Documents and Agreements
The following SOP Samarbeidsavtaler, informasjonsrutiner og delegering av oppgaver (Norwegian) contains detailed information about the documents and agreements needed.
It is important to clarify the delegation of tasks in the study and this must be formalised in accordance with the institutions guidelines and procedures.
Avtale med forskningsstøtte. Different hospitals offer different levels of research support. Each health region can offer monitoring and data management. Some may provide statistical support, help with local authority applications etc. Contact your local hospital and/or regional hospital to find out more about the level of support you can expect.
Service agreements are made following local hospital routines.
Mal avtale multisenterstudie (Norwegian) / Template Study Agreement Multicenter Study is for agreements between sponsoring institution and participating study sites. The English version is intended for use in international studies. A list describing roles and tasks is highly recommended. Contact local research support.
In international trials, the sponsor should be able to fulfil the sponsor duties for the participating countries, their country specific requirements should be mapped. NCI disclosure and commitment form is recommended used.
If the pharmacy you are working with does not have their own agreement template please use the following Samarbeidsavtale apotek (Norwegian) og Økonomisk avtale apotek (Norwegian).
For studies where some tasks are transferred to local hospitals without them being set up as separate sites, a special agreement, Avtale om overføring av behandling mellom sykehus (Norwegian) should be prepared together with Signaturlogg (Norwegian) or Signature log.