SOP Protokoll (Protocol)

It is recommended that you use the protocol template developed by TransCelerate. See here for details of how to access the template.

If you use a different protocol template, you can check that all the points are included by using this checklist.

If you want a Data Monitoring Committee/Data Safety Monitoring Board, you must have a description (charter) in place before the trial can begin.

If an investigational medicinal product is to be blinded, see SOP Randomisering, blinding og avblinding (Randomisation, blinding and unblinding).

To support transparency in research, the statistical description must be detailed enough to allow the results to be verified. It is therefore recommended to have a statistical analysis plan in addition to the protocol. See here for details of how to access the template.

In a small number of trials, selected centres will recruit patients from a large geographical area and provide the trial treatment. In order to limit the burden of travel for patients who live far away, it may be appropriate to transfer some simpler tasks to local hospitals without them being set up as separate centres. This must be described in the protocol. See SOP Overføring av enkelte behandlinger mellom sykehus (Transfer of certain treatments between hospitals). Templates for an agreement and the signature log (Norwegian) and the signature log (English) can be used in such cases.

It is a requirement that an ongoing risk assessment be made during the trial. The first assessment should be made during protocol-writing (see SOP Kvalitetsstyring (Quality Management)). It may be advisable to form an overview of the various roles and partners in the trial, and also to follow a template for risk assessment. The most important thing at this point is to include all relevant points in the protocol.