Clinical trials of medicinal products

The national procedures for clinical trials of medicinal products (LM SOPs) have been developed to meet mandatory requirements described in national and international laws, regulations and guidelines for good clinical research practice (GCP).

In addition to the LM SOPs, various templates, checklists, forms and logs have been developed. These are provided as attachments to the LM SOPs, and are practical aids or guiding documents that can be adapted for use in individual clinical trials.

Version 3.0 was published on the NorCRIN website in June 2017, and will apply to individual regional health authorities and health trusts from the date they implement the procedures in their own quality system. As an investigator or study employee in a clinical trial, you are responsible for following procedures that apply in your regional health authority, health trust or institution. Check whether the LM SOPs apply to your institution.

It is recommended that you read through the checklist for start-up of clinical trial during the planning stage of the trial to get an overview of the various processes and documents that must be in place before the trial can start. The checklist can be used as a to-do list, enabling tasks to be performed at the right time.

Should you find any errors or omissions in any of the documents, please let us know by e-mail at post@norcrin.no so that we can rectify the problem as soon as possible.

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