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Course content

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.

Learning outcome

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

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.

Prerequisites

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.

Overlapping courses

10 credits overlap with FRM9730 – Clinical Drug Trials

Teaching

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.

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.

Grading scale

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.

Evaluation

The course is subject to continuous evaluation. At regular intervals we also ask students to participate in a more comprehensive evaluation.

Facts about this course

Credits

10

Level

Master

Teaching

Every autumn

Cancelled 2018

Examination

Every autumn

Cancelled 2018

Teaching language

Norwegian