Introduction
Research governance is a framework for institutions to use to ensure that research is conducted responsibly and safely and is scientifically and ethically sound. Research governance considers legal compliance, financial management, accountability and risk management associated with research at a participating site. In the system for streamlined ethical review of multi-site clinical trials, research governance is administered by the process of site specific assessment (SSA).
Research governance/SSA is separate from ethics review. Research governance/SSA must occur at all organisations conducting a clinical trial. Both ethics approval and research governance/SSA authorisation are required before a research project can commence at a site.
The Research governance/site specific assessment - process and practice booklet provides a practical guide for investigators/trial coordinators, research governance officers and sponsors/contract research organisations. Information on clinical trial research governance/SSA should be referred to before and throughout the duration of a clinical trial.
This booklet can be downloaded and the appendices are available in a usable ‘word’ format.
- Research Governance and Site Specific Assessment Process and Practice
- Appendices - Research Governance and Site Specific Assessment Process and Practice
- Contact List Template (for project and site details)
Early research governance action
Once sites are chosen, sponsors/CROs should promptly organise delivery of project documentation to Principal Investigators at all sites involved in the trial. Principal Investigators should seek sign-off from departments or authorities. For example: nursing, health information, pathology, other local requirements, interpreting services, pharmacy, tissue bank(s), radiology/medical imaging, and budget approval.
The Research Governance checklist provides guidance to assist Principal Investigators meet the requirements of research governance/SSA.
How to make a SSA Application
Site-Specific Assessment (SSA) requires the site Principal Investigator to complete the Site Specific Assessment (SSA Form) on the ERM website .
All Principal Investigators, including the Coordinating Principal Investigator, must complete a SSA form for their site.
The SSA form addresses the resources, budget details, site-specific policies, and declarations from departments, etc. The organisation conducting the trial, following HREC approval, must authorise the SSA before a trial can commence at that site.
All site specific supporting documents should be uploaded to the SSA form.
See Applicant user guide to ERM for detailed instructions on how to create and complete a SSA form.
Accessing a SSA Form
For a single-site project, the site Principal Investigator (PI) creates the SSA as a sub-form from the original ethics application.
For a multi-site project, the Coordinating Principal Investigator (CPI) creates SSAs for all sites; each is a sub-form of the original ethics application. Use the ERM Roles+ action button to give each site PI access to their SSA in ERM. Once the PI has access via Roles+ they can complete and submit the SSA, as well as being able to view the ethics application form and its supporting documents.
For guidance refer to the Applicant user guide to ERM.
Submitting the SSA Form to the Research Governance Officer at a site
The SSA form can be submitted after the associated ethics application has been submitted to the reviewing HREC’s organisation.
Submission of the SSA form and supporting documents is through electronic submission from the ERM website. Use the application’s ‘Submit’ button to submit to the site’s research governance officer (RGO).
The documents will be received by the RGO for administration of the site assessment process. If the SSA form is correctly completed the RGO will validate the submission. If the SSA is not validated the RGO will notify the Principal Investigator via a notification email and request for the SSA application to be resubmitted. The application form can be updated and/or new/modified supporting documents uploaded to the form then re-submitted by the Principal Investigator.
The site’s research governance officer (RGO) will assess the SSA form and ensure all the required documents are completed including unique site documents. The RGO may request further information.
See the Signatures request and Submission in ERM document for more information.
Authorisation of an SSA
Evidence of HREC approval must be provided before the CEO/delegate can authorise or not authorise the SSA. Without CEO/delegate authorisation the project cannot commence at the site. The project can commence at a site when HREC approval and SSA authorisation is complete.
Participating Organisations
The following table contains the organisations participating in the streamlined system. The research governance contact details are below.
For any queries, contact the Coordinating Office on 0408 274 054.
Research Agreements
Clinical Trial Research Agreements (CTRAs) for commercially sponsored or collaborative group drug trials are available from Medicines Australia website. Amendments to the Medicines Australia CTRAs are considered by the South Eastern Border States (SEBS) Committee. Further information is available on the Medicines Australia CTRAs webpage.
A CTRA Teletrial Subcontract is also available for studies under a teletrial model.
The Medical Technology Association of Australia (MTAA) has a specific research agreement and other agreements for ‘medical device’ trials. MTAA have developed a suite of Clinical Investigation Research Agreements (CIRAs) for commercially sponsored studies of medical technology.
An Investigator initiated CTRA is available for use at sites in Victoria only. It was developed for investigator-initiated clinical trials by the Victorian Managed Insurance Authority (VMIA).
The joint position statement: Electronic Signatures and Clinical Trial Research Agreement execution in Australia provides guiding principles to optimise digital technology for executing CTRAs using eSignatures.
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