Site governance

There are a number of processes in place to ensure that ACT Health meets all of its legal and regulatory requirements. These steps protect participants, staff, researchers and the institution.

Requirements for a site governance submission

Your research study must have appropriate ethics approval before to being granted governance authorisation. However, you may begin your site governance submission process in parallel with your ethics review submission.

Getting approval for clinical trials, registry and biobank

If your research project includes clinical trials, registry and biobank studies it must undergo an initial feasibility assessment prior to submitting for ethical approval or site governance approval in the case of NMA exempted studies. This assessment is conducted by the Clinical Trials Management Group (CTMG).

Find out more about clinical trials including a checklist of requirements for site governance submissions.

Required documents

Your submission will include the following documentation.

• Cover letter, signed by the PI outlining reason for submission. Please use the ROAR acronym/method to draft submission cover letters:
  • Reason for submission
  • Overview of situation/amendment from PI
  • Any ethical implications
  • Required action/s
• Lead HREC approval letter(s),
  • Ensuring to provide the lead HREC approval letter listing Canberra Hospital as an approved site
• All documents listed on the lead HREC approval letter(s) including, but not limited to:
  • Human Research Ethics Application (HREA)
  • Protocol or research plan
  • Participant information sheet
  • Consent form
  • Site specific PICF(s)
  • Our office has developed a site specific PICF checklist to ensure site specific PICFs meet local requirements, please provide this checklist with your submission if you are submitting site specific PICFs
  • Current CV and GCP Certificate for each investigator (at site). GCP training is available online.
  • ACT Health Site Governance Checklist

Not all documents are required for all submissions. If you are unsure, contact research.governance@act.gov.au

Applications with an agreement

The following are additional documentation requirements for applications which include an agreement or contract with ACT Health.

1. Clinical Trial Agreement or other applicable agreements are required and must be the final version with approved budget.
2. Signed Medicines Australia standard form of indemnity is required if applicable and must be signed by the sponsor.
3. Current Insurance Certificate is required if applicable. HREC approval should be taken to include ACTIA insurance approval. A separate site governance sheet will be provided by the secretariat office. Email research.governance@act.gov.au for further information or call 02 5124 5659.

A site governance clearance sheet is required for all site governance applications. This includes multi-centre HREA submissions. Find out more about clinical trials.

Supplementary application documentation

1. A waiver of consent may be required. Find out more about the requirements of waiving consent in the National Statement Chapter 2.3. A waiver of consent is not required when accessing de-identifiable data.
2. A radiation safety report is required for research studies involving exposure of persons with ionising radiation.

Insurance requirements for sponsored clinical trials

The following is required to meet the Territory’s requirements:

• The insurance certificate must specifically name the Australian Corporate entity acting as commercial sponsor as a named insured under the relevant insurance policy.
• If the certificate is provided in the name of an overseas parent company, it must name the Australian entity as a subsidiary.
• The insurance certificate must include a valid coverage period for the policy
  The insurer providing the cover must be approved by the Australian Prudential Regulation Authority and must have a minimum financial strength rating of A- or above.
• The insurance certificate must provide coverage of AUD$20 million for each and every occurrence and AUD$20 million in the annual aggregate against a class of insurance appropriate for the risk associated with the research.

The requirements listed above do not apply to low risk ethics proposals. For more information contact research.governance@act.gov.au or call 02 5124 5659.