics Be able t use apprpriate statistical methds and cnduct relevant analysis

TL1 RFA 2017 7 Be cmpetent in apprpriate biinfrmatics Cmmunity & Cmmunicatins Understand the principles f cmmunity engagement in clinical and translatinal research Navigate cmpetently amng divers ppulatins and cultures Be able t cmmunicate scientific findings t yur peers and t disseminate scientific knwledge t thse utside yur field, including ther scientists, university administratrs, plicy makers, and the public Leadership & Training Participate in crss-disciplinary training and mentring Demnstrate leadership and prfessinalism Engage in translatinal teamwrk (Mre infrmatin: https://www.ctsacentral.rg/dcuments/ctsa%20cre%20cmpetencies_%20final%202011.pdf ) Graduate Interdisciplinary Specializatin in Bimedical, Clinical, and Translatinal Science The gal f the Graduate Interdisciplinary Specializatin in Bimedical Clinical and Translatinal Science (GISBCTS) is t prepare graduate and prfessinal students t be actively engaged in the field f clinical and translatinal science thrugh academic training and research. As defined by the Ohi State University Graduate Schl, a graduate interdisciplinary specializatin (GIS) invlves tw r mre graduate prgrams utside the student's hme prgram. Cmpletin f a GIS is nted n the student's transcript. The cre curse in this prgram fcuses n the basic cmpnents f clinical and translatinal science, while the electives allw students t pursue tpics acrss the ther health sciences clleges fr an interdisciplinary experience. Curriculum Requirements All students enrlled in the GISBCTS must take PUBHEPI 6412 Cnducting and Cmmunicating Research in Clinical and Translatinal Science. This is a 2 credit hur curse ffered each Autumn semester by the Cllege f Public Health. It is recmmended, but nt required, that this curse be taken first. Mst f the participating clleges have internal prcedures that are required t enrll in their curses, such as cntacting the instructr. Fr mst f these curses yu will need t talk t the instructr befre enrlling. Students must take at least ne curse frm each f the Cre Cmpetency Clusters. The Cmpetency Clusters are based n the Natinal Center fr Research Resurces (NCRR) Cre Cmpetencies fr Clinical and Translatinal Research. There are a ttal f 14 cmpetencies that have been gruped tgether t frm fur clusters. Specializatin Guidelines

TL1 RFA 2017 8 The GISBCTS require a minimum f 10 and n mre than 20 semester credit hurs f graduate level cursewrk taken frm at least 5 different curses. A graduate interdisciplinary specializatin invlves tw r mre graduate prgrams utside the student's hme prgram. Nine credit hurs must be taken utside f the student's hme prgram in at least three curses. Thus, if yu are a BSGP student, yu must select at least three curses frm the GISBCTS curse menu that cme frm utside that curriculum. These curses can cme frm ther prgrams in the Cllege f Medicine r frm ther clleges. Credit hurs can include wrk already required as part f the student's degree prgram. If there is a curse that fits the cmpetencies but is nt listed here, it is pssible t substitute it fr a listed curse. Cntact the GISBCTS prgram administratr fr mre infrmatin. Apply fr the Specializatin thrugh OSU Graduate Schl at this address: https://gradsch.su.edu/pursuing-yur-degree/career-develpment/degree-ptins/applyinggraduate-minrs-and Questins? Cntact the GISBCTS prgram administratr at Stuart.Hbbs@sumc.edu r 614-685-5972 Cre Cmpetencies In 2008, The Natinal Center fr Research Resurces and the Clinical and Translatinal Science Award (CTSA) Educatin and Career Develpment Steering Cmmittee develped natinal standards fr cre credentialing cmpetencies fr clinical and translatinal science. The verall gal was t create a cmpetency based educatin fr training clinician-scientists that will define the discipline f Clinical and Translatinal Science. The OSU CCTS uses these Cre Cmpetencies t develp its fundatin curses as well as evaluate Trainees.. There are a ttal f 14 cmpetencies that have been gruped tgether t frm fur clusters. Research Methds Identify majr clinical/public health prblems and relevant translatinal research questins Identify, interpret, and critique literature and assess the state f knwledge regarding a prblem Knw hw t design a study prtcl fr clinical and translatinal research Understand study methds, design and implementatin Use apprpriate labratry, clinical, and ppulatin research methds Understand the principles f the cnduct f respnsible research Analysis, Statistics, and Infrmatics Be able t use apprpriate statistical methds and cnduct relevant analysis Describe and make use f best practices fr managing, prtecting, and analyzing bimedical and health infrmatin Cmmunity & Cmmunicatins Understand the principles f cmmunity engagement in clinical and translatinal research Navigate cmpetently amng divers ppulatins and cultures Be able t cmmunicate scientific findings t yur peers and t disseminate scientific knwledge t thse utside yur field, including ther scientists, university administratrs, plicy makers, and the public Leadership & Training Participate in crss-disciplinary training and mentring

