2018 Center for Translational Medicine Clinical and Translational Research Scholars Program

Transcription

1 Request fr Applicatins (RFA) KL2 Prgram Directrs: Keith Argenbright, MD, MMM and Helen Yin, PhD TL1 Prgram Directr: Andrew Zinn, MD, PhD 2018 Center fr Translatinal Medicine Clinical and Translatinal Research Schlars Prgram Cntact infrmatin: Amy Mackenrth, M.A., Supervisr f Educatin Prgrams educatin@utsuthwestern.edu r Spnsred in part by a Clinical and Translatinal Science Award (CTSA) grant frm the Natinal Center fr Advancing Translatinal Science (KL2TR001103, UL1TR001105, TL1TR001104) Submit yur intent t apply by Nvember 1: Executive Summary: The Center fr Translatinal Medicine () at the University f Texas Suthwestern Medical Center (UTSW) invites cmpetitive applicatins frm junir faculty, fellws, and residents frm UTSW and partner institutins t participate in the 2018, tw-year Clinical and Translatinal Research Schlars Prgram (Prgram). The Prgram is designed t prvide intense research training and career develpment pprtunities in a multidisciplinary setting that culminate in the submissin f an extramural career develpment grant applicatin (r equivalent). Candidates with research r health prfessinal dctral degrees and a strng cmmitment t clinical and/r translatinal research are eligible and encuraged t apply. Deliverables include a cmpleted research prject, a publishable manuscript, and an extramural grant applicatin such as an NIH K award. Schlars will als acquire cmpetence in critical thinking, team science, leadership, bimedical statistics and infrmatics. Gal f the Prgram: The gal f the Prgram is t prepare junir investigatrs fr a successful career in clinical and translatinal research. It is expected that schlars will initiate a team-based clinical and translatinal research prgram leading t successful acquisitin f an extramural grant as a faculty member in an academic medical center. We aim t prduce successful junir investigatrs in clinical and translatinal research by prviding critical resurces and supprt t launch their research career. Prgram Highlights: Tw years lng. It is anticipated that schlars will btain a Graduate Certificate in Clinical Science by cmpleting the research practica prjects and curses.* Emphasizes a rigrus scientific apprach. The apprach embdies ur belief in hypthesis-driven, (especially but nt exclusively) mechanistic-based investigatin frm the mlecular t the ppulatin level. Offers training in research skills. The CTSA supprts research training that spans the spectrum f clinical and translatinal science as envisined by the Natinal Center fr Advancing Translatinal Science (Figure 1). Develps critical thinking skills. The Prgram is designed t enable trainees t lead teams that fcus n significant translatinal prblems. Critical thinking will be develped in the classrm using the Scratic Methd, in small grups by giving ral presentatins, and by written practica (Figure 2). Fsters team science. The Prgram recgnizes the cmplexities f human research in the areas f genmic and mlecular science require investigatrs t succeed thrugh multidisciplinary scientific teams. Offers mentrship and mentr training. The Prgram aims t develp critical leadership, team building, and mentring skills t equip ur trainees and their mentrs with the ability t navigate the clinical and translatinal research prcess and t cmmunicate with grups f different scientific expertise. Prvides additinal mentring and leadership training fr frmer schlar alums transitin t independence after cmpletin f the tw-year prgram. *Schlars may chse t enrll in the Master f Science in Clinical Science prgram. Cmpletin f the master s degree may require additinal cursewrk that extends beynd tw years. Updated: August Page 1

