Procedures for clinical trials applied to the Norwegian Medicines Agency through EudraCT
These procedures are valid throughout the transition period of 3 years, from the 31st January 2022.
The procedures and accompanying appendices cover the mandatory requirements described in National and International laws, regulations and guidelines for Good Clinical Practice (GCP).
A flowchart of how to use the LM procedures and appendices has been prepared. You can watch a video about the use of the flowchart.
The appendices are practical aids / guiding documents that can be adapted for use in individual clinical trials.
Course material for handling adverse reactions / safety reporting can be found under the tab ‘courses and activities’.
For monitors: Additional relevant documents for monitors can be found here.
Corona adaptations: Special adaptations in some documents can be found here.
If you find errors or omissions in any of the documents, please give us feedback via email@example.com so we can correct them as soon as possible.
To document overview
Document overview (LM)