The Clinical Investigation curriculum was created to provide didactic instruction in topics that are relevant and critical to all clinical research. Clinical Investigation courses are open to scholars participating in affiliated Washington University graduate or post graduate programs, and to individuals with a post-graduate degree in medicine or health who are employees of a partner institution. See the list of textbooks for the upcoming semester.
Click on a course below for more information:
Analysis of Clinical Data
Bench Fundamentals for Translational Research
Designing Outcomes and Clinical Research Workshop
Designing Outcomes and Clinical Research
Drug and Device Development
Epidemiology for Clinical Research
Ethical and Legal Issues in Clinical Research
Genomics in Medicine I
Genomics in Medicine II
Industry Partnering: Collaborations in Translational Research
Intermediate Methods for Clinical and Outcomes Research
Intermediate Statistics for the Health Sciences
Introduction to Biomedical Informatics I: Foundations
Introduction to Biomedical Informatics II: Methods
Introduction to Evidence Based Entrepreneurship
Introduction to Statistics for Clinical Research
MTPCI Research Seminar
MTPCI Mentored Independent Research
PIRTT Research Seminar
PICRT Mentored Independent Research
Scientific Writing and Publishing
Analysis of Clinical Data (1 credit) M17-5881 Syllabus (PDF)
This class teaches basic biostatistical analysis using clinical examples. Specifically, this course will cover: populations and samples; scales of measurement; variables; frequency distributions; central tendency; variability, probability, normal distribution, and sampling distribution; introduction to hypothesis testing and sample size; one-sample t-test, independent samples t-test, paired t-test; one-way ANOVA; nonparametric statistical procedures; post-hoc testing; correlation and regression; logistic regression; calculation of survival curves/life tables, and Cox-regression. TL1 PREDOCTORAL STUDENTS ONLY. 5 day course, daytime sessions, times vary. Summer Semester.
Bench Fundamentals for Translational Research (3 credits) M17-553
This course will introduce fellows-in-training and future physician scientists to the core principles of scientific investigation. This unique two-week intensive format will combine the theoretical knowledge with practical, hands-on application to provide students with an understanding of common and new innovative research approaches used in current scientific endeavors. The first week consists of online lectures by distinguished researcher in the following areas: molecular medicine; biospecimens and tissue banking; gene expression; immunoassays and controls; immunolocalization techniques; flow cytometry and cell sorting; cell signaling; sequencing technologies; microarray and related technologies; proteomics and mass spectroscopy; animal models and bioinformatics. The lectures will be complemented by a second week of hands-on laboratory experiences in tissue culture, protein extraction and blot, cell signaling and ELISA, PCR and electrophoresis; and plasmid purification. The first week of lectures is online from July 17-21. The second week of labs meet 10a-4p MTuWThF from July 24-28. Summer Semester.
Designing Outcomes and Clinical Research Workshop (1 credit) M17-504
Developed by Dr. Piccirillo, this Workshop is based on the Designing Clinical Research Course developed by Dr. Hulley and colleagues at the University of California – San Francisco School of Medicine. The goal of the course is to teach the methods of clinical investigation to physicians and other health professionals. The main part of the course runs in seven sessions, with a lot of active homework and two hours a week in class. Topics include: The Anatomy and Physiology of Clinical Research; Conceiving the Research Questions; Choosing the Subjects: Specification, Sampling & Recruitment; Planning the Measurements: Precision and Accuracy; Getting Ready to Estimate Sample Size: Hypotheses & Underlying Principles; Estimating Sample Size and Power; Designing an Observational Study – cohort, cross-sectional, and case-control studies; Enhancing Causal Inference in Observational Studies; Designing an Experiment – clinical trials; Designing Diagnostic and Prognostic Test Studies; Secondary Data Analysis; Designing Questionnaires and Data Collection Instruments; Implementing the Study; Data management; and Writing and Funding a Research Protocol. TL1 PREDOCTORAL STUDENTS ONLY. Daytime sessions, times vary. Summer Semester.
