This course is discontinued

Schedule, syllabus and examination date

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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.

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 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.

Overlapping courses

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

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.

Resit an examination

This course offers both postponed and resit of examination. Read more:

Special examination arrangements, use of sources, explanations and appeals

See more about examinations at UiO

Last updated from FS (Common Student System) Aug. 9, 2020 5:11:02 PM

Facts about this course

Credits
10
Level
Master
Teaching
Autumn

The course is last held autumn 2019

Examination
Autumn

Examination is last held autumn 2021

Teaching language
Norwegian