Agreements should clearly define the roles, activities and responsibilities for the clinical trial and be documented appropriately. (R3 10.2) 

Participating principal investigators/centres/pharmacies and other service departments should receive relevant documents such as the trial protocol, case report forms, and documentation on the investigational products (e.g. investigator's brochure) for review before agreements are made. The coordinating investigator should ensure that relevant updates of these documents are sent as soon as they are available. 

Agreements with internal and external parties should ensure access to all trial source data/documents and reports, as well as allow monitoring, auditing and inspections from the competent authorities. 

The principal investigator can delegate tasks to collaborators/staff involved in the trial within their own institution and/or can sign an agreement/contract with a service provider. 

Agreements between sponsor and sites 

All obligations/responsibilities should be described in written agreements with the participating health facility/centres for multicentre trials. The coordinating investigator shall ensure that the principal investigators responsible for the research at all participating centres are adequately informed about the trial, and that written agreements are made with all principal investigators/centres. Use of the Agreement Multicentre Trial is recommended. 

Agreements with service providers  

 It is recommended that the principal investigator has written agreements with hospital service providers which will provide services in the trial, e.g. pathology, radiography and laboratories. 

If applicable, the principal investigator must have written agreements with the pharmacy. The pharmacies usually wish to use their own agreements. 

The principal investigator may be supported by the sponsor in the identification of a suitable service provider(s); however, the investigator retains the final decision on whether the service provider intended to support the investigator is appropriate based on information provided by the sponsor. 

 Coordinating investigator should also have an agreement for monitoring and possibly other research support functions provided by Clinical Trials Units such as data management, statistics etc. Avtale med forskningsstøtte should be used. 

Agreements with funders 

Studies that receive funding, IMP or other support from a commercial company or similar, must have an agreement in place. It is recommended to use  Agreement for Support from External/Commercial Source for this purpose. The company may have their own agreement that must be used. The agreements should be reviewed by legal staff prior to signing, refer to institutional procedures. 

For trials receiving grants, the grant provider’s procedures should be followed. 

Establishing trial committees 

If trial committees such as steering committee, project group, scientific reference committee, etc. is established, an agreement or committee charter should be created, describing the committee’s mandate, decision making, frequency of meetings, face-to-face meetings or digital meetings, criteria for ad-hoc meetings, name and contact details for the committee members should be listed,and most importantly, publication rights and authorship for publications.  

For Data monitoring committees (or Data safety monitoring boards) see Data Monitoring Committee Charter.