2 Prgram Requirements: Tw-year cmmitment at 75% (faculty) r average 40 hurs/week (fellws) prtected time. Three written practica (Figure 2). Required curses*: Respnsible Cnduct f Research Clinical Research Management and Leadership Grant Writing & Funding Strategies Infrmatics fr Clinical Researchers Attend the tw scheduled schlar retreats per year fr the entire time, and present research at ne retreat per year, ne in Octber and ne in March. Additinal attendance requirements include: 50% f weekly Translatinal Science Frum Wrks-in-Prgress presentatins, and present at ne per year (Wednesdays 12-1 PM); At least 3 f 4 quarterly prgram meetings (usually a Tuesday, 12-1 PM August, Nvember, February, April). Active participatin in nging grup writing wrkshps, Center fr Translatinal Medicine sympsia, etc. Regular meetings with bth the Scientific and Career/Humanistic mentrs. Mentrship Requirements: Mentrs shuld be actively invlved in all areas f the prgram in rder t best supprt the develpment f their mentee(s). Regular attendance at Translatinal Science Frum, Schlar Retreats, and ther Scratic activities are expected. Mentrs shuld have regularly scheduled meetings with their mentee(s). Fr mre infrmatin, see the Mentring Guidelines. * Schlars may chse frm a menu f elective curses. Schlars are expected t take additinal curses custmized t their career develpment plan as needed t increase research cmpetency; subject areas such as bistatistics, epidemilgy, infrmatics, health services research, quantitative methds, clinical research design, clinical research prtcl develpment, ethics, as well as sme basic science curses are available. Prgram Deliverables: Three related practica: A Clinical/Translatinal Research Prject (chsen by the schlar and mentrs) A Publishable Manuscript (e.g., a Critical Literature Review, r scientific reprt) An Extramural Research Grant Applicatin such as a K23, K08, R01, r R21; ther grants may be acceptable but must be apprved in advance Cmpetencies: Scientific writing skills Netwrking with the research cmmunity Clinical research questins and study design Literature critique Research prtcl implementatin Statistical appraches Respnsible cnduct f research Team science Bimedical infrmatics Clinical research interactins Scientific cmmunicatin skills Cultural diversity Translatinal teamwrk Leadership skills Crss disciplinary training Cmmunity engagement Appreciatin: Fr new technlgies and methds pertaining t the spectrum f clinical and translatinal research. Fr ethical principles that influence the translatin f research results int practice. Fr methdlgical and analytical cncepts necessary t design rigrus clinical/translatinal research. Fr applying knwledge thrugh research experiences that will cntribute t future grant prpsals. Opprtunities: T wrk with a career and scientific mentring team cnsisting f faculty members wh are experts in career develpment and cmmitted t the schlar s success. Eligibility: The Clinical and Translatinal Research Schlar Prgram is designed t prvide additinal training and fcused mentrship t achieve the research career gals f individuals f exceptinal schlarship, aptitude and critical Updated: August Page 2

