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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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
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.
Credits: 0 Offered: Spring 2
Thesis Continuation for Clinical Research. By Permission Only.
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
CLR0001 Masters Thesis for Clinical Research (1-9 credits)
CLR0002 Independent Study for Clinical Research (1-3 credits)
CLR0020 Doctoral Thesis for Clinical Research (1-6 credits)
CLR1010 Clinical Trials Management (1 credit)
CLR8000 Clinical Research Thesis Continuation (0 credits)
CLR0001 Masters Thesis for Clinical Research (1-9 credits)
CLR0020 Doctoral Thesis for Clinical Research (1-6 credits)
CLR0002 Independent Study for Clinical Research (1-3 credits)
CLR0320 Applied Biostatistics in Clinical Trials (3 credits)
CLR8000 Clinical Research Thesis Continuation (0 credits)
CLR0001 Masters Thesis for Clinical Research (1-9 credits)
CLR0002 Independent Study for Clinical Research (1-3 credits)
CLR0011 Research Grant Writing Course (1 credit)
CLR0020 Doctoral Thesis for Clinical Research (1-6 credits)
CLR0207 Culture, Illness & Community Health (3 credits)
CLR8000 Clinical Research Thesis Continuation (0 credits)
CLR8001 Maintenance of Matriculation (0 credits)
Credits: 1-9 Offered: Spring 1
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 Master’s Thesis as a resource for the steps that need to be taken in fulfilling the Master’s Thesis requirement.
Credits: 1 Offered: Spring 1
Part II of CLR0012: 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 asked to practice their ability to critically analyze and appraise clinical /translational research data in an effort to integrate important concepts and tools learned across during required coursework
Credits: 3 Offered: Spring 1
Methods in Clinical & Population Based Research: Part II is divided into two sections. The first provides an in depth focus on study design and analysis, including randomized clinical trials, early proof of concept trials, phase II trials, including futility designs; phase III efficacy trials, small population clinical trials and n-of-1 studies. The second section of the course focuses on study implementation and conduct and will include the following topics: responsible conduct of research, good clinical practice; responsibilities of the principal investigators; working with the IRB; patientselection, allocation and recruitment; protocol adherence, adverse events and adverse event reporting; data and safety monitoring plans and monitoring boards; regulatory bodies and funding.
Pre-requisite: Spectrum of Methods in Clinical Research 1
Credits: 1-6 Offered: Spring 1
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.
Credits: 1 Offered: Spring 1
This class will meet weekly and will consist of a Journal Club alternating with a Seminar Series/Works in Progress. The Journal Club will provided 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 The Seminar Series/Works in Progress classes will include presentations by trainees & faulty, covering ongoing clinical research projects to facilitate constructive debate and discussion of specific research approaches and conceptual models under development. In addition, this forum will be used to cover specific additional topics of importance to clinical research, including: human subjects’ research compliance; scientific presentation skills; team science; study design; statistical methods.
Credits: 1-3 Offered: Spring 1
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.
Credits: 3 Offered: Spring 1
This course will present the fundamental methods for the design and implementation of analysis for clinical trials. The course will emphasize randomized comparative studies, including protocol preparation, randomization, intention-to-treat, sample size, interim monitoring, adaptive designs, endpoints and reporting. The relationship between protocol design and analytic plan will be highlighted. The Course has two broad aims: (1) to develop the skills necessary to be a more critical reader of medical literature and (2) to provide the basic statistical tools to aid in the design of clinical trial protocols. CLR-0320 Elective course for MSCR or PhD in CR; required for those students in MSCR/PhD who are concentrating on Clinical Trials research.
