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Fill out and authorise Project Details

Other references

Researchers Training Manual (Part A)

Researchers Training Manual (Part B)

​​​​​​​​​​​​In this page... 

After setting up the Sites and Members of your project (refer to Researcher Training Manual Part A) you should complete the Project Details tab. Project Details has been created to reduce Project Members duplicating data entry. The Project Details' information feeds into the ethics and governance application forms and allows the CPI or CPI Delegate to submit the ethics forms, and the PI or PI Delegate to submit the governance forms independently of each other (i.e. in parallel, ethics before governance or vice versa). This ability aligns with the NHMRC's Good Practice Process to assist with assessing the feasibility of a project (through the Budget Form) prior to submitting an application for ethical review.   

 

The 'Project Details' tab has four sections that must have all mandatory fields or questions  completed and authorised before the related application form can be added to the project and completed. The sections and their related forms are:

Project Details Section

Forms that Data Populates

  1. Project Header

Ethics & Governance

  1. Ethics Information

Ethics & Governance

  1. Governance Information

Governance only

  1. Investigator Contact Information

Ethics & Governance

 

All Project Members (including Sponsors) can edit, mark complete and unlock all four sections. However, only certain project roles are allowed to authorise and unauthorise a specific section, this is to ensure the Project Details' information is correct prior to populating the forms.

Project Member Role to Authorise / Unauthorise Project Details:

Project Details Section

Project Member Role

  1. Project Header

CPI, CPI Delegate, PI, or PI Delegate

  1. Ethics Information

CPI or CPI Delegate

  1. Governance Information

PI or PI Delegate

  1. Investigator Contact Information

CPI, CPI Delegate, PI or PI Delegate.

Fill out the Project Details tab (General Information)

1. In the project's workspace, click on the 'Project Details' tab.

Project Details Project Header banner_v2.png 

2.  Select a section in the index at the top right of the screen, and click Edit. You can toggle between the different sections in the tab using the 'Index' or click '<<Previous' or 'Next >>'. You need to select 'Edit' for each section of the Project Details as they operate independently.

Project Details Ethics Information buttons.PNG 

You will receive a warning that the Project Details will be checkout to you. Click 'OK'.

Project Details.JPG 

You are only allowed to edit the section when its status is 'Pending'. If you wish to edit the section and it has a different status, the following with apply:

  • If the status is 'In Use': you may need to contact the Project Member who is editing the form.  The other Project Member must click 'Cancel' or 'Save & Close' to release the lock on the form. If the Project Member is away for an extended period the CPI, CPI Delegate, PI or PI Delegate can 'Force Check-in the form. Alternatively, you may contact the RGS Administrator to 'Force Check-in' the form.
  • If the status is already 'Completed': the form must be unlocked first by clicking 'Unlock'.  This can be done by any Project Member.
  • If the status is already 'Authorised':  the section must be unauthorised first by clicking 'Unauthorise'. Only the CPI, CPI Delegate, PI or PI delegate can unauthorise their relevant sections.                                              

3.  Update the relevant fields.  All mandatory fields have a red asterisk (*) next to them.  Placing your pointer over the information iconinformation icon.jpg on the right-hand side of the screen will provide you with tool tips and information about the section or field to be completed. The tooltips can only be seen on 'Edit' mode.A subsection within Ethics Information is shown below:

User tip: Click 'Save' every 5-10 minutes to ensure entered data is saved. You can click 'Save and Close' at any time and log out of the RGS and then return to the form later.  

Project Details Ethics Information fields.PNG
 
4.  Click 'Save' to save changes, 'Save & Close' to save changes and exit 'Edit' mode, or 'Cancel' to discard any changes made. Changes will not be made to the Project Header until it is authorised by the CPI or CPI Delegate. 
 

Mandatory fields

If a mandatory field is left blank when you 'Mark Complete', you will receive a notification error and the RGS will automatically highlight fields that require mandatory information entered.

Project Details Ethics Information mandatory field error.PNG
Entering data in multi-select fields

If a field allows multiple selections, click on the desired option to add it into the list.  If you have selected an option in error and wish to remove it, click on the X beside the option.  Note: Clinical Trial Phase is multi-select, nominate multiple phases if required.

