Regulatory and Ethical Aspects of Clinical Research - TM, BM and MMA

2018/2019

Prerequisite/Recommended prerequisite for participation in the module

Participation in all exams of the 1. semester.

Content, progress and pedagogy of the module

Learning objectives

Knowledge

  • Describe the legal framework of translational medicine
  • Describe the regulatory process, including Good Clinical Practice, Good Laboratory Practice and Good
  • Distribution Practice (GCP, GLP, GDP).
  • Discuss the institutions and factors governing the conduct of research (legislation, boards, and guidelines)
  • Explain the Danish requirements for and process of obtaining approval of experiments with animals and with humans, in particular relating to drug testing
  • Discuss the interests and needs of healthy and ill subjects in research
  • Reflect on the concept “conflicts of interests” in terms of researchers and other actors (e.g. manufacturing companies, contract research companies, and patient organisations)
  • Discuss the issue of access to research results and research data
  • Discuss the concept “scientific fraud” and the related institutions in public and private research

Skills

  • Explain the role of the end user
  • Identify actors and their driving forces in research
  • Suggest how Good Clinical Practice, Good Laboratory Practice, Good Distribution Practice can be implemented in a specific experiment/research project or manufacturing process
  • Relate Good Manufacturing Practice to the work with research
  • Discuss the importance of following

Competences

  • Provisionally plan a (small) research project concerning approval, conduct and ethical considerations
  • Analyze case studies of clinical trials

Exam

Exams

Name of examRegulatory and Ethical Aspects of Clinical Research
Type of exam
Written exam
ECTS5
Assessment7-point grading scale
Type of gradingInternal examination
Criteria of assessmentAs stated in the Join Programme Regulations.

Additional information

Please contact the  programme student counsellors if you consider applying to the education and you have questions.

Please consult the Moodle page for your semester and contact the semester coordinator if you have academic questions, or the study secretary if you have administrative questions.

All other enquiries may be directed to Helene Nørgaard, secretary of the Study Board.

Facts about the module

Danish titleRegulatoriske og etiske aspekter i klinisk forskning - TM, BM og MMA
Module codeMEDMS13K2_1
Module typeCourse
Duration1 semester
SemesterSpring
ECTS5
Location of the lectureCampus Aalborg
Responsible for the module

Organisation

Study BoardStudy Board of Medicine
FacultyThe Faculty of Medicine