Research governance is a framework through which an institution is accountable for the scientific quality, ethical acceptability and safety of the research it allows to be conducted.
All applications for Site Specific Assessment/Research governance must be submitted via the Ethical Review Manager (ERM) Platform.
What is Site Specific Assessment (SSA)?
Site Specific Assessment (SSA) forms part of good research governance and is an essential component of the responsible conduct of research. These assessments:
- enhance ethical and scientific quality
- promote good research practice and accountability
- reduce adverse incidents and
- ensure lessons are learned, thus reducing the likelihood of poor performance and research misconduct.
Who needs governance authorisation (SSA authorisation) from the Women's?
- all new research applications require governance authorisation before the research project can commence at the Women’s
- all existing single-site research projects at the Women’s.
When can I submit my Research Governance/Site Specific Assessment for review?
- Research governance: SSAs may be submitted to the Research Office at any time. SSA reviews may begin before Human Research Ethics Committee (HREC) approval. The SSA will, however, not be issued until HREC approval is obtained and received.
- SSA submission will be reviewed at application entry for completeness of the package. Submissions that do not fulfill submission requirements will not be accepted for review.
- Review time frames are dictated by regulatory changes in the sector. The Research Office can therefore only ‘start the clock’ on receiving a complete submission package.
What are the Principal Investigator's responsiblities?
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 and the investigational product(s)
- 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.
The responsibilities of the Principal Investigator (PI) and sponsor are summarised in the document Roles and Responsibilities in a Research Project, which can be downloaded from the Victorian Government's website: Clinical Trials and Research: Roles and Responsibilities.
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 the Women's must 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.
What is the budget review process?
The Women's Research Office will now review all new research funding being administered at the Women's. The Women's will assist in establishing SPFs and cost centres. This will also include review and sign-off of research collaborative agreements. For more details, please email Ann Drummond.
Steps to take
All applications for Site Specific Assessment (SSA)/Research governance must be submitted via the Ethical Review Manager (ERM) Platform.
For useful advice on how to create, submit and manage your SSA/research governance applications in ERM, see: Ethical Review Manager - Clinical trials and research.
Forms:
The Site Specific Assessment (SSA) form is a sub-form of the main (ethics) form in ERM.
For more information on how to create a Site Specific Assessment sub-form, visit the Victorian Government's Clinical Trials and Research website.
1. Pre-submission survey via REDCap
A REDCap survey must be completed in EPIC-EMR for the project build of all research to be conducted at the Women’s.
Here is a link: EPIC Pre-Submission Survey via REDCap.
You will require your five or six digit ERM number to complete the survey. This number is generated by the ERM submission system - for example:
- HREC/XXXXX/RWHV
- SSA/XXXXX/RWHV
- LARF/XXXXX/RWHV
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.
2. 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 acknowledgment email from the Clinical Informatics Analyst Research team.
For more information, email Haustine Panganiban.
The following documents must be submitted:
1. All approved documents from the Reviewing Human Research Ethics Committee:
- Human Research Ethics Application (HREA)
- Victorian Specific Module (VSM)
- Protocol (including Clinical Trial Notification (CTN) form if applicable, advertisements, questionnaires, etc)
- Master Participant Information and Consent Form (PICF)
- Any research contracts or agreements, if applicable. These may include:
- Clinical Research Trial Agreement (CTRA)
- Collaborative Research Agreement (CRA)
- Data transfer agreement (DTA)
- Material Transfer Agreement (MTA).
2. Approval letter from the Reviewing Human Research Ethics Committee, stating the Women's is a participating site.
3. Sign off/approval from Women’s Heads of Departments/Divisions and other relevant Departments.
4. REDCap confirmation of completion email (Subject: Epic EMR Study Registration Survey, Study: RWHXXXXX).
5. Clinical Informatics Assessment.
6. The Women’s Participant Information and Consent Form (based on Master PICF and customised for the Women's use).
7. For a commercially sponsored project, an application fee of $1,650 (i.e. $1,500 + GST).
8. All investigators must provide:
- Certification of Good Clinical Practice training
- Curriculum vitae (CV)
- Evidence of relevant professional registrations.
Reviews/Authorisation
Site Specific Assessment/Governance authorisation will be reviewed/authorised by the Research Office, Chair of the Women's Research Committee and the Women's Chief Medical Officer.
Research contracts or agreements including the Clinical Research Trial Agreement (CTRA) may need approval by the Women’s General Counsel.
For any queries contact the Research Office: research.ethics@thewomens.org.au
The Victorian SSA form describes the activities, resourcing and research team members based only at the Women’s site.
