Application Process, Approvals and Start-up
The purpose of this Standard Operating Procedure (SOP) is to describe the procedures for application for approval and start-up of clinical trials.
For transition of trials approved according to the directives 2001/20/EC and 2005/28/EC (old legislation) to the Clinical Trial Information System (CTIS) according to Regulation 536/2014 see Working Instruction Transition LENKE lokal PDF from outgoing legislation to Reg 536/2014 LENKE lokal PDF.
This SOP ensures compliance with ICH Guideline for Good Clinical Practice (ICH GCP) and national and international laws and regulations, specified in the SOP Legislation and Guidelines. LENKE lokal Word.
This SOP is valid for all clinical drug trials sponsored by hospitals that have implemented the NorCRIN SOPs.
Sponsor is responsible for ensuring that for all clinical drug trials approvals are obtained and that the trials are started in accordance with this SOP.
For multicentre trials, the sponsor has overall responsibility for ensuring written agreements with cooperating healthcare companies / other partners.
The sponsor’s responsibilities shall be described in the quality system of his/her institution. Tasks are delegated according to SOP Roles and Responsibilities in clinical trials implemented in the institution.
The sponsor is responsible for obtaining approval of a clinical drug trial by ethics committees and competent authorities and other concerned bodies.
The sponsor may transfer any or all 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 application for a clinical trial consists of Part I and Part II. Part I contains general study documents i.e. study protocol, study drug documentation, etc. Part II contains site specific documents and patient facing material (e.g. informed consent). In Norway, Part I will be assessed by both the Norwegian Medical Products Agency (NoMA/DMP) and Regional komité for medisinsk og helsefaglig forskningsetikk (REK), Part II by REK only.
Genetically modified organisms (GMO-IMPs)
For clinical trials with investigational medicinal products (IMPs) that contain or consist of genetically modified organisms (GMO-IMPs) for use in humans, application must be sent both in CTIS and to (see Clinical trials with GMOs in medicinal products – Norwegian Environment Agency).
Genetically modified micro-organisms (including viruses, viroids, animal, and plant cells in culture) may have to be carried out under containment until given to the patient, to limit contact of these organisms with the environment. Such activities include or example the process of genetic modification, the use, storage, transport, destruction and disposal of GM microorganisms. NoMA (DMP) will involve the Health Directorate to assess whether approval for contained use is required. For details see Genterapi – Helsedirektoratet.
4.1 Application in the EEA
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4.1.1. Low intervention studies
4.1.2. Required documents
4.1.3. Redaction of personal information
4.1.4. Where to upload information into CTIS
4.2 Application outside EEA
Similar documentation will be required in non-EEA countries as in EEA-countries. CI should seek information about application process.
Information should be gathered by using the Feasibility Questionnaire Template. See also Working Instruction International Trials. See also Working Instruction for international trials.
4.3 Registration
The trial should also be published on the hospital's website once the trial is approved and ready for recruitment, according to local procedure.
CTIS is a registered data provider for the World Health Organization (WHO). Data from authorised trials published on the CTIS website is now included in the WHO’s International Clinical Trials Registry Platform (ICTRP). This applies to relevant clinical trial data, as required by WHO, published on CTIS since launch of the system on 31 January 2022. CI should verify that the trial is published on ICTRP before start of recruitment.
4.4 Start-up
Approval from the competent authority and ethics committee is a pre-requisite for initiation of the trial. It is recommended that the Start-up Meeting Checklist and the template Start-up Meeting Agenda are used to ensure that all requirements are complied with and all decisions are documented.