Multi-site Project Applications

Clinical Trial Sponsors

The Sponsor is the individual, company, organisation, or institution that:

• Takes overall responsibility for the conduct of the trial
• Owns the Protocol
• Intends to supply the goods
• Initiates, organises and supports a clinical study
• Is responsible for meeting the regulatory requirements of the Therapeutic Goods Legislation

All CTN and CTX trials must have an Australian Sponsor. For more information about the Sponsor's responsibilities, please see the Australian Clinical Trial Handbook.

Clinical Trial Sponsors typically all into three groups;

• Commercially Sponsored by a Private Company
• Collaboratively Sponsored by a Collaborative Group that is usually Not-for Profit
• Investigator Initiated where the sponsor is a public healthcare institution, University, Trust or Research Group.
  • See Barwon Health Sponsored Investigator Initiated trials

The responsibilities of a trial Sponsor, with respect to Good Clinical Practice (GCP), are extensive and are detailed in Item 5 of the Note for Guidance on GCP.

 

Good Clinical Practice (GCP)

All clinical trial research conducted under the auspices of Barwon Health and all research conducted in Australia, must comply with the Australian adopted version of ICH-GCP Guidelines.

The Note for Guidance on GCP (CPMP/ICH/135/95) is an internationally accepted standard for the designing, conducting, recording, and reporting of clinical trials.

Failure to conduct research in line with GCP guidelines contravenes the Australian regulatory framework and increases exposure to risk.

GCP Training

Barwon Health requires all investigators on clinical trials to hold current TransCelerate accredited GCP Certification.

For Barwon Health staff, TransCelerate Accredited GCP training can be accessed via GROW.  For assistance with access to this course via GROW or to upload a current certificate, please contact [email protected]

 

Agreements, Insurance and Indemnity

Commercially sponsored trials require indemnity,  insurance and a CTRA.

See Research Agreements, Insurance and Indemnity Page and the Barwon Health Agreements Guide for more details.

 

Therapeutic Goods Administration (TGA)

The TGA is Australia’s regulatory authority for therapeutic goods. The TGA ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic goods.

The TGA website contains comprehensive regulatory information on Clinical Trials.

 

The Clinical Trial Notification (CTN) Scheme

A notification scheme for clinical trials that investigate the use of a product in Australia which has either:  

• Not on the Australian Register of Therapeutic Goods (ARTG)
• On the ARTG, but being used outside the conditions of its marketing approval

The TGA does not review any data relating to the clinical trial, but acknowledges the trial in writing within ten days of receipt of the signed CTN form and appropriate payment.

The institution ‘Approving Authority’ gives the approval for the conduct of the trial at the site for TGA purposes, having due regard to advice from the HREC.

A separate CTN form must be completed for each potential trial site. The form is accessed via the sponsor TGA Business Services Website.

Where Barwon Health is acting as sponsor of your trial, please contact the Barwon Health Approving Authority below to create an account.

 

For Sponsors submitting eCTNs for clinical trials being conducted at Barwon Health, the approving authority information is provided below:

Name of Approving Authority: Barwon Health, University Hospital Geelong
Barwon Health HREC Code: EC00208
Approving Authority Contact Officer: Ms Natasha Savvides
Position: Senior Research Governance Officer
Contact Phone: (03) 4215 3372
Contact Email: [email protected]

 

For projects approved by the Barwon Health HREC, the HREC contact information is provided below:

HREC Name: Barwon Health Human Research Ethics Committee
Barwon Health HREC Code: EC00208
HREC Contact Officer: Mr Richard Larsen
Position: Research Ethics Officer
Contact Phone: (03) 4215 3371
Contact Email: [email protected]

The Sponsor or Barwon Health Principal Investigator (for Barwon Health investigator initiated projects) is responsible for preparation and submission of the CTN to the TGA.

CTN Acknowledgement should be sent to RGO once received by emailing [email protected]

 

The Clinical Trial Approval (CTA) scheme

The CTA Scheme is an approval process involving the following:

• A sponsor submits an application to the TGA seeking approval to supply 'unapproved' therapeutic goods in a clinical trial. The application must be accompanied by the relevant fee.
• The TGA evaluate summary information about the product including relevant, but limited, scientific data (which may be preclinical and early clinical data) prior to the start of a trial.
• The HREC is responsible for considering the scientific and ethical issues of the proposed trial protocol.
• The sponsor must notify the TGA of each trial conducted using the unapproved therapeutic good(s) approved in the CTA application.

If you are considering submitting a CTA application, you are strongly encouraged to contact the TGA for advice regarding the application process.

 

TGA Fees

TGA Fees are dependent on the type of submission. See current TGA fees

A CT notification can be made for all sites participating in the trial simultaneously, or several notifications can be made for sub-groups of sites.

A CT notification fee applies for each single notification.

CTN trials cannot commence until the TGA has been notified of the trial, and the appropriate notification fee has been paid.

 

Standard Operating Procedures

A standard operating procedure (SOP) is a set of instructions to help researchers carry out  operations associated with the research. SOPs aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with regulations.

A national approach to implementing SOPs at public health organisations has been developed and a generic version of SOPs are now available. While they have not yet been formally adopted and endorsed by Barwon Health, they are listed here as an introduction to support uniformity in systems and procedures in the organisation in preparation for accreditation.

Click here to view the National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia.

 

GMO/Gene Therapy

The use and release of genetically modified organisms is regulated under The Gene Technology Act 2000, to protect the health and safety of the public and their environment.

If you would like to obtain approval to conduct research using GMOs or Gene Therapy please contact our Senior Research Governance Officer via [email protected]

For more information about Gene Technology regulation visit the Office of the Gene Technology Regulator.

 

Investigator Brochure

For detailed information on Investigator Brochure requirements please click here.

 

Clinical Trials Involving Radiation

For detailed information on requirements for Clinical Trials involving Radiation please see Radiation in research guidelines page