3 thinking skills. Persns wh shw great scientific prmise and are cmmitted t pursuing a rigrus research training and career develpment plan are invited t apply. Applicants frm a wide range f academic disciplines and frm diverse backgrunds including underrepresented minrities, disadvantaged, and disabled individuals are encuraged t apply. Applicants must: Have explicit supprt and cmmitment frm their Department Chair(s) r Center Directr(s), t prvide: At least 75% prtected time (faculty) r an average f 40 hurs per week (fellws) fr tw years this cmmitment must be cnfirmed in writing; Funding fr the candidate s salary and fringes during this time (t the extent nt supprted by the (see belw under Financial Supprt); Be cmmitted t participate in the Prgram in a fcused, active manner fr tw years. Be cmmitted t a clinical and translatinal science research career. Be appinted as a resident, clinical research fellw r junir faculty at UT Suthwestern r ne f the CTSA s partner institutins; Have a terminal research r health-prfessinal dctral degree (e.g., MD, DO, PhD, PharmD, DNP, amng thers). Have a well-frmulated clinical and/r translatinal research plan and preferably previus research experience. Nt be, nr have been, a principal investigatr n an R01, R29, r subprject f a Prgram Prject (P01), Center (P50, P60, U54) r mentred career develpment (K-series) grants r ther equivalent research prject grant awards. R03 and R21 grants are permitted. Be a U.S. citizen r permanent resident. Individuals n temprary r student visas are nt eligible fr NIH funding. Financial Supprt: The Prgram is supprted by a NIH Clinical and Translatinal Science Award (CTSA) and UT Suthwestern Medical Center (UTSW). Schlar salaries may be funded by the nminating Department/Center (including departments with ther K/T training grants), by CTSA KL2/TL1 funds, r by institutinal funds. Award f KL2/TL1/institutinal funds fr salary supprt is fr tw years and is highly cmpetitive. Faculty: Schlars selected fr KL2/institutinal funding will receive 75% f their UT Suthwestern institutinal base salary (up t the NIH cap, which is 75% f $160,000 fr KL2 Schlars (faculty) fr tw years. Since supprt by KL2/institutinal funds is nt guaranteed at the time f applicatin, the nminating Department r Center must cmmit t prvide full salary supprt unless fficially ntified therwise by the. Fellws: Schlars selected fr TL1/institutinal funding 100% f their salary r a maximum f $58,560 fr TL1 Schlars (fellws/residents) fr tw years. Since supprt by TL1/institutinal funds is nt guaranteed at the time f applicatin, the nminating Department r Center must cmmit t prvide full salary supprt unless fficially ntified therwise by the. NIH statement n required effrt fr fellws: NIH rules fr training grants stipulate that TL1 funded trainees must put frth 40 hurs per week f effrt tward the respective training, and unrelated clinical wrk must take place utside that time frame. Clinical trainees must cnfine clinical duties t their research training experience, hwever, NIH is aware that sme clinical activities are necessary fr fellws t qualify fr fellwship accreditatin and sit fr the bards. Limited research funds may be available fr select schlars, based n the annual budget allcatin. Select Schlars may have limited travel funds t attend the Translatinal Science Meeting in Washingtn, DC (annually in April) r a specialty meeting such as AHA, ENDO, etc., based n the budget allcatin. Availability f service package grants and/r vuchers t acquire statistical supprt services are prvided fr all schlars whether r nt they are receiving salary supprt fr the duratin f the prgram. Tuitin prvided fr didactic curses, except fr trainees supprted by ther federal funds (e.g., institutinal training grants such T32 r ther K grants). Schlars receiving KL2 funds shuld be aware that tw years f salary supprt n the KL2 cunt tward time spent n a K grant (i.e. if yu receive a K23, then yu will have tw years less than the maximum years allwed n that funding mechanism). Updated: August Page 3

