Health Products (Clinical Trials) Regulations 2016 · As enacted · Part 2 · Clinical Trials of Therapeutic Products or Applicable Ctgt Products
24. Notifications of serious adverse events
Feedback & supportA principal investigator must immediately report any serious adverse event which occurs in a subject during a clinical trial to the sponsor to enable the sponsor to comply with the obligations of the sponsor under regulation 4.
As soon as possible after making the report referred to in paragraph (1), the principal investigator must furnish to the sponsor a detailed written report on the event.
Paragraph (1) does not apply to any serious adverse event specified in the protocol or investigator’s brochure for the clinical trial as not requiring immediate reporting.
Where the relevant institutional review board of the clinical trial requires any person to report to it any matter referred to in paragraph (1), the person must do so in accordance with the requirements of the board.
Subregulation 1
A principal investigator must immediately report any serious adverse event which occurs in a subject during a clinical trial to the sponsor to enable the sponsor to comply with the obligations of the sponsor under regulation 4.
Subregulation 2
As soon as possible after making the report referred to in paragraph (1), the principal investigator must furnish to the sponsor a detailed written report on the event.
Subregulation 3
Paragraph (1) does not apply to any serious adverse event specified in the protocol or investigator’s brochure for the clinical trial as not requiring immediate reporting.
Subregulation 4
Where the relevant institutional review board of the clinical trial requires any person to report to it any matter referred to in paragraph (1), the person must do so in accordance with the requirements of the board.