Project Details Ethics Information nhmrc for.PNG

Entering data in rich text fields

Rich text fields show a character or word count on the bottom left-hand corner of the box.  Use this as guide to ensure you do not go beyond the limit; otherwise, you will be prompted with an error.  
 
Project Details Ethics Information rich text count.PNG
 
You may also drag the border of the box to extend its length.   
Project Details Ethics Information rich text drag.PNG
5. Click 'Mark Complete' when all information in that section has been entered. The status of the section will update to 'Completed' to inform other Project Members that this section is now final and ready for authorisation. Any Project Member who is currently editing the section may click 'Mark Complete'.
 
Project Details Ethics Information mark as complete.PNG​​
Any Project Member can edit a section with the 'Completed' status by clicking 'Unlock'.

Unlock.png 


6. If the status is 'Completed', the section is ready for authorisation by the CPI, CPI Delegate, PI or PI Delegate (refer to 'Project Member Role to Authorise / Unauthorise Project Details'). If a section of Project Details is not authorised an alert at the top of the page will be present.

NMA PH5.JPG 

Completed.JPG 

 7. If you are the relevant role, click 'Authorise'.
Authorise.JPG 
 

Complete the Project Header information

1. In the project's workspace, click on the 'Project Details' tab.

Project Details tab.png 

2.  Select 'Project Header' in the index, and click 'Edit'.

Project Details Project Header section.png 

You are only allowed to edit the section when its status is 'Pending'

  • If the status is already 'Completed', the form must be unlocked first by clicking on 'Unlock'.  This can be done by any Project Member.
  • If the status is already 'Authorised', the project's CPI, CPI Delegate, PI or PI Delegate must unauthorise the form first by clicking on 'Unauthorise'.

3.  Update the relevant fields.  All mandatory fields have a red asterisk (*) next to them.  Place your pointer over the tooltips to read more information about the section or field to be completed.

            Project Details2.JPG 

4.  Click 'Save' to save changes, 'Save & Close' to save changes and exit 'Edit' mode, or 'Cancel' to discard any changes made.

5. When the project header is complete, click 'Mark Complete'. If you are the CPI, CPI Delegate, PI or PI Delegate, click 'Authorise'.

Once authorised by the CPI, CPI Delegate, PI or PI Delegate, the project header, found on all standard pages within the project's workspace, will be updated to show the updated information.

Complete Project Header for National Mutual Acceptance

WA Health is the Lead HREC (With a WA Health Specialist HREC)

1. For NMA, if a WA Heath HREC is the Lead HREC, select 'No' to the question 'Will the project be reviewed by a Lead HREC outside of WA Health (i.e. external Lead HREC)?'. Select the Lead HREC and add an Additional HREC (Specialist). Currently the Department of Health (Department) WA HREC is the only WA Health Specialist HREC and should be selected if access to the Department data collections or data linkage is required. Refer to Help Wiki: WA Specific Information.

NMA PH.JPG 

2. When complete, click 'Mark Complete' and 'Authorise' (refer to Help Wiki: Complete the Project Header information).

WA Health is the Lead HREC (Without a WA Health Specialist HREC)

1. For NMA, if a WA Heath HREC is the Lead HREC, select 'No' to the question 'Will the project be reviewed by a Lead HREC outside of WA Health (i.e. external Lead HREC)?'. Select the Lead HREC. No Additional HREC (Specialist) is selected.

NMA PH1.jpg 

2. When complete, click 'Mark Complete' and 'Authorise' (refer to Help Wiki: Complete the Project Header information).

External Lead HREC (With a WA Health Specialist HREC)

1. For NMA, if an External HREC (outside of WA Heath) is the Lead HREC, select 'Yes' to the question 'Will the project be reviewed by a Lead HREC outside of WA Health (i.e. external Lead HREC)?'. Select the Lead HREC jurisdiction and the External Lead HREC. The HREC must be participating in the NMA (Refer to NMA HREC, RG Offices and Organisations). Enter the External HREC Reference number if known; this is important for national reporting.