TL1 RFA 2017 9 Demnstrate leadership and prfessinalism Engage in translatinal teamwrk All students take the cre curse: PUBHEPI 6412: Basic Principles in Clinical & Translatinal Science Then students take at least ne curse frm each f the fur Cre Cmpetencies Research Methds BSGP 8050: Research Techniques & Resurces NURSING 8780: Research Methds I Analysis, Statistics, and Infrmatics Cmmunity & Cmmunicatin Leadership & Training HTHRHSC 7888: Grand Runds NURSING 8781: Research Methds II NURSING 8782: Research Methds III BSGP 7070: Fundamentals f Grant Writing I NURSING 7404: Leadership in Healthcare & Clinical Research Prject Management ONLINE NRSPRCT 8400: Leadership Thrughut Organizatins & Systems NURSING 7781: Respnsible Cnduct f Research. ONLINE NURSING/PHARMACY 7782 Research Design & Methds fr Clinical & Preclinical Research. ONLINE NRSPRCT 8780: Clinical Effectiveness & Translatin in Clinical Science PUBHEPI 7412: Principles & Prcedures fr Human Clinical Trials PUBHHBP 7532: Prgram Evaluatin PUBHHBP 7534: Research Methds in Health Behavir & Health Prmtin PUBHHBP 7522: Prgram Planning & Implementatin PUBHBIO 6280: Practical Bistatistics fr Bimedical Labratry Researchers PUBHBIO 6210: Design & Analysis f Studies in the Health Sciences I (nline available) PUBHBIO 6211: Design & Analysis f Studies in the Health Sciences II PUBHBIO 7245: Bistatistical Cllabratin PSYCH 6810: Statistical Methds in Psychlgy I PSYCH 6811: Statistical Methds in Psychlgy II STAT 5301: Intermediate Data Analysis I BSGP 7080: Fundamentals f Grant Writing II NRSPRCT 8401: Strategic Macrsystem Management fr the Dctr f Nursing Practice Nursing 6110: Health Literacy HTHRHSC 7300: Management & Leadership in Health Sciences PUBHHBP 7520: Cmmunity Health Assessment PUBHHBP 7544: Fundamental Determinants f Ppulatin Health & Implicatins fr Pub Health Research & Practice PUBHHBP 7558: Scial Eclgical Strategies in Preventin PUBHEPI 6413:Cnducting & Cmmunicating Research in Clinical & Translatinal Science VISSCI 7940: Oral Presentatin f Scientific Research HTHRHSC 7350: Issues & Plicy in Health Sciences PHR 5660: Success & Leadership in Pharmacy PUBHHMP 7617: Health Services Leadership & Organ-izatinal Change PUBAFRS 6000: Public Plicy Frmulatin & Implementatin PUBHHMP 8671: Health Care Outcmes Measurement PUBHHMP 7678: Appraches t Health Services Research VISSCI 7960: Ethics in Bimedical Research STAT 5302: Intermediate Data Analysis II VETCLIN 8783: Experimental Design & Data Analysis in Veterinary & Cmparative Medicine I VETCLIN 8784: Experimental Design & Data Analysis II VISSCI 7970: Grantsmanship VETCLIN 8781 Research Methds and Grantsmanship

TL1 RFA 2017 10 PHR 8520: Research Ethics Cre Curse: Cllege f Public Health Epidemilgy Curse Descriptins PUBHEPI 6412: Basic Principles in Clinical and Translatinal Science Identificatin f clinical and translatinal research issues, assessment f the literature, ethically respnsible research, crssdisciplinary training and mentring. 2 units. Other Curses t Select Frm: Cllege f Medicine Schl f Health and Rehabilitatin Sciences HTHRHSC 7300: Management & Leadership in Health Sciences Applicatin f management and leadership principles fr the develpment f administratin f allied health departments in the health care system. 3 units HTHRHSC 7350. Issues and Plicy in Health Sciences Students develp leadership skills and learn t explain and discuss the laws and plicies that influence allied health prfessins. 3 units HTHRHSC 7888 : Health and Rehabilitatin Science Grand Runds Intr Students develp skills in analyzing, discussing and synthesizing health and rehabilitatin research. Students present their wn research and critically appraise faculty research. Discussin and demnstratin f leadership will ccur. 1 units. Bimedical Science Graduate Prgram BSGP 7070: Fundamentals f Grant Writing I Intrduce students t the basics principles f grant writing. 2 units. BSGP 7080: Fundamentals f Grant Writing II Intrduce students t principles f grant writing. Students will als write their wn grants in the style f NIH submissins. Students will als learn abut the grant review prcess. 2 units BSGP 8050: Research Techniques and Resurces Survey f research techniques used t slve prblems in mdern cell and mlecular bilgy, immunlgy, bichemistry, micrbilgy, micrscpy, labratry safety, and related available resurces. 4 units. Cllege f Nursing: Nursing Practice NRSPRCT 8400: Leadership Thrughut Organizatins & Systems Scializatin t leadership and excellence in multiple dimensins f the Dctr f Nursing Practice rle. 3 units NRSPRCT 8401: Strategic Macrsystem Management fr the Dctr f Nursing Practice Integratin f theretical, leadership and cmmunicatin principles int strategic management strategies fr evidence based, innvative macr system health care ptimizatin fr selected ppulatins. 3units NRSPRCT 8780: Clinical Effectiveness and Translatin in Clinical Science Theretical underpinnings f nursing knwledge and critical appraisal f clinical relevant research related t clinical effectiveness and translatinal science cncepts. 3 units. Cllege f Nursing NURSING 6110: Health Literacy Examinatin and analysis f issues f lw health literacy, including ppulatins at risk, research, measurement tls, writing in plain language; health cmmunicatin techniques; and rganizatinal appraches. 2 units. Nursing 7504: Clinical Research Prject Management and Leadership Principles f prject management, strategic planning, and leadership in clinical research and regulatry settings. 3 credits. Summer. ONLINE

