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CTSI Clinical Study Design Types

1 credit


Full course description

The Georgia Clinical & Translational Science Alliance - Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI collaborate to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Course Description:

This course provides an in-depth exploration of various clinical trial design types (i.e., cohort, case-study, quasi-experimental, etc.) along with the statistical methods often used respective to each type (i.e., Chi-square test, T-test, non-parametric Wilcox logistic regression, etc.). Other topics discussed include development of a testable research question using PICOT criteria, data collection, and brief explanations on the advantages and disadvantages of each trial design type.

Learner Objectives:

  • At the end of this course, the learner will be able to:
  • Define different clinical trial study designs (i.e., descriptive, analytic, observational, cohort, case-control, quasi-experimental, crossover, cluster randomized, non-inferiority trials).
  • Formulate a research question using PICOT criteria.
  • Understand how study designs should align with the research question, data collection, and statistical analyses.
  • Define different types of data (i.e., continuous, dichotomous, ordinal categorial, nominal, count, and survival).

Course Topics:

  1. Clinical trial study designs and the associated statistical methods used
  2. PICOT criteria to develop the research question
  3. Statistical analysis plan
  4. Testing differences among groups
  5. Types of data
  6. Regression models


Wendy Mack, PhD, is the Director of the Biostatistics, Epidemiology, and Research (BERD) Core at the Southern California Clinical and Translational Science Institute (SC-CTSI) and a Professor in the Department of Preventative Medicine, Division of Biostatistics in the Keck School of Medicine at USC. She received her doctorate in Biometry from USC. She has over 25 years of experience in directing biostatistical and data coordination activities for multiple single-centered and multi-centered clinical trials and observational studies. She has directed the biostatistical and data coordination activities of randomized clinical trials (the majority being NIH- or PCORI-funded), as well as NIH-funded program projects, and has a wealth of experience and expertise in analysis of longitudinal clinical trial outcomes.With over 30 years of teaching USC students, Wendy remains deeply committed to training the next generation of clinical investigators and biostatisticians. As the former director of the MS programs in Biostatistics and Epidemiology in the Department of Preventive Medicine, she has mentored numerous K-awardees, junior faculty, and graduate students (MS and PhD).

Learner Level: Intermediate


This symposium is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals, or junior faculty with three or more years of experience seeking to further develop clinical research skills and principles. Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor / CRO challenges.

Learner Disclosures:

  • Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.
  • Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.
  • Awarding Contact Hours: To obtain contact hours participants must
    • Review the entire activity
    • Pass the quiz with 100% of questions answered correctly
    • Complete the evaluation at the end
    • Certificates will be distributed at the end of the evaluation.
  • Enduring Materials Dates:
    • Start Date: 09/30/2022
    • Expiration Date: 09/29/2025

Need Help with Registration? Please contact us at or 404-727-9208.

Program Information: This is the first course in a five (5) course program. To complete the entire program and earn a badge CLICK HERE.

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