Version 2 Adapted to remove old legislation (Clincal Trial Directive) and to include ICH-GCP R3

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.

At the Sponsor responsibility resides with

The sponsor may transfer any or all of the sponsor's trial-related duties and functions to a service provider 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, principal investigators (PIs), medical monitor, other trial staff, monitor, data manager and statistician. A brief description of the functions and associated roles, responsibilities and tasks are given below.

Coordinating investigator /principal investigator for single centre trials have the same responsiblities. The term Coordinating investigator is therefore used for both roles for simplicity.

NorCRIN procedures, located at metodebok.no are to be used for trials.

Sponsor

The health institution overall responsible for the trial and usually 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.

Under the Clinical Trial Regulation (CTR), there may be more than one sponsor. The responsibilities of the co-sponsors should be described and agreed by contractual agreement.

Participating 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 transferred/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 transfers/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 the different centers. In addition to ensuring that the investigators fulfill their responsibilities and tasks, the CI is responsible for performing sponsor tasks for all the  countries in multinational studies.

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

Data Manager

Sponsor will assign data management tasks to suitably qualified personnel who will function as data managers throughout the trial. The data manager should be able to set up the trial in a validated data acquisition tool based on the approved protocol, perform data validation, and contribute to central monitoring if needed.  The data manager should comply with the procedures for data management, see SOP  Data Capture and Management.  

Medical Monitor

Sponsor should have a person or a defined team with competence to assess the safety aspects for a clinical trial. This includes reviewing serious adverse events (SAEs), evaluating 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, or other safety issues 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 to the conduct of the trial at site. 

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 site 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 including conducting monitoring visits and reporting to the sponsor / principal investigator through monitoring reports / follow-up reports.

Statistician

The sponsor will assign a trial statistician who shall ensure that the statistical parts in the protocol, including design, is properly described and fit for purpose, that the statistical activities and analyses are validated and have the required quality. The statistician should follow the procedures for statistics, see SOP Statistics.