FRM5730 – Clinical Drug Trials
Schedule, syllabus and examination date
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
The course is primarily open to students who have been admitted to the School 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
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
Access to teaching
A student who has completed compulsory instruction and coursework and has had these approved, is not entitled to repeat that instruction and coursework. A student who has been admitted to a course, but who has not completed compulsory instruction and coursework or had these approved, is entitled to repeat that instruction and coursework, depending on available capacity.
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.
Explanations and appeals
Resit an examination
This course offers both postponed and resit of examination. Read more:
Withdrawal from an examination
It is possible to take the exam up to 3 times. If you withdraw from the exam after the deadline or during the exam, this will be counted as an examination attempt.
Special examination arrangements
Application form, deadline and requirements for special examination arrangements.
The course is subject to continuous evaluation. At regular intervals we also ask students to participate in a more comprehensive evaluation.