Course Investigator-initiated Clinical Trials and GCP

ECTS: 1.5

Course leader: Birgitte Olrik Schlemmer

Language: Danish

Graduate school: Faculty of Health

Graduate program: ClinFO

Course fee: 1,800.00 DKK

Status: Course is open for application

Semester: Spring 2023

Application deadline: 05/04/2023

Start date: 03/05/2023

Administrator: Lena Melchior Villadsen

This course will be held in Danish

You can only attend this course if you speak, read and understand Danish!

The course C160/14 Investigator-initiated Clinical Trials and GCP is being offered by the Graduate School of Health, Aarhus University, 2023.

Criteria for participation: University degree in medicine, dentistry, nursing, or master’s degree in other fields and/or postgraduate research fellows (PhD students and research-year medical students).

Aim: This course is intended for academic researchers in Denmark, who are about to conduct or are actively involved in a Clinical Trial with a Medicinal product. Focus will be on the practical aspects on how to comply with the principles of Good Clinical Practice (GCP) and requirements in the national regulations in Denmark for these types of trials.

Learning outcomes: 

  • Explain and implement the legal, regulatory and good practice framework – The principles of GCP, national regulations, application to the authorities
  • Illustrate and relate to the organization of the study - sponsor, investigator, contracts and agreements, delegation of responsibilities, training, internal and external communication
  • Discuss and assess on what’s important in the conduct of the study including ethical issues – informed consent, enrolment, essential documents in Trial Master File, biological samples, study monitoring, End of trial issues
  • Explain and implement the process in safety monitoring and reporting
  • Explain and apply the data-management process from CRF preparation, data collection, data analysis, clinical study report and publication

Workload: The full workload of the course is expected to be 37 hours

Content: The course covers the principles of Good Clinical Practice (GCP) and the roles of Sponsor, Investigator, Monitor, the ethics committee and the regulatory authorities.

Instructors: The GCP-unit and invited teachers (experts in research and representatives from the health authorities)

Venue: Aarhus University, Aarhus

Participation in the course is without cost for:

  • PhD students, Health Research Year students and Health Research Honours Programme students from Aarhus University
  • PhD students enrolled at partner universities of the Nordoc collaboration
  • PhD students from other institutions in the open market agreement for PhD courses

Course dates:

  • 03 May 2023 08:30 - 15:30
  • 04 May 2023 08:30 - 15:30
  • 10 May 2023 08:30 - 15:30