The Royal Melbourne Hospital Research Foundation

WESTERN HEALTH LREP SITE SPECIFIC FORM

1. Indicate the sites1 from which research participants will be recruited: Site Department Number of Participants

Footscray Hospital

Sunshine Hospital

Williamstown Hospital

Sunbury Day Hospital

Drug and Alcohol Services

Hazeldean Transition Care

Reg Geary House

2. Hospital/network services required for this research project: Indicate (please tick) which hospital services will be required (including host department) to undertake this research: Emergency, Medicine and Cancer Services Perioperative and Critical Care Services Acute Ambulatory Care Anaesthetics and Pain Management Addition Medicine Cardialogy Dermatology Colorectal and General Surgery Endocrinology & Diabetes General, Breast and Endocrine Surgery Emergency Medicine Intensive Care Services Gastroenterology Neurosurgery General Medicine Ophthalmology Geriatric Medicine Orthopaedic Surgery Haematology Otolaryngology, Head, Neck Surgery Hospital In The Home Paediatric Surgery Immunology Plastic, Reconstructive and Facio Maxillary Surgery Infection Disease Thoracic Surgery Medical Oncology Upper Gastro Intestinal and General Surgery Medical Staff Urology Surgery Nephrology Vascular Surgery Neurology Subacute and Aged care Services Renal Dialysis Aged and Complex Care Access Service Respiratory and Sleep Disorders Best Care for Older People Program Rheumatology Geriatric Evaluation and Management Palliative Care Rehabilitation Stroke Service Palliative Care Women’s and Children’s Services Care Coordination Maternity Services Aged Care Assessment Service Maternal Fetal Medicine Immediate Response Services

1 Sites where the Low Risk Ethics Committee will be responsible for the research participants

Western Health Site Specific Form Template Jan16 Page 1 of 4 WESTERN HEALTH LREP SITE SPECIFIC FORM Obstetrics and Gynaecology Hospital Admission Risk Program Paediatric Drug and Health Services Special Care Nursery Youth and Family Services Allied Health Adult and specialist Services Aboriginal Liaison Service Community Residential Withdrawal Services Audiology Community & Ambulatory Care Services Language Services Aboriginal Health, Policy and Planning Nutrition and Dietetics Cognition, Dementia and Memory Services Occupational Therapy Community Based Rehabilitation Pastoral Care Community Transition Care Program Physiotherapy Continence Clinic Podiatry Falls Clinic Psychology GP Integration Unit Social Work Parkinson’s Disease Unit Speech Pathology Post Acute Care Program Clinical Support and Specialist Clinical Other Services Bone Density Unit Health Information Services/Medical Records Medical Imaging2 Nursing Services Pathology2 Pharmacy

3. Statement of Approval forms  For each department ticked above, a separate Statement of Approval Form must be completed for every Service/Host Department involved in this research project. The Service Department Head and the Principal Researcher must sign each form.  Requirements for research projects should be discussed with service/department heads as required. Researchers must provide a copy of each signed and completed form to the relevant service/department for their records.  The above requirements also apply to research projects that are engaging Service Departments for procedures considered “Standard of Care”.  Medical Records/Health Info Services (HIS); Statement of Approval Form for HIS is only required if Physical Records are being retrieved. If researchers are collecting information from BOSSNET (electronic records) only, then a Statement of Approval is not required except when researchers are collecting patient data prior to 24 November 2011  2Medical Imaging & Pathology; please review additional information and requirements on the website as they require separate forms.

Western Health Site Specific Form Template Jan16 Page 2 of 4 Western Health – Office for Research

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 1. Charge to Western Health cost centre or option only 2. Provide Billing details below Contact name: Company name: Billing address :

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

SOA Last Updated March 2014 WESTERN HEALTH SPECIFIC FORM

SITE-SPECIFIC REQUIREMENTS CHECKLIST

Please check each of the following before you submit the application, otherwise approval may be delayed.

Include one copy of this checklist (completed and signed) with the original application.

Full project title

Forms Included YES NO NA

 Statement of Approval Forms for each department whose services are required

 Research Agreement

 Certificate of Insurance (for Clinical Trials)

 Indemnity for Clinical Trials

 Pathology Approval Application

 Approval to Examine Records for the Purposes of Research (for external monitors)

 RSO Safety Report for Research Involving Ionisation Radiation (to be appended to the Victorian Specific Module)

I confirm that this project does not require any other Western Health resources/services/departments not already declared on this form. If there are any amendments to the protocol that may impact any new or existing Western Health services, I will ensure that I will discuss them with the departments involved and complete a Statement of Approval to forward onto the Office for Research for acknowledgment. Principal/Associate Investigator Signature:

______Name: Date

Western Health Site Specific Form Template Jan16 Page 4 of 4