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Certifcate Program in Translational Research Tis innovative and rigorous program gives PhD students, postdocs, and junior faculty members at the Clinical & Translational Institute (ACTSI)-partner institutions the expertise and experience to translate fundamental biomedical scientifc discoveries into treatments that will beneft human health.

NIH-FUNDED CLINICAL AND TRANSLATIONAL SCIENCE AWARD ATLANTA CLINICAL & TRANSLATIONAL SCIENCE INSTITUTE (ACTSI)

1 Certificate Program in Translational Research

Te Certifcate Program in Translational Research (CPTR) is a multidisciplinary, innovative program which provides predoctoral or postdoctoral trainees with the expertise and experience to translate fundamental biomedical scientifc discoveries into treatments that will beneft human health. Te certifcation program requires 16 credits (14 core and 2 elective credits) of didactic training in the Laney Graduate School of . Te courses are taught by faculty at Emory University, Morehouse School of Medicine, and Georgia Institute of Technology (Georgia Tech). Trainees may take the course work over a single year or spread the work over two years for limited impact on the time required from their laboratory or clinical duties. Tere are no citizenship requirements.

2 Course Descriptions CPTR 501 – Translation to Clinical Medicine (2 credits) Tis is a key component of the CPTR program. Te goal is to pro- vide the students with a new set of experiences relevant to both their understanding of disease and their research interest(s) and to illumi- nate the potential impact of high- quality clinical and translational research (CTR) in clinical outcomes of individuals with disease. Tis course provides students with both teams). Te clinical internship can didactic and experiential learning. occur either in the inpatient and/or Tis includes: the outpatient setting. Students also have opportunities to observe diag- 1.) Introduction into Clinical nostic or therapeutic procedures (e.g. Medicine – Initial training and practi- imaging, surgery, physical examina- cal experience in common pathophysi- tions) in tertiary and community- ologic diseases including exposure to based research sites; understand- patients and study subjects with disor- ing and observing state-of-the art, ders involving the cardiac, pulmonary, hospital-based, analytical technolo- neurologic, endocrine system, gastro- gies; shadowing additional multidis- intestinal tract, and to infammatory ciplinary inpatient and/or outpatient or infectious disease conditions; teams caring for patients with 2.) Individualized Clinical Medicine disorders or diseases of interest; and Rotation – Te course instructor mentored examination of histologic meets with each student prior to the sections of human tissues with clinical course to discuss the student’s future investigations faculty of the Emory research career plans and designs a Clinical Pathology and Laboratory rotation based on the individual needs Medicine Department. of the student. Students are linked with a clinician working in their area MSCR 761 – Introduction to Clinical (e.g. who may also serve on their and Translational Research (CTR) mentoring team) and round with a (2 credits) is an introduction to CTR clinical service at Emory teaching and analytic medicine for clinical/ facilities (e.g., a student interested in translational investigators. Resources research will round in needed for designing and imple- the inpatient and consult menting CTR are discussed as well as

3 translational blocks and methods to subjects; development of data and overcome these blocks. Te course safety monitoring plans and data also covers protocol design, hypoth- and safety monitoring board (DSMB) esis development, and gathering of charters, conficts of interest; IRBs, evidence, modeling, and statistical HIPAA, ethics of genetic testing and inference including Bayesian infer- gene therapy, and ethical issues in ence. Other topics include design research in the developing world. All of clinical trials and observational students are also required to complete studies, human subjects issues, special the Emory IRB Human Subjects train- populations, adverse efects, and ing program (online course from the pharmacokinetics. Collaborative Institutional Training Initiative [CITI]). CPTR 500 – Fundamentals of Epidemiology (2 credits) MSCR 594 – Scientifc and Grant Tis course introduces the principles Writing (2 credits) and methods of epidemiology; it Tis course developed for the MSCR also includes concepts and methods program is focused on developing used for population-based research. writing skills for peer-reviewed Epidemiologic study designs and data publications and competitive grants. collection methods are described as Efective scientifc communication well as approaches to data analyses. and writing skills are reviewed and Te concepts of bias and confounding discussed as are key aspects of the are explored with examples from the NIH (and other organizations’) grant clinical epidemiology literature. review process. Each student prepares a grant proposal for extramural MSCR 593 – Ethical, Legal, and funding which is critiqued by the Social Issues of Responsible Clinical course directors and their mentors. and Translational Research (1 credit) Te fnal product is a grant (e.g., examines concepts inherent to the predoctoral NIH National Research ethical and responsible conduct of Service Award [NRSA]) tailored to CTR and covers a number of im- the individual student’s dissertation portant human subjects research research and which may be submitted training issues. A case-based ap- for funding. Students also meet proach is emphasized. Topics include: individually with the course directors overview of ethics and the history including Janet Gross, PhD who of the protection of human subjects; provides individualized feedback on informed consent and vulnerable the grant preparation in collaboration

