Graduate Student Handbook Clinical & Translational .

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Graduate Student HandbookClinical & TranslationalResearch Training2015-2016Center for Clinical & Translational Science & TrainingCollege of MedicineDepartment of Environmental HealthDivision of

Table of ContentsClinical and Translational Research Training Program Overview .1Certificate in CTR .2Sample Certificate Timelines .3Certificate Graduation Checklist .4Master of Science in CTR.5MS Focus Areas .6MS Thesis Statement of Intent .10MS Thesis .11MS Thesis Research IRB Review .12MS Graduation Checklist.13Academic Policies.14Advisor .14Minimum Credits Hours and Transfer Credits .14Research Credits .14Minimum Academic Performance .15Academic Misconduct .16Maintaining Active Student Status.16Time Limitations .16Graduation .16Frequently Asked Questions .17Center for Clinical and Translational Science and Training (CCTST) .20Pilot and Collaborative Translational and Clinical Studies Core .20Biostatistics, Epidemiology and Research Design (BERD) and Clinical Research Ethics (CRE) Core .21Biomedical Informatics (BMI) Core .21Regulatory Knowledge & Support core.21Clinical Translational Research Center (CTRC) Core .22Community Engagement Core .23Research Education, Training and Career Development Core .23Course Descriptions with Core Teaching Faculty .24Course Descriptions Offered Outside the Program .33Academic Resources .36How to Register for Classes .36Blackboard Course Management.36Study Space .36Fellowships and Scholarships.36Graduate Student Research Forum .37Libraries .37Computer Account and Printing Services .38University Bookstores .39University Health Insurance .39Mental Health Services .39ID Badges/Keys .39Parking .40Shuttle Bus .40Sports and Exercise .40Dining near the Medical Center .40Campus Security .40Sample Memos/FormsStatement of Intent Cover Memo .42Research Credit Pre-Approval Form .43Research Credit Verification Form . 44Campus Maps .45

Clinical and Translational Research Training Program OverviewThe Clinical and Translational Research (CTR) graduate program offers a Master of Science (MS) degreeand two Certificates in CTR: an online Certificate and a land-based Certificate. The MS falls under theCenter for Clinical and Translational Science and Training (CCTST), and its academic home is in the UCCollege of Medicine, Department of Environmental Health, Division of Epidemiology.The CTR training offered through these programs is designed to provide clinical professionals (physicians,nurses and other terminal degree clinical professionals) with the necessary preparation for successfulcareer development and independent investigator awards. The MS program emphasizes specific trainingin clinical epidemiology/clinical effectiveness, molecular epidemiology, clinical trials, quality improvement,informatics, and translational research that will enable clinicians to translate scientific advances intoapplications for improved clinical practice and human health. The Certificate programs give students moreof an introduction to the field of CTR, with basic coursework in epidemiology, statistics, and researchethics.The CTR training program offices are located in the Kettering Labs building (see map at the back of thishandbook).Please contact us with any questions or concerns: Haynes, DrPHAssociate Professor & DirectorKettering [email protected]: 513-558-5427fax: 513-558-4838Jackie Knapke, EdMProgram DirectorKettering [email protected]: 513-558-0809fax: 513-558-48381

Certificate in Clinical and Translational ResearchThe Certificate program consists of 10 credit hours. Students can enroll in any term to complete theprogram at their own pace. The Certificate can also be earned in an 8-week session offered JulyAugust.Qualified applicants include: Fellows and junior faculty interested in collaborating in research, or fellows/junior faculty justlaunching their career as clinical/translational researchers Health science students in the Colleges of Medicine, Pharmacy, Nursing, and Allied HealthSciences Basic science researchers crossing over into clinical translation Residents Post-doctoral fellows Health science professionalsRequired courses:Course #BE-7022BE-7076BE-7067/GNTD7003Course TitleIntroduction to BiostatisticsIntroduction to EpidemiologyScientific Integrity orEthics in ResearchCredit ngElective courses (minimum 3-4 credits total):The following electives are available online and recommended for Certificate students, but any courseoffered in the Division of Epidemiology or Division of Biostatistics and Bioinformatics will be accepted.Electives taken outside these Divisions must be approved by the program director.Course #BE-9070BE-8076BE-7081BE-7074BE-8069ENV-8091Course TitleSurvey of Clinical & Translational ResearchSuccessful Scientific WritingIRB Submission Process for ResearchersCommunity-Based Participatory ResearchStudy Design & AnalysisMentored Research ProjectCredit y Semester2

