MAFAR5000 Clinical Trials for Healthcare Professionals - Planning and Conduct Course description

Clinical trials are an important source of knowledge in evidence-based practice in the health services, and the Norwegian authorities aim to increase the number of clinical trials. To achieve this goal, healthcare professionals must have competence in relevant methodology, organisational requirements and regulations that apply to this type of research.

This course is designed for healthcare professionals who want formal and broad competence in clinical trials in order to be able to initiate or lead the planning and conduct of such research projects.

Clinical trials in this context include drug trials, testing of medical technical equipment/other technology, or other types of interventions, such as physical activity and nutrition.

• Students admitted should be capable of conducting independent literature searches in relevant databases and critically evaluating articles concerning clinical studies.
• They should be familiar with basic principles of clinical trials.
• Completion of a Good Clinical Practice (GCP) course prior to the start of the course is recommended. The following fully digital and free GCP course can be completed online: E-læring for projektpersonale - GCP-Enhederne

• Students must be admitted to the Master’s Programme in Pharmacy, the Master’s Programme in Health Sciences or the Master’s Programme in Health and Technology at OsloMet.
• The course is also offered as a single course, where applicants must hold at least a bachelor’s degree or equivalent in health sciences. The C grade requirement does not apply for admission to the single course.

After completing the course, the student should have the following learning outcomes defined in terms of knowledge, skills and general competence:

Knowledge

The student

• can discuss key methodological approaches in clinical research
• can identify and formulate relevant clinical research questions
• has in-depth knowledge of ethical considerations and regulatory requirements for conducting clinical trials

Skills

The student can

• plan a clinical trial, including writing a research protocol
• under supervision, conduct an independent and delimited clinical research project in line with regulatory requirements and applicable research ethics standards
• analyse and critically assess results from clinical studies
• evaluate results from clinical research in terms of implementation in practice

General competence

The student can

• identify relevant professional expertise necessary for conducting clinical trials
• reflect on social and cultural aspects of clinical trials
• update their own knowledge by finding, evaluating and interpreting scientific literature
• communicate research results from clinical trials

The course is delivered both on campus and digitally, using lectures and student-active teaching methods such as seminars and both group-based and individual assignments. Two intensive teaching weeks are organised, each lasting 4-5 days with a combination of on-campus and digital attendance.

The following must have been approved in order for the student to take the exam:

• Under supervision, students will conduct a group experiment (3-4 students) and submit a group report of 2,000-3,000 words.
• Oral presentation of the report in the final teaching week, with peer feedback. All group members must participate in the presentation.

Individual oral exam of up to 20 minutes.

None.

Grade scale A-F

All answers are assessed by two examiners. An external examiner is used regularly, at a minimum of every third completion of the course. When selecting answers for external evaluation, a minimum of 20 percent of the answers shall be included, with no fewer than 5 answers. The external examiner’s assessment of the selected answers shall benefit all students.

None.