Implementation of procedures (SOPs) at each regional health authority, health trust or institution
As part of their governing documents (internal control), all regional health authorities and health trusts must have a description of responsibilities and authorities in the planning, implementation and completion of clinical interventional studies.
For clinical trials of medicinal products and studies of medical devices as well as other interventional studies involving humans, a set of procedures has been established to ensure the quality of all stages of a trial, as well as to ensure consistency in the implementation of multicentre studies in Norway. Individual institutions can implement these SOPs.
We recommend each institution to have the following documents in its quality system:
The research procedure should describe who acts as sponsor’s representative in the regional health authority or health trust. The SOPs should be adapted to the local organisational structure. Nevertheless, it would be unfortunate for the delegation of sponsor tasks to deviate from what is proposed in the documents, as the rest of the SOP collection is based on the described distribution of tasks.