Clinical Trials
Ph.D. -course
- ECTS credits
- 2
- Teaching semesters
- Autumn, Spring
- Course code
- CCBIONEUR911
- Number of semesters
- 1
- Teaching language
- English
- Resources
- Schedule
Course description
Objectives and 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.
Recommended as part of the training component for all candidates affiliated with the Research School for Cancer Studies, CCBIO and Neuro-SysMed.
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.
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.
ECTS Credits
2 points.
For students who have finished GCP901, 1,5 ECTS point is given.
Semester of Instruction
Place of Instruction
Required Previous Knowledge
Recommended Previous Knowledge
Credit Reduction due to Course Overlap
Access to the Course
Registration for internal students in Studentweb with deadline 5. January.
The course is open to researchers, postdocs, students (PhD, students in the Medical Student Research Program) and others who are interested, nationally and internationally.
If you are not a student and don't need the ECTS, you may still attend the lectures by registering through this link:
Forms 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 they plan to implement this in their own research.
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 Coordinator
Line Bjørge
Øivind Grytten Torkildsen