Learning objectives
- Describe the various costs associated with all aspects of clinical trials for both the research and general community
- Analyze the factors that influence a study budget, including how different trial designs impact cost components.
- Evaluate the challenges involved in accurately estimating a study budget and identify strategies to address them
- Identify and differentiate the various types of costs encountered in clinical trial budget estimation
Module Summary
CONTENT
Learning outcomes
CONTENT
Learning objectives
At the end of the course, the participant can:
- Explain how to conduct a clinical trial
- Explain the roles and responsibilities of the investigator and site staff, the tools and documents needed and how to track and keep records during the course of the study
- Describe the informed consent process and the management of subjects’ safety and safety reporting
- Describe the process to handle, store and document the study medication and medical devices
- Teacher: Samantha Chan
Module Summary
At the core of the clinical trials process lays the investigational medicinal product (IMP). Successful studies rely on the quality and efficient, timely delivery of their clinical trial supplies. The EU Directive on Clinical Trials (2001/20/EC) requires that all commercial clinical trials must be conducted using Good Manufacturing Practice (GMP) compliant supplies. IMP should be manufactured, handled and stored in accordance with applicable GMP. In practice, the IML lifecycle involves 7 sequential steps: study and packaging design, label design and randomization, packaging, distribution, study conduct, returns and drug accounting and destruction.
Clinical trials on medicinal products are regulated under the Human Research Act (HRA), especially via the Clinical Trials Ordinance (ClinO). Swissmedic is the competent authority for medicinal products; swissethics is the body for ethics committee oversight. From 15 August 2025, Switzerland apply ICH GCP E6(R3) Principles and Annex 1.
Learning outcomes
CONTENT
Learning objectives
- Apply core principles of investigational product management to ensure regulatory compliance and maintain clinical trial integrity.
Module Summary
The basic Statistics course prepares learners to apply core statistical concepts in the context of clinical research. Participants will learn to apply key statistical principles, distinguish between common study designs and justify their selection based on specific research objectives, and construct research questions that are aligned to statistical principles. They will develop the ability to outline and critically review the key components of the statistic aspects of a study protocol and a statistical analysis plan. In addition, learners will assess when advanced trial designs—such as adaptive trials—are warranted and appraise their implications for study implementation and interpretation.
Learning outcomes
At the end of this course participants will be able to apply core statistical concepts relevant to clinical research, including outcome types, effect measures and underlying estimands.
Learning objectives
- Classify statistical objectives in clinical research: description, modelling, or causal inference.
- Implement the key attributes of the estimand framework
- Discuss the role of intercurrent events in planning a study and during study conduct
- Apply different handling strategies for intercurrent events
- Classify different types of statistical variables used in clinical research
- Select appropriate statistical endpoints for clinical research questions.
- Interpret common summary effect measures.
- Interpret the concepts of hypothesis testing, p-values and confidence intervals
- Implement the core components for a sample size calculation
- Select and implement research questions and hypotheses which are aligned to core statistical principles.