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University of Basel - ECPM

Ethical and Legal Aspects of Clinical Trials

Practical Information

Commencing Date:
tba
Language:
English
Location:
Basel Switzerland


Teaching Methodology:
Face-to-Face
Credits :
Short courses (CPD): 2 ECTS


European Fees:
2000 CHF
Scholarship Possibilities:
No

Course Contact

Annette Mollet

+41 61 267 19 52

annette.mollet@unibas.ch


Website

Office Link

University of Basel - ECPM

University Accreditation: Yes

Centre of Excellence

Description

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.

Outcomes

- Key principles of ethical considerations during clinical research and development - Ethical concerns for designing, conducting and reporting the results obtained through the conduct of clinical Trials - International and national principles and guidelines which have to be followed when performing a clinical Trials

Methodology

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