Course Requirements for Clinical Research Capstone Certificate
The Capstone in Fundamentals of Clinical Research consists of six courses for a total of 16 semester credits. We assume that, depending on the clinical and research load of the resident or medical fellow, students will be able to complete the course-work requirements within 2 years.
IMPORTANT: Applications to the Capstone Program are only accepted for the fall semester. Read below for complete application guidelines.
Required Courses:
Biostatistics and Medical Informatics 541
Introduction to Biostatistics (3 credits, Fall)
This course is designed for the biomedical researcher. Topics include: descriptive statistics, hypothesis testing, estimation, confidence intervals, t-tests, chi-squared tests, analysis of variance, linear regression, correlation, nonparametric tests, survival analysis and odds ratio. Biomedical applications are discussed for each topic.
Biostatistics and Medical Informatics 542
Introduction to Clinical Trials I (3 credits, Spring)
Intended for biomedical researchers interested in the design and analysis of clinical trials. Topics include definition of hypotheses, measures of effectiveness, sample size, randomization, data collection and monitoring, and issues in statistical analysis.
Prerequisite: Stat 541 or equivalent or instructor's consent
Biostatistics and Medical Informatics 544
Introduction to Clinical Trials II (3 credits, Fall)
This course will provide practical experience and training in clinical trial research. The course will focus on the design, implementation, and conduct of clinical trials. Topics include: regulatory requirements for clinical trials; data collection strategies, data quality and management; budget development and justification; federal, institutional, and sponsor-defined requirements; establishment of research infrastructures for safety and success; preparation of investigator-INDs; investigator responsibilities in Phase l-IV trials. Development of data collection and data management systems and a budget for the protocol developed in 541 are required components of this course.
Biostatistics and Medical Informatics 546
Practicum in Clinical Trial Data Analysis and Interpretation (3 credits, Spring)
Practicum in the analysis and interpretation of data from national and international clinical trials in a variety of diseases available. This has a potential to lead to NIH R03, Small Analysis Grant, applications based on generations of new hypotheses from the existing large scale clinical trial data. This Practicum will serve as the "Capstone" experience for individuals enrolled in the program.
One lecture course in ethical conduct of research selected from the following list of courses:
- Vet Med / Surgical Science 812
Research Ethics and Career Development (2 credits, Fall)
- Medical History and Bioethics 545
Ethical and Regulatory Issues in Clinical Investigation (1 credit, Fall)
This course will explore and examine the ethical issues central to clinical research, regulations governing clinical investigation, and the role of good clinical practice for clinical trials.
- Nursing 802
Ethics and Responsible Conduct of Research (1 credit, Spring)
Ethical issues in the design, conduct and reporting of research are examined in the context of the nature of the scientific endeavor, the structure of the research community, and professional and federal guidelines for supporting scientific integrity and controlling misconduct. - Oncology 675
Appropriate Conduct of Science (listed as "Advanced or Special Topics", 1 credit, Spring)
Population Health 797
Introduction to Epidemiology (3 credits, Fall)
Lectures and discussions on design, implementation and interpretation of epidemiologic studies; emphasis on methodologic problems in the measurement of disease frequency, natural history and risk factors.
Prerequisites: Graduate student in clinical/life science or consent of instructor.
