Mal for studieprotokoll
NorCRIN gir råd om bl.a protokollskriving, se Planlegger du en klinisk studie? – www.norcrin.no
Lenke til protokoll mal
The CT 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. It can be accessed at the TransCelerate site or you can also use a slightly adapted Protocol Template (according to requirements from the Norwegian Medical Products Agency). In most countries in the EEA, se Q&A, a protocol synopsis (Norwegian) in local language is required.
If you choose to follow a different template, the use of Protocol Content Checklist 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 Data Monitoring Committee Charter should be written before the trial can begin.
Information about how to blind and unblind investigational product can be found in CT SOP Randomisation, Blinding and Unblinding.
Statistics is described in the CT SOP Statistics which also includes a template for statistical analysis plan.
How to manage safety monitoring in a clinical trial is described in CT SOP Safety Planning. Safety reporting specifics should be used to summarise the roles and responsibilities as well as other safety details. For more information about safety, see CT SOP Safety Reporting. Reporting of Suspected unexpected Serious Adverse Events (SUSARs) requires a Responsible Person in the sponsor institution as well as a Data Processing agreement with either Oslo University Hospital or Helse Bergen, see SUSAR-reporting at norcrin.no. For those reporting SUSAR through Eudravigilance, see EudraVigilance Registration and SUSAR Reporting.
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 CT SOP Transfer of Clinical Trial Tasks to other Hospitals.
Risk assessments throughout the lifespan of the study are mandatory, see CT SOP Quality and Risk Management and Risk Assessment Template.