Designing Outcomes and Clinical Research (3 credits) M17-513 Syllabus (PDF)
DOC Research covers how to select a clinical research question, outline a research protocol, and execute a clinical study. Topics include: subject selection, observational and experimental study designs, sample size estimation, clinical measurement, bias and confounding, and data management. The course is designed for health care professionals who wish to conduct patient-oriented clinical research. Students incorporate research design concepts into their own research proposal. The course consists of lectures, weekly problem sets, weekly reading assignments, outlining a research protocol, and a final exam. Wednesdays, 4:00-6:15pm. Fall Semester.
Drug and Device Development (3 credits) M17-518 Syllabus (PDF)
This course will provide an overview of the commercial development pathways for both pharmaceuticals and medical devices, from inception to market. Through lectures and discussions, students will gain an appreciation for the role clinical study programs play in the broader scope of product development. Class topics will include preclinical, clinical, regulatory, and marketing factors which influence discovery and development of new medical products. Thursdays, 5:30-8:00pm. Fall Semester.
Epidemiology for Clinical Research (3 credits) M17-588 Syllabus (pdf)
This course will focus on: 1) common applications of epidemiologic principles and analytic tools in evaluating clinical research questions; and 2) developing skills to review and interpret the medical literature and utilize publicly available datasets to address clinical research questions. Mondays, 4:30-7:00pm. Spring Semester.
Ethical and Legal Issues in Clinical Research (2 credits) M17-510 Syllabus (pdf)
This course prepares clinical researchers to critically evaluate ethical and regulatory issues in clinical research. The principal goal of this course is to prepare clinical researchers to identify ethical issues in clinical research and the situational factors that give rise to them, to identify ethics and compliance resources, and to foster ethical problem-solving skills. The course aims to deliver practical guidance for investigators through discussion of critical areas of clinical research ethics. An additional aim of the course is to enable participants to recognize the different ways in which research participants may be vulnerable and the ethical issues raised by including and excluding vulnerable participants. By the end of the course, participants will understand the regulatory framework that governs human subjects research and the distinction between compliance and ethics; be able to identify major ethical concerns in the conduct of clinical research, including situational factors that may give rise to ethical concerns; and be able to apply an ethical problem-solving model in clinical research. Mondays, 4:00-6:00pm. Fall Semester.
Fundamentals of Clinical and Translational Research (3 credits) M17-404
Under the direction of clinician-researchers, this course immerses young investigators in clinical research though didactic sessions, seminars and mentored research experiences. Students will be introduced to topics in designing outcomes and clinical research as well as basic biostatistical analysis using clinical examples, while getting hands-on research experience. Open only to students in the Advanced Summer Program for Investigation and Research Education (ASPIRE). Course runs from June 1st to July 31st.
Genomics in Medicine I (1 credit) M17-532 Syllabus (PDF)
This course introduces principles of genomics in medicine as they apply to clinical research and provides a practical background in molecular biology and genetics. Students will be provided with an introduction to genomic research and applications of genomic technologies in the research environment and an understanding of the clinical application of genetic/genomic knowledge. Critical thinking and scientific/analytic competencies are emphasized throughout the course. Wednesdays, 4:00-5:00pm. Fall Semester.
Genomics in Medicine II (1 credit) M17-533
This is the second course in the Genomics in Medicine sequence. This course introduces principles of genomics in medicine as they apply to clinical research and provides a practical background in molecular biology and genetics. Students will be provided with an introduction to genomic research and applications of genomic technologies in the research environment and an understanding of the clinical application of genetic/genomic knowledge. Critical thinking and scientific/analytic competencies are emphasized throughout the course. Note you can enroll in this course if you have not taken M17-532. Wednesdays, 4:00-5:00pm. Spring Semester.
Grantsmanship (2 credits) M17-528
Scholars create a focused research plan that incorporates well-formulated hypotheses, rationales, specific objectives and long-range research goals; organize and present a sound research plan that accurately reflects the ideas and directions of the proposed research activities; develop and justify a budget for the proposed research activities; avoid many common grant-writing mistakes; discuss the peer review process in grant evaluation and formulate a grant proposal that is maximally compatible with that process. Students enrolled in this course should identify a grant to actively work on during the semester. Tuesdays, 5:15-7:15pm. Fall Semester.