4 Applicatin Instructins and Submissin Prcess: The ffice is lcated n Suth Campus in the 3 rd flr f the McDermtt Administratin Building (B Building). Please cntact Amy Mackenrth, M.A., Supervisr f Educatin Prgrams, at educatin@utsuthwestern.edu r with specific applicatin r selectin prcess questins. The applicatin cnsists f the fllwing: Kindly submit yur intent t apply by Nvember 1: 1. A curriculum vitae in the standard UT Suthwestern prmtin & tenure frmat; please add grants and teaching infrmatin at the bttm f the CV; (can be fund at W:\PUB\SMSDEAN\Prmtin and Tenure) 2. A career develpment and training plan; a wrds r less; shuld be single-spaced,.5 inch margins, 11 pint Calibri fnt: Include current area(s) f research interest, current areas f clinical/translatinal investigatin, a prpsed training plan including infrmatin abut additinal training, what yu hpe t gain frm the mentr experience, what curses yu think will be the mst beneficial t yur success, and career gals. 3. A persnal statement; a. 500 wrds r less; shuld be single-spaced,.5 inch margins, 11 pint Calibri fnt: Hw did yu arrive at this place in yur career? A career in clinical/translatinal research is challenging, with many pprtunities and frustratins. Why are yu attracted t this career? 4. A descriptin f the prpsed research prject; a. 500 wrds r less; shuld be single-spaced,.5 inch margins, 11 pint Calibri fnt. Citatins d nt cunt tward the wrd limit. 5. A minimum f 3 letters f recmmendatin: a. 1 letter f recmmendatin with a statement f cmmitment (75% prtected time) frm the Department Chair(s) r Center/Institute Directr(s); this letter shuld specifically state financial supprt in the event the salary funding is nt available t the applicant; b. 1 letter f recmmendatin frm a prfessinal reference; c. 1 letter f recmmendatin frm the scientific mentr wh will versee the schlar s research prject; 6. An nline applicatin t the Graduate Certificate Prgram in Clinical Science at UT Suthwestern Graduate Schl f Bimedical Sciences (must submit nline between 10/2/17 and 12/1/2017 fr summer admissin). Applicants will likely need t clear the cache n their brwsers t make the applicatin link wrk. The applicant shuld submit Items 1-4 t Amy Mackenrth via . The authrs f letters f recmmendatin (items 5a, 5b, 5c) shuld address their letters t Keith Argenbright, MD, MMM, Helen Yin, PhD, and Andrew Zinn, MD, PhD and submit their letters via t Amy Mackenrth. Item 6 shuld be submitted by the applicant nline (link t nline applicatin t the Graduate Schl; yu may need t clear the cache n yur brwser t make the lgin screen wrk; alternatively, yu may visit this page and click apply nw n the right hand clumn). Cmpetitive applicants will be invited fr interviews and will be asked t give shrt ral presentatins (10 minutes, vide recrded). Nte: The Prgram Selectin Cmmittee will nt cnsider incmplete r late applicatins. Applicatins will underg administrative review and the cmmittee will invite selected candidates fr interviews. Schedule fr Applicatin and Selectin Prcess: Call fr applicatins issued: September 2017 Applicatin due: December 1, 2017 Candidate presentatins (10 minutes): Individual presentatin between Octber 1 and December 1, 2017 Interviews: Friday, January 26, 2018 frm 1-3pm Mandatry rientatin: Wednesday, May 9, 2018 frm 5-6pm (mentr attendance required) Appintment start date: Faculty: May 1, 2018 (can be fellws transitining t faculty n r arund 7/1) Fellws: July 1, 2018 Updated: August Page 4

