Certificate in the Fundamentals of Clinical Research

The Fundamentals of Clinical Research certificate provides formal training and a practicum in research design and statistical analysis for professionals in health care, biotechnology, and in the pharmaceutical industry. To conduct clinical studies, it is necessary to understand the principles of research design and statistical analysis. The certificate program offers 13 to 14 credits of training to begin grounding current and future clinical researchers in clinical research methods.

  • Students who are not seeking a degree can earn a Capstone Certificate in the Fundamentals of Clinical Research.

For further information on the Certificate in the Fundamentals of Clinical Research, please email: studentinquiry@ictr.wisc.edu


 Course Requirements

The Certificate Program in the Fundamentals of Clinical Research consists of five courses for a total of 13-14 semester credits.

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.

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.

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)
  • Nursing 802: Ethics and Responsible Conduct of Research (1 credit, Spring)
  • Oncology 675: Appropriate Conduct of Science (listed as “Advanced or Special Topics”, 1 credit, Spring)
  • Pharmacy 800: Research ethics, Scientific Integrity and the Responsible Conduct of Research (2 credits, alternate Fall semesters, 2012, 2014, etc.)
  • OB/GYN 955: Responsible Conduct of Research for Biomedical Students (2 credits, Fall)

Note: Effective June 2013, BMI 546: Practicum in Clinical Trial Data Analysis & Interpretation (3 credits), is no longer required.

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