You need to be an active RGS user to access the projects and other features.
If you are a WA Health employee, click here. Otherwise, if you are a non WA Health employee, click here.
Once your request for access has been approved, you may now log in to RGS. For Help, click here.
You can now update or add to your profile details, with your qualifications, expertise, etc so that they can be used in future applications submission to either a HREC or Research Govrnance Office. For Help, click here.
If you are the CPI, you will need to create a new project workspace and nominate at least one site where the project will be conducted. The CPI can nominate a delegate in the form, the person has to be an active RGS user to be added. When the project workspace is approved the CPI Delegate will automatically receive their invitation to the project. If you are not the CPI you can still create the project, however the CPI must be in that position with RGS before any submission is made to either a WA HREC or a Research Governace Office. Only one workspace per project should be created as workspace can't be merged. For Help, click here.
The sites nominated in the 'Create Project Workspace' form will automatically populate into the Sites tab, additional sites can be added at any time. If there are multiple WA Health sites in a project, contact the Research Governance Office for advice before adding them.
The CPI/CPI Delegate or PI/PI Delegate must add all the project sites into the Sites tab that are covered by a WA Health HREC's approval or if the HREC approval is external to WA Health, all WA Health sites requiring authorisation . These sites will populate into the ethics/governance forms and allow Project Members to be associated with individual or all sites. For Help, click here. The CPI/CPI Delegate and PI/PI Delegate must add all Project Members that are covered by the ethics approval and site authorisation into the Members tab. It is important to understand RGS Roles before adding Project Members and their roles to the project (especially the 'sponsor' and delegate roles).
When adding Project Members they must be associated with an individual or all sites, which will dictate their access to site specific forms/documents. The Project Members nominated as investigators (i.e. CPI, PI, AI) will have their profile details populated into the ethics/governance forms. A person can have mulitiple roles within a project.
The CPI nominated in the 'Create Project Workspace' form will automatically populate into the Members tab but additional Project Members can be added at any time. The CPI or CPI Delegate must add the PI(s) associated to the sites in RGS. In single-centre research, the CPI must add the role of PI to either themselves or another project member to enable the creation of the governance application. The CPI and PI(s) can nominate Delegates to action most responsibilities in RGS, except for signing/authorising forms. For Help, click here.
All investigators (that are covered by the ethics approval and site authorisation) who have a conflict of interest to declare must complete their own 'Conflict of Interest Form' in the Declarations tab. These declarations will populate into the ethics/governance forms.
All Project Members that sign a Declaration of Confidentiality when joining the project will have their form recorded in the Declarations tab. For Help, click here.
The the 4 sections of the Project Details tab must be authorised before any forms can be created in the Applications tab. Sections 1, 2 and 4 are required to be authorised befor the ethics form can be created and all 4 sections have to be authorised before a research governance form can be created. Complete the 'Ethics information' before the 'Governance Information' section due to branching of questions. For Help, click here .
Once the Sites, Members, Declarations and Project Details tabs are completed, Project Members must add and complete the ethics/governance forms in the 'Active' section of the Applications tab. The forms will be populated with information added in the Sites, Members, Declarations and Project Details tabs. Any changes to the information must be made in these tabs for it to populate in to the forms. Additional questions will need to be completed in the forms to complete them.
All Project Members can add/complete 'Active' ethics forms, but the CPI must sign/authorise the WA Health Ethics Application Form (WAHEAF) before submission. The CPI Delegate can sign/authorise the WA Specific Module (WASM) For Help, click here.
All Project Members can add 'Active' ethics documents, once added they are automatically authorised and are ready for submission. For Help, click here.
If the HREC approval has or will be obtained under NMA from a HREC outside of WA Health, all the ethics forms and documents (includng the HREC approval) are still created (the WASM) or uploaded in the Ethics Approval section of the Applications tab and are submitted to a Research Governance Office.
The Project Members assoicated with a site (i.e. PI/PI Delegate, AI, RGM, Sponsor) can add/complete 'Active' governance forms for that site (the sponsor is unable to view the Budget Form). The PI/PI Delegate must invite Hospital Administrators (HA) to quote/authorise the forms before the PI or PI Delegate can authorise them before submission. The PI must sign the form after the HA. The Budget Form should be authorised by all HAs before HAs are invited to authorise the SSA Form.
For Help with Budget Form, click here. For Help with Access Request/ Site Specific Assessment (SSA) forms, click here.
All Project Members belonging to a site can add 'Active' governance documents for that site, once added they are automatically authorised and are ready for submission. For Help, click here.
The PI/PI Delegate must invite the relevant HA to authorise the Access Request, Budget or SSA forms in the Applications tab before they can authorise and submit them to the RG Office.
Once invited, the Head of a Supporting Department (HoSD) or their delegate must authorise the service and/or support for their department on the Budget Form. The HoSD and their delegate can alter the costing for any item within their department prior to authorisation. For Help, click here.
Once invited, the Head of the Research Departments (HoD) must provide authorisation for the budget at that site on the Budget Form. The HoD can alter the costing for any item within their department prior to authorisation. For Help, click here.
Access Request/ SSA forms:
Once invited, the HAs must provide authorisation for either access to the site or conduct of the project at the site on either the Access Request or SSA forms. For Help, click here.
Ethics Forms and Documents:
When all 'Active' forms and documents for the ethics application are authorised in the Applications tab, the CPI or CPI Delegate can submit them to the HREC(s). The initial ethics forms and documents must be submitted to the HREC as a package by the CPI or CPI Delegate.
The Ethics Officer (EO) will validate the 'Submitted' forms and documents and provide a validation decision for the Project Members to view in the Applications tab by clicking the link on the View under the validation date. Valid submissions will be tabled at the next HREC meeting. For Help, click here.
If the HREC approval has been obtain under NMA from a HREC outside of WA Health all approved forms and documents are still required to be submitted, they will be validated by a Research Governance Office.
Governance Forms and Documents:
When all forms and documents for the governance application are authorised in the Applications tab, the PI or PI Delegate can submit them to the RG Office. Governance forms and documents can be submitted to the RG Office individually by the PI or PI Delegate.
The Research Governance Officer (RGO) will validate the 'Submitted' forms and documents and provide a validation decision for the Project Members to view in the Applications tab by clicking the link on the validation date. Valid submissions will be reviewed by the RGO. For Help, click here.
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Please contact your Service Desk for assistance.