5 Appendices: Figure 1: Spectrum f Clinical/Translatinal Research Supprted by the Prgram Figure 2: Typical Timeline fr KL2/Clinical & Translatinal Schlars Mentr-Mentee Guidelines/Agreement Curse Requirements and Electives fr Schlar Graduate Certificate Curse Descriptins Typical Curse Schedule Cntact infrmatin: Amy Mackenrth, M.A., Supervisr f Educatin Prgrams educatin@utsuthwestern.edu r Updated: August Page 5

6 Fig. 1: Spectrum f clinical/translatinal research supprted by the Prgram (T= translatinal. T0 Basic science discvery; T1 translatin t humans; T2 translatin t patients; T3 translatin int practice; T4 translatin t ppulatin health.) Fig. 2: Typical timeline fr KL2/Clinical & Translatinal Schlars The research prject, manuscript, and grant applicatin shuld fcus n the same research questin/prject. Onging Research Activities Publishable Manuscript (by 15th mnth) Extramural Grant Applicatin (by 24th mnth) Research Prject (by 12th mnth) Year One Year Tw Updated: August Page 6

7 Mentr-Mentee Guidelines/Agreement Backgrund Effective mentrship is a critical element in the prcess by which mentees achieve excellence in the design and management f clinical research, facilitating their grwth as leaders in clinical and translatinal science. By the end f the first semester, the mentee must identify bth a scientific and career/humanistic mentrs. Being a mentr is a respnsibility and a privilege, as it enables ne t wrk with the best and brightest f the next generatin. Tgether, the mentee and mentrs will frm a relatinship fcused n mentee career develpment as a clinical/translatinal researcher. Expectatins f Scientific Mentrs Primary respnsibility fr guiding mentees tward research independence. Tgether with the mentee, the scientific mentr will help identify investigatrs t serve n the mentring team. The scientific mentr will prvide the mentee with the scientific and methdlgical expertise fr their research prjects. Clearly delineate specific expectatins f the substantive learning/research skills t be achieved. Primary respnsibility fr helping the mentee develp bth hyptheses and research prtcls; prviding the initial "peer review" that helps validate the scientific merit f all prpsals; helping the mentee t btain apprpriate interdisciplinary cnsultatins; assisting with all phases f grant preparatin; and the develpment f effective presentatins and publicatins. Overseeing and apprving all required practica mentr must submit a mentr apprval frm fr each practica submissin. a. Research prject b. Publishable manuscript with critical cmpnent c. Research grant applicatin (extramural; K23 r equivalent) Expectatins f Career/Humanistic Mentrs Develp with the mentee specific milestnes and timelines fr achieving career develpment gals; help mentee t develp his/her career identity. Assist mentee in navigating the culture f academic medicine. Encurage mentee t expand his/her prfessinal netwrk. Mentee/mentr can set expectatins that meet their specific needs assciated with life issues, cncerns, and celebratins; prvide guidance with particular issues specific t gender, race, etc. Expectatins f ALL Mentrs & Mentees The mentee is ultimately respnsible fr initiating and maintaining the relatinship with the mentr(s). The mentee has the right t change mentrs if his/her research questin changes and/r the mentring relatinships are nt meeting expectatins. Althugh the idea f team mentring is gd, the mentring relatinship shuld be ultimately handled slely by the immediate mentr and mentee (nt delegated). A standard expectatin is that mentrs will develp a relatinship with their mentee, be available/accessible, be an advcate, and be resurceful. Regular and frequent meetings are essential fr success. Thus, the mentee shuld have regular meetings with at least ne member f the mentring team, in additin t meeting with the entire mentring grup at least nce per quarter. The mentee shuld prepare a brief frmal summary f meetings with the entire mentring team. The mentee will request that his/her mentrs attend seminars at which the mentee is presenting. Attendance is highly encuraged as well as an imprtant aspect f the develpment and grwth f all mentees seeking a career in clinical research. Mentrs and the mentee shuld participate in (a) the Schlars retreats; (b) evaluatins and assessments f the individual mentee and team mentring relatinships; and (c) intimate invlvement in the executin f the mentee s practica fr the prgram. The mentee is required t meet every six mnths with the Center fr Translatinal Medicine, Educatin & Career Develpment team members t assess the verall mentring experience; mentrs & mentees will have an pen line f cmmunicatin with Keith Argenbright, M.D., M.M.M. (Multi-PI, KL2 Prgram) and Amy Mackenrth, M.A. (Supervisr f Educatin Prgrams). Updated: August Page 7

8 Graduate Schl f Bimedical Sciences Divisin f Clinical Science Required Curses fr Clinical & Translatinal Research Schlars Curse # UTSW Curses/Practicum Credit Hurs Semester Schlars 21 hurs 75% prtected time / 2 years 6 hurs required cursewrk; 15 hurs practicum credit 5501 Practicum: Research Prject 5 N/A required 5402 Practicum: Publishable Manuscript 4 N/A required 5603 Practicum: Extramural Research Grant Applicatin 6 N/A required 5107 Respnsible Cnduct f Research 1 Summer required 5208 Clinical Research Management & Leadership 2 Spring required 5106 Grant Writing & Funding Strategies 1 Summer required TBD Infrmatics fr Clinical Researchers 2 Fall/Spring required 5301 Intrductin t Principles & Methds f Clinical Research 3 Fall 5309/5391 Bistatistics I (Cnceptual r Mathematical) 3 Fall 5209 Practical Grant & Clinical Research Prtcl Develpment 2 Spring 5105 Ethics in Clinical Research 1 Fall (Odd) 5302 Bistatistics II 3 Spring 5115 Clinical Research frm Prpsal t Implementatin 1 Fall 5307 Epidemilgy fr the Clinical Investigatr 3 Spring 5201 Develping & Validating Measures 2 Fall 5203 Clinical Pharmaclgy & Drug Develpment 2 Fall 5207 Intr t Patient Centered Outcmes Research & Cmparative Effectiveness Research 2 Spring (Even) 5113 Advanced Clinical Research Design & Analysis 1 Spring CR 5301 Mechanisms f Drug Actin 3 Spring 5114 Preparing a Jurnal Reprt (Scientific Writing Wrkshp) 1 TBD - New 5118 Successfully Obtaining an R (SOAR) Grant Writing Seminar 0.5 Fall 5117 Mentring Excellence fr Develping Leaders 1 Varies 5211 Scratic Seminar 2 Varies 5XXX Develping & Cmmercializing Bimedical Research 2 Fall 5096 Independent Study 1-3 All electives UT Health Science Center at Hustn Curses in Public Health and Biinfrmatics Vary Vary Updated: August Page 8

