Singapore legislation
Regulation 12
Regulation 12
Notification of status of clinical trial
Subregulation 1
Within 14 days after the end of each reporting period of a clinical trial, the sponsor must provide to the Authority a report on the status of the trial in the form and manner specified on the Authority’s website, which must include the following:
whether the trial has commenced and, if so, the date of commencement of the trial;
the number of subjects who have been enrolled at a trial site;
the number of subjects who have completed the trial at a trial site;
whether any audit has been conducted on the trial;
whether the trial is concluded, terminated or suspended and, if so, the date of the conclusion or termination, or the date of suspension.
Subregulation 2
In addition to paragraph (1), the Authority may at any time require the sponsor to give the Authority a report on the status of the clinical trial immediately or within such other time as the Authority specifies; and the sponsor must comply with the requirement.
Subregulation 3
The sponsor must —
subject to paragraph (4), notify the Authority of the conclusion of the clinical trial within 30 days after the date of such conclusion; and
submit to the Authority a final report of the trial within one year after the date of such conclusion, or such longer period as the Authority may allow in any particular case.
Subregulation 4
The sponsor must notify the Authority of any suspension of the clinical trial, or its termination (if the termination takes place before the date of conclusion of the trial or the concluding event specified in the protocol for the trial), within 15 days after the date of the suspension or termination.
Subregulation 5
The notifications referred to in paragraphs (3) and (4) must be in the form and manner required by the Authority.
Subregulation 6
In this regulation, a reference to a reporting period of a clinical trial is a reference to —
a period of 6 months starting on the day the trial is authorised or the notification of the clinical trial is accepted; and
each successive period of 6 months of the trial, excluding any such period of 6 months during which the sponsor notifies the Authority of the conclusion or termination of the trial under paragraph (3) or (4), as the case may be.