REGIS Operational Webinar (2 August 2019)

Issues Resolved HREA - 1.9.10 role must be CPI – The system will not allow a submission of the HREA without a “Coordinating

Principal Investigator” and only 1 CPI.

Ethics amendments – addition of site. The Research Office can now process/approve multiple site additions on

one form.

Annual Report Form - Change is to fix an issue where previous CPI’s are showing on the Final/Annual progress

report form used by milestones.

Support tickets raised due to an issue where documents/attachments are missing after amendment submission.

After some investigation we have identified that the issue occurs when you submit a new version of a document

where the title of that document exceeds the 100 character limit.

Support tickets where users have had an issue submitting an SSA form due to a “Department head must not be

a PI or CPI for this site” validation message. We found that this occurs due to a combination of an error in

validation logic in the SSA form and when CPI information in the SSA form is missing.

HOD reminder email – link sending them to wrong location, location they were unable to review.

Issues Resolved – being tested Ethics amendments spontaneously un-submitting.

CSV download error

Reviews – multiple emails being sent to reviewers

(PID) editors can see option the share/edit but can't use it - should not be able to see

Application transfer failed to load project - 2 risk categories listed

Dash in the file name

Users can't change profile

Deleting related document with tags

Final report milestone being set to achieved

Potential Issues/Under Investigation Known issue: The “Pending Email” tile on homepages is currently showing data migrated files.

Work around: in the filter Without tag enter migrated.

ETA: in progress

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Known issue: Tags – The Ethics Pathway tag is not visible to a site that is not related to the HREC.

E.g. HREA submitted to HNE and there are sites at John Hunter Hospital, RPAH and Bathurst. RPAH and Bathurst

do not see the tag.

ETA: in progress

Known issue: Email template - addition of site approval email. Instances of incorrect site pulling though.

Work around: Manually correct in email.

ETA: in progress

email templates are also currently being looked at by the email working group.

Known issue: Site applications appearing as Eligible without ethics approval – should be Valid.

Work around: Report to helpdesk, then manually change status to Valid.

ETA: in progress

Site Application (SSA) output

Review completed, currently being tested

QRG’s Updates

None

Practical Demonstrations

Document Management/Related Documents - Changing Title and Type

NOTE: this functionality isn’t available for all document types as there could be system implications if this

document was to be changed. We are working with the vendor to confirm this is still essential given the system

changes over the past 12 months.

Documents that CAN’T be edited: Acquittal Report, Application Attachment, External Milestone Review Report,

General Amendment, Local Safety Events Report, Merged Documents, Milestone Documents, Milestone

Minutes, Milestone Report, Other, Project Agreement Approval Minutes, Project Agreement Schedules, Project

Agreement Variations, Project Agreements, Recipient Created Tax Invoice, RGO Brief, Serious Breach

Notification Report, Significant Safety Issue Report, User Generated Email, User Submitted Documents.

The screenshots below are different to the screenshots in the recorded webinar.

Manual Management of Related Document in the Internal Portal.

You must first click Edit on the left hand menu to complete any manual management of documents.

The document must be “Not visible in related projects applications” to edit it.

Any document that isn’t an “Application Attachment” can be managed in the internal portal.

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Click on Edit

Change the Document Title

The Document Title is the information that will pull through to the approval/authorisation communications.

Type the document title to appear in the internal and external portal.

Click save

Change the Document Type

Click the dropdown menu and start typing the new document type, this will reduce the menu options, or scroll down the

list until you locate the document type you want. This will appear in the internal and external portal.

Click Save

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Replacing/Merging

Use this function to manage document versioning in the internal/external portal. Click the Replace file toggle to

Yes and the select document wizard will appear. Click or drag and drop the new document to replace the

previous version.

The electronic file name DOES NOT need to be the same as the original. The system will

keep the original electronic filename. NOTE: You cannot change the Title/Type AND Replace file at the same time. If you are completing multiple steps

the Replace/Merge function has to be done separately.

How does it look on the External Portal?

In this example the Ethics application document title has been changed.

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How the system recognizes ethics approval in a STE when ethics is approved

outside of NSW/ACT. External Document Type “Ethics application decision

notification”

Research Governance Offices have reported instances where they can see an ethics approval letter in the

related documents but the system will not let them make the RGO recommendation. The system is looking for a

document type “Ethics application decision notification”.

If the document has been uploaded as part of a .zip you should save the document to your desktop and

manually upload the document, make sure you select document type to “Ethics application decision

notification”.

If the document exisits under another external document type, that can be edited, use change type/tile

instructions to change document type.

If there is no approval uploaded. The applicant can do this or you can manually upload it.

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Start Menu

FYI, this all personal preference:

Classic: Vertical:

Vertical: Start Settings (above log out) Menu style vertical save

The vertical menu is docked, meaning it is always there you don’t have to use the start icon every time but the

icons can not be reordered.

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Transfer HREC after approval

ETHICS

If an approved study is wanting to transfer HREC the current RO can mange this in the internal portal. The HREC

is known as the Principal organsation. This is seen in the summary page. Ethics project Details Summary

To change the Principal Organsiation navigate to Details Organisations

Click Edit the select the hamburger and + Add organisation

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The black pannel will pop out of the righ hand side of the screen. Here you search for the new HREC.

Select Organsation type Select HREC

Justificatoin Enter why the change is occuring

Principal Change toggle to the green yes

Click Ok then Save

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Governance

To change the Principal Organsiation navigate to Details Organisations

Click Edit the select the hamburger and + Add organisation

The black pannel will pop out of the righ hand side of the screen. Here you search for the new HREC.

Select Organsation type Select Lead HREC

Justificatoin Enter why the change is occuring

Principal Change toggle to the green yes

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The system will change the Ethics security setting so the new research office will be able to manage the ETH

project.