(1) The National Competent Authority shall keep an electronic database system on clinical trials in accordance with this section.
(2) The electronic database must contain —
(a) name and contact details of the investigator or sponsor;
(b) description of the investigational medicinal product or investigational medical device;
(c) purpose of the clinical trial;
(d) status of the clinical trial;
(e) reports on serious adverse events; and
(f) any other information required by this Act.