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18/02/25 - Project updates available 20/02/2025.
Update to HREA:
Changes to sites / Committee names
Update to Mater forms:
Major changes to the Mater Waiver SSA (renamed to Mater SSA – Short-form) and Mater Progress and Final Report forms.
Minor changes to Mater SSA, Amendment and Quality Assurance and Case Report forms.
17/10/24 - Project updates available.
Update to Queensland Health forms:
Minor updates to forms.
11/07/24 - Project updates available.
Update to Mater forms:
Four new Safety reporting forms introduced, to bring processes in line with current safety reporting requirements. These forms replace the current Safety Report and IB Updates form. The Serious Adverse Events form has been significantly modified.
Update to Queensland Health Forms:
Minor updates to subforms.
Update to VIC Forms:
The Victorian Low and Negligible Risk (LNR) VIC form has been renamed to Low Risk VIC form to align with the National Statement regarding low risk pathways for research projects in Victoria.
NEW: Low Risk Notification Form (used for the purpose of either an Amendment, Progress Report, Site Audit Report and Final Report) as a subform of the Low Risk VIC Form.
21/03/24 - Project update available 21 March 2024
Update to HREA:
-Update to include VIC site
Update to Mater forms:
-Major changes to layout of Amendment and Exempt Research forms, introduction of new QA Projects and Case Reports form, minor changes to SSA form.
Update to Victoria Forms:
-Minor updates to subforms
14/12/23 - Project update available 14 December 2023
HREA -
- Updates to hyperlinks such as National Statement, ARDC, Privacy Act
- Minor changes to questions and supporting information such as punctuation marks, text changes
- Dependency changes to one question stream:
The ‘Consent 1’ question set (Q2.2.1-Q2.2.2.3) and the ‘Alternatives to consent’ question sets (Q2.2.7-Q2.2.8) have been added so they appear alongside the ‘Consent 2’ question set when ‘Data associated with human beings only (i.e. as the primary object of research)’ is selected at Q1.18 AND ‘No’ is selected Q1.18.1.
This addition will allow a waiver of consent to be selected in the same proposal for a project involving data and does not involve the prospective collection of data.
Update to Queensland Health Forms:
Minor changes to Site Specific Assessment Form
Update to Mater forms:
Minor changes to pre-HREA questions, SSAs, Amendment and Exempt Final Report forms.
Sunday 15/10/2023 - This is a courtesy notice to advise that a systems maintenance event will occur at 0500 hours AEDST.
Sites will be unavailable to researchers and review side users alike for a duration of 30 minutes.
28/09/23 - Project update available 28 September 2023
HREA - Modifications to:
- Mater Fee Questions
- Target recruitment question.
Update to Queensland Health Forms:
Additional wording/corrections to SSA Form and Exemption Form.
Update to Mater forms:
Extensive changes to Mater SSA format and questions, changes to Mater Study Funding type on HREA, Mater SSA and Amendment forms
28/06/23 - Project update available 29 June 2023
HREA - Question numbering has been added to pages
Update to Victoria Forms:
QA VIC form includes additional signature options for the Head of Department and Principal Investigator.
Update to Mater Forms:
- Changes to study funding, contact and signature questions on Mater SSA, QA and Exempt and Amendment forms.
- Minor changes to Progress and Safety report forms.
Update to Qld forms
-Minor update to SSA Form Qld and Site Closure Report Form - Multi Centre Research Qld.
16/3/23 - Project update available 16 March 2023
HREA - Updated Clinical Trial / Does your research involve Children and Young People / Paediatrics questions
29/11/22 - Project update available 8 December 2022
Update to Victoria Forms:
Minor update to PreHREA questions.
Minor Change: Change to name of a Human Research Ethics Committee in Victoria:
- Update of organisation name from Ballarat Health to Grampians Health on sub forms.
Update to Mater Forms
Question and wording changes to Mater SSA and Progress and Final report forms.
Multiple changes made to Authorised Prescriber forms to collect relevant information as required by the Authorised Prescriber Scheme.
Update to QLD Forms:
Minor update to Pre-HREA questions.
12/09/22 - Project update available 15 September 2022
Update to Victoria Forms:
Minor update to the 'Project Progress Report' and 'Site Progress Report' forms.
