Course in clinical studies including ICH-GCP

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

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)

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

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.

Programme

Day 1: Monday 12 September (half day)
Day 2: Thursday 15 September (whole day)
Day 3: Friday 23 September (half day)

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

Contact

Irene Lavik Hjelmaas

irene.hjelmaas@uib.no

Academic responsibility

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