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Add, fill out and authorise a governance form

Other references

Researchers Training Manual (Part A)

Researchers Training Manual (Part B)

In this page... 

All Project Members (including Sponsors) associated with the site can add, edit, mark complete and unlock the governance forms. However, only certain project roles are allowed to force check-in, remove, sign, authorise, unauthorise and submit a governance form, this is to ensure the information is correct on submission.

Project Members, including the site PI can be added to a site through the Members tab. Refer to Help Wiki: Manage Project Members for the detailed steps.

Although the Access Request (AR) Form is typically completed and authorised by the CPI, the CPI must also nominate themself as the PI associated with all the sites nominated in the form to enable it to be submitted to a RG Office.

​​​​​Project Member Role for Governance Forms:

Action

Project Member Role

AR Form

Project Member Role

SSA Form

Project Member Role

Budget Form

  1. Add

All site Project Members

All site Project Members

All site Project Members

  1. Edit, Mark Complete Unlock

All site Project Members

All site Project Members

PI, PI Delegate, HA.

(mark complete & unlock N/A)

  1. Remove, Unauthorise

CPI, PI or PI Delegate

PI or PI Delegate

PI or PI Delegate

  1. Force-Check-In

CPI, CPI Delegate, PI or PI Delegate

PI or PI Delegate

PI or PI Delegate

  1. Sign

CPI or PI and HA

PI and HA

PI and HA

  1. Authorise

CPI or PI

PI

PI

  1. Submit

PI or PI Delegate

PI or PI Delegate

PI or PI Delegate

 

RGS governance forms

After Project Members have completed the Sites, Members and Project Details tabs, the governance application forms and supporting documents should be completed and uploaded.

Find information on which ethics and governance application forms to complete in the WA Health Research Authorisation Monitoring Form Guidelines. For a multi-centre research project several governance forms may be required.

The following governance forms are available in the RGS for completion and submission to the relevant WA Health Research Governance (RG) Office(s):

  • WA Health Site Specific Assessment Form and Budget Form
  • WA Health Access Request Form
  • WA Health Declaration of Confidentiality
  • WA Health Research Conflict of Interest Form.

Add a governance form 

1. Only the CPI, CPI Delegate and Project Members (e.g. PI, PI Delegate, AI, RGM, Sponsor) associated with a site can add governance forms for that site.

If you have the required authority in the project workspace, click on the 'Forms and Documents' tab.   

Forms and Docs menu.png 2. Click on the '+' sign next to the desired phase (e.g. Applications) and category (e.g. Site Authorisation) grouping to expand that section.  To add a governance form, you must click on the 'Applications', 'Site Authorisation' and 'Active' groupings to see the 'Forms' grid and the corresponding buttons.

A form may be added only after the required sections of the Project Details tab have been completed and authorised.  Otherwise, you will be prompted with an error message in the Site Authorisation section of the Forms & Documents tab.   Click on the link to the Project Details tab and complete and authorise the required sections (refer to Help Wiki: Fill out and authorise Project Details).  

​ FD message - PD gov.png

If the user changes anything in Project Details tab, any Active forms marked as complete must be unlocked, to ensure the updated information is populated into the forms and there are no additional questions that have to be answered or answers that should be amended.

3. Click 'Add' under the 'Forms' grid. The 'Add Selected Forms' screen will automatically launch.

Site authorisation.jpg 

4. 'Select' either the Site Specific Assessment (SSA) Form OR Access Request (AR) Form. Nominate one or multiple sites to be associated with the form. Users that do not have membership of that site in the Members tab will not be able to see the site name.

If the form is to cover multiple sites within the jurisdiction of one RG Office, please contact the RG Office to confirm that these sites can be grouped on one form (refer to the WA Health Research Authorisation Monitoring Form Guidelines for guidance on adding multiple sites to a governance form). You will find the RG Offices listed in the Contacts page.

Forms and Docs add project forms - gov.png

5. Click 'Add Selected Forms to Project'. When a SSA Form is added to a project an associated Budget Form will be automatically created. The Budget Form is not viewable by a Sponsor.

The RGS will only allow you to add either the SSA or AR forms for a site. The site name will disappear from this screen once a governance form has been added for the site.

