NEXT PLANNED OUTAGE 

Project update to occur on 29 March 2019 

MUST READ - 

You will see a warning message to update your project at the top of the form if your form was included in the update.

We advise that for any un-submitted or un-locked form(s), complete the signatures and submit the form WITHOUT updating the project to avoid losing data and re-signing the form.

This will mean any NEW questions added to the form or new rules will not apply to that version of the form. Please remember to update the project AFTER you have submitted.

IF YOU CHOOSE TO UPDATE, always print and save a copy of any un-submitted or un-locked form(s) before updating. WARNING! Answers in the form may disappear as the question or dependency may have changed.

 

HREA form update

new document question for Participant Information and Consent Form (Tracked) and  updates to document dependencies.

Victoria DHHS forms update

date field added to all post-approval and post authorisation forms
PICF question added to Amendment Request Form.

Queensland Health form will be updated with minor changes that include:

LNR 

    - Increased the size of the field of the question 9 “Description of the Project in Plain Language:” to 4000 characters (this question is shared with LNR SSA form)
    - Added “pop-up help” message for question 9. “Description of the Project in Plain Language:” 
    - Amended wet-ink signature upload to add version date 

SSA 
    - Other Documents to be given to Participants upload -now requires version and date
    - The signature block for Associate Investigator (AI) - Mandatory when AI is required to sign
    - CRO /Sponsor question renumbered to 7.3a and only displays and is mandatory if answer of the precursor question is “Yes”.
    - Swap order of question 7.4a and 7.4b
    - Added “pop-up help” message for question 2 “Description of the Project in Plain Language:”

LNR SSA 
    - New questions for entering the Associate Investigator details, CV and signature if applicable
    - New questions for entering the Head of Department details, CV and signature - now NOT mandatory
    - Updated text of question 6c to “For each supporting department, please complete the table below”.
    - Updated text of question 6d to “Please upload a Letter or Email of Support from each Head of Department listed above who is not signing in the Declarations and Signatures section.” – now NOT mandatory

Post Authorisation Notification Form – RGO
    - Re-added “Department of Health Queensland - RGO Only” to the drop-down list in the question “To which RGO in Queensland will this Post Authorisation Notification Reporting Form be submitted?”.

All forms 
    - CV Upload Document questions updated to require date but NOT version.
    - Questions shared from Main forms (HREA, LNR, MDF) with Subforms were updated to be NOT mandatory in the Subforms.  Note: Some questions may still be mandatory in the main form.

Mater Health have made a few minor updates to the following forms:
Mater SSA;
Mater Safety Reports, IB updates and Other Documents.


To login go to the black menu bar at the top and click LOGIN