Singapore legislation
Regulation 11
Regulation 11
Notification of serious breaches and urgent safety measures
Subregulation 1
The sponsor must notify the Authority in writing of any serious breach during the clinical trial of any of the following, as soon as possible and in any event not later than 7 days after becoming aware of the breach:
the principles of good clinical practice;
the protocol relating to the trial, as amended from time to time in accordance with regulation 10;
these Regulations.
Subregulation 2
Where the relevant institutional review board of a clinical trial requires any person to report to it any serious breach during the trial of any of the following, the person must do so in accordance with the requirements of the board:
the principles of good clinical practice;
the protocol relating to the trial, as amended from time to time in accordance with regulation 10.
Subregulation 3
The sponsor must, as soon as possible and in any event not later than 7 days after the date any urgent safety measure referred to in regulation 21 is taken in relation to a subject of the clinical trial, give written notice to the Authority of the measure taken and the circumstances giving rise to the measure.
Subregulation 4
In this regulation, “serious breach” means a breach during a clinical trial which is likely to affect to a significant degree —
the safety, or physical or mental integrity, of any subject of the trial; or
the scientific value of the trial.