University of Basel - European Center of Pharmaceutical Medicine (ECPM)

Ethical and Legal Aspects of Clinical Trials

Practical Information

Commencing Date:
TBA for 2021
Basel Switzerland

Teaching Methodology:
2 Day(s)
Credits :
Short courses (CPD): 2 ECTS

Non European Fees:
2000 CHF
Scholarship Possibilities:

Course Contact

Annette Mollet

+41 61 267 19 52


Office Link

University of Basel - European Center of Pharmaceutical Medicine (ECPM)

University Accreditation: Yes

Centre of Excellence


The implementation of clinical research projects requires conscientious review of research projects not only in terms of their scientific quality but also in regard to their ethical adequacy and appropriateness. How can we balance the risk-benefit of our projects? Given the importance of ethics for the conduct of drug development and research, it should come as no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics.

Each of these aspects will be carefully considered and discussed in the context of international and national principles and guidelines. These issues need to be carefully adhered to strengthen the health of the clinical trial enterprise to the benefit of patients and the overall health of the public. During our course, representatives from different institutions will introduce and discuss the most important concepts, tools, principles, and methods that can be useful in approaching and resolving ethical dilemmas. Realworld examples and case studies will be introduced and discussed.


By the end of the course, students will be able to:

  • Name key principles of ethical considerations during clinical research and development
  • Discuss ethical concerns for designing, conducting and reporting the results obtained through the conduct of clinical trials
  • Understand international and national principles and guidelines which have to be followed when performing clinical trials


Quality - GMP, GCP, GLP

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered