Site Specific Application

Click below headings to be taken to that section of SSA information page:
• CREATING AN SSA IN REGIS
• SITE GOVERNANCE SUBMISSION REQUIREMENTS FOR STUDIES NOT ETHICALLY APPROVED BY SWSLHD HREC
• TIPS FOR SSA SUBMISSIONS
• EXTERNAL INVESTIGATORS
• SITE SPECIFIC DOCUMENTS

CLINICAL TRIAL SITE GOVERNANCE SUBMISSION REQUIREMENTS
• CTRA/RESEARCH AGREEMENT
• STANDARD INDEMNITY
• CTN DOCUMENTATION
• INSURANCE CERTIFICATE
• EVIDENCE OF GOOD CLINICAL PRACTICE (GCP)
 

SWSLHD Research Governance Requirements

You can make an appointment to discuss your application by phoning the Research Directorate on 02 8738 8304 or email SWSLHD-Ethics@health.nsw.gov.au

Creating a Site Specific Assessment (SSA) Application in REGIS:

REGIS: https://regis.health.nsw.gov.au/

Quick Reference Guides: https://regis.health.nsw.gov.au/how-to/

Use the Site Application - Completing, Requesting Support and Submitting Guide

For REGIS walk-through videos, please click here.

Our Forms and Templates page also contains more information.

Site Governance submission requirements for studies that have been approved by a Human Research Ethics Committee that is not SWSLHD

• Submit the SSA application in REGIS:
  -  Go to QRG REGISTRATION including NMA: https://regis.health.nsw.gov.au/how-to/
  -  Follow the QRGs: National Mutual Acceptance (NMA) in REGIS and the Project Registration

Tips for STE submission in REGIS in addition to the above guidance

• HREC approval letter listing the SWSLHD site and principal investigator is to be uploaded in REGIS with the STE application.
• All HREC ethics approval letters and subsequent amendment approval letters for the study are to be uploaded in REGIS with the STE application.
  NOTE: Please provide all documents listed on the HREC Approval letters to be used at SWSLHD. If some documents are not being used at SWSLHD, please specify in a cover letter uploaded in REGIS with the STE application.
   
• Mandatory documents:
  - Protocol
  - HREA
  - Master Documents (if applicable) e.g. MASTER Participant Information Sheet, MASTER Consent Form, Investigator Brochure, Questionnaire, Data Collection Form, Flyer, Brochure, Telephone Script, Patient ID Card, Email Invitation Template, etc.

 Multi-Jurisdictional Multi-Party non Clinical Trial Collaborative Research Agreement

This agreement is designed to offer the non-clinical trials research sector the efficiencies realised in Australia when nationally accepted clinical trials contract templates were introduced.

Tips for SSA submissions:

• The Head of Department (HOD) and any supporting departments e.g. Medical Records, Radiology, Pharmacy etc must provide support for the STE application in REGIS prior to submission if applicable.

• NOTE: This cannot be an investigator of the study as this would be a conflict of interest.
  
   Conflict of interest and Clinical Trial related documentation.
  
  

• If access to SWSLHD Medical Records for the purpose of the study is required (this includes eMR/PowerChart even if you already have access to these systems for clinical purposes and is still required even if HREC has approved a waiver of consent), please provide head of department support for Medical Records in REGIS prior to submission.
   
• If NSW Health Pathology support is required for this study, please upload the quote from NSW Health Pathology outlining the services provided for the study with the REGIS STE application.

External Investigators

• Investigators that are NOT employees of NSW Health require the following documents to be uploaded with the STE application in REGIS: 
• Working on-site (including contacting patients via telephone and/or viewing identifiable data)
  - National Police Check (within the past 3 years) (https://www.afp.gov.au/what-we-do/services/criminal-records/national-police-checks)
  - Signed Confidentiality Statement (found on website under Forms and Templates)
   
• Working off-site
  - Signed Confidentiality Statement (found on website under Forms and Templates)

OHMR REGIS Videos
Please click here for helpful how to information and video content from eHealth NSW REGIS and the Office for Health and Medical Research's Ethics and Governance Unit.
These videos will support those submitting applications through REGIS.

