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.
Research governance/site specific assessment - process and practice booklet
This booklet is 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.
The 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
Investigator-initiated Clinical Trial Research Agreement (CTRA)
The investigator-initiated CTRA was developed for investigator-initiated clinical trials by the Victorian Managed Insurance Authority (VMIA). It is for use at sites in Victoria only. CTRAs for commercially sponsored or collaborative group research are available from Medicines Australia
Download the Investigator initiated CTRA.
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.
Research governance cover letter and checklist
The Research governance cover letter and checklist provides guidance to assist Principal Investigators meet the requirements of research governance/SSA.
A copy of the research governance cover letter and checklist should be attached to every SSA application form.
Research governance cover letter and checklist
How to make a site-specific assessment application
Site-specific assessment 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 an 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.
See Applicant user guide to ERM for detailed instructions on how to create and complete a SSA form.
Accessing an SSA Form
The Coordinating Principal Investigator is responsible for creating the SSA Forms for all Principal Investigators at sites and transferring the SSA Form using the Roles + button in ERM to each investigator.
A notification email ‘Applicant Role Share’ will be sent to each Principal Investigator indicating that a SSA Form is in their ERM account for completion. Each Principal Investigator requires the HREA or LNR VIC application and supporting documents (same as submitted to the reviewing HREC). All documents uploaded to the ERM ethics application (by the Coordinating Principal Investigator) are automatically available when the Coordinating Principal Investigator has shared the SSA with Principal Investigators at sites using Roles+ in ERM.
All site specific supporting documents should be uploaded (by the Principal Investigator) to the ERM website.
When completing the SSA Form some fields relating to declarations and authorisation are blocked as they are not to be completed by the Principal Investigator.
Submitting the SSA Form to the Research Governance Officer at your 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 that the SSA application is completed and supporting documents are correct.
The application form can be updated and/or new/modified supporting documents uploaded on the ERM website before the application is re-submitted by the Principal Investigator.
See the ERM Signatures and Submission Quick Reference Guidance document for more information.
Ongoing Communication with the Research Governance Officer
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 from the Principal Investigator - the application form can be updated and/or new/modified supporting documents uploaded on the ERM website before re-submitting the application. The RGO will make a recommendation regarding site specific assessment.
Authorisation of your 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 Organisation and Research Governance Officer Contact Details
The following table contains the research governance contact details for organisations participating in the streamlined system. For any queries, contact the Coordinating Office on (61 3) 9096 7398.