Site specific application submission and guidelines

The Research Governance team is responsible for the review of authorisation of all types of site-specific applications (SSAs) associated with a Human Research project.  These include:

• Site specific applications 
• Access request applications and
• Site-specific research governance amendments and significant safety issues

Please review the guidelines for further details on submission and review of the above documentation.

This may be conducted at any of the 6 sites within the Network.  These sites are:

• The Children’s Hospital at Westmead
• Sydney Children’s Hospital, Randwick
• NETS
• Bear Cottage
• The Children’s Court Clinic
• NSW Pregnancy and Newborn Services Network

Pre-Submission Meetings

• Implementation of Pre-Submission Meetings to assist researchers with GTLR site applications

  • The pre-submission meeting is a high-level overview of your project to assist in highlighting early any areas that have the potential to delay the review of your application.
  • It is not a pre-review of the documents in your application.
  • Mandatory from 1^st April and GTLR site applications submitted without a pre-submission meeting being conducted will be rejected.
  • Please email the RGO Inbox (SCHN-Governance@health.nsw.gov.au) to book an appointment for a pre-submission meeting – PRIOR to submitting your site application in REGIS.
    • Available times are Monday; Tuesday; Wednesday; Thursday
    • 9.30am; 11.30am; 1pm; 4pm
    • 30min timeslots
    • In your email please include 3 preferred meeting dates / times so we can accommodate you
  • We look forward to meeting with you!

 How to submit your SSA

Documentation Required for Access to Medical Records in Research  

If you require access to patient medical records for your research project you will need sign off from the network manager of Health Information Unit (Nadine Ghassibe). Please Include Health Information Unit in Part C of your STE application. It is strongly recommended that you discuss your project with the supporting department Head/s prior to the submission of the application in REGIS.

SCHN Data Custodian/ Health Information Unit requires the below listed information to process the Health Information (Medical Records) HOD sign off in REGIS.

• Site Specific Application Reference number (STE)
• Is your research study for CHW or SCH data
• What kinds of data are you collecting
• How much data will you collect
• How will your data be stored
• Is it identifiable or de-identifiable
• Who can access the data

Once the project is finalised, how will your data be stored once completed and for how long

Reminders

• SCHN branded USBs should only be used for information sharing if required
  To obtain a SCHN branded USB contact the Health Information Unit
  Data as part of this project will not be reused without approval form the ethics and research committee

TGA changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical Trial Approval (CTA) scheme.

The change in terminology from CTX to CTA more accurately reflects the nature of the scheme under the Therapeutic Goods Act 1989, which involves sponsors applying for the TGA’s approval to supply unapproved therapeutic goods in Australia via a clinical trial despite the therapeutic goods not being entered in the Australian Register of Therapeutic Goods (ARTG). The scheme’s previous name of CTX underscored the exemption given by the TGA to a sponsor from entering their therapeutic good in the ARTG before conducting a clinical trial.

The TGA website has been updated to reflect the name change, and we are also asking our stakeholders to update their documentation to replace CTX with CTA. Read our news item to learn more.

2021-22 TGA Annual Charges - Important Information for Sponsors

Please find attached  2021-22 TGA Financial and Important Dates, a document containing the 3^rd round of communications in the lead up to end of financial year 2020-21. 

The document contains important information about upcoming Therapeutic Goods Administration (TGA) Annual Charges for financial year 2021-22, requirements for the annual charge exemption (ACE) scheme, reminders to review your ARTG entries and manufacturing licences, reminders about accessing the TGA Business Services (TBS) Portal, requirements for updating your billing details, notifications of changes of sponsorship, and information about how to deactivate your organisations TGA Business Services account if it is no longer required.

Please contact us at your earliest opportunity if you have any questions in relation to any of the matters contained within.

We will promptly respond to any relevant TBS Portal or annual charge billing matters. Enquiries about the ACE scheme should be sent directly to the ACE Team for their attention, and manufacturing licence enquires should be directed towards the Manufacturing Quality Branch.

Contact details for each of the afore-mentioned teams are set out below.

SCHN Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN)/Clinical Trial Authorisation (CTA) Details

SCHN Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN)/Clinical Trial Authorisation (CTA) Details

Good Clinical Practice (GCP) Resources

Good Clinical Practice (GCP) Resources

Fees

Additional forms

• RGO clinical trial start-up report
• CHW radiation safety report application form
• SCH radiation safety report application form
• SSA factsheet for department heads 
• REGIS head of department cheat sheet
• Research governance invoice authorisation form
• Research governance invoice authorisation form - Printed and scanned