9 Curse Curse Name # Summer Curses Grant Writing & Funding 5106 Strategies (Tt) Center fr Translatinal Medicine Curse Offerings Credit Hurs Curse Descriptin 1 2-Day intensive curse. This curse will review the different types f federal grant mechanisms as well as grants r cntracts frm research fundatins, advcacy rganizatins and industry. Hw t write a persuasive, well-reasned applicatin will be the fcus f the curse including the budget, resurces and envirnment, preliminary data, and the research plan Respnsible Cnduct f Research (Hlbein) Scratic Curriculum (Varies) 1 Regulatry requirements f clinical research (IRB, GCP, HIPAA, and investigatinal filings), ensuring patient safety, interactins with gvernment and industry, cntract negtiatins, successful strategies and tactics. 2 Students will participate in seminars dedicated t their cmprehensive understanding f clinical and translatinal research, careers in academic medicine, and ther relevant prfessinal develpment tpics. Fall Curses Ethics in Clinical Science 5105 (Heitman) 5096 Offered in dd numbered years nly. Develping & Cmmercializing Bimedical Research (Grassler & Taussig) 1 Shrt curse (8 weeks). This curse is a systematic examinatin f the ethical cncepts and standards f respnsible cnduct f research in bimedical science and clinical investigatin. Its aim is t prvide pstdctral trainees and junir faculty in bimedical clinical research a framewrk in which t recgnize, examine, reslve, and prevent ethical questins and cnflicts in their prfessinal wrk and prepare them fr independent research and mentring f thers. NEW Fall This curse reviews basic cncepts in develping and cmmercializing research in bimedical sciences. Students will learn principles f designing experiments fr clinical and regulatry relevance, discerning inventins frm research data, btaining intellectual prperty legal prtectin, structuring licenses f inventins t existing cmpanies, frming new start-up cmpanies, attracting investment capital, and regulatry apprval f prducts fr human therapy. Skills in prject management will als be attained by cnducting semester-lng special prjects. NEW Fall Mathematical Bistatistics fr the Clinical Investigatr (Reisch) Cnceptual Bistatistics fr the Clinical Investigatr (Hynan) Intrductin t Principles & Methds f Clinical Research (Jacbe) Clinical Research frm Prpsal t Implementatin (Tt) 3 Traditinal, mathematical apprach t statistical analysis f bimedical data. Tpics include data descriptin, summary statistics, elements f prbability, distributins f randm variables including applicatins f the binmial and nrmal distributins, estimatin and cnfidence intervals, hypthesis testing, analysis f variance, crrelatin and regressin and cntingency tables. Additinal tpics include statistical pwer, sample size, and study design. 3 Cnceptual apprach t statistical analysis f bimedical data. Review f fundamental statistical principles fcusing n explanatin f the apprpriate scientific interpretatin f statistical tests rather than the mathematical calculatin f the tests themselves. The curse cvers All tpics typically used in bimedical publicatins, including data descriptin, summary statistics, p values, and nn-parametric tests, analysis f variance, crrelatin, regressin, and statistical pwer & sample size estimatin. 3 This is an intrductry curse designed t teach basic cncepts in clinical research. This curse serves as an verview f basic principles and methdlgies underlying clinical research. It is nt designed t prvide an expert level educatin n these subjects (i.e. mastery in terms f planning, cnduct, and analysis f an bservatinal study r the like). This curse is designed fr thse wh are interested in understanding the basic cncepts that underlie clinical and translatinal research. This curse will prvide the necessary backgrund t the Practical Grant and Clinical Prtcl Develpment curse where these principles will be applied t the develpment f yur wn grant/prtcl. 1 This curse reviews basic elements fr a research prpsal and implementatin. Tpics include regulatry apprvals; cntinuing regulatry versight; mnitring patient safety; recruitment; clinical assessments, data treatment, data cllectin, entry and auditing; prvisin f experimental tests/tasks; data analyses; publicatin Updated: August Page 9