4 with the student’s mentoring team. conducting community-based partici- CPTR 502 – Biostatistics for Transla- patory research across the continuum tional Research (2 credits) of research including planning, imple- Tis course introduces statistical mentation, evaluation, dissemination, concepts and analytical methods with and translation; and ethical issues special attention to data encoun- and current community-based par- tered in the biomedical and ticipatory research projects at Emory, biotechnology as well as translational Morehouse School of Medicine, and research. It emphasizes the basic con- the Atlanta-area. cepts of study design including clinical trials, quantitative analysis of data, MSCR 592 – Clinical Research probability, and statistical inferences. Colloquium (1 credit) Tis seminar-style course covers a MSCR 591 – Community-based wide-array of practical issues in CTR Participatory Research and Health including: research administration Disparities (1 credit) and grants management; federal fund- Tis course, developed by the More- ing process; IRB and HIPAA; confict of house School of Medicine and Emory interests; legal aspects of translational MSCR programs, introduces and research; drug discovery; industry emphasizes the concepts of “T2” interactions (drug discovery and de- research. It also incorporates social vice development); multidisciplinary science and behavior theory con- research and team science; mentor cepts in understanding of health and mentee training; and translational disparities and research in this area; research informatics, health services, principles and historical roots of ef- and implementation science research. fective community engagement and partnership in CTR; community and MSCR 595 – Health Services academic perspectives in developing Research (1 credit) and sustaining collaborative, multidis- Tis course provides students with an ciplinary research; practical issues in understanding of the nature, meth-

5 ods, scope, magnitude, and impact CRN sites in Atlanta (e.g., Emory, of Health Services Research (HSR). Grady, Children’s Healthcare of Students gain a better appreciation for Atlanta, Hope Vaccine Clinic, the importance and relevance of HSR HIV Clinic, etc.). in improving healthcare delivery as well as key tools employed in HSR Eligibility and areas of funding (e.g. Patient PhD Students: PhD graduate Centered Outcomes Research Insti- students in the biomedical sciences tute [PCORI], Agency for Healthcare and/or biomedical engineering at Research and Quality [AHRQ]). Emory University, Georgia Institute of Technology, or Morehouse Other Program Requirements School of Medicine with a desire Include: to become qualifed clinical and/or • Journal Club – meets monthly in translational investigators and obtain collaboration with MSCR program and the knowledge and skills necessary to allows interaction with physician-sci- translate laboratory discoveries into entists, PhD level scientists interested new medical treatments are eligible in careers in clinical investigation to apply. • IRB Rotation – attend and observe PhD students will generally apply in one committee meeting. Students their second year of graduate school may attend one IRB meeting at either and will begin CPTR training at the Emory, Georgia Tech, or Morehouse onset of their third year of graduate School of Medicine school afer completing comprehensive • Didactic and Individualized ACTSI examinations. Completing the CPTR Clinical Research Network (CRN) program early in their training would Rotation – Students learn about the ensure an impact on their dissertation resources available through the CRN (facilitating translational research) and for CTR (including those that would their career direction. Te CPTR can be beneft their own research), meet completed in one year but most gradu- with CRN directors, with the PIs of ate students take this 16-credit program NIH-funded and IRB-approved CRN over a two-year period. projects, attend CRN Safety Advisory Subcommittee meetings, and are Emory Postdocs and Junior Faculty: linked with CTR investigators and Emory postdocs and faculty are also research coordinators working eligible to apply to the program. in their area of interest using 6 How to Apply – Rolling Deadline Provide to the program office by e-mail to [email protected], the following items:

1. Cover sheet – Request form by e-mail 2. NIH-style Biosketch from applicant and mentor/supervisor 3. Personal statement (maximum one page, single-spaced, 11 point font, 1 inch margins) 4. Letter of support from supervisor

Deliver to the program office: • Original ofcial transcripts from all colleges and universities previously attended in envelopes sealed by those colleges. Tis requirement does not apply to current PhD students at Emory University. • Check payable to Emory University in the amount of $75 for the application fee. (Not necessary if current student at Emory.)

Applications will be reviewed by a committee consisting of the program directors and key leadership team and acceptances will be based on candidates’ interest and potential for a translational research career.

Questions Cheryl Sroka ([email protected] or 404-727-5096), Room 6.112, 1599 Building, 1599 Clifon Road

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Certificate Program in Translational Research gs.emory.edu/sites/translational

Further information about the Atlanta Clinical & Translational Science Institute (ACTSI) is available online: ACTSI.org

Contact: Cheryl Sroka 1599 Building 1599 Clifon Road NE, Room 6.112 Atlanta, GA 30322 404-727-5096 [email protected]

ACTSI IS SUPPORTED BY A GRANT FROM THE NIH/NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES (NCATS) (UL1TR000454).

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