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Upload supporting documents

Other references

Researchers Training Manual (Part A)

Researchers Training Manual (Part B)

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RGS supporting document templates

Ethics Supporting Document Templates

The following ethics supporting documents are available from the RGS as document templates. These can be completed externally and uploaded to the RGS as supporting documents:

  • Research Protocol Templates
  • Participant Information & Consent Forms.

Governance Supporting Document Templates

The following governance supporting documents are available from the RGS as document templates. These can be completed externally and uploaded to the RGS as supporting documents:

  • Student Research and Confidentiality Declaration
  • Confidentiality Agreement
  • Clinical Trial and Clinical Investigation Research Agreements
  • Research Agreements
  • Indemnity Forms. 

Upload a supporting document

Ethics Supporting Documents

In addition to forms, you can add ethics supporting documents relevant to your project (e.g. participant information and consent forms, recruitment letters, survey tools, information brochures). As a minimum all research projects should have a protocol added as a document.

Currently the NHMRC's Human Research Ethics Application (HREA) is not available in the RGS. To facilitate its submission to WA Health HRECs, the HREA must be completed externally and uploaded to the RGS as a supporting document. The HREA must accompany the WA Specific Module.

Governance Supporting Documents

In addition to forms, you can add governance supporting documents relevant to your project (e.g. sponsor contracts, site participant information and consent forms, insurance certificates and indemnity forms).

Process for Ethics and Governance

1. In the project's workspace, click on the 'Forms & Documents​' tab.

Forms and Docs menu.png 

2.  Under the desired phase (i.e., Application or Monitoring) and category (i.e., Ethics Approval, Site Authorisation, Ethics or Governance Monitoring), click 'Add' under the 'Active' header and 'Documents' grid:

   Supporting Document.jpg
 

3.  The screen will automatically launch the screen 'Add Project Documents'. Select the 'Document Type' from the list provided. For governance documents you have the option of selecting draft and final documents. Drafts are normally unsigned documents that may require review and approval to ensure they are correct before the final submission.

   Supporting Document1.jpg
 

​4.  Enter a 'Document Name'.  For governance documents you must choose an 'Associated form', except for the 'Confidentiality Agreement' under 'Document category' draft or final. Fields under the 'Document Details' section are optional at this point, but you may wish to provide the 'Version number', 'Version date', and whether the document is a hard copy (paper) or soft copy (electronic).  Please be aware that the information you enter will be populated into the approval letters. Click 'Save' and then 'Close' to return to the 'Forms & Documents' tab.

Ethics Sample:

Forms and Docs add project docs-2.png 

Governance Sample:

 Add Project Documentsv2.jpg

5.  Based on your selection in 'Is this a hard copy (paper) or soft copy (electronic) document?', these fields are mandatory:

Hard Copy (paper)

Forms and Docs add project docs-3-hard.png  

Soft Copy (electronic)

Forms and Docs add project docs-3-soft.png
 

6.  Click 'Save' to save changes or 'Cancel' to discard any changes made.

7.  If a hard/soft copy has been provided, the document's status will be set  to 'Attached'.  Otherwise, the document's status is 'Not Attached'.  Only 'Attached' documents are ready for authorisation.

Forms and Docs add project docs-4.png

If the EEO or RGO requires revisions to a document and has marked it as 'Additional Information Required' (AIR), a placeholder for the new version of the document will automatically be created under the 'Active' grid.  You must upload the revised document version to this placeholder that addresses the EEO or RGO review comments, which will then be submitted to the EEO or RGO for their review.

Authorise a supporting document

Prior to submission the documents need to be authorised. The CPI, CPI Delegate can authorise ethics documents and the PI and PI Delegate can authorise governance documents. The documents need to be individually 'selected' and 'authorised'.  Note the governance documents are associated to a form and site as per this example:

 Authorise a supporting document gov.jpg

Edit a supporting document

1. Prior to submission, you can edit a supporting document. Select the document and click 'Edit'.

Edit document.JPG 

2. The Edit Project Document screen will launch. Click 'Authorise' to authorise the document in this screen (you don't need to click 'Save'). Alternatively you can update document details, click 'Save' to retain your changes or 'Cancel' to discard them.

Edit document2.JPG 

 

Other references

Researchers Training Manual (Part A)

Researchers Training Manual (Part B)


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