CLR Fall Courses

CLR0006 Spectrum of Methods in Clinical Research I

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

CLR0012 Integrative Prob Solving in Clin & Trans Res

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.

CLR0001 Masters Thesis for Clinical Research

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.

CLR0002 Independent Study for Clinical Research

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.

CLR0017 Clin & Translational Research JC & Seminar-Fall

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 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.

CLR0020 Doctoral Thesis for Clinical Research

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.

CLR0301 Tools in Qualitative Research in Clinical and Translational Science

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 and community-based research intended for graduate students and researchers in clinical and translational science with minimal or no experience in qualitative methodologies.

CLR0501 Computational Tools & Information Sources for Clinical Research

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.

CLR1010 Clinical Trials Management

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.

CLR8000 Clinical Research Thesis Continuation

Credits: 0 Offered: Fall

Thesis Continuation for Clinical Research. By Permission Only.