Clinical trials of medicinal products

The document overview below includes national procedures (Standard Operating Procedures – SOPs) and associated attachments such as templates, checklists, forms and logs for clinical trials of medicinal products. These have been prepared to meet mandatory requirements described in national and international laws, regulations and guidelines for “Good Clinical Practice” (GCP).

A Flowchart for using procedures and attachments has been developed, which is a useful tool for users of the documents in the overview below.

The attachments are practical aids and/or guiding documents that can be adapted for use in individual clinical trials.

The procedures are applicable in individual regional health authorities and health trusts from the date the institution implemented the procedures in its own quality system.

Regional health authorities and health trusts are responsible for defining roles and responsibilities in their own institutions.

Training material for safety reporting is available under Courses and activities.

For monitors: Please see this page in addition to the relevant documents below.

Special adjustments in selected documents relating to the coronavirus are discussed here.

Should you find any errors or omissions in any of the documents, please let us know by e-mail at so that we can rectify the problem as soon as possible.

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Document overview (LM)

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