Site Governance

There are a number of processes in place to ensure that ACT Health meets all of its legal and regulatory requirements. 

Requirements for Site Governance Submission

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

Every research study must have appropriate ethics approval prior to being granted governance authorisation. See the section on requirements for ethics submission for more information.

Use the site governance checklist to ensure that the documentary requirements are met.

Clinical Trials Approval

All clinical trials must seek in principle support from the Clinical Trials Committee (CTC) prior to submitting for ethical approval or, in the case of NMA exempted studies, site specific governance approval. For more information, please see the Clinical Trials section.

Required Documents

Please include the following documents with your submission:

1. Cover Page
A Cover page is required for all ethical and site governance review applications.
 

2. Human Research Application Form (HREA)
An electronic application for signed by ACT-based researchers must be provided.  The may be provided within the REGIS platform or through the online forms website.
 

3. Protocol or Research Plan
The ACT Health HREC will not accept submissions without a protocol or research plan.  Example protocol templates are provided, however these may be varied as required:

  • Clinical research
  • Social research
  • Data linkage projects
     

4. Participant Information Sheet
An updated PIS for the ACT is required for all applications that include participant recruitment.
 

5. Consent Form (CF)
An updated CF for the ACT is required.
 

6. Site PICF Checklist
A Site PICF checklist is required for all applications that include participant recruitment.
 

7. Current CV for each investigator
An updated CV for each investigator is required for both ethical and site governance applications.
 

8. Evidence of current Good Clinical Practice (GCP) training for each investigator
This is required all clinical applications. Each investigator and research team member must provide evidence of GCP training for both ethical and site governance applications.  A free online GCP training course can be found through the Global Health Training Centre.
 

9. ACT Health Site Governance Checklist
An ACT Health Site Governance Checklist is to be submitted with all site governance applications including multi-centre HREA submissions.

 

For applications with an agreement/contract with ACT Health

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

10. Clinical Trial Agreement or other applicable agreements
This must be the final version with approved budget.

11. Signed Medicines Australia Standard Form of Indemnity (if applicable)
This must be signed by the sponsor.

12. Current Insurance Certificate (if applicable)
See the Insurance dropdown for requirements.  Please Note: HREC approval should be taken to include ACTIA insurance approval. A separate site governance sheet will be provided by the secretariat office. Please direct queries to research.governance@act.gov.au or 02 6174 7968.

13. ACT Health Site Governance Clearance Sheet

An ACT Health Site Governance Clearance Sheet is to be submitted with all site governance applications including multi-centre HREA submissions.

Supplementary Application Documents

14. Waiver of Consent

Please consult the National Statement Chapter 2.3 on the requirements for waiving consent. A waiver of consent is not required when accessing de-identifiable data.

15. Radiation Safety Report

This is required for research studies involving exposure of persons with ionising radiation.

Insurance

Insurance Requirements for Sponsored Clinical Trials

The following is necessary 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 queries please contact research.governance@act.gov.au or 02 6174 3949

Page last updated on: 4 Oct 2018