OFFICE USE ONLY
Date Received
QA Number
Date Of Approval
QUALITY ASSURANCE CHECKLIST AND SITE SPECIFIC INFORMATION FORM
Date:
A. Routine Care Does the research project involve ANY of the following? (Tick all)
1.
Does the proposed QA activity seek to gather information about the patient beyond that collected in
routine clinical care? Note: Information may include observations, blood samples, additional investigations,etc.
2.
Does the proposed QA activity pose any risk for patients beyond those of their routine care? Note: Risks
include not only physical risks but also psychological, spiritual and social harm or distress. (e.g. stigmatisation or
discrimination)
Does the proposed QA activity impose a burden on patients beyond that experienced in their routine
care? Note: Burdens may include intrusiveness, discomfort, inconvenience or embarrassment e.g. persistent
phone calls, additional hospital visits or lengthy questionnaires.
Does the proposed QA activity involve any clinically significant departure from the routine care provided
to the patients? Note: Prospective studies comparing “standard of care” require ethical review.
3.
4.
B. Privacy Does the research project involve ANY of the following? (Tick all)
1.
Is the proposed quality assurance activity to be conducted by a person who does not normally have
access to the patient’s records for clinical care or a directly related secondary purpose? (e.g.
Practitioners or Health Information Staff)
2.
Does the proposed QA activity risk breaching the confidentiality of any individual’s personal
information, beyond that experienced in the provision of routine care? Note: A QA activity that requires a
letter, fax or email to a patient that includes sensitive health information could lead to a breach of confidentiality,
if the communication is read by someone other than the proposed recipient.
3.
Does your proposed QA activity involve the collection and use of identifiable data? Note: QA projects
must collected and use non-identifiable or de-identified data.
4.
Does your proposed QA activity involve a waiver of consent to use patient data for a purpose other than
the primary purpose for which the data was collected? Note: A QA project cannot use personal information
about an individual for a purpose unrelated to the primary purpose of collection (e.g. using data without the
consent of the participant for the purpose of quality assurance is a related activity however using the same data
for the purpose of research is unrelated and requires ethical review).
5.
Does the proposed QA activity potentially infringe the rights, privacy or professional reputations of
carers, health care providers or institutions? Note: These issues should be considered by management and
may have legal implications.
YES
NO
YES
NO
YES
NO
C. Project Design Does the research project involve ANY of the following? (Tick all)
1.
Does the proposed QA Activity involve a retrospective review of data extracted from medical records?
2.
3.
Does the proposed QA Activity involve a review of a databank/base?
Does the proposed QA Activity involve a prospective audit of routine clinical care?
Only complete section D, if you answered no to all questions in Section C.
D.Consent Does the research project involve ANY of the following? (Tick all)
1.
2.
YES
NO
Does your proposed QA activity include participants who are unable to consent for themselves?
Does your proposed QA activity involve collecting data prospectively from participants unable to
consent? E.g. Children; Pregnant women; People with a cognitive impairment, an intellectual disability or a
mental illness
Please do not complete this form if you answered YES to any item in sections A, B or D above, as your
project is likely to be beyond the scope of quality assurance/improvement and may require ethical review by
the Western Health Low Risk Ethics Panel (WH LREP) or the Melbourne Health Human Research Ethics
Committee (HREC). Please refer to the Western Health Office for Research website regarding submission for
research projects.
If you are unsure about how to respond to any item on the checklist, contact the Office for Research.
WH Quality Assurance Checklist September 2015
Page 1 of 7
SITE SPECIFIC INFORMATION AND RESEARCHER DECLARATIONS
This form is to be used only for projects suitable for Quality Assurance and Quality Improvement
Please refer to the Office for Research for guidelines, templates etc. The Office for Research may be contacted
on (03) 83958073 or via email ethics@wh.org.au if assistance is required.
Please Submit: One electronic copy to ethics@wh.org.au and one signed hardcopy original of all relevant
project documents to the Office for Research.
Note: The Western Health CV Template and The Statement of Approval template are included with this form.
