New guidelines on clinical drug trials for CROs and industry sponsors
NorTrials Coordinating Unit has developed a guideline for sponsors and CROs (Clinical Research Organisations) wishing to conduct clinical drug trials in Norway.
The purpose of the guideline is to inform industrial sponsors about what is important to know regarding specific Norwegian conditions when planning and applying for a clinical study. We assume that the regulations and guidelines implemented in Norwegian legislation, such as the European regulations for medicinal product testing (Clinical Trials Regulation, CTR), are familiar to users.
Among the topics included are:
- Regulations
- Insurance
- Information sheets and consent forms
- Internal anchoring at the study site
- Data and material transfer to countries outside the EU/EEA/UK
- Study agreement
- Pharmacy agreement
- Registration and visibility
- Guidance and advisory services
The aim is that the tips in the guideline can lead to better applications and associated documentation, thereby reducing the number of questions from the authorities and decreasing the time from application to trial start.
The guideline has been written in collaboration with Inven2, Helse Bergen HF, and representatives from CROs and the pharmaceutical industry.
If you have comments or suggestions for improvements to the guideline, please send an email to contactnortrials@ous-hf.no.
This page was translated from Norwegian using Optimizely auto-translate and reviewed by Ellen Johnsen.