Singapore legislation
Regulation 10
of Human Biomedical Research (Tissue Banking) Regulations 2019
Regulation 10
Notification of serious adverse event
Subregulation 1
A person conducting any tissue banking activity carried on or conducted under the supervision and control of a tissue bank must immediately report to that tissue bank any serious adverse event which is associated with that tissue banking activity.
Subregulation 2
As soon as possible after making the report mentioned in paragraph (1), the person mentioned in that paragraph must submit to the tissue bank a detailed written report with all relevant information.