Students of the Master’s Programme in Translational Medicine have a priority to attend. The course is also offered for students of the Doctoral programmes at the Faculty of Medicine and the students of the Systems biology and medicine – study track in Master’s Programme in Life Science informatics. Attendance is limited to 30 students.
The aims of the course are to familiarize students with basics of clinical research, methodology of clinical investigation and underlying legislation. The student will learn to prepare research plans which follow and respect the legal and ethical guidelines concerning clinical investigation, are based on appropriate research methods, and are accompanied by necessary documentation for clinical study.
Period I, second study year in TRANSMED studies.
* Lectures: Introduction; Different study settings in clinical investigation; Legislation,
regulations and declarations; Study plans and applications for ethical approval; Execution of
clinical study; Clinical investigation and clinical medicine.
* Group work and seminar:
o Introduction to group work: groups will be introduced to the group work and how to
complete the work.
o Students will form small groups (6-7 participants/group, each group will have a
tutor). Each group prepares a study plan (including study protocol, financing plan,
and application for ethical approval with all necessary documentation) for a clinical
study. The group work emphasis is on formal issues, not on substance.
o Seminar: Groups will present results of their group work and individual contribution
of each group member.
All materials are provided during the course, including scientific articles.
Suggested reading and background reading for seminar work:
· Eardley, William, Carr, James, Page, Piers. 2012. Available as ebook in Terkko.
· Renato D. Lopes, Editor, Robert A. Harrington, Editor. Lange, 2013. Available as ebook in Terkko.
· More material in Moodle portal
Lectures and participation in tutored group work.
Completion of 80% of lectures, and active participation in group work and seminar.
Grading scale: Pass/Fail
Lectures: Min. 80% attendance to lectures
Group work and seminar: Group work and seminar are required. The groups must
inform contribution to seminar work of each group member. Group work is evaluated as
accepted/unaccepted. In case student's contribution is insufficient, compensatory studies will be required.
Number of participants in group work is limited.
Lectures: 10 h
Group work introduction and seminar: 3 h
Independent study and literary assignments: 41 h