Section 1: Project Details and Departments Involved
1.1 Full Project title
1.2 List all Western Health sites at which this
research project will be undertaken
1.3 How many patient records or participants
are required? (Or tick NA if applicable)
Footscray
Sunshine
Williamstown
Sunbury
Other:
Number of Records to be accessed:
or NA
Number of Participants to be recruited:
or NA
1.4 Hospital/network services required for this research project
List all Western Health Departments involved or accessed with this QA Project. Please provide Signed
Statements of Approval for each supporting service department. (Form attached).
Note: Approval from Health Information Services is not required unless you are retrieving hard copy Medical
Records for presentations prior to 24 November 2011. If you do not already have access to BOSSNET then you
will need to seek approval from Health Information Services.
Indicate (please tick) which hospital services will be required (including host department) to undertake this
research:
Emergency, Medicine and Cancer Services
Acute Ambulatory Care
Addiction Medicine
Dermatology
Endocrinology & Diabetes
Emergency Medicine
Gastroenterology
General Medicine
Geriatric Medicine
Haematology
Hospital In The Home
Immunology
Infection Disease
Medical Oncology
Medical Staff
Nephrology
Neurology
Renal Dialysis
Respiratory and Sleep Disorders
Rheumatology
Palliative Care
Stroke Service
Women’s and Children’s Services
Maternity Services
Maternal Fetal Medicine
Obstetrics and Gynaecology
Paediatric
Special Care Nursery
Allied Health
Aboriginal Liaison Service
Audiology
Language Services
Nutrition and Dietetics
Perioperative and Critical Care Services
Anaesthetics and Pain Management
Cardiology
Colorectal and General Surgery
General, Breast and Endocrine Surgery
Intensive Care Services
Neurosurgery
Ophthalmology
Orthopaedic Surgery
Otolaryngology, Head, Neck Surgery
Paediatric Surgery
Plastic, Reconstructive and Facio Maxillary Surgery
Thoracic Surgery
Upper Gastro Intestinal and General Surgery
Urology Surgery
Vascular Surgery
Subacute and Aged care Services
Aged and Complex Care Access Service
Best Care for Older People Program
Geriatric Evaluation and Management
Rehabilitation
Palliative Care
Care Coordination
Aged Care Assessment Service
Immediate Response Services
Hospital Admission Risk Program
Drug and Health Services
Youth and Family Services
Adult and specialist Services
Community Residential Withdrawal Services
Community & Ambulatory Care Services
Aboriginal Health, Policy and Planning
Cognition, Dementia and Memory Services
Community Based Rehabilitation
WH Quality Assurance Checklist and Site Specific Form August 2015
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Occupational Therapy
Pastoral Care
Physiotherapy
Podiatry
Psychology
Social Work
Speech Pathology
Clinical Support and Specialist Clinical Services
Bone Density Unit
Health Information Services/Medical Records
Medical Imaging*
Nursing Services
Pathology*
Pharmacy
Community Transition Care Program
Continence Clinic
Falls Clinic
GP Integration Unit
Parkinson’s Disease Unit
Post Acute Care Program
Other
*these departments have their own forms
1.4 Anticipated start dates for commencement of data collection and the finish dates for the QA/QI project
Start date
(dd/mm/yyyy):
Finish date
(dd/mm/yyyy):
Duration
(Months):
Section 2: Investigators
Instructions:
 Please note at least one Western Health staff member must be listed as an Investigator and the
Principal Investigator must be a senior member of staff or have the relevant research experience to
take on the responsibility for ongoing data storage.
 Non-Western Health investigators need to submit an honorary researcher application form
Investigator Details: (Click on ‘Select Position’ to use drop down list for investigator position as applicable)
Select Position (Click here)
Select Position (Click here)
Title and First Name
Title and First Name
Surname
Surname
Address
Address
Email
Email
Phone (BH)
Phone (BH)
Mobile
Mobile
Affiliation
Affiliation
Role
Role
Select Position (Click here)
Select Position (Click here)
Title and First Name
Title and First Name
Surname
Surname
Address
Address
Email
Email
Phone (BH)
Phone (BH)
Mobile
Mobile
Affiliation
Affiliation
Role
Role
If more investigators are involved, please list all investigators using similar format above:
Section 3: Project Information and Protocol
3.1 Name any external organisations involved in this project and explain the nature of their involvement.
Will any data or results be provided to an external organisation?
