Course Investigator-initiated Clinical Trials and GCP

Title: Investigator-initiated Clinical Trials and GCP

Reg.no: C160/12

is being offered by the Graduate School of Health, Aarhus University, spring 2021.

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:

• 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

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 trial documents, application to the authorities, risk assessment and monitoring plans, initiation and conduction of a clinical trial, including sponsor oversight and investigator supervision, trial medication, safety monitoring and reporting, contracts and agreements, biological samples, data collection and quality assurance.

Language: English (Danish if only Danish speaking participants)

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

Dates and times: 26 - 27 May and 2 June 2021 from 8:30 – 15:30

Place: Online teaching

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

Course dates:

• 26 May 2021 08:30 - 15:30
• 27 May 2021 08:30 - 15:30
• 02 June 2021 08:30 - 15:15