Version 3.3. This SOP replaces SOP 1.1 version 3.2. English version. Roles and responsibilities for Clinical trials are removed.

Format change and alignment with Roles and responsibilities for Clinical

Sponsor has the overall responsibility for conducting clinical investigations in accordance with applicable laws, regulations and guidelines. See section 4.1 for description of the sponsor’s responsibilities.

The Principal Investigator at each investigational site is responsible for the conduct of the clinical investigation according to the CIP/protocol and applicable laws, regulations and guidelines.

Tasks can be delegated. Responsibilities and delegated tasks are summarised in table 1. 

The most important functions/roles in the conduct of clinical investigations of medical device are: sponsor (the health institutions, research responsible), principal investigators (PIs), national coordinating investigators, investigational staff and monitor. A brief description of the functions and associated roles, responsibilities and tasks is given below.

The current NorCRIN procedure is to be used for investigations. 

Sponsor

The health institution where the PI is employed is the investigational sponsor, in single center investigations. For Multicenter investigations, the sponsor is the health institution where the national coordinating investigator is employed.

For clinical investigations of medical device in Norway in collaboration with universities, the sponsor will be the health institution.

In clinical investigations of medical device on behalf of the industry or for a non-commercial organisation in Norway or abroad, the company/organisation will generally be the sponsor.

According to the Helseforskningsloven, cooperating institutions in a multicenter investigation are responsible for the research in the project that is carried out in their own institution. This means that there will be several research-responsible institutions in a multicenter investigation, however there is only one sponsor. Legally, the sponsor responsibility is assigned to the managing director/leader of the institution. Usually the sponsor will however have one or more representatives in their own institution depending on the size of the institution.

Responsibilities and tasks

The sponsor's responsibilities and tasks for clinical investigations are recorded in Table 1 section 7. These follow from Norsk Standard NS-EN ISO 14155:2020 and sections 5 and 6 of the Health Research Act with regulations.

Tasks can be delegated to a larger extent than described in this SOP, e.g. in international clinical investigations where sponsor is not a Norwegian institution and the tasks of practical reasons should be performed nationally. These delegations must be regulated in an agreement between the parties.

National Coordinating Investigator

Multicenter investigations must have a National Coordinating Investigator (NCI) with the overall responsibility for the investigation at the Norwegian investigational sites. The NCI is the same person as the project leader defined in Helseforskningsloven and hence responsible for obtaining the necessary approval from REK, including any reporting.

NCI is the link between the sponsor and the Norwegian investigational centers. NCI may also be PI in own institution and will then additionally have the PI responsibilities.

Responsibilities and tasks

NCI’s responsibilities and tasks are recorded in Table 1 section 7 and follow from NS-EN ISO 14155:2020 and Helseforskningsloven section 5 when appropriate for clinical investigations.

Principal Investigator

The principal investigator (PI) is the investigator leading the investigation at the individual investigational site (hospital). Documentation of qualifications to lead and conduct the investigation in own institution must be available, including documented GCP knowledge.

Responsibilities and tasks

PI’s responsibilities and tasks are recorded in Table 1 section 7 and follow from NS-EN ISO 14155:2020 and Helseforskningsloven section 5 when appropriate for clinical investigations.

In single center clinical investigations, the PI will also have the responsibilities and tasks of the NCI.

Investigational Staff

The principal investigator can delegate tasks to named investigational staff. The delegation must be in writing. Investigational staff will normally be other investigators and nurses from the same institution that contribute in the project.

By delegation, the principal investigator has the responsibility to ensure that the investigational staff has sufficient competence to carry out the assigned tasks. Only defined tasks can be delegated, not the responsibility.

Responsibilities and tasks

Investigational staff performs tasks after specific delegation from the principal investigator. These tasks must be specified in a delegation log.

Investigational staff defined as health personnel by the Helsepersonelloven has however an independent responsibility under § 4 on requirements for proper patient care.

Monitor

All clinical investigations must have a monitor appointed responsible for monitoring the investigation. Monitor carries out its activities on behalf of the sponsor. Monitor cannot be the same person as any of the investigators or investigational staff.

The monitors should have a thorough knowledge of all relevant laws and regulations and sufficient scientific and/or clinical knowledge of the investigations.

Responsibilities and tasks

Monitor shall carry out monitoring according to the current monitoring plan and in accordance with GCP including conducting monitoring visits and reporting to the sponsor / principal investigator through monitoring reports / follow-up report.

For multicenter studies some additional tasks will be performed by the lead monitor. In single center studies the monitor will have the role as the lead monitor as appropriate.

Lead monitor

Lead monitor is the monitor assigned to sponsor’s site.  

Lead monitor is responsible for keeping an overview of the monitors for the different investigational sites.  

Tasks

Lead monitors tasks are:

• to assist the investigational team conduct risk assessment, if requested
• to assist the investigational team to develop monitoring plan for all centers based on the risk assessment, if requested
• to develop national cost estimate for monitoring of the investigation and send to the other monitors for review
• to provide the other monitors with final versions of risk assessment, monitoring plan, cooperation agreement and cost estimate
• to provide training in the monitoring plan
• schedule phone meetings and other meetings with the other monitors when needed
• share information from NCI on an ongoing basis

Deviations from this SOP should be handled according to the individual health institution’s procedures for handling of deviations and/or according to Protocol Deviation Handling - SOP 1.10.b.