Update to Mater Forms:
Wording changes to questions on multiple Mater forms, to make questions more easily understood.
Update to Queensland Forms:
Minor update to the Site Closure Report Form - Multi Centre Research Qld.
28/06/22 - Project update available 30 June 2022
Update to Victoria Forms:
Update to Site Progress Report
Minor update to Safety Report VIC to update link.
Update to Mater Forms:
Changes to questions and wording on Mater SSAs, Mater Progress and Final report form, Mater Safety Report form and Early Phase Risk Assessment form.
Update to QLD:
Change to HREC names ‘Royal Brisbane & Women’s Hospital HREC’ and ‘The Prince Charles Hospital HREC’ appearing in the drop-down options in the HREA/MDF/Exemption forms. Applicants will instead see Metro North Health Human Research Ethics Committee A and Metro North Health Human Research Ethics Committee B.
All Ethics sub forms will route directly to the reviewing HREC
Minor update to the SSA form QLD.
Update to MDF
8 December 2022
Update to Victoria Forms:
Minor update to PreHREA questions.
Update of organisation name from Ballarat Health to Grampians Health on sub forms.
15 September 2022
Update to Victoria Forms: Minor update to the 'Project Progress Report' and 'Site Progress Report' forms.
Update to Mater Forms: Wording changes to questions on multiple Mater forms, to make questions more easily understood.
Update to Queensland Forms: Minor update to the Site Closure Report Form - Multi Centre Research Qld.
30 June 2022
Update to Victoria Forms:
Update to Site Progress Report
Minor update to Safety Report VIC to update link.
Update to Mater Forms:
Changes to questions and wording on Mater SSAs, Mater Progress and Final report form, Mater Safety Report form and Early Phase Risk Assessment form.
Update to QLD:
Change to HREC names ‘Royal Brisbane & Women’s Hospital HREC’ and ‘The Prince Charles Hospital HREC’ appearing in the drop-down options in the HREA/MDF/Exemption forms. Applicants will instead see Metro North Health Human Research Ethics Committee A and Metro North Health Human Research Ethics Committee B.
All Ethics sub forms will route directly to the reviewing HREC
Minor update to the SSA form QLD.
Update to MDF
10 March 2022
Update to Victoria Forms:
Update to SSA form to include teletrial questions.
Update to SSA form to include additional signature methods.
3 March 2022
Update to Victoria Forms:
Update to SSA form to include teletrial questions.
Update to SSA form to include additional signature methods.
Update to Mater Forms:
Minor Help text modifications to Mater SSA and Amendment forms
Update to pre-HREA: New recruitment questions
9 December 2021
Update to Victoria Forms: Minor Update to include guidance in completing Sponsor Details sections.
Update to Mater Forms: Mater has released a new form (Waiver SSA), updated the Mater sites on several forms and applied minor fixes to forms.
15 September 2021
Updates to HREA and MDF - minor changes including NMA guidance, new Covid-19 question and committee name change
Updates to Mater Research forms - New Form available for Exempt projects - "Final Report or Extension Request"; minor changes to SSA, Project Report form and Early Phase Risk Assessment.
Updates to Victoria forms
Updates to Queensland forms version 2.19: Minor spelling changes to the SSA Form to correct typo
Note: If the project contains a form that has pending/recent signatures and has not yet been submitted, update after you have submitted the form (otherwise updating will invalidate the electronic signatures). Please contact HIIRO 07 3082 0629 or HIIRO_REG@health.qld.gov.au for assistance updating your project.
* The form's version number is displayed in the heading of every form page
17 June 2021
Updates to Mater forms: New ‘Mater Honours Student Project’ application form available; minor changes to Mater SSA, Mater Biomedical SSA and Mater Progress and Final Report forms
11 March 2021
The project update available 11 March 2021 covered an update to the HREA and MDF form - committee name change.
8 February 2021
The project update available 10 February 2021, only affects the HREA and MDF forms, all other forms are unchanged at this time. Northern Territory are now part of the National Mutual Acceptance (NMA) Scheme for single ethical review, and will be available for selection in several questions within the HREA and MDF.
