CLR Spring 2 Courses

CLR0001 Masters Thesis for Clinical Research

Credits: 1-5 Offered: Spring 2

Students should register for their Master’s Thesis credits (5 credits) during the Spring 1 or Spring 2 term of their second year while preparing to submit their Thesis. Students may be able to register for additional Master’s Thesis credits (1-3), instead of elective credits, with permission of the Program Director.

Please refer to the Guide to Completing the Masters Thesis as a resource for the steps that need to be taken in fulfilling the Masters Thesis requirement.

CLR0002 Independent Study for Clinical Research

Credits: 1-3 Offered: Spring 2

An Independent Study is an elective option providing the student with an opportunity to delve more thoroughly into an area of specific interest. The Independent Study Proposal should be submitted at least three weeks prior to the anticipated start of the proposed project/course of study. The proposal will be reviewed to ensure that the goals of the project meet the overall objectives of the Clinical Research Program. Approval of a form submitted less than three weeks prior to the anticipated start of the project/course of study will not be guaranteed. The student assumes any risk that missing appropriate deadlines may entail. Approval, when granted, is conditional upon the student completing all of the outlined requirements. The student must submit a Postscript Report and request that the faculty sponsoring the Independent Study submit an Evaluation Form.

Three credits are the maximum number of credits that may be awarded to any Independent Study. Please note that while the total hours committed to the pursuit of the Independent Study may be sufficient for more than three credits or more than one elective, students will not receive any more than three credits for one project/course of study. Each student may complete no more than two independent study projects.

An Independent Study must be a unique experience. Material covered during an independent study project should be highly targeted and not simply a review of the regularly offered coursework.

To apply to take an independent study students should contact the Clinical Research Program Manager.

CLR0011 Research Grant Writing Course

Credits: 1 Offered: Spring 2

This course will familiarize students with the basic elements and approach to writing grants, from initial concept through institutional routing to agency submission and review. Students will select a research topic, identify a potentially fundable research problem, develop a research plan, and draft a grant application in the appropriate format of the PHS 398 form for submission to a funding agency. Each draft will be presented to the class by the students for critique and discussion. Student evaluation is based on class presentations and draft submissions; drafts produced for the course can be further revised to serve as the student’s thesis proposal. Grant applications for both investigator-initiated research projects (e.g., NIH R01, R03, R21) and mentored career-development awards (e.g., K12, K23) will be covered. Features of successful research grant applications will be presented and a description of the grant review process will be covered. The course also will cover the development of writing skills for publication and competitive grants, and explore principles of research strategy in the context of requirements of funding agencies. Effective scientific communication and writing skills are reviewed, institutional routing, and discussion of the NIH grant review process will be covered.

CLR0007 Spectrum of Methods in Clinical Research III

Credits: 3 Offered: Spring 2

Methods in Clinical & Population Based Research: Part III is divided into four sections. The first focuses on the use of specific databases & analytical programs in the conduct of clinical research. The format for this section of the course includes lecture and laboratory sessions. The second section of the course focuses on Omics & clinical research and covers genomics, proteomics, microarray technologies, methylation arrays, and bioinformatics principles. Also covered are the clinical and genomic databases that are essential for conducting omics clinical investigations and the resources and tools for personalized medicine research. Review of the Biobank and access to the de-identified database will be provided to the student to demonstrate the use of this unique resource for conductingnovel clinical investigation.

The third section of the course will provide an initial introduction to health services research, including topics concerning health care disparities, community engagement & participatory research; and comparative effectiveness research. Finally, the last segment of the course will focus on practical aspects of clinical research including, graphic presentation of data and scientific writing as well as an overview of the nuts and bolts of securing peer review funding as well as opportunities for new clinical investigators, in particular.

CLR0008 Introduction to Health Survey Research Methods

Credits: 3 Offered: Spring 2

This course will provide participants with an understanding of survey development, sampling strategies, modes of data collection, maintaining data quality, data processing, ethical considerations and management of survey study teams. We will also touch on statistical methods to analyze survey data and handle missing values. Examples will be provided from existing secondary national survey databases, cohort studies and instructor's prior experience. Practical hands on guidance in survey development will be provided. Best practices to summarize and present survey findings in research papers will be discussed. No prior experience working with surveys or statistical methods is necessary.

CLR0015 Integrative Prob Solving in Clin and Trans Research III

Credits: 1 Offered: Spring 2

This course is designed to prepare PhD in Clinical Research candidates for the mandatory written comprehensive examination. The course is comprised of problem sets reflective of foundational course work and the integration of methodology and experimental design highlighted throughout the common required course work. Students will be ask to practice their ability to critically analyze and appraise clinical /translational research data in an effort to integrate important concepts and tools learned during required coursework.