Industry Partnering: Collaborations in Translational Research (3 credits) M17-519 Syllabus (pdf)
Innovative new products are the life blood of the biopharmaceutical industry. In the U.S., most discovery research originates at the university level and is transferred via licensing agreements to industry partners or to start-up biotech companies for final development and commercialization. The process of moving this innovation from the lab to industry and then to the patient is the focus of this course. The course examines the market for intellectual property that exists between academic institutions and the private sector and explores commercialization of translational research through collaboration with industry partners. In addition to studying the complex relationship between science and business, the course employs a case study methodology to illustrate specific examples of the translational process from lab to marketed product. Tuesdays, 5:30-8:00pm. Spring Semester.
Intermediate Methods for Clinical and Outcomes Research (3 credits) M17-589 Syllabus (pdf)
This course focuses on principles of epidemiology and outcomes research beyond the basics as they apply to clinical research. The course provides tools used in clinical epidemiology, which are crucial for making informed decisions in the care of patients. Critical thinking and scientific/analytic competencies are emphasized throughout the course. Prerequisites: Designing Outcomes for Clinical Research (M17-513) or Epidemiology for Clinical Research (M17-588). Wednesdays, 4:30-7:00pm. Spring Semester.
Intermediate Statistics for the Health Sciences (3 credits)
This 15-week course builds on skills developed in Introduction to Statistics for the Health Sciences. The course fosters basic expertise required to independently use common multivariate biostatistical methods to analyze clinical research data for peer-review presentation and publication. Prereq M17-522 or equivalent. Thursdays, 4:00-6:30pm. Spring Semester.
Introduction to Biomedical Informatics I: Foundations (3 credits) M17-5302 Syllabus (pdf)
This survey course provides an overview of the theories and methods that comprise the field of biomedical informatics. Topics to be covered include: 1) information architecture as applied to the biomedical computing domain; 2) data and interoperability standards; 3) biological, clinical, and population health relevant data analytics; 4) healthcare information systems; 5) human factors and cognitive science; 6) evaluation of biomedical computing applications; and 7) ethical, legal, and social implications of technology solutions as applied to the field of biomedicine. The course will consist of both didactic lectures as well as experiential learning opportunities including “hands on” laboratory sessions and journal club style discussion. The course will culminate with a capstone project requiring the in-depth examination, critique and presentation of a student-selected topic related to the broad field of biomedical informatics. Biomedical Informatics I is designed primarily for individuals with a background in the health and/or life sciences and who have completed a course in introductory statistics (e.g., MATH 1011). No assumptions are made about computer science or clinical background; however, some experience with computers and a high-level familiarity with health care will be useful. This course does not require any programming knowledge, and it will not teach students how to program. Mondays, 4:00-7:00pm. Fall Semester.
Introduction to Biomedical Informatics II: Methods (3 credits) M17-5303 Syllabus Forthcoming
This course introduces students to the methods needed in order to apply the foundational theories covered in Biomedical Informatics I. The course will cover a broad spectrum of such methods including both computational and quantitative science techniques that can be employed in the design, conduct, and analysis of basic science, clinical, and translational research programs. This course is intended to enable individuals to critically select such methods and evaluate their results as part of both the design of new project as well as the review of results available in the public domain (e.g., literature, public data sets, etc.). Core concepts to be reviewed during this course include: basic computational skills, data modelling and integration, formal knowledge representation, in silico hypothesis generation, quantitative data analysis principles, and critical thinking skills surrounding the ability to ask and answer questions about complex and heterogeneous biomedical data. Prerequisite: M17-5302 or instructor permission. Mondays, 4:00-7:00pm. Spring Semester.
Introduction to Evidence Based Entrepreneurship (1 credit) M17-542
This course provides an overview on how to identify viable new venture concepts in the biomedical field, build plans for a sustainable and scalable enterprise, and get ventures off the ground. In addition to the workshop, students will engage in hands on practice applying these concepts to their own venture capital idea as well as be exposed to venture capital resources available at Washington University and in the local St. Louis area. This class is specifically targeted at scholars already holding or currently pursuing an advanced degree in a health science field. Mondays, 4:00-5:30pm. Spring Semester.