10 planning Successfully Obtaining an R (SOAR) Grant Writing Seminar (Yin) Spring Curses Intrductin t Patient 5207 Centered Outcmes Research & Cmparative Effectiveness Research (Halm) Offered in even numbered years nly. 0.5 SOAR is designed t increase NIH R-type grant acquisitin success rates in basic, translatinal, and clinical research. SOAR includes tpics such as demystifying the grant writing prcess, grantsmanship, surviving the NIH study sectin review, writing tips and tricks, navigating NIH requirements, peer-review, etc. 2 This curse cvers the methds used in utcmes and health services research, which includes research design, thery, measurement, methds f analysis, and evaluatin f published research. Curse bjectives are: 1) describe basic cncepts, definitins, and types f utcmes and health services research; 2) understand structure, prcess, utcmes and underuse, misuse, veruse cnceptual mdels; 3) identify cmmn appraches and challenges t measuring cst, quality, access, and equity in health and health care; 4) describe experimental and bservatinal research designs used t assess the impact f health services (drugs, devices, prcedures, strategies, delivery and financing systems) n patient-riented, clinical, and resurce use utcmes TBD Bistatistics fr Clinical Sciences II (Reisch) Practical Grant & Clinical Research Prtcl Develpment (Jacbe) Epidemilgy fr the Clinical Investigatr (Haley) Clinical Research Management & Leadership (Argenbright) Infrmatics fr Clinical Researchers 3 Linear and lgistic regressin mdels (cntrl f cnfunding and predictive mdels); categrical data analysis (binmial and Pissn distributins, analysis f paired categrical data, nnparametric methds fr rdinal data); survival analysis (Kaplan- Meier curves. Hazard functins, types f censring, lg-rank tests and generalized Wilcxn tests, Cx regressin mdel). Prerequisite: 5309 r 5391 r instructr cnsent. 2 Defining and develping a research questin; distinguishing between crrelative and mechanistic questins, matching methds t questins, understanding bias and cnfunding, randm and systemic errr, quantifying clinical infrmatin. Practical aspects f research prtcl cnceptualizatin and develpment. Enrllees will learn hw t translate a research questin int a hypthesis; hw t identify and describe hypthesis apprpriate study subjects and study measurements; select a specific study design apprpriate t the research questin and resurces available; synthesize the elements int a study plan; develp a statistical sectin and analytical plan. Prtcls develped by the enrllees will frm the primary basis fr grup discussins. Prerequisite: 5301 r instructr cnsent. 3 Cncepts f multivariate causality; criteria fr establishing causality; risk; rates; incidence, prevalence and attack rates; incidence density; crude, specific and adjusted rates; relative risk, dds rati, case-fatality rate and attributable risk; sampling errr, selectin bias, infrmatin bias, definitin bias, and cnfunding; statistical techniques t cntrl fr bias; variables; verview f statistical analysis; multiple cmparisns crrectin; study designs t avid bias: survey and sample selectin, crss-sectinal, chrt, case-cntrl; prspective vs. retrspective; attributes f chrt studies; design principles f case-cntrl studies; types f cntrl grups; strategies f matching in case-cntrl studies; experiential intrductin t statistical cmputing fr different types f clinical epidemilgy studies. 2 This curse is a structured review and discussin f the basics f management and leadership thery and practice. Tpics include prject management and budgeting, infrmatin systems, leadership style, effective interviewing and hiring techniques, cnflict reslutin, and the basics f rganizatinal culture. Predminant theries and research, as well as shared experiences f the instructr and the grup will be discussed in rder t enhance each participant s effectiveness as a manager and leader. It will be a cmbinatin f assigned readings, didactic lectures, active grup discussin, a mid-term prject and final examinatin. 2 TBD Updated: August Page 10

11 Typical Curse Schedules (subject t change) Updated: August Page 11

12 Updated: August Page 12

13 Updated: August Page 13