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Research

Audit or Quality Improvement Projects

Please note Ethics Review Manager (ERM) submission is not required for Audit or Quality Improvement (QI) Applications at Austin Health. Please refer to the Audit/QI Application form below.

What is an Audit application?

An audit is defined as an activity instigated by an Austin Health principal investigator (audit activity applications for external investigators will not be accepted) involving a research hypothesis which includes the analysis of data from previously collected patient information with an intention to publish or otherwise present the data beyond the staff of the hospital.

Audits are generally retrospective reviews; however, prospective audits can be conducted in certain circumstances.

An audit activity does not involve:

 ·   the collection of new raw data (other than information that would ordinarily be collected as part of patient management / standard of care) from a patient either in person, through a survey/questionnaire; and 

·  activity instigated by an external person.

FORMS: Audit Submission

Audit Package

·       Audit Application Form

·       Data Collection Tool

·       Data Linking Document

 

If Applicable:

·       Research Agreement

·       Protocol

 

If you are unable to open any of these links in Internet Explorer, please try an alternative browser eg: FireFox or Google Chrome

Process of Review

The Office for Research will review each application and ensure that it is indeed an audit. If this confirmation takes place and all other relevant information has been provided, the project can be granted with ethics approval. Investigators will be notified of the outcome via email.  

The costs associated with administering this process will be covered by the institution to encourage and support audits at Austin Health.

Projects approved under this process will still be required to fulfil monitoring requirements. At a minimum, the Office for Research will require submission of a final report at the completion of the audit. If the audit has been approved to continue for longer than 12 months then an annual report and a final report is required. 

The review of audits under this process will only take place if the audit has not yet been conducted (i.e. prospective approval). Approval will not be granted for a project that has already been conducted (i.e. retrospective approval).

Audit/QI Amendment

An amendment application will be required if investigators wish to change any aspect of the approved project.

FORMS: Amendment Request

·       Amendment Form

·       Updated document (e.g. PICF, Protocol, etc.) with updated version numbers & dates – Tracked & Clean

(Tracked documents should include all additions and changes to the text and strike through any deleted original text and highlight in bold or by underline any new text. Please use the 'Track Changes' option in MS WORD)

 

If Applicable:

·       Change of Research Personnel Form

·       Austin Health Investigator Curriculum Vitae

 

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Submitting an Amendment

 

1. Prepare an electronic copy of your amendment with original signatures (this original signed document should be retained by the Principal Investigator in their study file for the required storage period).

2. Email a scanned electronic copy of your amendment to ethics@austin.org.au - Please title the email '[Project reference number] Amendment Request'.

Progress Reports/Final Reports - AUDITS ONLY

Progress Reports

Ongoing ethical approval is contingent on receipt of a progress report annually. Failure to submit an annual progress report may lead to suspension of ethical approval.

A Progress/Annual Report for each project must be submitted to the Office for Research each year. Please email a copy of your completed report to ProgressReports@austin.org.au. Annual Reports are due by the approval anniversary date of each study.

[Please title the subject of the email "Progress/Final Report for [Austin Health Project Number]”

 

Final Reports

Once a project has been completed, a final report must be submitted to the Office for Research summarising the project findings/outcomes and any unexpected developments. If available, inclusion of a published manuscript with this report is encouraged.

Please email a copy of your completed report to ProgressReports@austin.org.au.

[Please title the subject of the email "Progress/Final Report for [Austin Health Project Number]”

For immediate confirmation that your email has reached us, set up an automated 'Delivery Receipt Notification' before you send your email.

 

Progress/Final Report

·       Project Report Form

·       Project Final Report Form

 

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What is a Quality Improvement (QI) Activity?

Quality Improvement (QI) is an organised process that evaluates, assesses and seeks to improve health service delivery to improve patient and population outcomes and health service efficiency. It is also known as Quality Assurance. QI activities often involve the collection, use and disclosure of health, personal and sensitive information for the purpose of funding, management, planning, monitoring, improvement or evaluation of health services. Common QI activities include sentinel event monitoring, incident monitoring, root cause analysis, medical record review, and clinical audit. QI activities may include activities involving staff, patients or members of the community.

All QI projects must be registered with RiskmanQ, you will be required to provide a RiskmanQ registration number as part of your application. Please refer to the Austin Health guidelines on how to enter a RiskmanQ activity.

 

FORMS: Quality Improvement Submission

Quality Improvement Package

·       Quality Improvement Application Form

 

If Applicable:

·       PICF for QI Projects

·       Information Statement

·       Verbal Script for Project Introduction and Consenting

·       Telephone Script

·       Research Agreement

·       Protocol

·       Data Collection Tool

·       Data Linking Document

 

If you are unable to open any of these links in Internet Explorer, please try an alternative browser eg: FireFox or Google Chrome

 

Submitting your Audit/QI Application

 

1. Prepare an electronic copy of your audit application with original signatures of all investigators & head of department (this original signed document should be retained by the Principal Investigator in their study file for the required storage period) and if applicable a Research Agreement.

2. Email a scanned electronic copy of your audit application to ethics@austin.org.au - Please title the email 'Audit Application - [insert project title]'

Please note Audit Applications are reviewed out-of-session; therefore, they are not required to be booked into a meeting.