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
• Have good insight into different types 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.

Recommended previous knowledge

PhD and Master students in healthcare or related disciplines such as biology, biotechnology, physiology, nutrition, molecular medicine, pharmacy etc.

Course materials

Slides from the lectures

Guidelines for ICH-GCP

NorCRIN - Clinical trials including procedures, checklists and templates (www.norcrin.no)

Guidance for health research (https://i.ntnu.no/en/helseforskning)