Credits: 2-3 Offered: Spring 1
This seminar will explore the complex issues raised by human subject research. The seminar will begin with a review of some of the landmark cases of unethical use of human subjects in research, the policies that shape our current understanding of the ethical conduct of research, and the mechanisms for research oversight that have been instituted. Then, through reading a broad selection of seminal articles and papers from the recent literature, seminar presentations and discussions, we shall engage in a conceptual analysis of a number of controversial and pressing issues. We shall discuss the moral and public policy aspects of topics such as research design, risk-benefit assessment, informed consent, the use of “vulnerable” subjects, research without consent, confidentiality, inducements, conflicts of interests, disclosure of research findings, tissue use, vaccine development, and international research. In addition to exploring the moral landscape of this rich and provocative domain,the seminar will clarify and inform participants’ understanding of basic moral concepts such as autonomy and justice. It will also serve as a model for approaching other issues in applied ethics.
Credits: 0 Offered: Spring 1
Thesis Continuation for Clinical Research. By Permission Only.
Credits: 1-9 Offered: Fall
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.
Credits: 1-3 Offered: Fall
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.
Credits: 3 Offered: Fall
This first term covers fundamental concepts of relevance to the formulation of meaningful questions in clinical investigation and provides an overview of non-experimental, quasi-experimental and experimental study designs utilized in the conduct of clinical investigation. The course is divided into 4 sections: 1) The Research Question & Stating the Hypothesis; 2) Finding the evidence & discerningthe burden of disease; 3) Measurement Science & Sampling; and 4) Study Design
Credits: 1 Offered: Fall
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 appraiseclinical /translational research data in an effort to integrate important concepts and tools learned across during required coursework.
Credits: 1 Offered: Fall
This class will meet weekly and will consist of a Journal Club alternating with a Seminar Series/Works in Progress. 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. The Seminar Series/Works in Progress classes, which meet on the alternate week, will include presentations by trainees & faulty, covering ongoing clinical research projects to facilitate constructive debate and discussion of specific research approaches and conceptual models under development. In addition, this forum will be used to cover specific additional topics of importance to clinical research, including: human subjects' research compliance; scientific presentation skills; mentor: mentee relationships; team science; & time management
Credits: 1-6 Offered: Fall
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.
Credits: 3 Offered: Fall
Clinical and translational researchers frequently face a number of challenges in their work when traditional statistical approaches are used exclusively to plan clinical studies. These include low clinical trial participation, failed interventions due to low engagement of stakeholders or misunderstanding of causal mechanisms affecting outcomes, low engagement of trainees due to lack of understanding of their experience. This course will provide tools to address these and other challenges. This is an applied introductory course in qualitative, community-based, and mixed-methods research intended for graduate students and researchers in clinical and translational science with minimal or no experience in qualitative methodologies.
Credits: 3 Offered: Fall
The overall objective of this course is to provide the researcher with a working knowledge of essential tools for the acquisition, management and analysis of data. The data acquisition section of the course reviews the various methods for collecting primary data in the setting of clinical trials and registries. The course will review direct collection of data from electronic health records and primary data entry via electronic data capture systems, both local and web-based. It will cover principles of case report form design, compliance with good clinical practice standards and with 21CFR part11. It will review specialized software for managing multicenter studies, which address a variety of functions, including trial registration, randomization, tracking, site communication and performance measures.
Credits: 1 Offered: Fall
In this course students will learn the essentials of coordinating and managing the day-to-day operations of a clinical research study, from the planning site logistics and constructing timelines for study initiation visit to closing out a study. Students will learn how to estimate staff requirements, prepare realistic budgets and timelines and review source documents (Case Report Forms (CRFs), protocols and study budgets). Students will also learn the role and responsibilities of each member of a clinical research group, process of recruitment, informed consent, confidentiality and communication with patients, regulatory authorities and collaborating investigators. Students will also learn the basics of data management and regulatory compliance, including measurement of patient baselines;preparation, logging and tracking CRFs; cross checking documentation for accuracy, source documentation; preparing for an audit and responding to data queries.
Credits: 0 Offered: Fall
Thesis Continuation for Clinical Research. By Permission Only.
Credits: 0 Offered: Fall
PhDCR students preparing for the mandatory written comprehensive examination may register for this course, provided they are concurrently registered for CLR0012, CLR0014 or CLR0015. Program permission is required