course-details-portlet

KLMED8020

Clinical trials and good clinical practice (GCP)

Assessments and mandatory activities may be changed until September 20th.

Credits 3
Level Doctoral degree level
Course start Autumn 2025 / Spring 2026
Duration 1 semester
Language of instruction Norwegian
Location Trondheim
Examination arrangement Home examination

About

About the course

Course content

Clinical trials are fundamental to gain reliable knowledge about the effectiveness and safety of a new drug. This knowledge is essential to be able to make decisions about whether new drugs should be recommended or whether we could apply already available drugs for other indications.

The course provides an introduction on how to perform clinical trials with high scientific and ethical quality according to the Good Clinical Practice (GCP) standard.

The course is also relevant for students who will carry out other clinical intervention studies, as many of the topics are of importance to clinical studies in general. GCP is mandatory in clinical trials but can also be followed in other clinical intervention studies to potentially increase scientific and ethical quality.

Learning outcome

After completing the course, the student must have acquired the following knowledge:

  • Know the most important legislation for clinical trials
  • Be familiar with the responsibilities of the primary investigator and sponsor in a clinical study and especially clinical trials
  • Be familiar with the authorities responsible for prior approval of clinical studies and especially clinical trials
  • Know when a privacy impact assessment (DPIA) must be carried out and which templates can be used
  • Know where and how to register a clinical study
  • Understand the importance of training study staff, how it can be carried out and documented
  • Have good knowledge of handling study medication and drug accounting
  • Know different types of adverse events and how they should be handled
  • Know what a monitoring plan, data management plan and statistical analysis plan are, and when and why these are important documents in clinical studies
  • Understand the importance of data management and the use of data collection tools
  • Know the processes related to end-of-study and how data and documents should be stored
  • Know the possibilities for inspection of clinical trials

After completing the course, the student must have acquired the following skills:

  • Be able to create a study protocol/project description in collaboration with a supervisor
  • Be able to set up a study archive
  • Be able to carry out a risk assessment of a clinical study in collaboration with a supervisor

After completing the course, the student must have acquired the following general competence:

  • Be able to identify new relevant ethical and scientific issues related to the implementation of a clinical trial
  • Know research ethical principles and be able to carry out clinical research with professional integrity

Learning methods and activities

The course consists of two digital seminars. The course consists of lectures.

Further on evaluation

6-hours case-based home exam.

If the exam is not passed, the student can take the exam at the same time as the ordinary exam in the following semester. The course runs every semester.

Course materials

Slides from the lectures

Guidelines for ICH-GCP

Credit reductions

Course code Reduction From
KLMED8012 1.5 sp Autumn 2025
KLMED8013 1.5 sp Autumn 2025
This course has academic overlap with the courses in the table above. If you take overlapping courses, you will receive a credit reduction in the course where you have the lowest grade. If the grades are the same, the reduction will be applied to the course completed most recently.

Subject areas

  • Clinical Medicine
  • Medicine

Contact information

Course coordinator

Lecturers

Department with academic responsibility

Department of Circulation and Medical Imaging

Examination

Examination

Examination arrangement: Home examination
Grade: Passed / Not Passed

Ordinary examination - Autumn 2025

Home examination
Weighting 100/100 Date Release 2025-11-28
Submission 2025-11-28
Time Release 09:00
Submission 15:00
Duration 6 hours Exam system Inspera Assessment

Ordinary examination - Spring 2026

Home examination
Weighting 100/100 Duration 6 hours Exam system Inspera Assessment