Singapore legislation
Regulation 11
of Human Biomedical Research (Tissue Banking) Regulations 2019
Regulation 11
Notification by tissue bank of serious adverse event
Subregulation 1
For the purposes of section 35(3)(b) of the Act, a tissue bank must notify the Director‑General of any serious adverse event which is associated with any tissue banking activity carried on or conducted under its supervision and control.
Subregulation 2
Where the serious adverse event results in death or is life‑threatening, the tissue bank must ensure that ––
all relevant information about the serious adverse event is recorded;
the recorded information on the serious adverse event is submitted to the Director‑General as soon as possible and in any event not later than 7 days after the tissue bank or the principal person in charge designated first becomes aware of the event, whichever is the earlier; and
any additional relevant information about the serious adverse event is recorded and submitted to the Director‑General within 8 days after the record is made.
Subregulation 3
Where the serious adverse event does not result in death and is not life‑threatening, the tissue bank must ensure that all relevant information about that event is —
recorded; and
submitted to the Director‑General as soon as possible and in any event not later than 15 days after the tissue bank or the principal person in charge designated first becomes aware of that event, whichever is the earlier.
Subregulation 4
The notification of the serious adverse event must be submitted to the Director‑General in the applicable form set out at the relevant website.