Add an Additional HREC (Specialist). Currently the Department of Health (Department) WA HREC is the only WA Health Specialist HREC and should be selected if access to the Department data collections or data linkage is required. Refer to Help Wiki: WA Specific Information.

 NMA PH2.JPG

2. When complete, click 'Mark Complete' and 'Authorise' (refer to Help Wiki: Complete the Project Header information).

External Lead HREC Only

1. For NMA, if an External HREC (outside of WA Heath) is the Lead HREC, select 'Yes' to the question 'Will the project be reviewed by a Lead HREC outside of WA Health (i.e. external Lead HREC)?'. Select the Lead HREC jurisdiction and the External Lead HREC. The HREC must be participating in the NMA (Refer to NMA HREC, RG Offices and Organisations). Enter the External HREC Reference number if known; this is important for national reporting. No Additional HREC (Specialist) is selected.

NMA PH4.JPG 

2. When complete, click 'Mark Complete' and 'Authorise' (refer to Help Wiki: Complete the Project Header information).

Add the funder details in the Governance Information

1. All funders (both monetary and in-kind) involved with the project must be added to question 7 in the Governance Information section of the Project Details tab before the governance forms are commenced, as this information is populated into the Budget Form. If you cannot find a funder, contact the RGS Support.

2. For monetary funding: the funder organisation is where the funding or grant is coming from (e.g. the sponsor or NHMRC), not who the administrating organisation or contract research organisation is. There may be several funders providing monetary funding in a project. The administrating organisation or contract research organisation details can be added to question 7.1 for invoicing.

Funder.JPG 

3. For in-kind funders: the funder organisation is the one that is providing the in-kind support, examples include:

  • in-kind support of project member's salaries if they are not covered by monetary funding; their employing organisation must be nominated (e.g. Royal Perth Hospital)
  • in-kind support by organisations hosting HRECs and RG Offices for the ethics and governance review fees that are not charged for non-commercial projects (e.g. East Metropolitan Health Service Executive).

Contact the Ethics and RG Offices to find out how much should be recorded in the Budget Form either for monetary fees or in-kind support. If the latter, also ascertain which host organisation name should be added as a Funder.

Funder2.JPG 

Authorise or unauthorise a section of the Project Details tab​

Authorise

Only the CPI, CPI Delegate, PI or PI Delegate (refer to 'Project Member Role to Authorise / Unauthorise Project Details') have the authority to authorise the Project Details sections once it has the 'Completed' status.

1. If you have the authority to authorise (or unauthorise) a project the 'Authorise' button will appear at the bottom of the screen.  Click on 'Authorise' to mark the specific section of Project Details as 'Authorised'.

Ensure there are no pending membership invitations before you authorise the Investigator Contact Information.  This means, there should not be any rows under 'Invited' in the Members tab.

Project Details Ethics Information authorise.PNG

​​2. Once relevant sections are authorised, Project Members can add new forms in the Forms & Documents tab.

Forms and Docs menu.pngUnauthorise

Only the CPI, CPI Delegate, PI or PI Delegate (refer to 'Project Member Role to Authorise / Unauthorise Project Details') have the authority to unauthorise a Project Details section once it has an 'Authorised' status. 

1. If you wish to make changes to the section but the status of the section is 'Authorised' the section must be unauthorised by clicking 'Unauthorise'. 

Systematic unauthorisation of the Project Details tab

​Note that changes to other tabs in the project workspace will trigger certain sections of the Project Details tab to be automatically unauthorised, and reverted back to 'Completed' status. This is to show Project Members that updates have been made to the relevant tab:

Project Details Section

Project Workspace Tab

Ethics Information

Unauthorised when there are changes to the project sites (Sites tab)

Investigator Contact Information 

Unauthorised when there are changes to the project sites (Sites tab) and/or in the project membership (Members tab)


If the user changes anything in Project Details tab, any Active forms (i.e. unsubmitted) marked as complete must be unlocked, to ensure there are no additional questions that have to be answered or answers that should be amended.      

 Other references

Researchers Training Manual (Part A)

Researchers Training Manual (Part B)

               
 

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