TL1 RFA 2017 11 Nursing 7781: Respnsible Cnduct f Research Cncepts and plicies fr the respnsible cnduct f research (RCOR), Institutinal Review Bards, and disseminatin f findings. 3 credits Autumn/Spring. ONLINE, face-t-face as needed Nursing/Pharmacy 7782 Research Design and Methds fr Clinical and Preclinical Research Study f research design and methds used in clinical and preclinical research. Measurement issues, bias and cnfunding, statistical cnsideratins, evaluatin f published clinical and preclinical research designs, and prtcl and prpsal develpment. 3 credits. Autumn/Spring. ONLINE NURSING 8780: Research Methds I Survey f quantitative, qualitative and mixed methds appraches relevant t Nursing and health. Emphasis is placed n cmmn research designs in Nursing and health research. 3 units. NURSING 8781: Research Methds II Survey f quantitative, qualitative and mixed methds appraches relevant t nursing and health. Emphasis is placed n cmmn measurement and sampling in nursing and health research. 3 units. NURSING 8782: Research Methds III Integratin and applicatin f theretical and measurement appraches applied at micr-, mesand macr-levels in nursing and health research. Emphasis is n selected measures f individual and ppulatin health. 4 units. Cllege f Pharmacy PHR 5560: Success & Leadership in Pharmacy Explre the meaning f success and leadership, attributes f successful leaders and what can be dne t be a successful leader. 0.5 1.5 units PHR 8520 Research Ethics Basic cncepts f integrity in the prcess f research. The curse fulfills NIH requirement fr research ethics. 1 unit. Pharmacy/Nursing 7782 Research Design and Methds fr Clinical and Preclinical Research Study f research design and methds used in clinical and preclinical research. Measurement issues, bias and cnfunding, statistical cnsideratins, evaluatin f published clinical and preclinical research designs, and prtcl and prpsal develpment. 3 credits. Autumn/Spring. ONLINE Cllege f Public Health Bistatistics PUBHBIO 6210: Design and Analysis f Studies in the Health Sciences I Thery and applicatin f basic statistical cncepts fr design f studies in health sciences, integrated with statistical sftware applicatins. In class & nline sectins available. 3 units. PUBHBIO 6211: Design and Analysis f Studies in the Health Sciences II A secnd curse in applied bistatistical methds and data analysis. Categrical data methds, nnparametric statistical testing, analysis f variance designs, and regressin methds. Integrated with use f cmputer statistical packages. 3 units. PUBHBIO 6280: Practical Bistatistics fr Bimedical Labratry Researchers Intrductin t statistical principles and methds apprpriate fr experimental labratry data with applicatins in bimedical sciences. 3 units PUBHBIO 7245: Bistatistical Cllabratin Basic bimedical research methdlgies; cllabrate with bimedical researchers t design experiments and plan analyses; prtcl preparatin; prfessinal skills develpment; statistical reprt preparatin. 2 units. Cllege f Public Health Epidemilgy PUBHEPI 6412: Basic Principles in Clinical and Translatinal Science Identificatin f clinical and translatinal research issues, assessment f the literature, ethically respnsible research, crss-disciplinary training and mentring. 2 units. PUBHEPI 6413: Cnducting and Cmmunicating Research in Clinical and Translatinal Science Design and writing f prtcl, study methds and implementatin, cmmunity engagement, infrmatics, translatinal teamwrk. Scientific cmmunicatin skills and disseminatin f clinical and translatinal science. 2 units. PUBHEPI 7412: Principles and Prcedures fr Human Clinical Trials Principles and prcedures fr clinical prfessinals in the design, cnduct and analysis f human clinical trials. 3 units. Cllege f Public Health Health Behavir and Health Prmtin PUBHHBP 7520: Cmmunity Health Assessment

