Singapore legislation
Regulation 10
Regulation 10
Amendments and substantial amendments to clinical trial, etc.
Subregulation 1
The Authority may, at any time, direct the sponsor to make an amendment (including a substantial amendment) if it appears to the Authority that the amendment is necessary to ensure —
the safety or scientific validity of the clinical trial;
compliance with the principles of good clinical practice in relation to the clinical trial; or
compliance with the conditions of the Authority’s authorisation or acceptance of notification,and the sponsor must comply with the direction.
Subregulation 2
Subject to regulation 21, in the case of a clinical trial that has been authorised by the Authority under regulation 8, the sponsor must not make a substantial amendment, except with the approval of the Authority.
Subregulation 3
An application for approval of a substantial amendment referred to in paragraph (2) must be made by the sponsor in the form and manner specified on the Authority’s website.
Subregulation 4
Subject to regulation 21, in the case of a clinical trial that has been notified to the Authority under regulation 9, the sponsor must not make a substantial amendment until the substantial amendment has been notified to the Authority and the sponsor has received the Authority’s acceptance of the notification.
Subregulation 5
A notification of a substantial amendment referred to in paragraph (4) must be made by the sponsor in the form and manner specified on the Authority’s website.
Subregulation 6
The sponsor must —
keep records of all amendments; and
send such records, or copies of such records, to the Authority, in accordance with any request by the Authority for the same.