Governance processes

The following documents are mandatory for all projects, regardless of whether they are using EMR-EPIC.

Upload all documents in the SSA application in ERM.

a. Pre-submission survey via REDCap

An EMR-EPIC REDCap survey must be completed for all research, that is being conducted at the Women's. EPIC Pre-Submission Survey via REDCap.

You will require your five or six digit ERM number to complete the survey. The ERM submission system generates this number, for example:

• HREC/XXXXX/RWHV
• SSA/XXXXX/RWHV
• LARF/XXXXX/RWHV

As part of your SSA 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.

b. Clinical Informatics Assessment

All new projects must submit a Clinical Informatics Assessment, to assess the feasibility of obtaining data from EPIC-EMR.

• Include a document that lists of all data (dataset) being accessed in ERM-EPIC

As part of your SSA submission, you are required to include an acknowledgment email from the Clinical Informatics Analyst Research team in the ERM submission

For more information, email Haustine Panganiban.

A budget review by the Office for Research is required for all projects where RWH receives or pays funds.

Every project requiring SSA review at the Women’s must submit a budget.

The Women’s Research Office reviews 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 a review and sign-off of research collaborative agreements.

For more details, please email Ann Drummond.

The following documentation and information are required for the budget review:

1. Agreements (outlining financial income and/or expenses to the Women’s)

A clinical trial research agreement, research collaboration agreement, funding agreement or letter of offer detailing the source of external funding for the project. A completed draft version of the relevant agreement for preliminary review is sufficient. A finalised, signed version of the agreement will then be required for final budget approval.

2. Project protocol

A project protocol is the document that describes the objective(s), design, methodology, statistics and organisation of a project.

3. Details of other project expenses

Consider any other project expenses. These expenses may include archiving costs, capital equipment, ethics fees, meal allowances, postage, printing and stationery, statistical analysis, software, travel allowances.

4. Cost centre number (Women’s only)

Provide the RWH cost centre number from which the project will operate.

The Women’s will assist in establishing SPFs and cost centres. please email Ann Drummond for more information.

5. Invoicing and payment clauses

All funding agreements to which the RWH is a party must include the standard invoicing and payment clauses in:

• "Schedule 2 - Payments" of the appropriate Medicines Australia Clinical Trial Research Agreement template.
• Item 9 MACH Research Collaboration

e.g. Standard Invoicing

Invoices will be raised and sent from Royal Women’s Hospital to request payment for a visit or otherwise invoiceable item. For RWH invoicing, please include: All requests to raise an invoice from (insert Funding Body name) to the Royal Women’s Hospital, including payment schedule.

Where research involves more than one party or organisation, a research agreement assigning responsibilities to each of the partners must be executed before research commences.

The research agreement is a contractual agreement between the institutions involved in the research project, not between individual researchers. The purpose of the agreement is to define the terms, responsibilities, and obligations of the institutions participating in the project, and it governs the legal relationship between those institutions.

The Women’s recommends use of standard agreements, including those developed by Medicines Australia and the Melbourne Academic Centre for Health (MACH).

• Ensure you are using the latest version from their website

These may include:

• Clinical Trial Research Agreement (CTRA)
• Collaborative Research Agreement (CRA)
• Data transfer agreement (DTA)
• Material Transfer Agreement (MTA)

Review of the research agreement can be lengthy and may slow the SSA review process. The Research Office encourages the submission of the SSA with research agreement as early as possible. This allows time to begin an early review of the research agreement. The Research Office will accept a draft version of the research agreement and its budget information for initial review.

The research agreement is a crucial aspect of research governance/SSA. It is a legal document between the parties which agrees to the terms of conducting the project at the site.

What is the process for a Research Agreement?

1. How to initiate an agreement:

Contact the Research Office to discuss the appropriate agreement for your project. A meeting with the Research Office team is advised early in your planning (research.governance@thewomens.org.au).

