(1) An investigator shall report any serious adverse event which occurs in a subject at a trial site at which he or she is responsible for the conduct of a clinical trial immediately to the sponsor.
(2) A report under subsection (1) may be made orally or in writing.
(3) Following the report of a serious adverse event, the investigator shall make a detailed written report on the event.
(4) Subsections (1) to (3) do not apply to serious adverse events specified in the protocol or the investigator's brochure as not requiring immediate reporting.
(5) Adverse events, other than adverse events under subsections (1) to (3), that are identified in the protocol as critical to evaluations of the safety of the clinical trial must be reported to the sponsor in accordance with the reporting requirements, including the time periods for such reporting, specified in that protocol.
(6) The reports made under subsections (1), (3) and (5) shall identify each subject referred to in the report by a number assigned to that subject in accordance with the protocol.
(7) The number assigned to a subject in accordance with the protocol must be different from the number of any other subject in that clinical trial.
(8) Where the event reported under subsection (1) or (5) consists of, or results in, the death of a subject, the investigator shall supply —
(a) the sponsor;
(b) the Ethics Committee; and
(c) the National Competent Authority, with any additional information requested by the sponsor, ethics committee or National Competent Authority.
(9) The sponsor shall keep detailed records of all adverse events relating to a clinical trial which are reported to him or her by the investigators for that clinical trial.
(10) The Ethics Committee or National Competent Authority may, by sending a notice in writing to the sponsor, require the sponsor to send the records referred to in subsection (9), or copies of such records, to it.