Sample Certificate TimelinesCCTR Sample 1 Year Timeline – OnlineOnlineIntro to EpidemiologyIntro to BiostatisticsScientific IntegrityScientific WritingCredits2312FallStudy Design & Analysis2SpringNoneSummer10Total Credit HoursCCTR Sample 1 Year Timeline – Online/In-SeatSummerFallSpringOnlineIntro to EpidemiologyIntro to BiostatisticsScientific WritingStudy Design &AnalysisCredits232In-SeatCreditsEthics inResearch1210Total Credit HoursStudents participate in a workshop to learn how to best translateresearch to community audiences.3

Certificate in CTR Graduation ChecklistStudent NameM#Core Courses Introduction to BiostatisticsCredit hoursIntroduction to EpidemiologyCredit hoursScientific IntegrityCredit hoursElective Courses Credit hoursCredit hoursCredit hoursCredit hoursCredit hoursMinimum GPA ( 3.0) Total Credit Hours ( 10 credit hours) Student Applied to Graduate Student Certified by Program Student Certified by Graduate School4

Master of Science in Clinical and Translational ResearchThe educational objective of the Master of Science in Clinical & Translational Research (MSCTR) is totrain clinical professionals (physicians, nurses, and other terminal degree clinical professionals) tobecome independent investigators and to provide them with training necessary to prepare successfulcareer development and independent investigator awards. The disciplinary purpose and ultimate goalof the program is to move practitioners from the realm of personal clinical experience to objectiveevidence. Successful graduates of the program will acquire the methodological skills to conductindependent and collaborative clinical studies in their special areas of practice and interest.Please note the program Curriculum Committee examines and evaluates all courses regularly, sochanges may occur.Required Courses for the Clinical & Translational Research Training ProgramCourse urse TitleEpidemiology Seminar*Introduction to Biostatistics (online summer only)Introduction to Epidemiology (online summer only)Design & Management of Field Studies in EpidemiologyClinical Research Scholars Seminar**Master’s Thesis Research***Choose one of the following:Scientific Integrity (online summer)Ethics in ResearchChoose one of the following:Introduction to SAS Programming (recommended)Computational Statistics (SAS and R)Statistical Principles in Clinical Research (JMP)Applied Statistics in Criminal Justice (SPSS)Choose one of the following:Advanced BiostatisticsRegression AnalysisStatistical Data Analysis II (online)Choose one of the following:Study Design & Analysis (online)Decision-Analysis and Cost-Effectiveness AnalysisMeta-AnalysisPrinciples of Clinical mmer/FallSpringFall AND FallSpringFallFallor any biostatistics course offered under the BE course code.*Students can either attend seminars or present their research in at one seminar. If students choose to present, thepresentation will fulfill that semester’s attendance requirement.**The Clinical Research Scholars Seminar is held once a month for the fall and spring semesters. You cannot register for thiscourse until spring semester, but attendance is taken year-round and credit given if you have attended the required numberof sessions.***Students must take 2 Master’s Thesis Research credits before graduating. However, Master’s Thesis Research creditsbeyond these 2 do not apply towards the 30 credits needed to graduate. If you plan to take Research credits as electives, youshould register for Non-Thesis Research: ENV-8091.5