Site Specific Documents

The study documents that are site specific are:
• Participant Information Sheets
• Consent Forms
• Withdrawal of consent form
Please upload site specific documents with the STE application in REGIS if applicable (this is in addition to the master document approved by the lead HREC).

*Please ensure the following is included on the site specific versions:

• A site specific version number/date must be included in addition to the master version number/date. There should be two version numbers/dates, e.g. Liverpool Hospital, Version 1.0, 10 January 2024, MASTER Version 1.0, 8 January 2024
  
  
• South Western Sydney Local Health District logo must be used. This is available on request.
   
• For Participant Information Sheets only: The SWSLHD Research Governance Office complaints paragraph must be used in addition to the lead HREC complaints paragraph. Please insert the following:
  
  “The conduct of this study at [insert Hospital name] has been authorised by the South Western Sydney Local Health District, any person with concerns or complaints about the conduct of this study may also contact the Research Governance Officer on (02) 8738 8304, email: SWSLHD-Ethics@health.nsw.gov.au and quote project number “2024/STEXXXXX”

Please refer to this document on how to prepare site specific documents: Preparing Site Specific Documents (SSD)

Clinical Trial Site Governance Submission Requirements (in addition to the above requirements)

• CTRA/Research Agreement
   https://medicinesaustralia.com.au/policy/clinical-trials/indemity-and-compensation-guidelines/
   The CTRA/Research Agreement can be accepted electronically or as a hard copy.
  
  Once the agreement has been reviewed and recommended for signing, the Office will provide instructions for execution in the SSA Authorisation or Approval letter. (NOTE: SWSLHD is to be the last signatory)
  
  Correct Institution Details for SWSLHD
  South Western Sydney Local Health District
  Administration Building, Eastern Campus, Liverpool Hospital
  Locked Bag 7279, Liverpool BC 1871, ABN: 46 738 965 845
  
  
  
• Standard Indemnity
  https://medicinesaustralia.com.au/policy/clinical-trials/indemity-and-compensation-guidelines/
  The Standard indemnity can be accepted electronically or as a hard copy. Once the indemnity has been reviewed and are recommended for signing, the Office will send instructions for execution
  NOTE: Must be signed by Sponsor
  
  
  
• Once an agreement has been approved for signatures, it should be initiated by the sponsor or study team via Docusign or Adobe Sign using the instructions linked here.

• CTN documentation (if applicable)
  https://www.tga.gov.au/clinical-trials
  Please update the CTN documentation if applicable in REGIS with the STE application prior to submission.
  Please ensure that the CTN has been filled out with the correct details as below:
  1. Name of approving authority: South Western Sydney Local Health District
  2. Name of approving authority contact officer: Rachel Goldrick
  3. Position: A/Manager, Research and Development
  4. Email: SWSLHD-ethics@health.nsw.gov.au
  5. Phone Number: 02 8738 8304
  
   
• Insurance Certificate
  Please upload the insurance certificate from the sponsor in REGIS with the STE application prior to submission.
  Please ensure that the Insurance Certificate meets our standard requirements as below for Commercially Sponsored studies:
  1. Insurance cover must be at least $20 000 000 AUD per occuence and in the annual aggregate
  2. The excess/deductible must be less than $25 000 AUD per claim
  3. Must be within current date range
  4. Ensure that it covers Australia and is from a local sponsor
  5. Must state it covers for Clinical Trials or includes Professional Indemnity or Products liability.
   
• Radiation Safety Officer Report (if applicable)
  Please upload the Radiation Safety Officer Report if applicable in REGIS with the STE application prior to submission or visit their website for more information.
   

Evidence of Good Clinical Practice (GCP) Training
Investigators cannot commence a Clinical Trial without this training. Please upload evidence of GCP training for all investigators in REGIS with the STE application prior to submission. GCPs are valid for 3 years.

Please refer to the Clinical Trials website for current GCP training for SWSLHD, Ingham Institute, UNSW and WSU staff.