Course in clinical studies including ICH-GCP
Ph.D. -course
- ECTS credits
- 1
- Teaching semesters
- Autumn
- Course code
- GCP901
- Number of semesters
- 1
- Teaching language
- Norwegian
- Resources
- Schedule
Course description
Objectives and 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
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 September 23rd (half day)
Day 2: Thursday September 26th. (whole day)
Day 3: Friday October 4th (half day)
Day 2 is joint with the ICH-GCP course at Haukeland University Hospital.
Learning Outcomes
Upon completing this course the candidate should:
Knowledge:
- Be familiar with legislation to be followed in clinical trials
- Be able to design and conduct clinical trials in line with current legislation
Skills:
- Be able to document necessary GCP-qualifications /
- Be able to write applications to the Regional Committee for Medical and Health Research ethics. (https://helseforskning.etikkom.no), The Norwegian Directorate of Health, The Norwegian Medicines Agency (www.legemiddelverket.no) and EudraCT (eudract.ema.europa.eu)..
General qualifications:
- Understand the importance of ethical considerations in clinical trials.
ECTS Credits
Level of Study
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
Required Previous Knowledge
Qualified to be a PhD candidate in medicine or health related research.
Recommended Previous Knowledge
Credit Reduction due to Course Overlap
Access to the Course
Registration at StudentWeb by September 1.
PhD candidates and students at the Medical Student Research Programme.
The course is relevant for those planning clinical trials.
Forms 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
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