Gov forms.jpg 

6. When the form is successfully added, you will be directed back to the Forms & Documents tab. Version 1.0 of the selected governance form now appears under the 'Site Authorisation, Active section of the Forms & Documents tab. If you added the incorrect form, you must remove the existing form by selecting it and clicking 'Remove' before adding the correct one.

SSA1.jpg 

7. All Project Members affiliated with the site can click on the embedded link in the form name to open it, allowing for viewing or editing.

SSA 2.jpg 

Following submission, if the Research Governance Officer (RGO) requires revisions to a form and has marked it as 'Additional Information Required' (AIR) in the 'Submitted' grid, a new version of the form will automatically be created under the 'Active' grid.  You must implement the required changes to this version, which will then be submitted to the RGO for their review. Refer to Help Wiki: Governance Submission, Validation and Review Assessment.

Fill out a governance form

1. The form created is automatically populated with information previously entered in the Sites tab, Members tab and Project Details tab. Refer to Help Wiki: Fill out and authorise Project Details for the steps to complete and authorise the Project Details tab. To edit the other form fields that were not populated from the Project Details tab, click 'Edit'. Refer to Help Wiki: Fill out an ethics form for directions on completing forms.

SSA Index.jpg 

2. If a Project Member has completed all of the form's fields and the form is ready for signing and authorisation, click 'Mark Complete'. The form's status is now 'Completed', this is to inform all Project Members that the form has been finalised and is ready for authorisation.

 Project Details Ethics Information mark as complete.PNG

Sign, authorise and unauthorise a governance form

Once marked complete, if you have the authority to sign or authorise a form, a 'Sign' or 'Authorise' button will appear.

Sign and authorise a Site Specific Assessment Form

The SSA Form requires the site PI to sign the Declarations section prior to inviting the Hospital Administrators (e.g. Business Manager, Divisional Director and Regional Director) to sign prior to the site PI authorising the SSA Form.

1. To sign a SSA Form, click on the embedded link in the form located in the project workspace's Forms & Documents tab, under 'Applications', 'Site Authorisation, 'Active' groupings. Navigate to the 'Declaration' page.

2. If you are the PI, click 'Sign' next to your name (do not click 'Edit' on the form, if  you edit the form you will have to click 'Mark Complete' again before signing).  A confirmation message will appear stating that "You are signing for both the SSA Form and Budget Form for all sites", and that signing cannot be undone. Click 'OK' to proceed.

Sign Declaration SSA.jpg SSA Message.jpg 

3. If you are the PI or PI Delegate, click 'Add' to invite the Hospital Administrator (e.g. Business Manager, Divisional Director or Regional Director) to sign.   You can invite as many Hospital Administrators as required to sign the SSA Form, though at a minimum it should be signed by a Business Manager and Divisional Director. If your Divisional Director has already signed the Budget Form (instead of a Head of Department) a second signature on the SSA Form may not be required, check with your RG Office.

Note: You should not invite the Hospital Administrators to sign the SSA Form before the Budget Form has been 'Authorised' by the PI.

Invite SSA.jpg 

4. The Invite to Sign screen will launch, add the Hospital Administrator's name, click the person icon to display the link. Select the Position and Site, and click 'Add', or 'Cancel' to discard the changes.

Add BM.jpg 

5. Select  the Hospital Administrator and click 'Invite to Sign' or 'Remove' if you wish to remove them. The Hospital Administrator User will be sent an email and Task, to review and sign the form. Refer to Help Wiki: Sign the declaration on a SSA Form (for Hospital Administrators). If you remove a Hospital Administrator once you have invited them, they will receive a notification email that you have withdrawn your request to sign the declaration. You can remove Hospital Administrators if their status is 'pending' or 'invited' without unlocking the form. Note: If you unlock the form, you will remove any signatures.

