General

An overview of definitions and abbreviations is provided in SOP Definisjoner (Definitions).

An overview of legislation is provided in SOP Referansedokument (Reference document).

Special considerations for trials of advanced therapies using medicinal products (e.g. tissue therapy, somatic cell therapy and gene therapy) are described in SOP Clinical Trials of Advanced Therapy Medicinal Products. This is in addition to the requirements described below.

A working group consisting of members from all six NorCRIN partners (Norway’s university hospitals) has prepared a procedure for early-phase units (see SOP First in Human and Early Phase Clinical Trial). It describes the responsibilities and tasks that early-phase units must address, and applies regardless of whether or not the sponsor is a commercial organisation.