Course C160/11 Investigator-initiated Clinical Trials and GCP

ECTS: 2.4

Course leader: Birgitte Olrik Schlemmer

Language: English

Graduate school: Faculty of Health

Max seats: 22

Applicants: 28

Status: Course is started

Application deadline: 20/10/2020

Start date: 17/11/2020

Administrator: Annette Poulsen

Title: Investigator-initiated Clinical Trials and GCP C160/11

is being offered by the Graduate School of Health, Aarhus University, fall 2020.

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, 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 for these types of trials.

Learning outcomes:

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

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

The following will be explained and discussed: Requirements regarding protocol, application to the authorities, initiation and conduction of a clinical trial, trial medication, safety monitoring and reporting, contracts and agreements, biological samples, data collection and quality assurance.

Language: English (Danish if only Danish speaking participants)

ECTS: 2,4

Head of course: Birgitte Olrik Schlemmer

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

Number of participants: Max 22

Dates and times: 17, 18 and 27 November 2020 approx. 8:30-15:30

Place: Victor Albeck Bygningen, Vennelyst Boulevard 4, 8000 Aarhus C

  • 17 and 18 November: Det Blå Auditorium (1266-222)
  • 27 November: Kollokvierum Øst (1268-218),

Course fee: DKK 2880

Participation in the course is without cost for:

  • PhD students, Research Year students and 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

Application deadline: 20 October 2020