Singapore legislation
Regulation 9
Regulation 9
Notification of serious adverse event
Subregulation 1
A researcher conducting research must immediately report to his or her research institution any serious adverse event —
which occurs to a participant during the research, regardless of whether the participant is in or outside Singapore at the time of the occurrence; or
which the researcher knows or has reason to believe has occurred to a participant during another research that is conducted outside Singapore but which is connected with the research mentioned in sub-paragraph (a).
Subregulation 2
As soon as possible after making the report mentioned in paragraph (1), the researcher must submit to the research institution a detailed written report on the serious adverse event.
Subregulation 3
Where the relevant institutional review board requires any serious adverse event to be reported to the board, the person required by the board to do so must make the report to the board in accordance with the board’s requirements.