Governance processes

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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.

Research Governance/Site Specific Assessment review

All research projects involving humans receive approval by the Research Advisory Committee.

Once approved by the RAC, projects will progress to the Research Governance Committee (for consideration and authorisation).

More information: Committees & meeting dates.

When can I submit my Research Governance/Site Specific Assessment for review?

Research governance: SSAs may be submitted to the Research Office via ERM at any time

For Research Advisory Committee meeting deadlines, visit Committees & meeting dates.

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 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

Step 1: Create SSA sub-form in ERM

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.

Step 2: EPIC Electronic Medical Record (ERM)

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.

Step 3: Documentation for the Women's Governance

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 applies. For details, please contact the Research Office.

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

Step 4: Submit (via ERM)

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:

please provide a response to each point raised in the letter, and upload this response to ERM
if document revision is required, please upload any revised documents in tracked and clean format (including versions and dates) to ERM
a delay in your responses will delay the progress of your submission.

Additional information to refer to

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

Patient Information and Consent Forms

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 Information 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

Name:
Position:
Telephone:
Email:

For matters relating to research being conducted at the Women’s, the details of the local site complaints person are:

Complaints contact person

Name:	Consumer Liaison
Position	The Women’s Consumer Liaison Team
Telephone	8345 2290
Email	Consumer.liaison@thewomens.org.au

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)

Name:	Research Office
Position:	Women’s Research Governance Officer
Telephone:	8345 3716
Email:	Research.office@thewomens.org.au

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.