TL1 RFA 2017 12 Mdels f cmmunity health assessment; skills in identifying, analyzing and integrating infrmatin cncerning cmmunity resurces and needs. 3 units. Evaluatin f specific techniques fr measuring utcmes in clinical and health services research studies. 2 units. PUBHHBP 7522: Prgram Planning and Implementatin Planning and implementatin f prgrams t address public health issues in defined ppulatins; develpment f a health prmtin prgram fr a specific cmmunity partner. 3 units PUBHHBP 7532: Prgram Evaluatin in Public Health Examinatin f evaluatin mdels fr public health prgrams; explratin f philsphical and scientific issues in evaluatin; and skill building in bth qualitative and quantitative evaluatin methds. 3 units. PUBHHBP 7534: Research Methds in Health Behavir and Health Prmtin Scial science research methds emphasizing methds used t assess the dimensins f healthrelevant behavirs and cmmunity-based preventin research. 3 units. PUBHHBP 7544: Fundamental Determinants f Ppulatin Health and Implicatins fr Public Health Presents the ideas that ppulatin health is determined by factrs utside f health care and individual behavir ccurs within a scial cntext. 3 units. PUBHHBP 7558: Scial-Eclgical Strategies in Preventin Cmmunity health prmtin strategies using plicy, systems, and envirnmental change perspectives. 2 units Cllege f Public Health Health Services Management and Plicy PUBHHMP 7617: Leadership in Health Care. Overview f leadership in health care with an emphasis n thery, leadership develpment, and leadership styles. 3 units PUBHHMP 7678: Appraches t Health Services Research Overview f the field f health services research and the rle f health services research in imprving health care delivery. 3units. PUBHHMP 8671: Health Care Outcmes Measurement Jhn Glenn Schl f Public Affairs PUBAFRS 6000: Public Plicy Frmulatin and Implementatin Overview f the public plicy prcess and the histrical and cntemprary cntext in which plicy making and implementatin are carried ut in the United States at the federal, state and lcal levels. Psychlgy PSYCH 6810: Statistical Methds in Psychlgy I Basic cncepts f descriptive and inferential statistics; includes estimatin, hypthesis testing, nn-parametric techniques, and analysis f variance. 4 units. PSYCH 6811: Statistical Methds in Psychlgy II Simple linear regressin and crrelatin, multiple linear regressin, interactins; intrductin t ther related methds such as nnlinear regressin and randm effects mdels. 4 units. Statistics STAT 5301: Intermediate Data Analysis I The first curse in a tw-semester nn-calculus sequence in data analysis cvering descriptive statistics, design f experiments, prbability, statistical inference, ne-sample t, gdness f fit, tw sample prblem, and ne-way ANOVA. 4 units. STAT 5302: Intermediate Data Analysis II The secnd curse in a tw-semester sequence in data analysis cvering simple linear regressin (inference, mdel diagnstics), multiple regressin mdels, variable selectin, mdel selectin, tw-way ANOVA, mixed effects mdel. 3 units. Cllege f Veterinary Medicine VETCLIN 8781: Research Methds and Grantsmanship Intrductin t grantsmanship, including the develpment f a research questin, use f apprpriate statistical methds, and the preparatin f a research prpsal that will be reviewed by the class.1 unit. VETCLIN 8783: Experimental Design & Data Analysis in Veterinary & Cmparative Medicine I

TL1 RFA 2017 13 Principles and practice f study designs and data analyses cmmnly used in veterinary and cmparative medical research. 1 unit. VETCLIN 8784: Experimental Design & Data Analysis in Veterinary & Cmparative Medicine II Intrductin t the principles and practice f study designs and data analyses cmmnly used in veterinary and cmparative medical research. 1 unit. Visin Science VISSCI 7960: Ethics in Bimedical Research Prvides a general understanding f the issues surrunding the ethical cnduct f science including issues related t research invlving human subjects, scientific miscnduct, and authrship f scientific papers. Real-life case studies will be used. 2 units. VISSCI 7970: Grantsmanship The structure f the Natinal Institutes f Health, the principles f gd grantsmanship, and descriptin f the grant review prcess. Emphasis fcused n Mentred Clinical Scientist Develpment Award (K23) and Research Prject Grant (R01). 2 units. VISSCI 7940: Oral Presentatin f Scientific Research Student gives a talk based n his/her research r schlarship and imprves his/her speaking skills. 1-3 units.