5 November 2020
In the latest release, 5th November 2020, the following changes have been made to the Project Page:
-A new column called 'Action required' replaces the 'Ready for Submission' column. This column indicates if any actions are required by the user - Yes or No.
-When the 'Action required' displays Yes, the text is blue, and the user can click it to run completeness check. This lists the actions required before the form can be submitted.
-The column header 'Status' replaces 'Review Status'. This column indicates the status of the form.
-Prior to submission, the status will now display as 'Not submitted'.
21 July 2020
Queensland Health are starting to phase out the use of the LNR form for low risk applications and moving towards utilising the HREA for all research.
Please consult with your local research office to ensure you are completing the correct form
16 July 2020
Project Update
Mater Form Update:
• Additional Contact Email field added to Contact questions
• Removed questions no longer required from SSA
• Added Help Text to Early Phase Risk Assessment form
QLD Form Update:
• Updates to Q1.1 in SSA form marking as a mandatory question for applicant
• User-friendly look and feel changes in SSA and LNR SSA contacts section.
• Pathology will be accepting SSA applications (Governance (RGO) only) submitted through the ERM system.
• To modify question related to ‘Sequential Id’ in sub forms and to allow provision to add appropriate reference text as form names
• Minor changes to the PRE-HREA filter questions have been implemented to simplify the collection of clinical trial and study site information.
30 April 2020
Project update
HREA Form Update
• New Mater-specific questions in HREA filter questions
Mater Form Update
• New Mater locations added to Mater SSA and Amendment forms
• New question added to Mater Serious Adverse Event Follow-up form
QLD Form Update
• Updates to options in the drop-down list of question Q6.A (“What is the phase of this drug trial or stage of this device trials?”) in the SSA form.
• Uploading the Researcher CVs file is no longer a mandatory requirement for SSA application submission.
• Fixed the issue that allowed creation of HREC Amendments before the HREA/LNR application was approved.
• Fixed the issue that prevented ‘Further information’ from being submitted for data migrated applications.
3 May 2019
Project update
HREA form update
• new document question for Cover Letter and Response Letter.
• update to Q4.3 Northern Health - Low Risk Research Ethics Committee
Mater form update
• Minor changes to Mater forms, including introducing electronic signatures only on all Mater forms.
QLD form update
• All forms including signature question(s): Updated the text at the end of the form to “Once you have received all requested signatures you can submit the form (action on the left panel).”
• All forms not including signature question(s): Updated the text at the end of the form to “When you have completed uploading all documents please remember to submit the form (action on the left panel).”
• LNR SSA form: Fixed the mapping between question 1g and Cairns HHS
• HREC Amendments QLD – Post Approval form: Set the ORCID field to be not mandatory
29/03/2019
Project update
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.
1/03/2019
Project update -
- Mater forms update v2.5 - Minor updates to Mater SSA, Serious Adverse Event, Progress and Final Reports, Other Safety Reports and QA and Exempt forms.
- Queensland Health forms will be updated with minor changes that include changing the CPI, PI and Form Contacts from dynamic lists with a drop-down menu to static questions and a new question to enter sequential submission numbers for selected post approval documents.
17/1/2019
Planned outage. Software update v2.0.4.1 - Hot Fix for bug ERM-410
16/1/2019
Planned outage. Software update v2.0.4.0
14/12/2018
Mater RGO Data migration. Planned outage from Friday 14 December 7pm AEDT through to Monday 17 December 8am AEDT.
13/11/2018
Project update to occur on 16 November 2018.
18/10/2018
Project update to occur on 19 October 2018. New Mater SSA Form.
24/9/2018
FIX APPLIED for issue whereby no QLD amendment forms were available in the subforms list for Migrated DM HREC forms as changes were made to subforms and QLD removed their old amendment form. The newer sub-forms were not reflected in this version of the DM HREC form as the form was locked. An update button is now available for projects with this scenario.
Applications to Queensland
We have updated the QLD SSA form so that researchers can use it to create a subform for Amendments, Reports and Notifications for an authorised Site Specific Assessment form that is NOT already in Ethics RM.
We also created an option for a very short form to facilitate researchers to submit SSAs that were completed in On-line forms but not uploaded into AuRED prior to data migration.
