Course in clinical studies including ICH-GCP

Ph.D. -course

Course description

Course content

  • Introduction to ICH-GCP and laws relevant to clinical research including the Health Research Act and related regulations ICH-GCP
  • Different units inform what they can assist with in the implementation of clinical trials
  • Provide information on the design and conduct of clinical trials and development of some applications that are relevant to clinical research
  • Learning outcomes

    Upon completing this course the candidate should:


    • Be familiar with legislation to be followed in clinical trials
    • Be able to design and conduct clinical trials in line with current legislation


    General qualifications:

    • Understand the importance of ethical considerations in clinical trials.

    Credits (ECTS)

    1 study point (25-30 hours student work time)
    Language of instruction
    Course registration and deadlines
    Registration at StudentWeb by September 1.

    Qualified to be a PhD candidate in medicine or health related research

    Recommended Previous Knowledge
    Qualified to be a PhD candidate in medicine or health related research
    Part of training component

    Approved PhD course, recommended for candidates whose PhD project includes clinical trials.

    The course is included in the portfolio of the Research School in Clinical Medicine

    Form of assessment

    Home assignment to be completed during the course and submitted by a set deadline after the completion of the course: Simple application to local ethical committee and medical agency or Health Department (medical advices).

    Pass/ Fail

    Course overlap
    The GCP-course provided by Haukeland University Hospital will no longer be approved as part of the training component.
    Who may participate

    PhD candidates and students at the Medical Student Research Programme.

    The course is relevant for those planning clinical trials.

    Supplementary course information
    GCP is an international ethical and scientific quality standard for clinical trials involving human subjects. In addition to being an introduction to GCP, the course also provides information on study design, commercialization, relevant legislation, cooperation with industry and internet based application portals for clinical trials.

    Day 1: Monday October 2nd (half day)
    Day 2: Thursday October 5th (whole day)
    Day 3: Friday October 13th (half day)

    Day 2 is joint with the ICH-GCP course at Haukeland University Hospital.

    Academic responsible
    Research School of Clinical Medicine
    Reading list

    - Fra Idé til Publikasjon-Forskningshåndboken (a Norwegian research handbook)

    - Guidelines for ICH-GCP

    - Health Research Act (Norwegian)

    - Clinical trials of drugs - Norwegian Medicines Handbook