Clinical Trials

Language of instruction

English

Course content

The course is designed to prepare the participants to conduct clinical trials in humans. The modules included will be based on the ICH_GCP, and the participants will receive a certificate in Good Clinical Practice on completion of the course.

Learning outcomes

Upon completing this course the candidate will have the following learning outcomes defined in terms of knowledge, skills and general competence:

Knowledge

Knowledge about how and why clinical trials are performed, according to good clinical practice and

regulatory protocols for clinical trials.

Skills

Be able to critically assess the feasibility and challenges when running clinical trials.

Be able to prepare research staff in conduction of clinical trials.

Be able to select relevant literature that deals with clinical trials.

General Competence

The modules included will be based on the ICH_GCP, and the participants will receive a certificate in Good Clinical Practice on completion of the course.

Study period

2023

Credits (ECTS)

2 points.

For students who have finished GCP901, 1,5 ECTS point is given.

Pre-requirements

Master degree, or students in the Medical Student Research Program.

Recommended previous knowledge

Master's degree or equivalent education level is required with the exception of students on the Medical Student Research Programme.

Part of training component

Recommended as part of the training component for all candidates affiliated with the Research School for Cancer Studies, CCBIO and Neuro-SysMed.

Form of assessment

Oral presentation, group work.

Pass / Fail

To pass the course the candidate must have:

o a participation of minimum 90 % during the course.

o prepared for and participated actively in the group assignments and also prepare an oral presentation together with the group. The course coordinators will be the evaluators.

To pass the course, the participants will have to write a reflection note of 500-1000 words, with basis in their own research, about what they have learnt and how theyplan to implement this in their own research.

Course overlap

The course partly overlaps with the semi-annual GCP courses conducted by the R&D department Haukeland University Hospital but has a stronger focus on the importance of planning and practical implementation of clinical studies, and thus has a different target group. The two courses wil supplement each other, and will together give increased knowledge of how to conduct clinical trials.

Who may participate

The course is open to researchers, postdocs, students (PhD, students in the Medical Student Research Program) and others who are interested, nationally and internationally.

Supplementary course information

The course will consist of 5 different modules:

General principles

Formalities

Regulations

Success factors

Clinical trials in the future

The course is designed to prepare the participants to conduct clinical trials in humans. The modules included will be based on the ICH_GCP, and the participants will receive a certificate in Good Clinical Practice on completion of the course.

Contact

Academic responsibility CCBIO: Line Bjørge
line.bjorge@uib.no

Academic responsibility Neuro-SysMed: Øivind Grytten Torkildsen
oivind.fredvik.grytten.torkildsen@helse-bergen.no

Coordinator CCBIO: Benedicte Sjo Tislevoll
benedicte.tislevoll@uib.no

Coordinator Neuro-SysMed: Hilde Norborg
hilde.norborg@uib.no

Administration: Kjetil Harkestad
kjetil.harkestad@uib.no

Academic responsibility

Line Bjørge

Øivind Grytten Torkildsen

Reading list

Reading before course start:

GCP:
o https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice
o https://www.ich.org/page/efficacyguidelines

Reading after course start:
Clinical trials:
o https://pubmed.ncbi.nlm.nih.gov/26469047/
o https://pubmed.ncbi.nlm.nih.gov/28169302/
o https://www.oncotarget.com/article/13258/text
o ALS drug development guidances and trialguidelines: Consensus and opportunities for alignment - PubMed (nih.gov)
o Autologous Hematopoietic Stem Cell Transplant in Multiple Sclerosis: Recommendations of the National Multiple Sclerosis Society | Stem Cell Transplantation | JAMA Neurology | JAMA Network

Helpful links:
o https://www.norcrin.no
o https://www.clinicaltrials.gov
o https://www.helsenorge.no/en/clinical-trials/about/

Course location

Digital event through Zoom. Access links will be provided to the registered participants.