The publication of this updated form should resolve the main issues raised by researchers during the data migration and implementation phase of Ethics RM.
If a QLD SSA was created prior to 6 August 2018, please download the documents and print the SSA prior to updating the form. This will ensure that you have a copy of the data when the project is updated.
Guidance for researchers:
The ERMS forms for QLD have been updated. To complete the current version of a form, please click on update form or project, if requested.
For each project, you must create the SSA as a sub-form of your main ethics (or MDF) form.
To create a sub-form, you must go into your main project and click on create sub-form action in the left Action pane.
The SSA form is then generated.
The QLD SSA form has been updated to now ask you to choose between 3 purposes of the form i.e.
1. a new SSA
2. create an SSA for an SSA form that was not uploaded into AuRED before 13 July 2018
3. to be created for the purpose to allow the creation of sub-forms for post-authorisation, amendments, reports and notifications for the RGO only
It takes less than 10 minutes to complete options 2 and 3.
After you submit your QLD SSA form, you create a sub-form on the SSA by clicking on the create sub-form action in the left Action pane. Select the sub-form you require, in this example it is “Amendments, Reports & Notifications (RGO)”.
TIP: You will be asked to select what type of document you are submitting. Use the “other” option if anything doesn’t fit the categories.
Note: You will be asked to sign the form and submit (note the parent form must be submitted first).
Thank you again for your patience during ERM data migration and implementation.
ERM is used to create and submit all applications and post-approval reports for Mater Health, Queensland and Victoria. You should be able to log into with your existing Online Forms email login and password if your submitted application/s have been uploaded to Mater Health, Queensland and Victoria's Research Ethics Database (RED) systems (and the password can be reset if you have forgotten it). Please see FAQs on how to use the system.
PLANNED OUTAGE 5pm 10 August to 9am 13 August 2018. The purpose of this downtime is to migrate information provided by researchers in the past that have been stored on the research ethics database (RED) system.
If you are the project or form owner of a project or have been given access to a project through shared roles, you may notice new forms in your project tree.
• DM HREC PAF (Data Migration HREC Post approval form) or DM SSA PAF (Data Migration SSA Post authorisation form). This is a form with data that has been copied from the RED system relating to the study status and any reports provided and tracked by the research office. This is a READ ONLY form. This form cannot be modified or re-submitted. No further action is required for these specific forms. For additional updates to the research office, Researchers should use post approval/authorisation subforms created by VIC, QLD, Mater such as progress reports and safety reports and so forth.
• DM HREC Amendment or DM SSA Amendment. This is a form with data that has been copied from the RED system relating to amendments that have been provided to research office. For Amendments that have been approved/authorised, no further action is required. Note: for amendments that were sent to the research office prior to 13 July that appear in your ERM account as an DM HREC Amendment or DM SSA Amendment, if the research office requests any further information or modifications, this will need to be sent via the Correspondence tab or via email. This form cannot be modified or re-submitted. For new amendments, Researchers should instead use post approval/authorisation subforms created by VIC, QLD, Mater such as amendments, progress reports and so forth.
The migrated Amendments may include supporting documents. Between 13 August to 20 August, these documents that appear will be place holders only. You will get an error if you try to open the documents. Documents can be opened after 9am 20 August 2018. Documents will be migrated from 5pm 17 August to 9am 20 August. NOTE: we do not anticipate any down time during the migration of the documents, however Ethics RM performance may be affected.
16 July 2018 - As part of the go live to Ethics RM, HREC/SSA applications associated with VIC/QLD/Mater that were registered in the research ethics database (RED) system were also migrated into Ethics RM.
• DM HREC MDF (Data Migration HREC Application). This is a form with data that has been copied from the RED system. If the research office uploaded the submission code, then a copy of the Application PDF, Supporting documents and contact details will have been migrated. This is a READ ONLY form. This form cannot be modified or re-submitted.
• DM SSA MDF (Data Migration SSA Application). This is a form with data that has been copied from the RED system. If the research office uploaded the submission code, then a copy of the Application PDF, Supporting documents and contact details will have been migrated. This is a READ ONLY form. This form cannot be modified or re-submitted. |