HEL-8018 Introduction to Randomised Control Trials (RCT) - 2 stp

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.

• 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.

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.

Knowledge

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.

Skills

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.

Competence

After finishing the course, participants will

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