Clinical Drug Trials

NorCRIN has developed National procedures (Standard Operating Procedures -SOPs) for clinical trials of drugs for use in the individual Health Trust after implementation in their quality assurance systems.

The transition period for the new regulations will happen from 31st January 2022 – 31st January 2025. During this period, both the old Medicinal (LM) and new Clinical Trial (CT) procedures will be available.

LM Procedures

This can be used throughout the transition period, up until 31st January 2025 for studies that have been applied tothe Norwegian Medicines Agency through EudraCT.

CT Procedures

These procedures will be used for studies applied to the authorities through CTIS (Clinical Trial Information System). This system will be available from 31st January 2022, and will also be used for studies that are transferred from EudraCT to CTIS.