Introduction to Statistics for Clinical Research (3 credits) M17-522 Syllabus (pdf)
This is an introductory course in statistics with a focus on the use of statistical analysis in clinical research. It is taught using SPSS, statistical analysis software commonly used in clinical research. The course teaches basic statistical methods with which clinical researchers will have the facility to execute their own analyses. Thursdays, 4:00-6:30pm. Fall Semester.
MTPCI Research Seminar (1 credit) M17-5140
Weekly seminar series are required for Postdoctoral Program and Career Development Program scholars for four semesters, one credit per semester. An important learning experience in research is the presentation and critical discussion of research ideas and projects at various points in their evolution. Seminars will alternate discussion of work in progress with critical reading of current clinical research in order to practice and enhance analysis and communication skills. Each scholar will formally present his or her own research in progress twice per year for feedback by peers and faculty from multiple disciplines. In addition to presenting their own work in oral and written form for peer and faculty evaluation, scholars will formally review the written proposals of their peers in a way that emulates the duties of a member of an NIH study section. This formal research evaluation exercise is a highly successful element of other clinical training instruction at Washington University. The Program Director and Co-Directors will lead a weekly seminar with participation of other core faculty. The weekly, small group, intensive discussions of research issues are one of the most valuable aspects of the program, allowing scholars to learn in an active and participatory fashion. CRTC POSTDOC PROGRAM SCHOLARS ONLY. Tuesdays, 4:00-5:00pm. Fall and Spring Semesters.
MTPCI Mentored Independent Research (variable credit) M17-5110
Scholars earn Mentored Independent Research credits for conducting clinical research. Mentored Independent Research will be presented each semester to an advisory committee that includes the scholar’s departmental mentors as well as Clinical Research Training Center program faculty. The research presented will be in the form of a research paper submitted for publication in a peer reviewed journal. Under some circumstances, a grant application submitted for review will be acceptable in place of the research paper. MTPCI Mentored Independent Research will provide scholars with the practical application of skills learned in the Clinical Research Training Program didactic coursework and seminars. CRTC POSTDOC PROGRAM SCHOLARS ONLY. Fall, Spring and Summer Semesters.
PIRTT Research Seminar (2 credits) M17-515
Pre/Postdoctoral Interdisciplinary Research Training in Translation (PIRTT) Seminar is a weekly requirement for TL1 trainees. An important learning experience in research is the presentation and critical discussion of research ideas and projects at various points in their evolution. Seminars will alternate discussion of work in progress with critical reading of current clinical research in order to practice and enhance analysis and communication skills. Trainees are also required to complete journal entries and required readings. The Program Director will lead a weekly seminar. These small group, intensive discussions of research issues are a valuable aspect of the program, allowing scholars to learn in an active and participatory fashion. Trainees are also required to attend monthly Career Development Seminars with the Clinical Research Training Center’s Postdoctoral and KL2 Career Development Scholars. PREDOC ONLY. Tuesdays, 10:30am-12:30pm. Fall and Spring Semesters.
PICRT Mentored Independent Research (variable credit) M17-503
Trainees earn Predoctoral Interdisciplinary Clinical Research Training Mentored Independent Research credits for conducting clinical research, completing a report and developing and presenting a poster describing their work. They are also expected to attend a half-day research symposium in the fall with other clinical investigators. Mentored Independent Research will be presented each semester to an advisory committee that includes the scholar’s departmental mentors as well as Clinical Research Training Center program faculty. The research presented will be in the form of a research paper submitted for publication in a peer reviewed journal. Under some circumstances, a grant application submitted for review will be acceptable in place of the research paper. PICRT Mentored Independent Research will provide scholars with the practical application of skills learned in the Clinical Research Training Program didactic coursework and seminars. PREDOC ONLY. Fall, Spring and Summer Semesters.
Scientific Writing and Publishing (2 credits) M17-529 Syllabus (pdf)
The objective of this course is to teach the proper techniques of writing and publishing a biomedical manuscript. Writing a working title and structured abstract as well as hand drawing of figures and tables is covered. Publishing strategies are also discussed. Tuesdays, 5:15-7:15pm. Spring Semester.
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