MSCTR Focus AreasStudents can specialize in Clinical Epidemiology/ Clinical Effectiveness, Molecular Epidemiology, Clinical Trials,Research Informatics (T1 or T2), or Translational Research. Additional coursework is required for each of thesetracks (see below). Students may select one of the five specialized tracks to fulfill their remaining credits, or theycan take electives or complete research. The tracks below were designed by clinical research experts to providespecialty training in each of the five focus areas. Students do not have to complete a track to complete the MSprogram. If students wish to ‘specialize’ in a particular focus area, they are encouraged to meet with the directorof the focus area to discuss courses, research opportunities, and career pathways.Clinical Epidemiology and Clinical EffectivenessCo-directed by Joel Tsevat, MD, MPH and Jackie Grupp-Phelan, MD, MPHUsing a combination of didactic material and seminars, the Clinical Epidemiology/Clinical Effectiveness FocusArea enables participants to develop the analytic and quantitative skills necessary to conduct clinical research.The required courses will provide training in traditional epidemiologic research methods including study designand analysis. Additional courses will address the relative merits of various designs; the design and conduct ofclinical trials; the health decision sciences; health services research; informatics; questionnaire development; andother clinical and outcomes research topics. Didactic sessions will be supplemented by small discussion groups,practical exercises, and invited guest speakers.Additional Required Courses for Clinical Epidemiology/Clinical Effectiveness (11-13 credits)Course Course TitleCredit HoursPrinciples of Clinical Trials3Regression Analysis (fulfills the biostatistics core3curriculum requirement)*Health Services Research2*Introduction to Medical Informatics2*Quality Improvement and Patient Safety1*Decision Analysis and Cost-Effectiveness Analysis3*Quantitative and Qualitative Data Collection Methods2for Health Services Research*Must take 3 of the listed 5 courses.OfferedTBASpringFall (odd years)FallFall (even years)SpringSpring (odd years)Translational ResearchDirected by TBA (meet with Dr. Haynes, if interested in the focus area)The translational research track is intended for physicians who plan to be involved in developing IND- type earlyphase clinical trials. This area includes preclinical and early phase clinical testing of new therapeutic or diagnosticreagents, as well as collection and handling of patient specimens. Students will take courses in the College ofPharmacy geared towards clinical trials and regulatory affairs and in Developmental Biology, Disease andDevelopment. Two new courses have been created for this focus area: Patient Specimen Methods and DiseaseSpecific Translational Research. To gain a more solid understanding of the molecular mechanisms underlyingdiseases, trainees may fill the elective hours with the molecular biology series offered at UC each year. Ideally,research projects will encompass late preclinical or early clinical projects.Additional Required Courses for Translational Research (12-15 credits)Course 7099Course TitleStatistical Principles in Clinical ResearchPre-Clinical/Non-Clinical Studies for IND ApprovalMolecular EpidemiologyDisease and DevelopmentPatient Specimen MethodsDisease Specific Translational ResearchIntroduction to Bioinformatics **electiveCredit Hours3322113-5OfferedFallSpringSpringSpring (even years)TBATBASpring6

Molecular EpidemiologyCo-directed by Ranjan Deka, PhD and Kim Dietrich, PhDWe define molecular epidemiology as the use of biological markers in epidemiologic research to evaluate eventsoccurring at the physiologic, cellular, subcellular, and molecular levels. The Molecular Epidemiology Focus Areaencompasses biomarker, cancer, and genetic epidemiology. The overall objective of the Molecular EpidemiologyFocus Area is to establish an interdisciplinary training program in molecular epidemiology for clinicians seekingan advanced degree (MS or PhD). With the requisite didactic coursework, laboratory experience, and mentoring,students will develop the knowledge base and conceptual framework of scientific inquiry to foster independentresearch careers in mo

informatics, and translational research that will enable clinicians to translate scientific advances into applications for improved clinical practice and human health. The Certificate programs give students more of an introduction to the field of CTR, with basic coursework in