Quality assurance

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Quality assurance (QA) projects are an essential and integral part of improving the quality of healthcare service and delivery.

All QA applications must be submitted via the Ethical Review Manager (ERM) platform. 

All QA projects must be complete within two years of the date of approval in ERM. If the study is to continue beyond two years, a new QA project will need to be submitted.

Submitting for quality assurance

The Women’s endorses quality assurance activity that complies with the:

Quality Assurance VIC Form

Complete the Quality Assurance (QA VIC Form) for submission of these research applications in ERM:

  • Negligible Risk
  • Clinical Audit
  • Quality Assurance
  • Evaluation Activities
Upload documents

Upload the research proposal/description of the project including:

  • project title
  • investigators
  • QA questions
  • aims
  • methodology
  • sample size/number of records
  • questionnaires
  • outcomes
  • the curriculum vitaes (CV) of all investigators
  • data collection*

*The term “de-identified data” or “de-identified health information” should be avoided. Clarify whether:

  1. Data is non-identifiable and cannot be linked to an individual
  2. Data is re-identifiable, in which identifying information has been removed but the means still exist to re-identify the individual. Often, a unique study identifier may be utilised to control who can re-identify individuals.

The QA form should be signed by the Principal Investigator (PI) and relevant Head of Department (HoD).

What are the Principal Investigator's responsibilities?

Principal Investigators (PIs) at the Women's must:

  • have sufficient and appropriate education, training, experience and resourcing to undertake the PI role and manage the conduct of the study.

  • be thoroughly familiar with the research protocol.

  • be a paid employee of the Women's; unless compelling circumstances exist (eg: works on site but employed by an external organisation with an honorary appointment at the Women's), to demonstrate that the PI can fulfil their duties.

QA and EPIC Electronic Medical Record

All new projects that will run at the Women’s site must complete the REDCap survey for the project study build in EPIC-EMR: EPIC Pre-Submission Survey via REDCap

You will require your 5 or 6-digit ERM number to complete the survey. This number is generated by the ERM submission system - for example:


As part of your ethics submission in ERM you are required to include the email you received from the EMR EPIC Research Team as confirmation that the REDCap survey has been completed for your project.

QA and Clinical Informatics Assessment

All new projects must submit a clinical informatics assessment to assess the feasibility of obtaining data from EPIC-EMR.

As part of your ethics submission, you are required to include an acknowledgement email from Haustine Panganiban in Clinical Informatics Analyst Research.

If you have queries, please email Haustine Panganiban.

QA registration and length of project

The Research Office will acknowledge the QA project via ERM following assessment against QA criteria.

The study must be complete within two years of the date of approval in ERM.

If the study is to continue beyond two years, a new QA project will need to be submitted

Annual progress reports are not required for QA projects

QA projects will receive approval for RWH only.

Is my project quality assurance?

Sometimes it's difficult to determine whether a project is quality assurance or research. 

The ethical principles of integrity, respect for persons, beneficence and justice as set out in the National Statement on Ethical Conduct in Human Research 2018 also apply to QA.

The Women's staff conducting QA activity must consider a range of issues, including:

  • consent
  • privacy
  • relevant legislation
  • professional standard
  • whether ethical review is required.

Answer a series of questions to help determine whether your project fits the criteria for QA review.

For your project to be considered QA you must be able to answer ‘Yes’ to part 1 and 'No' to part 2.

Part 1

You must be able to answer YES to these statements for your project to be considered QA.

  • Does the project aim to use the outcomes to improve delivery of health care?
  • Does the project seek to identify and/or quantify problems within, or impediments to, good healthcare delivery and to identify ways of improving those problems?
  • Does the project seek to evaluate current health practices or to monitor the introduction of a new practice?

Part 2

You must also be able to answer NO to these statements for your project to be considered QA.

  • The project may cause more than discomfort.
  • The project involves more risk than just inconvenience (physical, psychological and information/privacy risks).
  • Could this project infringe on ethical principles that guide human research (merit and integrity of the project, justice, beneficence and respect)?
  • Written consent from the participants required.
  • The project could impact the reputation and/or privacy of researchers and/or the organisation.
  • The project involves targeted data analysis of minority or vulnerable groups.
  • The project involves secondary use of data - use of using data/analysis from QA activities for another purpose.
  • The project aims to generate new generalisable knowledge - that is, by testing a hypothesis, collect or use data, tissue and/or blood samples from patients, carers, or their relatives, and require written consent.
  • The project intends to gather new medical, health or sensitive information.
  • The project proposes activity that significantly deviates from standard practice.
  • The project involves comparison of cohorts, randomisation or the use of control groups or placebos.
  • A person would reasonably expect the project to be reviewed by the HREC.
  • Money will be received from, or paid to the Women's, by an external entity.
  • The project involves collaboration with a commercial entity.
  • The project will last more than two years.
  • The project collects data that will be transferred to an external organisation.

Is my project actually research?

If you answered 'No' to the part 1 statements and/or 'Yes' to the part 2 statements, your project is considered to be research and you will need to submit an ethics application.

Date reviewed: 24 June 2024

Date reviewed: 24 June 2024