autumn 2023
HEL-8018 Introduction to Randomised Control Trials (RCT) - 2 ECTS

Type of course

PhD course. This course is available for both program students and course students.

The course is organised by the Clinical Research Department at the University Hospital of Northern Norway (UNN) in Tromsø and the Department of Clinical Medicine at the Faculty of Health Sciences, UiT The Arctic University of Norway.

Admission requirements

PhD students and students at the Student Research Programme, or holders of a Norwegian master´s degree of five years or 3+2 years (or equivalent) may be admitted.

External applicants apply for the right to study by June 1st for courses that are taught in the autumn semester. Application is sent through SøknadsWeb. Please use the appliction code "9301 - Singular courses at the PhD level". If granted admission to the course students must register for class and exam in Studentweb by September 1st for autumn semester.

Course content

  • Fundamental principles and practice of RCT.
  • Guidelines and standards in RCT.
  • Design of RCT, choice of randomization method.
  • Protocol writing/documentation requirements.
  • Approach to data analysis and introduction to statistical methods.
  • Challenges in planning and conducting RCTs.

Objectives of the course


After finishing the course, participants will

  • have knowledge about the fundamental principles of RCT, such as random allocation to experimental groups, blinding, precision, types of bias, ethical issues, data analysis etc, as well as a practical approach to this type of studies.


After finishing the course, participants will

  • be able to define research question to be answered by RCT.
  • be able to define comparison groups (inclusion and exclusion criteria).
  • be able to choose optimal design and randomization method.
  • be able to plan, initiate and conduct an RCT (primarily under supervision or in team).
  • know the requirements for documentation and registration of clinical trials.
  • be familiar with statistical analysis methods and challenges of RCT; reporting of RCT results; critical independent appraisal of published RCT reports.


After finishing the course, participants will

  • have basic competence necessary for planning and conducting RCT.
  • have a basis for further development.

Language of instruction and examination


Teaching methods



Examination: Date: Grade scale:
Off campus exam 11.09.2023 09:00 (Hand out)
09.10.2023 13:00 (Hand in)
Passed / Not Passed

Coursework requirements:

To take an examination, the student must have passed the following coursework requirements:

Participation in all lectures Approved – not approved
UiT Exams homepage

More info about the coursework requirements

It is mandatory to attend all lectures.

Re-sit examination

Re-sit examination is offered for the course.
  • About the course
  • Campus: Tromsø |
  • ECTS: 2
  • Course code: HEL-8018
  • Tidligere år og semester for dette emnet