2. Review and Agreement on Terms:

Prior to any institutional sign-off, all parties involved in the research project must review the agreement in full. The agreement must undergo the necessary internal approval process within each party's respective institution. This may involve review by legal, financial, or compliance including research governance. Each party (institution) must confirm in writing that they agree with the terms, conditions, and obligations outlined in the agreement.

The Research Office will seek review from Legal Counsel on the researchers behalf. Use of non-standard agreements may further delay reviewing times.

3. Negotiation and Amendments (if applicable):

If there are any changes or amendments to the agreement, these must be discussed, negotiated, and agreed upon by all parties. This includes resolving any concerns related to intellectual property, confidentiality, or funding obligations. The agreement will not proceed to institutional sign-off until all parties have formally agreed to the amended terms.

4. Final Institutional Sign-off:

Once the internal approvals have been completed, each institution’s authorised representative will sign the agreement. For the Women’s, this will be a member of the executive – the Chief Medical Officer (CMO).

All agreements requiring review and signature by the CMO should be emailed to research.governance@thewomens.org.au (include ERM ID in the subject header).

The agreement will not be considered fully executed until signatures are obtained from all required parties.

5. Upload the Executed Final Agreement in ERM:

After all signatures are obtained, a fully executed copy of the agreement will be distributed to all parties for their records. Upload the fully executed agreement in your SSA via ERM.

For more information on agreements: Reources to support research webpage.

All Women’s clinical research must abide by the relevant Women’s policy and guidelines. These can be accessed via PROMPT and include:

• Digital Innovation - Data Handling Framework
• Data Governance Framework
• Clinical Research SOP
• Digital Innovation - Email Framework

Ensure the information in your protocol is consistent in both your SSA subform and VSM.

1. Data Generation, Collection and use:

1. Data collection information required for SSA submission:

Documents defining the project data, such as code book, data dictionary, data sets, case report form must be included in your SSA submission.

If these documents are not part of the ethics approved protocol/documents, a separate document (e.g., dataset defining all variables, where the variables will be accessed from) must be uploaded in the SSA via ERM.

2. Use of the data:

• Specify how the data will be used (e.g., for the purposes and analyses specified in the protocol ± the Statistical Analysis Plan).
• Following the completion and analysis of the project, specify whether the data will be retained for the mandatory archive period or for long-term use in future research projects.

3. Data to be created

List the data sources, collection instruments and systems you are using or intend to use and specify who (i.e., the position) will collect the data. This comprises but is not limited to:

• Questionnaires or assessments (paper and/or electronic – if electronic, what systems/software)
• Standard measures
• Multimedia sources such as video, audio, image
• Externally sourced data e.g., lab results, previous projects
• Tracking data e.g., recruitment, longitudinal follow-up, biological sample storage

4. Existing data

List the data sources and specify who (i.e., the position) will have access to the resources to collect the data.

Local resource, e.g.:

• RWH electronic medical record (EPIC)
• RWH medical record (paper via HIS)
  • If accessing paper records, ensure an item for this cost is included in the budget
• RWH repository/databank (include ERM ID)
• RWH research projects

2. Data storage and security

List the location/s where records will be held. If there are multiple locations, list the exact data to be held at each location.

Describe how confidentiality of all study data will be ensured via the security mechanisms in place.

How will you provide access to, disclose, use/re-use, transfer, destroy or archive the information that you collect/gather?

Examples: data location

• The database used for this research project, clinical trials will be the current version of REDCap at Royal Women’s Hospital (availability of REDCap TBC). The data held in the database is list exact data, medical records, surveys, lab results, consent, other…

And/OR

• The database used for this research project, clinical trial will be the current version of insert the name of the database system, and the system location/institution. The data held in the database is list exact data, medical records, surveys, lab results, consent, other…

And/OR

• This project will not make use of a central database. Both raw and prepared data relevant to the project will be stored in the Royal Women’s Hospital instance of SharePoint, MS Teams, g:drive, in an access-controlled folder accessible only by the project team. The data held in this location is list exact data, medical records, surveys, lab results, consent, other…

And/OR

• All paper-based records related to the project informed consent forms, case report forms, medical records, surveys, list other documents, will be securely stored in a designated, access-controlled facility location, room number. The storage area will be protected by physical security measures locked cabinets, restricted access to authorised personnel only.

