Writing a protocol

The SOP Protocol contains key information to the content and review process for writing a strong protocol.

It is recommended that you use the protocol template developed by TransCelerate. A description of how to get access to the template can be found in the document “Guidance for access to TransCelerates protocol and SAP templates”. You can also use a slightly adapted template.

If you choose to follow a different template, the checklist sjekkliste for innhold i en protokoll (Norwegian) will ensure all key components are included in the protocol.

When having an independent committee (Data Monitoring Committee) to assess safety, efficacy or futility, a DMC charter should be written before the trial can begin.

Information about how to blind and unblind investigational product can be found in SOP Randomisering blinding og avblinding (Norwegian).

A description of how to get a template for statistical analysis plan can be found in the document “Guidance for access to Trancelerates protocol and SAP templates”.

How to manage safety monitoring in a clinical trial is described in SOP Safety Planning. Safety reporting specifics should be used to summarise the roles and responsibilities. For more information about safety, see Side effect/safety reporting in clinical trials of medicinal products.

In some studies, selected study sites will recruit patients from a large geographical area and provide the experimental treatment. It may be relevant to transfer some tasks to local hospitals without them being set up as separate sites. This transfer must be described in the protocol. Information can be found in SOP Overføring av enkelte behandlinger mellom sykehus (Norwegian). Risk assessments throughout the lifespan of the study are mandatory, see SOP Quality and Risk Management and template Risikovurdering (Norwegian).