Human Biomedical Research (Tissue Banking) Regulations 2019 · 2025 Revised Edition · Part 2 · Tissue Banks Generally
10. Notification of serious adverse event
Feedback & supportA 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.
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.
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.