Section 12: Application for trial licence

12. Application for trial licence (1) A sponsor who wishes to obtain a trial licence shall make a written application to the Council in such form and manner as may be prescribed. (2) An application under subsection (1) shall be accompanied by the prescribed application fee and— (a) a protocol; (b) an investigator’s brochure; (c) a brief curriculum vitae of every investigator; (ca) a Certificate of Good Manufacturing Practice (GMP) in relation to every medical device from its country of origin; (d) a Certificate of Good Manufacturing Practice (GMP) and a Certificate of Pharmaceutical Product (COPP) in relation to every investigational medicinal product from its country of origin; and (e) the separate and different forms to be used for the purposes of patient and subject information, informed consent, recruitment of subjects, adverse event reports and adverse reaction reports. (3) The sponsor shall provide— (a) information as to the quantity of every investigational medicinal product or medical device to be used in the clinical trial; (b) information relating to the measures to be taken for the health, welfare, safety and protection of subjects; (c) information relating to financial aspects of the clinical trial, in particular— (i) sources of funding for the clinical trial and information on the financial or other interests of the sponsor relevant to the clinical trial; (ii) the arrangements for the reimbursement of expenses incurred by the subjects; (iii) any provision for compensation in the event of injury or death resulting from the clinical trial, including details of any insurance cover to be contracted for the protection of subjects; (iv) details of any insurance or indemnity to cover the liability of the sponsor and investigator; (v) summary details of any financial arrangements between— (A) the sponsor and the investigator; and C25A – 11 [Issue 10] Clinical Trials Act (B) the sponsor and the owner or occupier of the site; (d) information relating to the anticipated benefits and risks of the clinical trial; (e) information relating to the location, structure and amenities of any site where the clinical trial is to be conducted; and (f) such other information as the Council may require. (4) Where the Council receives an application under subsection (1), it shall refer the application and such other documents as it thinks fit to the Ethics Committee for an opinion. [S. 12 amended by s. 9 (b) of Act 10 of 2017 w.e.f. 1 October 2017.]