SOP LM/CT 1.0 Version 3.6. This SOP replaces SOP 1.1 version 3.5. Adapted to include also the clinical trial regulation no 536/2014 including serious breach reporting and other reporting through CTIS.

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

The sponsor may transfer any or all of the sponsor's trial-related duties and functions to a third party vendor such as a Contract Research Organisation (CRO), but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf. Transfer of duties shall be specified in a written agreement.

The principal investigator at each study centre is responsible for the conduct of the clinical trial according to the 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 trials are: sponsor (the health institutions, research responsible), coordinating investigator /principal investigator for single centre trials / national coordinating investigator for multicentre trials, principal investigators (PIs), medical monitor, other trial staff and monitor. A brief description of the functions and associated roles, responsibilities and tasks is given below.

Coordinating investigator /principal investigator for single centre trials / national coordinating investigator for multicentre trials have the same responsiblities and is hence synonymous terms in this document. The term Coordinating investigator is therefore used for simplicity.

NorCRIN procedures are to be used for trials, and flow charts for their use is available.

• LM Oversiktskjema
• Flow chart”lenke”

There is a 3 year transition period for implementing the new regulation (Regulation 536/2014) for clinical trials. During this transition period, two sets of NorCRIN procedures are available; LM procedures (old legislation based on Directives 2001/20 and 2005/28) and CT procedures (new Regulation 536/2014).

For choosing right set of procedures for each trial see NorCRIN.

Sponsor

The health institution responsible for the trial overall and where the coordinating investigator is employed, is the study sponsor.

For trials in Norway in collaboration with universities, agreements defining the sponsor may apply.

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

In the new regulation, there may be more than one sponsor. Co-sponsors should all be subject to the obligations of a sponsor. However, the co-sponsors should be able to split up the sponsor tasks by contractual agreement.

Cooperating institutions in a multicentre trial are responsible for the research in the trial that is carried out in their own institution.

Responsibilities and tasks

Tasks can be delegated to a larger extent than described in this SOP, e.g. in international trials where tasks for practical reasons should be performed nationally. These delegations must be regulated in an agreement between the parties.

Coordinating Investigator

For clinical trials, a coordinating investigator (CI) has the responsibility for the coordination of all investigators at different centers. In addition to ensuring that the investigators fulfill their responsibilities and tasks, the CI is responsible for performing sponsor tasks for the other countries in multinational studies as well as its own, see Table 1 section 7.

The CI may delegate sponsor task to principal investigators or CTUs/others in other countries through a written agreement. The responsibility for the tasks resides with the CI.

The National Coordinating Investigator– valid for trials under old regulation only

The national coordinating investigator, according to outgoing legislation, is the responsible person towards the ethics committee (REK in Norway). This role is not described in the Regulation 536/2014.

The national coordinating investigator has the overall responsibility for the trial in his/her country.

The national coordinating investigator is the link between the sponsor and the study centres. The national coordinating investigator may also be PI in own institution and will then additionally have the PI responsibilities.

Responsibilities and tasks

The national coordinating investigator’s responsibilities and tasks are recorded in Table 1 section 7 under coordinating investigator. 

Medical Monitor

Sponsor should have a person or a defined team with authority to assess the safety aspects for a clinical trial. This includes reviewing serious adverse events (SAEs), evaluation the risk/benefit ratio at all time, reporting suspected unexpected serious adverse reactions to relevant authorities, writing an annual safety report, informing the investigators about SUSARs and any change in the risk/benefit evaluation of the trial. This medical monitor can be the same person as the coordinating investigator, although it is recommended to have a group of persons. In blinded trials, the medical monitor should be able to see unblinded data if necessary.

Principal Investigator

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

Responsibilities and tasks

PI’s responsibilities and tasks are recorded in Section 7 Table 1.

In single centre clinical trials, the PI will also have the responsibilities and tasks of the coordinating investigator.

Trial Staff

The principal investigator can delegate tasks to named trial staff. The delegation must be in writing. Trial staff will normally be other investigators and trial nurses/coordinators from the same institution that contribute in the trial.

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

Responsibilities and tasks

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

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

Monitor

All clinical trials must have a monitor appointed responsible for monitoring the trial. Monitor carries out his/hers activities on behalf of the sponsor. Monitor cannot be the same person as any of the investigators or trial staff.

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

Responsibilities and tasks

Monitor shall carry out monitoring according to the current monitoring plan and in accordance with ICH GCP 5.18 including conducting monitoring visits and reporting to the sponsor / principal investigator through monitoring reports / follow-up report.