It is the aim of the Office for Research to encourage and facilitate the approval and conduct of Quality Assurance (QA) projects at Western Health. QA projects are essentially an evaluation or monitoring of a current service or practice with the aim of improving that service or practice. They may also be audits to identify and/or quantify the extent of a problem, practice or behaviour to gain knowledge that may then be used to improve a service or practice. Projects that seek to gain knowledge from monitoring and evaluating the introduction of a new practice/procedure may also fit the criteria of quality assurance.
If you would like advice regarding the process for submission of a QA Application, or would like guidance to complete the documents, please contact Mrs Kerrie Russell (03) 8395 8074 or Mr Bill Karanatsios (03) 8395 8073 at the Office for Research [email protected].
It is best that you make contact with the Office for Research prior to submission if you are not sure of the process or are new to Research and QA submissions.
Please ensure you are familiar with the WH Standard Operating Procedures - Good Clinical Practice (WH SOP-GCP) for research. The WH Office for Research may conduct an audit at any time.
All applications will only be accepted by the Office for Research as one complete package. Do not try to submit your application in multiple separate parts.
This instruction applies to all applications, including those for commercially sponsored clinical trials.
Incomplete applications will not be accepted and will be returned to the principal investigator and study contact without being reviewed.
Why are we enforcing this instruction?
Receiving a complete application in one package allows that application to be reviewed once, as opposed to multiple times. This promotes efficiency and will allow the Office for Research team to provide a more timely and comprehensive service to all of our researchers and research partners.
BRIEF SUMMARY OF MANDATORY DOCUMENTS FOR ALL NEW QA APPLICATIONSSee QA Process Map Overview QA Process Map Overview Aug15.pdf
1. QA Checklist and Site Specific Form – to be signed by study investigators and Head of Department.
2. Statement of Approval Form for supporting services/departments.
3. Study Protocol.
4. Western Health Researcher Curriculum Vitae. All PIs must also provide a current certificate of completion for ICH-GCP training (within 3 years).
5. A Data Collection Form and/or copy of database spreadsheet for data entry designed by researchers. (excel spreadsheets to be submitted electronically only. Do not provide hardcopy of excel spreadsheets)
6. Application Fee of $100 exl GST– Compliant Tax Invoice.
7. Log into Ethics Review Manager (ERM) website and submit QA application with all attached documents to Western Health.
The following will depend on the nature of your project only provide, if applicable:
1. Western Health Participant Information and Consent Form.
2. Databank Registration Form.
3. Letters of Invitation, Surveys, Questionnaires, Transcripts etc.
4. Western Health Honorary Appointment Form (Include Police Record Check Form & immunisation form)
5. Approval to Examine Records for the Purpose of Research Form.
Please see the detailed QA submission guide for further information if required. (This document will be available shortly).
A Western Health employee should be nominated as an Associate Researcher in ALL projects undertaken at Western Health.
If this is an externally initiated project, a Western Health employee should be inovled in the project and should be listed at the very least, as an associate researcher and must:
Please download forms on right hand side links
Please contact the Office for Research if unsure of anything:Email: [email protected]au
Telephone: 03 8395 8074
QA Applications can be submitted at any time. They are reviewed by the staff of the Office for Research and a member of the Western Health Low Risk Ethics Panel. When approval is granted the application is then ratified at the next monthly meeting of the Western Health Low Risk Ethics Panel. The Western Health Low Risk Panel reserves the right for Panel members to escalate a QA Application to a full review by the Panel at the next available Low Risk Meeting.
Applicants must submit electronically onto ERM, email a set of documents to [email protected] & provide hardcopy submission to be reviewed.
Please DO NOT combine documents into one PDF, project will not be processed if submitted in this manner. Ensure that the subject line of the email indicates clearly that the email contains a new QA application for review.
Mandatory Electronic file name convention:
To ensure the electronic copies submitted are easily identifiable, the format outlined below must be used for all electronic files. As shown in example below, include version numbers and dates in the file name.
Projects submitted with documents that do not follow the below naming convention/format will not be considered and will be returned via email to sender.
Convention: [ERM Project ID] [Document Name] [version number] [Date DDMMMYY]
E.g. 41234 QA Application Checklist 01Jan19; 41234 Protocol v1 01Jan19; 41234 Data Collection Sheet v1 01Dec18.
A hard copy of the submission documents must also be sent to the Office for Research.
There are a number of ways to do this.
1. Hand Deliver the hard copy documents to the Office for Research if you are located at Sunshine Hospital to either the Office located on Level 3. Western Health Centre for Health Research & Education – Sunshine Hospital, 176 Furlong Road, St Albans VIC 3021
2. Deliver to the Office for Research Drop Box which is located in the Ground Level Staircase (right of the elevators) of the Western Health Centre for Health Research & Education Building, Sunshine Hospital, 176 Furlong Road, St Albans VIC 3021.
Please note that this box will be checked once a day.
3. Post via Internal Mail Service or Australia Post addressed to Manager, Office for Research, Level 3, Western Health Centre for Health Research & Education, Sunshine Hospital, 176 Furlong Road, St Albans VIC 3021.
1. An email notifying you that the application has been received and allocated a reference number. If the documents submitted are not satisfactory or there are any other further requirements you will be advised in this email. Once any matters are addressed the application will be sent to a reviewer and the reviewer is given 2 weeks to review the application.
2. An email advising you of the review outcome. It will indicate whether the project has been approved unconditionally or if there are any revisions or additional information required. Researchers are given 2 weeks to provide their response.
3. Researcher responses are reviewed by the Office for Research and if necessary forwarded to the reviewer for further comment or clarification.
4. Researchers are notified by email of their project Approval and will also be provided with a formal QA Approval letter for their records.