CT SOP version no 1.1.

Main changes from version 1.0 Specified archiving format for eCRFs.

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 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 should ensure that trials are completed, reported and archived according to the requirements of this SOP.

Principal investigators (PIs) at each centre shall ensure that the trial is completed at the centre and that essential documents are archived in the local investigator’s site file.

Trial completion and archiving tasks can be delegated. The delegation of tasks shall be documented.

Completion of the trial is defined as when the last subject is out of the trial and data collection is completed at all centres. Completion must follow the protocol and in compliance with the approvals from competent authorities and ethics committees (for example, the Norwegian Medicines Agency (Statens Legemiddelverk, SLV)) and the Regional Committee for medical and health professional research ethics (REK) in Norway).

It is recommended that to use Checklist Completion of Clinical Trial - Sponsor - Template and Checklist Completion of Clinical Trial - Centre - Template to ensure that all tasks are completed and documentation archived.

Required trial completion tasks

Internal and external partners must be informed that the trial has been completed.

The trial must be recorded/reported in compliance with the current internal procedures for each healthcare facility/institution.

A final monitoring visit should be carried out at each trial centre in compliance with the trial monitoring plan if not already performed before database lock, see Monitoring - SOP 1.14.a.

Investigational medicinal products (IMPs) should be accounted for and documented at each trial centre. Destruction or return of unused IMPs will be carried out and documented in compliance with Investigational Medicinal Product Management at Clinical Trial Completion - SOP 1.14.b.

The coordinating investigator shall provide the following final reports/notifications to the competent authorities (CA) and ethics committees through CTIS for EEA:

*Where, for scientific reasons detailed in the protocol, it is not possible to submit a summary of the results within one year, the summary of results shall be submitted as soon as it is available. In this case, the protocol shall specify when the results are going to be submitted, together with a justification. Conducting trials including countries outside EEA could be such a justification.

In a situation where no subject was included a sponsor may:

1. Notify early termination of the CT in the country concerned or
2. Submit a substantial modification to ask for an extension of the authorisation, including a justification clarifying the feasibility of the CT. If an extension was not submitted and approved within two years from the decision on the clinical trial, the authorisation shall expire in that country. The sponsor will then have to submit a new application.

The healthcare webpages must be updated.

Archiving

Essential documents must be filed in compliance with the Study Files – SOP 1.6.a, both in the sponsor’s Trial Master File (TMF) and at each trial centre in the investigator’s site file (ISF).

Pseudonymised subject data (CRF data) should be archived in different formats. The files should be traceable with audit trails and metadata (e.g. PDF) and be easily upload into the programs for analysis (e.g. CSV). It is highly recommended to also include a format that is easily searchable (e.g. xls) and, if applicable, a format that can be uploaded back into the data capture system (e.g. ODM xml). The archived files should not be editable.

The TMF/ISF will be archived and retained for at least 25 years after the end of the trial (as defined in the protocol/submission to authorities, e.g. last patient visit). If longer archiving is warranted, ethics committee approval should be obtained.

There are different requirements for trials involving somatic cell therapy, gene therapy or tissue regenerative therapy, GCP for Advanced Therapies – SOP 1.11.a. The archiving requirement is 30 years.

Trial data/case report forms (CRF), source data and essential documents, including the code list, must be archived securely and access must be restricted. Procedures should be in place to prevent accidental deletion during the filing period.

The media used to archive the content of the TMF/ISF shall be such that the documents remain complete and legible throughout the period they are to be kept.

Procedures should be in place to ensure that any alteration to the content of the TMF/ISF shall be traceable (for example an audit trail for electronic documents).

The content of the TMF/ISF shall be archived in a way that ensures that it is readily available and accessible, upon request, to the competent authorities.

It is recommended that archived documents are clearly marked with EU CT number, name of trial, date of destruction, and telephone number of sponsor and contact person, see Labels for Archiving - Template.

It is also recommended that there are records of trials for which the institution has archiving responsibility for, see Archiving log - Template.

Source data in the subjects' patient records must be kept in compliance with the current provisions in the regulations on patient records (forskrift om pasientjournal).

When required by the ethics committee, the trial data and code list will be deleted or anonymised. The sponsor institution should have a system in place to check which trials should be deleted or anonymised a given year.

The sponsor will ensure that all centres involved in a multicentre trial are notified in writing (an email is acceptable) when trial data and essential documents in the ISF are no longer required to be archived.

• Checklist Completion of Clinical Trial - Sponsor - Template
• Checklist Completion of Clinical Trial - Centre - Template
• Archiving log - Template
• Labels for Archiving - Template