Research and Ethics Office

Site Specific Application

SITE GOVERNANCE SUBMISSION REQUIREMENTS FOR STUDIES THAT HAVE BEEN ETHICALLY APPROVED BY THE SWSLHD HREC
• 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
• 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

Site Governance submission requirements for studies that have been ethically approved by the SWSLHD Human Research Ethics Committee

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: Create a new site application, Site Application - Completing, Requesting Support and Submitting
    - Site Application - Head of Department (HOD) Not Supported

Hints for STE submission in REGIS:

Site Specific Documents

These are study documents that are site specific e.g. Participant Information Sheets, Consent Forms, Posters, Flyers etc. 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 2015, MASTER Version 1.0, 8 January 2015
  • 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 “2019/STEXXX”

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

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.
     

 

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Last Updated: 13 November, 2019
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