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Clinical trial notification (CTN) form - user guide

V1.2, August 2020

21 August 2020

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Full text of sponsor declaration

Before submitting your application(s) please read the declaration below and click the Accept button to proceed with this submission; or click on the Decline button to return to the Submission form.

In this declaration, unless the contrary intention appears:

I means the individual assigned to the eBS login ID associated with the submission of this form to the TGA.

Secretary means the Secretary of the Department of Health and includes a delegate of the Secretary.

Sponsor means the company, organisation, institution, body or individual that is notifying the TGA as named in the 'Sponsor Name' field located on the application tab of this notification.

Declaration

By clicking the Accept button:

I declare that I am authorised by the sponsor to notify the TGA on its behalf in relation to this clinical trial.

I acknowledge that:

  • the sponsor is taking overall responsibility for the trial
  • the relevant goods only remain exempt by reason of their use in the clinical trial only for so long as:
    • the approval of the goods for the trial has been given by the sponsor (if the sponsor is conducting the trial), or by the body or organisation conducting the trial for the sponsor, having regard to the advice of the ethics committee responsible for monitoring the conduct of the trial, on terms no less restrictive than terms advised by that committee
    • the sponsor has not received advice from the ethics committee that is inconsistent with the continuation of the trial
    • the requirements in regulation 12AD of the Therapeutic Goods Regulations 1990 (in the case of therapeutic goods other than medical devices) and regulation 7.5 of the Therapeutic Goods (Medical Devices) Regulations 2002 (in the case of medical devices) are complied with, including that the use of therapeutic goods in the trial must be in accordance with the Guidelines for Good Clinical Practice and the National Statement on the Ethical Conduct in Research Involving Humans published by the National Health and Medical Research Council, as defined in the Therapeutic Goods Regulations
    • the Secretary has not under Item 3 of Schedule 5A of the Therapeutic Goods Regulations (in the case of therapeutic goods other than medical devices) or Item 2.3 in Part 2 of Schedule 4 of the Therapeutic Goods (Medical Device) Regulations 2002 directed that the trial not be conducted on the basis that the Secretary has become aware that to conduct the trial would be contrary to the public interest
  • the Secretary can under the Therapeutic Goods Act 1989 (the Act), require the sponsor to provide specified information or documents relating to any exempt goods
  • the Secretary can provide information obtained in response to an authority or the Commonwealth, or a State or Territory that has functions in relation to therapeutic goods or the registration or medical practitioners or pharmacists in the relevant State or Territory
  • it is an offence under the Act to fail to provide that information or documents required by the Secretary, or to provide information or documents that are false or misleading in a material particular, to the Secretary
  • it is a requirement of the Guidelines on Good Clinical Practice that the sponsor report all serious and unexpected adverse reactions arising from the use of the relevant goods in the trial to the TGA
  • it is a serious offence under Commonwealth law to provide information for the purposes of this notification that is false or misleading in a material particular.

I declare that all information provided for the purposes of the notification is true and accurate and that all required information has been included.

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