FRM5730 – Clinical Drug Trials
Schedule, syllabus and examination date
Changes in the course due to coronavirus
Autumn 2020 we plan for teaching and examinations to be conducted as described in the course description and on semester pages. However, changes may occur due to the corona situation. You will receive notifications about any changes at the semester page and/or in Canvas.
Spring 2020: Teaching and examinations was digitilized. See changes and common guidelines for exams at the MN faculty spring 2020.
The objective of the course is to provide the students with an understanding of the framework surrounding the clinical testing of medicine. The participants are to receive insight into the different clinical trial phases, test methodology, testing ethics, quality assurance, as well as how to evaluate results and statistical evaluations.
The course is intended to provide the relevant and fundamental information to those who, in one way or another, plan to be involved with clinical trials. During the course, the students are to acquire the necessary information in the following areas:
- Fundamental theory concerning clinical drug trials
- Ethical issues
- Safety reporting
- Research methodology
- GCP (Good Clinical Practice)
- The handling of medicine
- Evaluating the results
- Evaluating the statistics
- Quality assurance
Admission to the course
The course is primarily open to students who have been admitted to the Department of Pharmacy at the University of Oslo. If there is space available then others may also apply to take the course as long as their academic background is adequate.
Formal prerequisite knowledge
The course is only available to students who have passed their pharmacy apprenticeship and have passed all previous pharmacy courses or have the equivalent within pharmacology.
- 10 credits overlap with FRM9730 – Clinical Drug Trials (discontinued).
- 5 credits overlap with FARM4120 – Drug Development.
Lectures, seminars, and compulsory group assignments.
The majority of the course will be taught through lectures and seminars, and will cover the design and planning of clinical testing of medicine. The students are expected to work in groups of 3-4 and write a clinical trial protocol, as well as determine which officials or institutions one needs to apply to in order to start a clinical trial.
Inactivity and / or excessive absences in compulsory education means that the student does not receive final assessment / examination
A four hour written exam/oral exam after the number of students. The group assignment of writing a clinical trial protocol is worth about 1/3 of the final grade but will not be graded separately.
Examination support material
As of 1 August, 2016, the use of own calculators is no longer permitted. Casio FX-991EX calculators are handed out to all exam candidates at the beginning of the exam.
Grades are awarded on a scale from A to F, where A is the best grade and F is a fail. Read more about the grading system.
Resit an examination
This course offers both postponed and resit of examination. Read more: