Designing Clinical Research for Beginning Investigators


Course description

The course focuses on the most important aspects of clinical research, which are finding a meaningful research question and planning an efficient, effective, and ethical study design. Designed as a practical guide, the course addresses basic and advanced concepts of most forms of clinical research, including translational research, clinical trials, patient-reported outcomes research, epidemiological studies, behavioural science and health services research conducted by physicians, nurses, pharmacists and other health professionals. It explains terms and principles of epidemiology, emphasizing a systematic and common-sense approach to challenging judgments one has to make when designing and implementing a clinical study.

Course structure

This 12-week course requires students to:

  1. complete weekly assignments (1-2 questions related to the specific topic of the week) and
  2. attend a 2-hour session (1-hour lecture on the specific topic of the week+ 1-hour presentation and discussion of assignment responses).

Required Book

Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB. Designing Clinical Research, 4th Edition, Lippincott Williams & Wilking

Course dates

September 17 until December 12, 2024.

This course will be taking place on-site at the University of Basel

Download agenda 

Target audience/prerequisites for attending

PhD students of the PhD subject Clinical Research enrolled at the University of Basel, Faculty of Medicine.

Moreover, PhD students of the other PhD subjects of the Faculty of Medicine (Biomedical Engineering, Biomedical Ethics, Medicines Development, Nursing Science, Public Health/ Epidemiology or Sport Science) are eligible to register for the course.

Minimum 8 and maximum 15 registered participants.

Learning objectives:

Upon successful completion of this course, the students will be able to

  1. Understand basic principles of patient-oriented and translational studies, epidemiological and behavioural studies, public health and health services research
  2. Critically analyse study design (research questions, study populations, measurements, hypotheses, and sample size)
  3. Evaluate different research design options, i.e., cross-sectional and cohort studies, case control and diagnostic test studies, and different types of clinical trials
  4. Apply additional skills needed for designing and implementing clinical research i.e., analytic approaches used to enhance design of clinical research

Work load and credits

60 hours of work load distributed over 12 weeks

The crediting of 2 ECTS requires:

  1. Written response to all weekly assignments related to the course content
  2. Leading and moderating one of the weekly journal clubs
  3. Active participation in weekly discussions

Attendance to all but two sessions is required. 

Assessment format

To add this course to your academic record, please create a Learning Contract on MOnA, choosing:

  • your supervisor as the assessor
  • pass/fail as assessment

before the start day of the course and follow the instructions of your respective faculty.

Study direction

Prof. Maria C. Katapodi, PhD, RN, FAAN

Teaching staff

- Prof. Dr. Maria C. Katapodi, Department of Clinical Research, Faculty of Medicine, University of Basel, Adjunct Associate Professor, University of Michigan School of Nursing

- Chang Ming, Postdoctoral Fellow, Department of Clinical Research, University of Basel

- Zhongxing Zhang, Senior Scientist, Center for Sleep Medicine, Sleep Research and Epileptology, Clinic Barmelweid AG

- Alexandra Kulinkina, PhD, Project Leader Swiss TPH, Adjunct Ass. Professor, Tufts University Friedman School of Nutrition Science and Policy


Mareike Gräter
Training and Education, Department of Clinical Research


The course is free of charge for PhD students of the Faculty of Medicine of the University of Basel.


Course language is English
Confirmation of attendance will be issued after successful course completion


The next course cycle will be starting in September 2024. You can subscribe here and we will inform you about your admission status and all details in summer 2024. 

Registration Deadline: August 5, 2024