The core curriculum consists of 22 credits focusing on a variety of topics related to clinical and translational research. Completion of these 22 credits is required for both the Certificate and Master’s programs in Clinical and Translational Research.
This course will provide a critical overview of how bioinformatics is used to drive biological insights, how this has changed in the era of Big Data, and how genomic data can be used to develop more accurate diagnoses, better treatment selection, and the development of novel therapies. To explore the various approaches, and challenges, to analyzing high throughput sequencing datasets, we will follow the lifecycle of an RNAseq dataset, from generation of raw data to identification of genes differentially expressed between conditions. Finally, the course will explore the unique ethical and privacy challenges posed by the proliferation of both public and commercial genomic datasets, and the benefits and harms that can arise from genomic knowledge.
This course is designed using the flipped classroom model, in two parts: a 5 modular eLearning pre-requisite and an in-person faciliated discussion section. Topics covered include the drug development process from discovery to post-marketing . Participants will increase awareness about the processes involved in how drugs are discovered, explore preclinical studies, describe a clinical development plan and the phases of human drug trials, and examine post-marketing and safety of drugs. Students completing the course will understand drug target identification, drug metabolism and pharmacokinetics, drug phase trials, global regulation policies, FDA approval and review processes, and post market regulation activities. The Pharmacology and Drug Development course (via Canvas) is required prior to enrollment.
This workshop is designed as the first part of a 2 part series presented over 2 days during the Spring semester. The spring section describes the different kinds of NIH grants, resources for applying (at WCM, as well as NIH provided resources), information about budgets and the NIH study section, and an introduction to the approach to writing a grant. An interactive exercise integrated into the workshop provides an opportunity for peer and expert feedback to help students develop a clear research question that leads to more successful development of specific aims for a grant.
This workshop is designed as a 2 part series presented over 2 days during the fall semester. The fall section dives into the nuts and bolts of the different components of the grant itself, the review process, during which CTSC alums are invited to describe their review and resubmit processes. Trainees also receive one-on-one consultations with the instructor to review red-lined written feedback of components of their grants. Students completing the course will understand the fundamental components of a grant proposal such as the abstract or summary, background and significance, specific aims/goals and objectives, project design and methods. They will also increase the skills needed to develop competitive grant proposals. Students have the opportunity to draft grant proposals among peers.
This course is an introduction to the fundamental statistical issues in the design of clinical research studies. Its primary emphasis is on understanding the design and analytic methods of clinical research from a statistical perspective. Lectures and discussions will focus on the following: exploratory data analysis; basic concepts of statistical analysis; construction of hypothesis tests and confidence intervals; the development of statistical methods for analyzing data; development of mathematical models used to relate a response variable to explanatory or descriptive variables; and an introduction to statistical analysis of microarray and genomic studies.
This course will provide an overview of how to design, conduct, and analyze clinical trials. Completion of this course will lead to an understanding of the theoretical and practical aspects of clinical trials related to the strengths and limitations of randomized clinical trials; theoretical and practical aspects of randomization, stratification, and blinding; challenges of designing and implementing single center and multi-center clinical trials; major issues in the analysis of clinical trials; role of clinical trials in the drug development process; and investigator’s roles and responsibilities in conducting clinical trials.
Pre-requisite: Introduction to Biostatistics in Clinical Research
This course is designed to give participants an understanding of selecting, accessing, and retrieving information from web-based quality information resources for clinical research. They will also learn importance of properly designed data collection instruments to the quality of study results. Participants will be able to differentiate between spreadsheets, desktop databases and server-based databases, as well as learn the pros and cons of each. Students will also learn the definition and fundamental features of a relational database and the structure of Web-based data management systems. Participants will learn importance of securing your data, and the different mechanisms used to achieve this. At the end of this course trainees will gain knowledge of the current government standards related to data sharing, and practices that promote data interchange. They will be taught HIPAA considerations in clinical research data management as well as the importance to clinical research of the medical record, clinical data warehousing, and the use of national standards for data representation.
This course is an examination of various ethical aspects that arise when conducting biomedical research. In order to evaluate such ethical concerns, students will review and critically analyze the philosophical underpinnings of current guidelines and regulations for the responsible conduct of research. Pre-requisite: Tri-Institutional Responsible Conduct of Research (offered in fall).
This is a 3-credit, course designed for students interested in Clinical Research. Course objectives: Evaluate research questions critically; discuss core epidemiological concepts applied in clinical research, including bias and confounding; assess the appropriateness, strengths, and weaknesses of different study designs for answering a variety of clinical research questions; and demonstrate preference for evidence over authority in the evaluation of clinical research literature interventions.
Through a combination of video-conferencing and live lectures, this course will provide students with an introduction to basic and intermediate epidemiologic methods to build the foundation for further work in epidemiology either as practicing epidemiologists or as sophisticated users of epidemiologic information.
This is a graduate-level course designed for students interested in the application of fundamental principles and technologies of molecular biology and genetics in clinical and translational research. Goals and Objectives: The objectives are to provide: 1) basic concepts and principles of molecular biology and molecular genetics; 2) basic and contemporary technology of molecular biology and genetics in translational and clinical research; 3) hands-on practice how to use some molecular and genetic tools as related to clinical research and clinical medicine. The topics covered include the human genome, genomic variation, gene structure, gene expression, gene therapy, epigenetics, stem cells and cloning, animal models of human diseases, microbiota and molecular diagnostics and personalized/precision medicine
This course is part of a two-part series designed to heighten students’ awareness to ethical considerations relevant to conducting research. It will inform trainees of federal, state, and institutional policies, regulations, and procedures, and provide trainees with critical analysis and problem-solving skills for ethical decision-making. The first component is an eight-week internet-based course offered in the fall term. The second part, Ethical, Social and Legal Issues in the Responsible Conduct of Research, is offered during the summer semester.