CLR0019 Clin & Translational Research JC & Seminar-Spring II

Credits: 1 Offered: Spring 2

The Journal Club will provide a forum for the development of critical thinking and fosters real time utilization of recently learned analytical tools and methodology. A structured format focused on dissecting and discerning the specific research question and hypothesis posed; the appropriateness of the experimental design and the nature of the statistical methods employed in a given article, is employed so as to facilitate the emergence of astute and critical readers of the scientific literature & to reinforce relevant issues being discussed in other didactic courses.

CLR0020 Doctoral Thesis for Clinical Research

Credits: 1-6 Offered: Spring 2

Student should register for Doctoral Thesis credits during the Fall, Spring 1 and Spring 2 of year 3. Number of credits to register each term will depend on the student’s track. Please refer to the curriculum guide or track checklist for details.

CLR0207 Culture, Illness & Community Health

Credits: 3 Offered: Spring 2

This course considers Franz Boas’ definition of culture as culture is everything but natural science.[1] Any interaction or encounter with another individual or group of individuals is in fact a cultural experience which occurs within a cultural context. Broadly, this course aims to demonstrate how culture is conceptualized, considered, and explored in a broad range of issues in the basic, clinical, and community arenas around health and illness and to distinguish the cultural context in each session. The course utilizes class room lecture and small group discussion sessions and a small group project to enable participants to integrate culturally effective approaches into the design and implementation of research across the translational spectrum that improve patient and community healthoutcomes and reduce health care disparities.

Course Objectives: At the end of this course the student should be able to: • Demonstrate an understanding of one’s own cultural context and its impact on patients, communities and on health care outcomes • Analyze evidence of health care disparities from available resources • Integrate culturally effective approaches into the design and implementation of research across the translational spectrum that improve patient and community health and reduce health care disparities

CLR1020 Regulation and Clinical Trials of Medical Devices

Credits: 1 Offered: Spring 2

This course will serve as a broad introduction to the development of novel medical devices within the current regulatory landscape. This course will focus on the classification system of medical devices and the associated differences in regulations that are set forth by the FDA. Guest speakers will be invited to explore early feasibility trials, larger pivotal trials, assigning predicates and highlighting the different pathways (Humanitarian Device Exemption, De Novo, etc) a device can be approved by. Emphasis will be placed on illuminating the difference between pharmaceutical and MedTech expectations of design. Grading will be based on weekly homeworks, closed note tests, and a project that will require teams to classify a device, determine predicates and describe a protocol for testing the device given their proposed pathway.

CLR1114 Drug Development From Discovery to Commercialization

Credits: 1 Offered: Spring 2 This course provides a comprehensive overview of the regulatory, methodological and scientific pathways for drug development within the field of oncology. The cycle of drug development will be discussed and cover stages from drug discovery, screening, regulatory considerations and compliance, manufacturing and drug delivery, to clinical deployment. Woven into these themes are aspects related to intellectual property and commercialization.

Aside from the scientific and practical aspects of the cycle, a wider perspective on drug discovery is also illuminated. Experts in the fields of economics will share their findings on the fiscal impact of new medicines, and specialists in ethics will discuss the compassionate use of investigational new drugs.

Learning objectives: 1. To delineate the regulatory steps in drug development. 2. To understand how translational research principles can be applied to speed up the implementation of diagnostic and therapeutic interventions 3. To discuss the future trends in drug development and novel approaches for anti-cancer target discovery

CLR0610 Meta-Analysis and Systematic Reviews for Clinical Research

Credits: 3 Offered: Spring 2

The goals of this course are to provide students with a theoretical understanding and hands- on experience in literature synthesis methods. Areas to be covered include literature searching, study selection, data extraction and synthesis. The course will provide a review of each method within an interactive computing environment. Students will have opportunities to learn how to develop an appropriate question and to use software for assignments on each topic. There will be weekly lectures plus small group sessions. Students should come to the first class prepared to propose a possible topic for systematic review or meta-analysis.

CLR8000 Clinical Research Thesis Continuation

Credits: 0 Offered: Spring 2

Thesis Continuation for Clinical Research. By Permission Only.

CLR8001 Maintenance of Matriculation

Credits: 0 Offered: Spring 2

Matriculated students must either register for at least one credit-bearing course or register for "Maintenance of Matriculation" for every term, up until graduation. Maintenance of Matriculation allows students continued access to essential academic and student services, such as access to the ISMMS network and email; however, students on Maintenance of Matriculation status will not be eligible for financial aid. Students with compelling circumstance who wish not to maintain their matriculation status but need to discontinue their studies for a period of time can apply for a Leave of Absence from the program (see Leave of Absence and Withdrawal section). The Maintenance of Matriculation fee is $500 per academic semester or $333 per term for students in programs on trimesters