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Capstone Certificate - Fundamentals of Clinical Research

To conduct clinical studies adequately, it is necessary to understand the principles of research design and statistical analysis. With the increasing complexities in clinical research, it is imperative that clinical researchers receive a minimum training in clinical research methods. The objective of this capstone certificate program in clinical research methodology is to provide formalized training and a practicum in research design and statistical analysis for clinical research to professionals in health care and biotechnology and in the pharmaceutical industry. For more information, contact Debora Treu or (608) 262-3768.

Course Requirements and Descriptions

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, they may complete the course-work requirements in 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
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 l , 3 credits
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 ll , 3 credits
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
Practicum in the analysis and interpretation of data from national and international clinical trials in a variety of diseases available in the Department. 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.

Medical History and Bioethics 545
Ethical and Regulatory Issues in Clinical Investigation, 1 credit
Ethical and regulatory issues in the design, conduct and reporting of research will be examined. Topics include history, consent, randomized clinical trials, special subjects, medical records and database research, cultural issues, research in developing countries, animal studies and institutional review boards and responsible conduct of research.

Population Health 797
Introduction to Epidemiology , 3 credits
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.

Admission Requirements and Application Process

All students must register with the Division of Continuing Studies to be considered for admission to the Capstone Certificate Program. This certificate does not require GRE scores.

Application Guidelines:

  • Applicant must complete both steps one and two to be considered. Steps one and two may be completed concurrently;
  • Admissions to the program will be for the fall semester only. August 1, 2008 is the deadline for all applications to be complete and submitted to ICTR;
  • The only exceptions to the rule of exclusive fall admissions would be for students who have already taken BMI 541 and are ready for BMI 542 in the spring semester, or have taken BMI 541, 542, and 544 and are ready for BMI 546; and
  • International students can only be admitted in the fall semester due to a minimum credit load of 6 credits they must carry with this program; the sequencing of courses does not allow for the minimum credit load if the program is begun in the spring.

 

Step One: Submit to the Division of Continuing Studies:

 

Step Two: Submit to the Institute for Clinical and Translational Research:

  • Photocopy of electronic application
  • Photocopy of official transcripts from each institution attended
  • Statement of Purpose: a one-page essay describing how the program relates to the applicant’s current research and career plans
  • 2 letters of recommendation
  • CV/Resume

     

Send to:
Debora Treu
Student Services Coordinator
Institute for Clinical and Translational Research
2112 Health Sciences Learning Center
750 Highland Avenue
Madison, WI 53705

NOTE: For details regarding tuition fees, timetable, and financial assistance, please refer to the University of Wisconsin website at: www.wisc.edu

Any questions? Please contact Debora Treu at dltreu@wisc.edu or 608.262.3768.