3.2 Will Western Health incur any expenses in undertaking this QA project? If Yes, give
details.
WH Quality Assurance Checklist and Site Specific Form August 2015
Yes
No
Yes
No
Page 3 of 7
3.3 A Research Protocol must be submitted with this form.
The Protocol is to include a Version Number and Date in the footer or header, and the names and roles of the
personnel involved along with the following key information:
1. Relevant background information and literature review
2. Aim of the project
3. The problem, procedure, or practice being assessed
4. An outline of the likely benefits of conducting the QA project
5. The method of data attainment (study design, ascertainment, inclusion/exclusion criteria, timing and
duration of study, data collection and Identification)
6. Consent
7. Permanent Database
8. Data Storage
9. Statistical Analysis
10. Dissemination of results
If preferred researchers can use the Western Health Protocol Template available on our intranet or internet.
Section 4: Declarations
4.1 Declaration by Principal Investigator/s and Associate Investigators
1. I declare the information in this form is truthful and accurate to the best of my knowledge and belief
and I take full responsibility at this site.
2.
I will only start this research project after obtaining approval from the Western Health Low Risk
Human Research Ethics Panel (WHLREP) and authorisation from the Western Health Office for
Research;
3.
I accept responsibility for the conduct of this research project according to the principles of the
NHMRC National Statement on Ethical Conduct in Research and abide by the Western Health
Researcher’s Code of Conduct (2012).
4.
I undertake to conduct this research project in accordance with the protocols and procedures as
approved by the WH LREP and the ethical and research arrangements of the organisation(s) involved.
5.
I undertake to conduct this research in accordance with relevant legislation and regulations.
6.
I will adhere to the conditions of approval stipulated by the WHLREP and will cooperate with WHLREP
post approval monitoring requirements for reporting unexpected events and submission of annual
reports.
7.
I will inform the WHLREP and the research governance officer if the research project ceases before
the expected date. I will discontinue the research if the WHLREP withdraws ethical approval.
8.
I understand and agree that study files and documents and research records and data may be subject
to inspection by the WH LREP, research governance officer, the sponsor or an independent body for
audit and monitoring purposes.
9.
I understand that information relating to this research, and about me as a researcher, will be held by
the WHLREP, research governance officer, and on the Research Ethics Database (RED). This
information will be used for reporting purposes and managed according to the principles established
in the Privacy Act 1988 (Cth) and relevant laws in the States and Territories of Australia.
Name of Principal Investigator:
Signature:
Date: ___________________
Name of Associate Investigator:
Signature:
Date: ___________________
Insert more names, signatures and date using similar format above for all investigators:
WH Quality Assurance Checklist and Site Specific Form August 2015
Page 4 of 7
4.2 Declaration by Head of Department *(or Divisional Director or other authority) where the Principal
Investigator will do the research





I certify that I have read the research project application named above.
I certify that I have discussed this research project and the resource implications for this Department,
with the Principal Investigator.
I certify that all researchers/students from my Department involved in the research project have the
skills, training and experience necessary to undertake their role.
I certify that there are suitable and adequate facilities and resources for the research project to be
conducted at this site.
My signature indicates that I support this research project being carried out using such resources.
Signature:
Date: ___________________
Name of Department Head (Signatory name):
Name of Department:
Note: The Head of Department does not need to complete a separate statement of approval form if this section is signed.
*Where the investigator is also the head of department certification must be sort from the person to whom the head of
department is responsible. Investigators must not approve their own research on behalf of their own department.
Section 5: Pre- Submission Checklist of Documents Required
All items on list must be included in the submission. Please tick boxes indicating they have been attached.
