Committed to Research

The menu items below contain the information and forms you will need for initial submission, post-approval, and reporting activities related to your Research Governance application.

If you have any questions please contact the Research Office at 88909007 or
[email protected]



Preparing and submitting your governance application

  1. Governance Submission Cover letter
  2. RO-008-Guide to Preparing your Governance Application
  3. RO-006-Guide to Declarations of Support
  4. RO-007-Guide to Access Request

PLEASE NOTE: If your study is multicentre, please provide the ethically approved Master documents and the site documents based on the approved master with your Site application.

 

Eligibility Criteria for New Governance Submissions

If any of the following criteria are not met, the submission will be marked ineligible and returned to you.
  • Cover letter – RGO submission cover letter
  • Staff link numbers for all investigators (if all team members complete their profile in REGIS this information will pull through when they are added to any project)
  • Fee transfer or invoice form - (if required, please see the fee policy)
  • Participant Information and Consent Forms
  • Single Site
    • correct complaints contact
    • clinical contact must be the Principal Investigator
    • page numbering and footer correctly formatted
  • Multicentre
    • Correctly tracked from the HREC approved Master/s – including correct referencing to the Master in the footer.

Complaints Contacts
  • Patients Westmead and Auburn Hospitals
    Patient Experience Unit
    Telephone: 02 88907014
    Email: [email protected]

  • Patients Blacktown Mt Druitt Hospital
    Office of the General Manager, Blacktown-Mt Druitt Hospitals
    Telephone: 02 9881 8000 (Blacktown Hospital switchboard) and ask to be connected to the Office of the General Manager
    Email: [email protected]

  • Non-patients and Staff
    WSLHD Research Governance Office
    Telephone: 02 88909007
    Email: [email protected]

  • Mental Health Patients
    Mental Health Patient Liaison Officer
    Telephone: 02 9840 3000

 

Contracts and Agreement

TGA Submissions

Amendments

Any changes made to an approved project must receive ethics approval and governance authorisation. Regardless of the size of the change, it cannot be incorporated into the project until it is approved.

  1. RO-GUIDE - Submission of a Governance Amendment - February 2024

Amendments are submitted in REGIS, using the “Forms” tab on the STE. There are several forms available, please choose the one that describes your requested change:
  • Reporting Local Safety Events to the Institution
  • Site Amendment
    • Addition of a new site
    • CPI Change Notification
    • PI Change Notification
    • Extension of HREC approval notification
    • Change site investigators or site administration contacts
    • Change to contracts
  • General

Amendments will not be accepted if annual reports are not up to date.

 

 

Release of Unit Record Data

The conditions for the release of data from the WSLHD are described in PD2018_001 Disclosure of unit record data by Local Health Districts for research or contractor services.  This policy is currently under review by the Ministry.  Until a revised policy is released the PD2018_001 will remain in effect within WSLHD.
If your project requires the release of data, please contact the research office for assistance.

 

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