autumn 2019
HEL-8018 Introduction to Randomised Control Trials (RCT) - 2 ECTS

Last changed 20.09.2019

Application deadline

Registration deadline for PhD students and students at the Student Research Program at UiT - The Arctic University of Norway: August 15th

Application deadline for other applicants: June 1st. Application code in SøknadsWeb is 9301.

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 or holders of a Norwegian master´s degree of five years or 3+ 2 years (or equivalent) may be admitted. PhD students must upload a document from their university stating that they are registered PhD students. This group of applicants does not have to prove English proficiency and are exempt from semester fee.

Holders of a Master´s degree must upload a Master´s Diploma with Diploma Supplement / English translation of the diploma. Applicants from listed countries must document proficiency in English. To find out if this applies to you see the following list:

Proficiency in English must be documented - list of countries

For more information on accepted English proficiency tests and scores, as well as exemptions from the English proficiency tests, please see the following document: Proficiency in English - PhD level studies

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


Teaching methods



Participation requirements: Mandatory attendance in all lectures.

Exam and evaluation: Home exam (1-3 pages), graded as passed/not passed. The assignments shall be completed in English.

A re-sit exam will arranged for this course.

  • About the course
  • Campus: Tromsø |
  • ECTS: 2
  • Course code: HEL-8018