Create a Victorian Site Specific Assessment (SSA) Form in Ethics Review Manager (ERM)
- Include all members of the study team from the Women's, and any people from other sites who will attend the Women’s to undertake study activities. An honorary appointment may be required for persons outside of the Women’s to undertake study activities.
- Do not list researchers from other sites who will not attend the Women’s to undertake research activities.
- All members of the study team must have sufficient and appropriate education, training, experience and resourcing to undertake their role in the study.
- All investigators must provide:
- Certification of Good Clinical Practice training
- Curriculum vitaes (CVs)
- Evidence of relevant professional registrations
- Obtain e-signatures of all researchers from the Women's on the appropriate researcher declaration (PI or AI).
- Obtain e-signatures on the Head of Department declaration from the Women’s 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.
Responding to queries
The Principal Investigator will be advised of the outcome of the review and any further queries or requirements.
To respond:
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please provide a response to each point raised in the letter, and upload this response to ERM
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if document revision is required, please upload any revised documents in tracked and clean format (including versions and dates) to ERM
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a delay in your responses will delay the progress of your submission.
1. Guidance on governance and SSA checklist
Additional information can be found on the Victorian Government Clinical Trials and Research website:
Clinical Trials and Research: GUIDANCE
Clinical Trials and Research: DOWNLOADS
2. Patient Information and Consent Forms (PICF)
Complete a Patient Information and Consent Form (PICF) if the study involves participants from who you are obtaining consent. Different templates are available on the Department of Health website.
Use the template(s) that are appropriate for the type of research you are conducting.
Clinical Trials and Research: DOWNLOADS
Contact details for the Patient Infomation and Consent Form
Include the following details in the PICF when the Women's Human Research Ethics Committee is reviewing:
Example below:
Further information and who to contact
The person you may need to contact will depend on the nature of your query. If you require further information concerning this project or if you have any medical problems which may be related to your involvement in the project (for example, any side effects), you can contact the principal study doctor on 8345 2000 or any of the following people:
Clinical contact person
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Name: |
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Position: |
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Telephone: |
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Email: |
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For matters relating to research being conducted at the Women’s, the details of the local site complaints person are:
Complaints contact person
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Name: |
Consumer Liaison |
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Position |
The Women’s Consumer Liaison Team |
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Telephone |
8345 2290 |
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If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant, then you may contact:
Local Human Research Ethics Committee - Office contact (Research Governance Officer)
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Name: |
Research Office |
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Position: |
Women’s Research Governance Officer |
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Telephone: |
8345 3716 |
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Email: |
Participation is voluntary. If you do not wish to take part you don’t have to. If you decide to take part and later change your mind, you are able to withdraw at any stage.
3. Other participant-facing documents
Depending on the study, the other documents for submission in ERM may include:
- letters of invitation
- transcripts for telephone contact
- wallet cards
- participant diaries
- questionnaires/self-assessment tools
- advertising materials
- radio scripts
- social media text/scripts.
4. Document control
The purpose of using document control is to achieve a consistent approach for maintaining the history of trial documents using the footer content.
Before submission, please check the names of the files. They must be labelled to reflect the document and the study title (including version numbers and dates).
- The document file name/title is to remain the same throughout the study. The only changes to the document file name should be to the version number and date. To change the title of an approved document an amendment must be submitted to the Human Research Ethics Committee (HREC).
- Do not delete any previous versions of documents. These must remain as a reference for document control and auditing purposes.
- Site-specific versions of documents should always be created from the approved Master, and not copied from the last site-specific version to avoid missing major updates to the Master.
- Please ensure all submitted documents include page numbering (preferably in the format page x of y or x/y) and the following identifiers, as outlined below. There may be variations in the order of wording; however, the minimum requirements are a title, version and date. Examples include:
Protocol: a file name for a Protocol should include:
- protocol number - (ABC)
- version number - (V2.0)
- version date - (17Nov2023)
- preferred file name:
- ABC_Protocol_V2.0 _ 17Nov2023
Patient Information and Consent Forms (PICFs): File names for PICFs should include:
- protocol number - (ABC)
- type of PICF - (e.g. Master Main, the Women's site-specific)
- version number – (V1.0)
- version date – (17Nov2023)
- preferred file name:
- multi-Centre: ABC_Master Main PICF V1.0_17Nov2023
- single Centre: ABC_RWH_Main PICF V1.0_17Nov2023
If you have queries, contact the Research Office: Research.Ethics@thewomens.org.au
5. The Women’s Privacy Brochure
A copy of the Women's Privacy Brochure must be provided to all research participants following their consent to participate in research.
The Women's Privacy Brochure is available at: Your Privacy. Hard copies are also available at the Women's Welcome Centre.