CT-Application to the regulatory authorities

Before a clinical trial of medicinal product can start, the trial need an approval from the regulatory authorities (Ethics Committee and Norwegian Medicines Agency (SLV)). A guide to the regulatory authorities and how to apply for approval can be found in the CT SOP Application Process, Approvals and Start-up. A template for the CTIS Application is also available.

If another party than sponsor will apply for approval from authorities outside EEA, the sponsor should provide the applicant with a Power of Attorney.

Required documentation of the medicinal product are described in CT SOP Investigational Medicinal Product (IMP) at Trial Start. The use of IMP Handling Checklist can be helpful. If the drug/product being tested does not have approval for use, an Investigator’s Brochure (IB) must be included in the submission to the Norwegian Medicines Agency and Ethics Committee. A template can be found in Investigator’s Brochure Template. Investigator’s Brochure Checklist to guide the process is provided