Research

Audit or Quality Improvement Submission

An audit is defined as an activity involving a prospective or retrospective review of information that has been or will be collected for clinical purposes (e.g. a review of a medical record). 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.

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 previous 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 DOES NOT involve the collection of new raw data (other than information that would ordinarily be collected as part of patient management) from a patient either in person, through a survey/questionnaire nor can it be instigated by an external person.

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.

 

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 then the project will be granted ethics approval, investigators will be notified of the outcome via email.  

Projects approved under this process will have approval for a one-year period with the opportunity of request an extension of ethical approval.  

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 HREC 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. 

HREC review of audits under this process will only take place if the audit has not yet been conducted (ie prospective approval).  The HREC will not grant approval for a project that has already been conducted (ie retrospective approval). 

 Submitting your Audit Application

1. Prepare a hard 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 ONLY of your audit application to ethics@austin.org.au - Please tilte 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.

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

FORMS: Audit or Quality Improvement Submission

Audit Package

·       Audit or Quality Improvement Application Form

If Applicable:

·       Research Agreement

·       Protocol

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