Section 1: Mandatory components for all SSA submissions

1a. Obtain a local project number and Evaluation Tool template 

Local Project Number

If the RMH was the reviewing HREC for your project, you will already have this number. This is the same number as the RMH HREC project number (that is, 2022.999).

For Research Governance only submissions, click and complete the following email template: research@mh.org.au to request a project number.

For commercially sponsored clinical trials, ensure that you obtain this number immediately on confirmation of site selection by the sponsor.

Label Site Specific Assessment (SSA) documents and correspondence with the RMH Local Project Number and the EPIC EMR number. Using these numbers will assist our office to track, review and file your project documents.

Evaluation Tool Template

Along with your Local Project Number, the OfR will send you the Evaluation Tool Template. This is a spreadsheet that must be completed and lodged with each SSA submission. It is an RMH internal review tool that summarises and confirms information that reviewers require. The Evaluation Tool Template takes less than 30 minutes to complete.

After a six-month pilot phase, the OfR confirmed the Evaluation Tool saved assessors and applicants a great deal of time during the review and query process.

ERM / EMR – What's the difference?

ERM is the Ethics Research Management platform used to create the HREA and SSA forms.

EMR is the RMH's Electronic Medical Record (also called EPIC EMR)

The EPIC EMR number uses the five-digit number within the ERM code given during the creation of the ethics HREA or SSA form as your EPIC EMR number. Confused? See example below:

1b. Victorian SSA form

The Victorian SSA form describes the activities, resourcing and research team members at the RMH site only.

1. Create a Victorian Site Specific Assessment (SSA) Form in Ethics Review Manager (ERM).
   • Include all RMH members of the study team and any persons from another site that will attend the RMH to undertake study activities. Persons from another site that attend the RMH to undertake study activities may require an honorary appointment.
   • Do not list researchers from other sites who will not attend RMH to undertake research activities.
2. All members of the study team must have sufficient and appropriate education, training, experience and resourcing to undertake their role on the study.
   • Gather CVs and GCP certificates for each study team member in the application.
3. Obtain e-signatures of all RMH researchers on the appropriate researcher declaration (PI or AI).
4. Obtain e-signatures on the Head of Department declaration from the RMH Head in the department where the Principal Investigator works.
   • Note: where the Head of Department is also a researcher on the study, the SSA for must be signed by the person to whom the Head of Department reports.
5. Submit the application within the ERM platform and download a copy of the form to submit in the email submission.
6. Submit study team CVs and GCP certificates for each study team member in the application in the email submission.

Coordinating Principal Investigator (CPI) and Principal Investigator (PI) Guidance

The RMH CPI and PI must:

• Have sufficient and appropriate education, training, experience and resourcing to undertake the CPI/PI role and manage the conduct of the study.
• Be a paid employee of the RMH.

The responsibilities of the Coordinating Principal Investigator (CPI), Principal Investigator (PI) and sponsor are summarised in the document Roles and Responsibilities in a Research Project, which can be downloaded from the state government's Coordinating Office website. In summary:

• Roles in single-site research project: For a single-site project, the Principal Investigator (PI) has overall responsibility for the ethics application and conduct of the research project.
• Roles in multi-site research project: For a multi-site project, the Coordinating Principal Investigator (CPI) has overall responsibility for the ethics application and conduct of the research project. Each site has its own Principal Investigator (PI) who is responsible for the site’s SSA application and conduct of the research project at that site.
• In all instances, the Principal Investigator at RMH must be a paid employee of the RMH.

For investigators in states other than Victoria and Queensland

Instructions for investigators on how to create an SSA form for jurisdictions that do not use ERM can be found on Coordinating Office website.

Help and support

For help using ERM, download a copy of the Applicant User Guide to ERM available on the Coordinating Office website.

Contact the Coordinating Office for Clinical Trial Research

• Phone: 0408 274 054: General enquiries and ERM application advice
• Phone: 0408 410 938: Enquiries and ERM for Research Office administrators
• multisite.ethics@ecodev.vic.gov.au
• 9am – 5pm AET, Monday – Friday

ERM technical support

• Infonetica Helpdesk
• (02) 9037 8404
• helpdesk@infonetica.net
• 9am – 5pm AET, Monday – Friday

1c. Statement of Approval forms and Departmental forms

Statement of Approval form

Complete a Statement of Approval (SOA) for per each RMH service or department. Ensure that each SOA form is signed by the Head of Department/Unit before Governance submission. See points of contact in the table below for the most commonly used services.

Statement of approval (30KB - docx document)

NTCP statement of approval (47KB - docx document)

RMH departmental requirements and Melbourne Private

In addition to submitting SoAs, the following departments require additional information. Please complete all as they apply to your project.

