GCP e-learning course
GCP refresher course for those who have previously taken the GCP foundation course
NorCRIN has assessed several available e-learning courses in GCP that meet the agreed TransCelerate criteria for ICH E6 (R2) GCP. The courses have been reviewed with ease of use, content and testing in mind. We recommend the following courses:
Whitehall ICH GCP in English
This is a wide-ranging course. There are tests after each chapter, and a certificate is issued after you pass the final test. The course can be ordered and paid for via the website. To get a 20 per cent discount on this course, use discount code “NORCRIN20”.
PharmaLessons International GCP Training
This is a wide-ranging course. A certificate is issued after you pass the final test. The course can be ordered and paid for via the website.
GCP unit e-learning course
This is a short Danish course that has been developed for a Danish context. The course is therefore best suited as a refresher course for those who have taken GCP courses before. Principal investigators and sponsors should supplement this course with an expanded course.
Additional information about Norwegian conditions for those about to take a Danish e-learning course:
Within the Nordic region, there is considerable cooperation in connection with clinical trials in humans. A group at NorCRIN has assessed the content of the Danish course as also being satisfactory for those working in Norway. However, please be aware that Norwegian law applies in Norway, and the information about SLV and REK below complements and partially replaces the chapter “Notification of a clinical trial”:
The Norwegian Medicines Agency (SLV)
The Norwegian Medicines Agency must evaluate clinical trials of medicinal products for humans where the objective is to examine or test knowledge about the medicinal products’ effects on physiological function, interactions, side effects, uptake, distribution, metabolism, excretion and therapeutic value. This applies to medicinal products both with and without marketing authorisation. For more information about the application process, please visit the SLV website: SLV
Regional Committees for Medical and Health Research Ethics (REK)
All trials subject to notification to SLV must also be submitted to REK for approval. REK also approves research on health data and biobanks. The Norwegian Data Protection Authority will not be involved in clinical trials of medicinal products. For more information about application deadlines, please visit the REK website: REK
In order to meet the regulatory requirements in an appropriate manner and to avoid duplicate assessments, the authorities have distributed the tasks as follows:
- REK: approval of the recruitment process, patient information and consent, as well as all information presented to trial participants
- SLV: ongoing safety reporting in the form of SUSAR and annual reporting/DSUR
A description of the REK and SLV application process can also be found in our national SOP “Application process, approvals and start-up”: SOP
If you have any questions about this issue, please feel free to contact one of the members of the NorCRIN Secretariat.
Contact information can be found on the NorCRIN website: NorCRIN contact