course-details-portlet

KLH3206 - Clinical intervention studies - Research methodology

About

New from the academic year 2023/2024

Examination arrangement

Examination arrangement: Home examination
Grade: Passed / Not Passed

Evaluation Weighting Duration Grade deviation Examination aids
Home examination 100/100 6 hours

Course content

Clinical studies are the most important tool we have to gain reliable knowledge about how safe and effective a medicine, a surgical procedure, a lifestyle change, a rehabilitation method or medical equipment is. This knowledge is important for making decisions about whether new methods should be implemented, continued, phased out or only offered to a few patients where the effect is significant. Clinical intervention studies are of priority in Norway and will contribute to better and more personalized treatment for the individual patient.

The course will go into detail about how to plan and carry out clinical intervention studies both in patients and healthy participants (for example elderly or inactive people to prevent disease). The course focuses on research quality, and deals with practical parts of the planning phase such as creating a study protocol, applying for approvals, carrying out risk assessments, etc. The course also deals with practical parts of the implementation phase, such as patient recruitment, data collection, handling of biological sample material etc. Researchers who work with different types of clinical intervention studies will share their experiences and give good tips for both the planning and implementation phases. In addition, we will present and work with available tools and templates that ensure high quality research and simplify the tasks related to clinical intervention studies.

Learning outcome

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

  • Advanced knowledge of theoretical and practical aspects related to clinical intervention studies.
  • Be able to assess professional issues related to the implementation of clinical intervention studies.
  • Have in-depth knowledge of how to apply for approvals for clinical intervention studies.
  • Know different types of study design and the principles for creating an analysis plan.
  • Have in-depth knowledge of study logistics, including patient recruitment, data collection and handling of biological material.
  • Have knowledge of legislation for clinical research.

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

  • Be able to design, plan and carry out a clinical intervention study under supervision and in line with ethical guidelines.
  • Be able to create a study protocol for a clinical intervention study under supervision.
  • Be able to carry out risk assessment and data protection impact assessment for a clinical intervention study under supervision.
  • Be able to use relevant methods and tools for clinical intervention studies independently.

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

  • Be able to analyze relevant ethical and scientific issues related to the design and implementation of a clinical intervention study.

Learning methods and activities

Seminar-based teaching (lectures and group work) and two compulsory homework assignments.

Compulsory assignments

  • Home assignment 1
  • Home assignment 2

Further on evaluation

Homework will be assigned related to session 1 and session 2. Peer student assessment of submitted homework is an important part of the educational plan and will be carried out as a group activity during the sessions. The homework is assessed as approved/not approved. If not approved, the student gets one additional opportunity to hand in an improved assignment. This applies to both mandatory submission requirements. Compulsory activity is valid for 4 semesters.

Required previous knowledge

Completed bachelor's degree or equivalent in a relevant subject area.

Course materials

Will be announced at the start of the semester.

More on the course

No

Facts

Version: 1
Credits:  7.5 SP
Study level: Second degree level

Coursework

Term no.: 1
Teaching semester:  SPRING 2024

Language of instruction: Norwegian

Location: Trondheim

Subject area(s)
  • Health Science
  • Clinical Medicine
Contact information
Course coordinator:

Department with academic responsibility
Department of Circulation and Medical Imaging

Timetable

List view
Calendar view

Examination

Examination arrangement: Home examination

Term Status code Evaluation Weighting Examination aids Date Time Examination system Room *
Spring ORD Home examination 100/100

Release
2024-05-28

Submission
2024-05-28


09:00


15:00

INSPERA
Room Building Number of candidates
  • * The location (room) for a written examination is published 3 days before examination date. If more than one room is listed, you will find your room at Studentweb.
Examination

For more information regarding registration for examination and examination procedures, see "Innsida - Exams"

More on examinations at NTNU