Good clinical practice (ICH-GCP) for PhD candidates
Study facts
| Course code | GCP901 |
| Study level | PhD level |
| Belongs to | Department of Clinical Medicine |
Course description
Language of instruction
Norwegian
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
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:
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 (https://eudract.ema.europa.eu)..
General qualifications:
- Understand the importance of ethical considerations in clinical trials.
Credits (ECTS)
1 study point (25-30 hours student work time)
Specific terms
Course registration and deadlines
Registration at StudentWeb by September 1.
Pre-requirements
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
From the autumn of 2013 candidates who are in need of a GCP-course, and wants to have it approved as part of their training component, must follow this course. Registration via StudentWeb within the given deadlines. 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.
Addtional information
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.
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.
Programme
Consists of two half days and a whole day.
Day 1 (half dag): Introduction. Study design. Preparing the home assignment.
Day 2 (whole dag): Joint programme with the GCP course organized by Haukeland University Hospital (HUS)
Day 3 (half day): Innovest, cooperation with industry, BTO and patent. Questions and answers related with home assignment.
Programme
Consists of two half days and a whole day.
Day 1 (half day): Introduction. Study design. Preparing the home assignment.
Day 2 (whole day): Joint programme with the GCP course organized by Haukeland University Hospital (HUS)
Day 3 (half day): Innovest, cooperation with industry, BTO and patent. Questions and answers related with home assignment.
Contact
marianne.myhren@k1.uib.no
Academic responsibility
Eyvind Rødahl/ 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