Sign1.jpg 

6. Once the Hospital Administrators have signed the form their signature will display 'Signed'. The PI can now authorise the SSA Form so that it can be submitted. Open the form and Click 'Authorise', which appears at the bottom of each page of the SSA Form (there is no requirement to click edit or unlock). Click 'Unlock' to edit the form before authorisation if you wish to change something before authorisation. Note: If you unlock the form, you will remove any signatures.

authorise1.jpg 

7. After authorising a form, the 'Unauthorise' button should appear. To exit the form, click on the Forms & Documents tab at the top of the form. 

SSA 3.jpg 

Alternatively, a PI can authorise and a PI or PI Delegate can unauthorise a form in the project workspace's Forms & Documents tab after selecting a form or document. Note the Budget Form must be authorised within the form and not in the Forms & Documents tab. 

authorisation2.jpg 

8. Once the SSA Form and Budget Form are authorised, the PI and PI Delegate will be allowed to submit them to a RG Office. Refer to Help Wiki: Governance Submission, Validation and Review Assessment. The SSA Form and Budget Form must be submitted together.

Sign and authorise an Access Request Form

The CPI with additional Site PI role (CPI/PI) should sign and authorise the AR Form after it has been signed by the relevant Hospital Administrators in the Site Declaration of Support.

1. Refer to 'Sign and authorise a SSA Form' above for steps in inviting a Hospital Administrator to sign the form, and for the CPI/PI to sign and authorise the AR form.

AR Form.jpg 

2. Once the Hospital Administrator has signed the form, the CPI/PI can sign the form. The 'Authorise' button should then appear. Click 'Authorise'. To exit the form, click on the Forms & Documents tab at the top of the form.

3. Once the AR Form is authorised, the PI and PI Delegate will be allowed to submit it to a RG Office. The CPI must add themself as the PI for the relevant site(s) to enable submission of the AR Form. Refer to Help Wiki: Governance Submission, Validation and Review Assessment.

Unauthorise a Site Specific Assessment Form

Only the site PI and PI Delegate can unauthorise a SSA Form. Note that when you unauthorise the SSA Form, all signatures will be removed, the PI will have to resign the form and then the PI or PI Delegate will have to reinvite the Hospital Administrators to re-sign the form, prior to the PI authorising the form

1. You can unauthorise a form in the project workspace's Forms & Documents tab after selecting a form or document.

2. Alternatively in the form, click 'Unauthorise'. Click 'Edit', make your changes and then click 'Mark Complete'.

Unauthorise1.jpg 

3. . If you are the PI click 'Authorise'. To exit the form, click on the Forms & Documents tab at the top of the form.

Unauthorise an Access Request Form

Only the CPI with additional site PI role (CPI/PI) and PI Delegate can unauthorise an AR Form. Note that when you unauthorise the AR Form, you do not have to reinvite the Hospital Administrators to re-sign the form, prior to the CPI/PI re-signing and authorising the form.

1. You can unauthorise a form in the project workspace's Forms & Documents tab after selecting a form or document.

2. Alternatively in the form, click 'Unauthorise'. Click 'Edit', make your changes and then click 'Mark Complete'.

3.  If you are the CPI/PI click 'Authorise'. To exit the form, click on the Forms & Documents tab at the top of the form.

Systematic unauthorisation of the governance forms

​Note that changes to the project will trigger certain forms to be automatically unauthorised:

Location of changes made WAHEAF​ WA Specific Module​ ​Site Specific Assessment Form Access Request Form​
Sites tab 
​UnauthoriseUnauthorise​​Unauthorise only the form that includes a site that has been removed​Unauthorise only the form that includes a site that has been removed
​Members tab​UnauthoriseKeep as 'Authorised'​

​Unauthorise only the form that includes investigator changes

Unauthorise only when the CPI is changed​
Project Details tab - Project HeaderUnauthorise​​Unauthorise​Unauthorise​Unauthorise
Project Details tab - 
Ethics Information
​Unauthorise​Unauthorise​Unauthorise​Unauthorise
​Project Details tab - Governance Information​Keep as 'Authorised'​​Keep as 'Authorised'​​Unauthorise​Keep as 'Authorised'​
Project Details tab - Investigator Contact Information​​UnauthoriseKeep as 'Authorised'​​Unauthorise​Keep as 'Authorised'​​

         
 Other references

Researchers Training Manual (Part A)

Researchers Training Manual (Part B)



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