Example: Access control

• Access to the database system/s, folders, files will be restricted to authorised personnel involved in the research project, clinical trial. User access will be granted based on predefined roles aligned with the individual's responsibilities within the study, ensuring that each user has the minimum level of access required to perform their duties. The roles for those accessing the information are Principal Investigator, Data Manager, Research Coordinator, and Research Assistant, list other, as outlined in the protocol, data management plan.

And

• Each user’s access will be controlled through name database system role-based permissions system, which enables administrators to assign specific permissions based on the user's role.
• Permissions will include access to data entry, data editing, data export, and administrative functions, with certain functions (such as data export or deletion) restricted to specific high-level roles Principal Investigators or Data Managers as outlined in the protocol, data management plan.

Example: transfer / sharing

• Data sharing in this research project, clinical trial will be conducted in a manner that ensures compliance with applicable ethical, legal, and regulatory standards, including patient confidentiality, informed consent agreements, and Women’s policies and guidelines.
• All electronic documents containing data, will be shared internally, externally via the Women’s network using a Secure File Sharing system MS teams, sharepoint, REDCap, other. The file will be password protected and the link will have an expiry date of 1-14 days. The link will be shared using the sender and recipient’s institutional email.

NOTE: Staff are to use their allocated Women’s email address as the only email address for communicating with the Women’s, and completing work related to their role at the Women’s. Personal e-mail accounts (e.g. Outlook.com accounts, Gmail, iCloud) must not be used (Refer Women’s Digital Innovation – Email Framework)

• The data accessed and collected in this study will be identifiable, re-identified, non-identifiable/anonymous. The data used and stored in this study will be identifiable, re-identified, non-identifiable/anonymous. All personal identifiers including names, addresses, contact information, date of birth, URL, and any other unique identifiers list will be removed, or coded. All data will be de-identified before being shared. Identifiable data and the unique coding system will remain within the Women’s network.
• A research agreement, data transfer agreement will be executed between the institutions involved to clearly define the terms, conditions, and responsibilities associated with data access and use.

Examples record keeping

• All records for clinical research (including observational studies, QA/QI) should be kept for a minimum of 5 years post study closure or post publication,
• All records for clinical trials (eg contains a CTN drug/device) must be kept for a minimum of 15 years post study closure or post publication.
• All records for clinical research involving paediatric participants, must be retained for 15 years after study completion, or 7 years after the participant's 18th birthday, whichever is longer.

For projects involving culturally sensitive data/information, vulnerable groups, and gene therapy, records may need to be stored for longer than 15 years or kept indefinitely – refer to NHMRC guidelines

3. Data Management plan:

A data management plan can be outlined in your protocol, or it may be a separate document.

A data management plan outlines how you will store, provide access to, disclose, use/re-use, transfer, destroy or archive the information you collect/gather.
Include a data management plan in accordance with National Statement 3.1.44, 3.1.45 and 3.1.56. 

The plan should include, but not be limited to, details regarding: 

a. physical, network, system security and any other technological security measures;

b. policies and procedures; 

c. contractual and licensing arrangements and confidentiality agreements; 

d. training for members of the project team and others, as appropriate; 

e. the form in which the data or information will be stored; 

f. the purposes for which the data or information will be used and/or disclosed; 

g. the conditions under which access to the data or information may be granted to others; and 

h. what information from the data management plan, if any, needs to be communicated to potential participants. Researchers should also clarify whether they will seek: 

i. extended or unspecified consent for future research (see 2.2.14 to 2.2.16); or 

j. permission from a review body to waive the requirement for consent (see 2.3.9 and 2.3.10).

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 Victoria - Downloads webpage

Where Master versions of consent forms were approved in the ethics application, complete Women’s specific Participant Information and Consent Form (PICFs) for .

