Australia Therapeutic Goods (Medical Devices) Regulations 2002 r7.3-sch4-2.3: Clinical trials: notify the Secretary (CTN) before the device is used and before each new site starts, approve the trial on ethics committee advice no less restrictively, give National Statement assurances and information undertakings, allow inspection, follow the approved protocol, stop when the ethics committee says so, and provide safety data within 14 days of request

What does r7.3-sch4-2.3 require?

For a trial under the clinical trial approval scheme (CTA), the approval holder and principal investigator must give the Secretary, before any trial starts, written assurance that it follows the NHMRC National Statement and undertakings to supply trial information and to allow authorised persons the regulation 7.4 entry, search, test and questioning powers. Users of the device must follow the protocol approved by the responsible ethics committee and the National Statement and must stop if that committee says use is inconsistent with the protocol or conditions. Under the notification scheme (CTN, Schedule 4 item 2.3) the sponsor must notify the Secretary in the approved form with the fee before the device is first used (or within an agreed later period) and before use at each additional site; the sponsor or trial organisation must approve the device's use having regard to ethics committee advice on terms no less restrictive; the trial must not be under a stop direction or contrary ethics advice; the sponsor and any trial organisation must answer authorised persons' information requests and allow inspection; and the sponsor must give safety or performance information requested in writing within 14 days or any longer allowed period.