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Site Specific Application
Click below headings to be taken to that section of SSA information page:
• CREATE STE APPLICATION
• HINTS FOR STE SUBMISSION
• HEAD OF DEPARTMENT SUPPORT
• EXTERNAL INVESTIGATORS
• SITE SPECIFIC DOCUMENTS
CLINICAL TRIAL SITE GOVERNANCE SUBMISSION REQUIREMENTS
• CTRA/RESEARCH AGREEMENT
• STANDARD INDEMNITY
• CTN DOCUMENTATION
• INSURANCE CERTIFICATE
• INSTRUCTIONS FOR ELECTRONIC SIGNATURES
• EVIDENCE OF GOOD CLINICAL PRACTICE (GCP)
SITE GOVERNANCE SUBMISSION REQUIREMENTS FOR STUDIES NOT ETHICALLY APPROVED BY SWSLHD HREC
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
Create a STE application in REGIS:
https://regis.health.nsw.gov.au/
Go to REGIS Quick Reference Guides (QRGs): SITE GOVERNANCE: https://regis.health.nsw.gov.au/how-to/
Follow the QRGS in the below order:
- Project Registration
- Create a new site application - Part B for HREC Approval external to NSW
- Site Application - Completing, Requesting Support and Submitting
For REGIS walk-through videos, please click here.
Hints for STE submission in REGIS:
- The Principal Investigator (PI) must submit the SSA on behalf of the Research Team in REGIS.
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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.
https://www.afp.gov.au/what-we-do/services/criminal-records/national-police-checks
Please see our Forms and Templates page for 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.
- 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)
- 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”
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 have been reviewed and are reccommended for signing, the Office will send instructions for execution.
NOTE: Must be signed by Sponsor and Principal Investigator
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
- 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: Cameron Lutman
3. Position: Research Ethics and Governance Manager
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 for all Investigators
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.
NOTE: TransCelerate GCP evidence is accepted: https://transceleratebiopharmainc.com/gcp-training-attestation/training-providers/
OR
For onsite GCP training please contact: SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au
Please see below GCP training courses from OHMR:
- Introductory GCP Training: Self Directed Online Course
- Refresher GCP Training: Self Directed Online Course
- Workshop
- SMGCP online Refresher & Short course modules (for SPHERE partners)
1. Some additional key points about the SMGCP course:
2. To enrol click on ‘Enrol Free’ button right underneath the header. Don’t click on individual courses first, that way they can access the full list of courses.
3. Please enter full name as it will appear on the certificate, use work email ONLY to create the account, enter SPHERE related organisation as place of work
4. Some SPHERE partners include SWSLHD, UTS, WSU, UNSW and the Ingham Institute
5. Alternatively interested parties can easily search for a GCP course via the following platforms:
• ARCS
• Praxis
Site Governance submission requirements for studies that have been approved by a Human Research Ethics Committee that is not SWSLHD
Hints 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.
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