CLR Spring 1 Courses

CLR0001 Masters Thesis for Clinical Research

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.

CLR0014 Integrative Prob Solving in Clin and Trans Research II

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

CLR0016 Spectrum of Methods in Clinical Research II

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

CLR0020 Doctoral Thesis for Clinical Research

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.

CLR0018 Clin & Translational Resrch JC & Seminar-Spring I

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.

CLR0002 Independent Study for Clinical Research

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.

CLR0320 Applied Biostatistics in Clinical Trials

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.

CLR0700 Professionalism & Ethical Issues in Clinical 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.

CLR8000 Clinical Research Thesis Continuation

Credits: 0 Offered: Spring 1

Thesis Continuation for Clinical Research. By Permission Only.