1. Study Protocol (with version and date)
YES
NO*
YES
NO*
YES
NO*
NA
YES
NO*
NA
YES
NO*
NA
YES
NO*
7. A signed Western Health CV Form for all new Researchers
YES
NO*
8. The Department Head of the Principal Investigator has signed the
declaration page of this form
YES
NO*
9. The declarations section of this form is signed by all relevant personnel
YES
NO*
2. Evidence of support from the Managers of any other departments that will
be involved in the project. (A signed statement of approval form or an
email from the Manager to the Investigator must be included in this
application)
3. A copy of the Patient Information and Consent Form or Patient Information
Sheet, if one is going to be used.
4. A copy of any letters, telephone scripts, surveys etc. that will be used in the
project
5. A copy of the paper data collection form (with version and date) if one is to
be used
6. A copy of the database with fields for data entry. (e.g. excel/access
spreadsheet) including an example of a master re-identifier list if the data
collected will be re-identifiable
*Please explain why this item has not been attended:
For more information, please refer to the following documents:


Western Health Researcher’s Code of Conduct 2012
http://www.nhmrc.gov.au/guidelines/publications
o The Australian Code for the Responsible Conduct of Research 2007
o The National Statement on Ethical Conduct in Human Research 2007
WH Quality Assurance Checklist and Site Specific Form August 2015
Page 5 of 7
WESTERN HEALTH – Office for Research
(Please provide a separate Statement of Approval Form for all departments involved or accessed.)
STATEMENT OF APPROVAL FORM
If the project is to be undertaken in the same department at more than one site, complete a separate
form for relevant departments at each site.
Service Department:
Project No:
Expected Commencement Date:
Short title of project:
Principal Researcher:
I have discussed this study with the Principal Researcher having seen the application and protocol and
I am:
Able to do the investigations indicated with the present resources of the
(insert name of Service Department)* and/or support the conduct of this project.
Unable to do the investigations within the present resources of the Department but would
be willing to undertake them with financial assistance for:
Staff
Equipment
Maintenance
Other (Please specify below)
Comment (Please specify nature of assistance and estimated costs)
Service Department Cost Centre to be Credited:
Charges - select one
option only
1.
2.
Charge to Western Health cost centre
Provide Billing details below
Contact name:
Company name:
Billing address :
or
I am unable to undertake the investigations on the following grounds:
Signature (Head of Department)
Date:
(Note: If the Principal Investigator is also the Head of Department, sign off should be obtained from the next line of reporting
e.g. Divisional Director/ Clinical Director)
I have discussed this project with (insert name of Department Head) and appropriate
arrangements have been made for this service/department to assist with this project as outlined
above.
Signature (Principal Investigator)
Date:
*If applying for Cardiology, Radiology or Nuclear Medicine Services – please complete below
I agree to provide the following department a list of study patients in this trial within 7
days at the end of each month:
Cardiology
Radiology
Nuclear Medicine
WH Quality Assurance Checklist and Site Specific Form August 2015
Page 6 of 7
Based on WH CV Template Aug 13
Western Health Investigator Curriculum Vitae
Title, First and Family Name:
Present appointment:
(Job Title, Department)
Address:
Full work address including postcode
Qualifications:
Degree and other professional
qualifications
( relevant qualifications, or specify)
AHPRA Registration number:
(or equivalent)
Previous appointments/
Experience:
(Include only relevant therapeutic/
practical experience after gaining
qualifications)
Publications: (
appropriate box)
(Number of articles published)
Previous research experience:
Clinical Trial Research – Drug/Device
Clinical Research – non-drug
Health and Social Science
Quality Assurance/Improvement
Other – please specify:
Training: (accredited courses)
Please provide evidence of training i.e.
certificates
PhD
Other:
0
MBBS
1-2
MSc
3-5
BN
6-10
BSc
11-20
›20
Protocol design
Recruitment
Consent
Data collection
Data management
Trial procedures
Other - please describe
below:
GCP
Research Ethics
Research Conduct
No Training
Other - please describe
below:
List all HREC projects that you held or
currently hold the role of investigator
(Principal and/or Associate):
I,
have read and agree to comply with the Western Health Researcher’s Code of Conduct [2012].
Signature
WH Quality Assurance Checklist and Site Specific Form August 2015
Date
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