CT SOP version no 1.1.

Added template for Agreement for Support from External/Commercial Source - Template for use with commercial companies.

The sponsor has overall responsibility for ensuring that this SOP is followed.

The sponsor’s responsibilities shall be described in the quality system of the sponsor institution. Tasks are delegated according to SOP Roles and Responsibilities in clinical trials implemented in the institution.

The sponsor has overall responsibility for entering into a written agreement with all principal investigators/participating health facilities/other business parties in multicentre trials.

When a clinical trial has more than one sponsor, all co-sponsors shall in principle have the responsibilities of the sponsor if not otherwise is described in a contract. Responsibilities for specific tasks will be defined in a written agreement (see "Co-sponsorship" under "Procedures" for details).

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 coordinating investigator has the responsibility for ensuring that tasks are carried out according to the requirements of this SOP.

Delegation of Trial Specific Tasks

The principal investigator can delegate tasks to collaborators/staff involved in the trial.

The principal investigator at each site will prepare and maintain a log of qualified staff to whom specific trial related tasks are assigned. Use of the attached Delegation Log - Template is recommended.

All trial related tasks and functions should be clarified, defined and assigned before the start of the trial.

The delegation log should be updated to show changes which occur during the trial.

All personnel listed on the delegation log must be informed that their CV and their contribution to the trial will be archived according to regulatory requirements. The trial personnel should be informed about the use of their personnel data, see Privacy Notice for Clinical Trial Staff - Template. If the personal data is to be used for purposes other than compliance with GCP, the purposes should be detailed in the declaration.

Qualifications

Tasks should only be delegated to qualified persons. Principal investigators should be qualified doctors or dentists, and conduct trials in accordance with the protocol, ICH GCP, the law and regulations governing clinical drug trials and other relevant regulations.

Participating investigators should be qualified to perform the actual trial, and the centres should have sufficient resources to carry out all trial-related activities.

Trial staff should have relevant expertise and be qualified for the task. Trial staff should conduct trial-related tasks in compliance with the protocol, ICH GCP, the law and regulations governing clinical drug trials and other relevant regulations. Investigators and other persons, who carry out protocol-required procedures, must be GCP-trained. GCP training should not be more than 3 years old.

Qualifications should be documented on an up-to-date CV for Investigators - Template and CV for Non-investigators - Template and GCP training certificate.  All trial-specific training should be documented on a training log, see Training and Qualification – SOP 1.7.a.

Agreements

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 - Template is recommended.

If applicable, there must be written agreements with the pharmacy. Samarbeidsavtale apotek - Template and Økonomisk avtale apotek - Template can be used if pharmacies does not use their own agreements.

It is recommended that written agreements be made with hospital services/departments which will provide services in the trial, e.g. pathology, radiography and laboratories.

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 - Template should be used.

Studies that receive funding, IMP or other support from a commercial company or similar, must have agreement in place. It is recommended to use Agreement for Support from External/Commercial Source - Template 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.

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 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 regulatory authorities.

Agreements should also specify the allocation of trial-related tasks.

Co-sponsorship

The co-sponsors shall agree, in a written contract, which of the following tasks will be the responsibility of only one sponsor and will not be shared between the different sponsors:

• Compliance with a sponsor's obligations in the authorisation procedure (including any substantial modification and the procedure for the addition of a Member State concerned).
• The contact point for receiving questions from subjects, investigators or any Member State concerned regarding the clinical trial and for replying to them.
• Implementing corrective measures imposed by any of the Member states concerned.

The co-sponsors may also assign all remaining responsibilities in the written contract, but if they do not do this, the principle of joint responsibility applies.

Start-up Meeting

The coordinating investigator should make sure that all trial staff are adequately informed about the protocol, investigational product(s), and all trial-related tasks and procedures assigned to them.

In order to ensure that all sites are properly trained, it is recommended to hold a start-up meeting at each centre before the start of the trial (i.e. before the inclusion of the first trial subject person at the centre), see attached Start-up Meeting Agenda - Template and Start-up Meeting Checklist - Template.

Minutes should be written from the start-up meeting. The completed checklist, with the list of participants as an appendix can be used as the minutes of the meeting. Copies of the minutes will be kept in the investigator’s site file (ISF) and the Trial master file (TMF).

The start-up meeting and the trial initiation visit performed by the monitor may be combined, see Monitoring - SOP 1.14.a.

Distribution of Other Information

The coordinating investigator shall inform all parties of the trial progress, modifications to the protocol and other significant changes which may affect the conduct of the clinical trial.

It is recommended to have a written communication plan for each trial.

The coordinating investigator should inform all investigators of suspected adverse reactions that are both severe and unexpected (see Safety Reporting - SOP 1.4.b).

Principal investigators have further responsibility to inform all sub-investigators and relevant trial staff at their health facility.

The coordinating investigator shall notify without undue delay, all parties working on the trial, of the completion/termination of the trial.

The following will be filed in ISF and TMF:

• Signed agreements.
• The current documentation of the roles and allocation of trial-related tasks, e.g. updated delegation log (ISF only).
• The CVs and GCP training certificate for all principal investigators (ISF and TMF) and other trial staff listed on the delegation log.
• For trials involving co-sponsors, the sponsor responsibility split (TMF only).

• Avtale med forskningsstøtte - Template
• Tilleggsavtale med forskningsstøtte - Template
• Agreement Multicentre Trial - Template
• Samarbeidsavtale apotek - Template
• Økonomisk avtale apotek - Template
• Delegation Log - Template
• Privacy Notice for Clinical Trial Staff - Template
• CV for Investigators - Template
• CV for Non-investigators - Template
• Agreement for Support from External/Commercial Source - Template
• Start-up Meeting Agenda - Template
• Start-up Meeting Checklist - Template