Site Specific Application

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.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.ed to offer the non-clinical trials research sector the efficiencies realised in Australia when nationally accepted clinical trials contract templates were introduced.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.eft">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
• There is also walk through videos which can be found at: https://www.youtube.com/@ohmrregisregu4228/videos.

Hints for STE submission in REGIS:

• The Principal Investigator (PI) must submit the SSA on behalf of the Research Team in REGIS.
• 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
  - Insurance Certificate (Clinical Trials only)
  - Signed Confidentiality Statement (found on website under Forms and Templates)
• 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 12 months) Link: Australian Federal Police: https://www.afp.gov.au/what-we-do/services/criminal-records/national-police-checks
  - Insurance Certificate (Clinical Trials only)
  - Signed Confidentiality Statement (found on website under Forms and Templates)
• Working off-site
  - Signed Confidentiality Statement (found on website under Forms and Templates)

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)

• CTRA/Research Agreement - https://medicinesaustralia.com.au/policy/clinical-trials/indemity-and-compensation-guidelines/
  3 x Hardcopies to be mailed or delivered to the Level 2, Clinical School, Liverpool Hospital.
   NOTE: Must be signed by Sponsor and Principal Investigator
  OR
  Electronic version of the signed CTRA is acceptable, if acceptable by the sponsor. In this case, please upload the signed CTRA with the STE application in REGIS prior to submission.
  NOTE: Correct Institution Details for CTRAs:
  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/
  3 X Hardcopies to be mailed or delivered to the Level 2, Clinical School, Liverpool Hospital.
  NOTE: Must be signed by Sponsor and Principal Investigator
  OR
  Electronic version of the signed Standard Indemnity is acceptable, if acceptable by the sponsor.  In this case, please upload the signed Standard Indemnity with the STE application in REGIS prior to submission.
  NOTE: Correct Institution Details for Indemnity:
  South Western Sydney Local Health District
  Administration Building, Eastern Campus, Liverpool Hospital
  Locked Bag 7279, Liverpool BC 1871
  ABN: 46 738 965 845  
• 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.
• Insurance Certificate
  - Please upload the insurance certificate from the sponsor in REGIS with the STE application prior to submission.
• Radiation Safety Officer Report (if applicable)
  - Please upload the Radiation Safety Officer Report if applicable in REGIS with the STE application prior to submission.
• 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: Kelsey Dobell-Brown via SWSLHD-ClinicalTrialsSupportUnit@health.nsw.gov.au

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

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.