• Pathology: Visit Pathology Clinical Trials for instructions
• Clinical Engineering: Email clinicalengineering@mh.org.au for necessary forms
• Melbourne Private Hospital: Contact the Melbourne Private Hospital Research Governance Officer directly to determine specific requirements

New Technology and Clinical Practice (NTCP) Committee

RMH has introduced the NTCP SOA for all new device and/or surgery trials. The SOA provides evidence of approval for operational considerations relating to new technology and procedures.
This process removes duplication of review by the RMH HREC and the NTCP Committee while ensuring appropriate oversight and approval for RMH operational considerations.

RMH staff can access further information on the New Technology and Clinical Practice Committee via the RMH intranet.

NTCP statement of approval (47KB - docx document)

1d. Budget

All research projects using RMH facilities and resources requires a budget review. A budget forms part of the Site Specific Application.

Instructions on how to request a budget review from RMH Research Finance are available here: Budget reviews for site specific assessment.

1e. RMH Participant Information and Consent Forms (PICFs)

Where Master versions of consent forms were approved in the ethics application, complete site specific Participant Information and Consent Form (PICFs) for the RMH (including mental health).

• Create the site documents from the final Master document templates approved by the reviewing HREC – update only the RMH specific information.
• Ensure the footer of site specific document references the final HREC approved Master version and add the RMH site version number and date.
• RMH site specific versions of documents must be submitted in MSWord format – not PDF.

Contact details for PICFs at the RMH

Complaints contact person

• Name: Director Office for Research
• Position: Complaints Manager
• Telephone: (03) 9342 8530
• Email: research@mh.org.au

1f. REDCap survey and the EPIC Electronic Medical Record (EMR)

Complete the REDCap survey for all projects involving the RMH as a site. Access the survey here: REDCap Survey

Provide evidence of completion of the survey with your application – that is, email confirming you submitted the ‘Epic EMR Study Registration Survey’. When completing the survey note that:

1. the survey consists of two parts both of which need to be completed:
   • a Study Registration Form; and
   • an EMR Research Study Questionnaire.
2. responses provided in the study questionnaire will determine if the study requires configuration to enable association and management of study participants in the Parkville Electronic Medical Record (EMR).
3. you will need your 5- or 6-digit Ethical Review Manager (ERM) number to complete the survey. This is a unique 5- or 6- digit number generated by the ERM submission system (for example, HREC/XXXXX/RMH)

Questions? Email the EMR Research Liaison Coordinator

Why do you need to do this?

Completion of the survey is required for every project being conducted at the RMH regardless of whether your project will involve accessing and/or documenting in the Parkville EMR.

If you do not need to use or access Parkville EMR functionality the 'Research Study Questionnaire’ will confirm this by only asking key mandatory questions required to determine this.

If your project requires patient orders to be placed in the Parkville EMR you may require a Research SmartSet/Orderset to be configured. Based on your responses to the survey you may be requested to submit a SmartSet proforma in addition to completing the survey. The completed proforma will need to be returned to the central EMR team who will configure the order details. Timely return of the proforma is essential to ensure the build is completed and validated and ready for when Site Specific Authorisation is granted.

Please note that SmartSet build will take a minimum of two (2) weeks post return of the SmartSet proforma and will depend on the workload of the build teams as well as the accuracy and completeness of the details provided.

Associate RMH clinical trial participants to your research record in the Parkville EMR

RMH requires that every clinical trial participant, enrolled or consented to an RMH trial (patients and healthy controls), is registered, and associated to the trial in the Parkville EMR as a research participant. This must be done in real-time, regardless of where consenting takes place, to ensure safety of every person enrolled in research at RMH.

The RMH Privacy brochure How the Royal Melbourne Hospital is Protecting Your Privacy must be provided to all RMH patients being recruited to a research project that will access the patient’s medical record.

How the RMH is protecting your privacy

1g. Agreements

All applicants must complete the Contract Kickstarter Form.

The information provided will help the Contracts Office assess whether any agreements or other contractual arrangements are required for your project and, where required, determine the most appropriate agreement pathway. If you have been provided with a draft agreement by a collaborator, upload it into the Contract Kickstarter Form.

Requests will be reviewed by the Contracts Office once your completed SSA application has been received by the Governance Office. The Contracts Office will contact you directly following the initial review.

1h. Fee payment

The Office for Research at the Royal Melbourne Hospital has recently updated the method of payment for submission fees. All fees will now be via RMH invoice or internal journal transfer. 

• Fee Payment Form - New Projects - Commercial
• Fee Payment Form - New Project - Non Commercial