Key messages

  • 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 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.

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. 

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.

Organisation

Contact person

Role of contact person

Email

Phone

Albury Wodonga Health

Glenn Davies

Executive Director Medical Services & Clinical Governance

enquiries@awh.org.au

glenn.davies@awh.org.au

(02) 6051 7278

Alfred Health
Nicole Rosenow
Senior Governance Officer

research@alfred.org.au

n.rosenow@alfred.org.au

(03) 9076 5491
Emily Bingle Governance Officer
e.bingle@alfred.org.au
 (03) 9076 3619 

Austin Health

Sharon Reid

Manager, Research Governance

rgo@austin.org.au

(03) 9496 2901

Ballarat Health Services

Diane Clingin

Secretary, HREC

researchethics@bhs.org.au

(03) 5320 8661

Barwon Health

Lisa Fry

RGO

regi@barwonhealth.org.au

(03) 4215 3373

Bendigo Health

Sally McCarthy

Manager, HREC

ethics@bendigohealth.org.au

samccarthy@bendigohealth.org.au

(03) 5454 6412

Eastern Health

 

RGO

ethics@easternhealth.org.au

(03) 9895 3100

Goulburn Valley Health

Md Rafiqul Islam

Director of Clinical Research

mdrafiqul.islam@gvhealth.org.au

(03) 5831 0035

Latrobe Regional Hospital

Anita Raymond

RGO

hrec@lrh.com.au

(03) 5173 8554

Melbourne Health

Angela Watt

Manager, Office for Research

researchgovernance@mh.org.au

angela.watt@mh.org.au

(03) 9342 8530

Monash Health

Michael Kios

RGO

research@monashhealth.org

michael.kios@monashhealth.org

(03) 9594 4606

Northeast Health Wangaratta Helen Haines Director Education and Research helen.haines@nhw.org.au

(03) 5722 5058

Northern Health

 

Senior Coordinator, Ethics

ethics@nh.org.au

(03) 8405 2918

Peninsula Health

Lee-Anne Clavarino

Manager, Office for Research

rgo@phcn.vic.gov.au

lclavarino@phcn.vic.gov.au

(03) 9784 2679

Peter MacCallum Cancer Centre

Dianne Biermann

RGO

ethics@petermac.org

(03) 8559 7540

South West Healthcare Barbara Moll  Manager Education, Research and Workforce development bmoll@swh.net.au (03) 5563 4080

St. Vincent's Hospital (Melbourne)

Tam Nguyen

Executive Officer for Research

research.ethics@svhm.org.au

(03) 9288 3930

The Royal Children's Hospital (Melbourne)

Kelly Hoffman

Research Governance Manager

rch.ethics@rch.org.au

(03) 9345 4112

The Royal Victorian Eye and Ear Hospital Andrea Johannessen Research Manager and RGO
ethics@eyeandear.org.au (03) 9929 8525
Kerryn Baker HREC ethics@eyeandear.org.au

The Royal Women's Hospital

Arthur Hui

Administrative Officer

research.ethics@thewomens.org.au

arthur.hui@thewomens.org.au

(03) 8345 3720

Western Health

Virginia Ma

RGO

ethics@wh.org.au

(03) 8395 8074