• Create the site documents from the final Master document templates approved by the reviewing HREC - update only the RWH specific information.
• Ensure the footer of site specific document references the final HREC approved Master version and add the RWH site version number and date.

Contact details for the Patient Information and Consent Form

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:
Women’s Research 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.

Note: 
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.

Therapeutic Goods Administration (TGA) Clinical Trial Notifications (CTN)  
A notification to the TGA is required for clinical trials involving an ‘unapproved’ drug or device. The Sponsor of the clinical trial is responsible for this. 

Where The Women’s is the Sponsor (eg Investigator-initiated trials): 
The CTN is completed online via the TGA Business Services portal.  The Women’s already has a TGA Client ID and all submissions for the Women’s must be registered and submitted centrally through the Research Office via the Research Governance Officer (research.governance@thewomens.org.au). 

• Please do not create a separate client ID for The Women’s. The Researcher will be responsible for drafting the CTN. 

To request a log in for the Women’s account, email research.governance@thewomens.org.au. Once the user (researcher) has been added by the research office, the researcher will receive a log in email separately from the TGA – note this login expires after 24 hours if not activated by the researcher. 

1. The researcher drafts the application and submits a draft version to the Research Governance Officer for review and attaches the draft version in the ethics application in ERM. 
2. When the project has received HREC approval, and no further  changes to the project are expected, the researcher notifies the Research Governance Officer who will SUBMIT the CTN on behalf of the researcher. 
   Note: submitting a CTN raises an invoice which will be passed on to the researcher for payment.  
3. Once the invoice has been paid, you must provide evidence (ie receipt) to the Research Governance Officer so that the submission can be finalised.  
4. Once the submission has been acknowledged by the TGA, the Research Governance Officer will send a copy to the Researcher. The submission will then move to the Clinical Trials Repository. The researcher is responsible for maintaining and updating any variations to the CTN throughout the trial including notifying the Research Governance Officer of any changes. 

Please refer to the TGA CTN User Guide for details on completing the CTN.
When filling in the form, you'll be asked to enter the details of the Approving Authority for the site. For the Women's, this will be the Chief Medical Officer.

Where the Women’s is not the Sponsor or lead site: 
Please ensure you obtain a copy of the lodged CTN from the Sponsor and submit it with the SSA. 

For further information contact the Women's Research Governance email address.

Complete the Fee application document and upload it to the SSA.

For details, please contact research.governance@thewomens.org.au.

The following documents must be submitted:

1. All documents approved by the Reviewing Human Research Ethics Committee:

• Approval letter from the Reviewing Human Research Ethics Committee, stating the Women's is a participating site.
• Human Research Ethics Application (HREA).
• Victorian Specific Module (VSM).
• Protocol: Ensure the protocol includes the following information:
  • Project title
  • List of authors and affiliated organisations
  • Version number and date
  • A list of study sites and what aspects of the protocol that will be undertaken at those sites
  • A data management plan (may be a separate document)
  • Include data collection tools, such as:
    • Questionnaires
    • Assessment tools
    • Data collection sheets
  • Include all advertising material 

• Clinical Trial Notification (CTN) form if applicable 
• Master Participant Information and Consent Form (PICF)
• Site specific Participant Information and Consent Form (PICF)
• Data: Dataset, Case Report form, data dictionary, data management plan
• Research Agreements
• Budget 
• Insurance / indemnity for commercially sponsored clinical trials
• Insurance for clinical research where the Women’s is not the sponsor 
• Fee form for commercially sponsored trials

• Obtain e-signatures from the Women’s site PI on the appropriate researcher declaration (PI).
• Obtain e-signatures on the Head of Department declaration form from the Women’s Head of 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.
• Sign off/approval from Women’s Heads of Departments/Divisions where the project is to be undertaken and other Heads of Departments that are impacted by, or provide a service for the project.
• Ensure you have hit the submit button, and the project is uploaded.
   

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

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

Complaints contact person

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)

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.

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.

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