Frequently Asked Questions

What is Ethics RM

It is an Ethics Application System

Which jurisdictions use Ethics RM?

Research proposals should be submitted via Ethics RM to Human Research Ethics Committees (HRECs) associated with public health institutions in the following jurisdictions: Queensland, Victoria or Mater Research (Brisbane, Qld).

How do I know if I have an Ethics RM account?

If you owned an application that was submitted prior to July 2018, then you should be able to login with the same details as your AU Online Forms account. If your email address and password does not allow you to gain access, contact helpdesk@infonetica.net.

How do I create an Ethics RM account?

Click on "New User". Fill in the applicable information (you can skip fields that are not relevant to you), and agree to the Terms and Conditions. NOTE: Password must be 8+ characters long, contain both upper and lowercase characters and contain at least 1 number. Click "Register" and an activation email will be sent to the entered address. Access email and click the activation link provided. Return to the login page and click "Log in".

How do I change my password?

To change your password click on your name in the top right corner. Click on Change Password. You will need to enter your old password, then enter your new password and reconfirm the new password.

I have forgotten my password what do I do?

Click on "Forgotten Password" on the login window. Enter your email address. You should receive an Password Reset email with the link. If you do not receive an email eg yahoo emails do not accept donotreply@infonetica.net emails, please contact Helpdesk@infonetica.net to reset your password.

My details have changed what do I do?

To update your details click on your name in the top right corner. Click Edit Person Details and edit the required fields. To update your email address/login you must email Helpdesk@Infonetica.net please also provide a contact number.

When an Ethics RM User is flagged as Unavailable, what do I do?

Ethics RM users can flag themselves as Unavailable. To update your availability click on your name in the top right corner. Click Edit Person Details and edit the required fields. By clicking unavailable, other Ethics RM users cannot share a form with your or request a signature and when they try to, a red message "User is not available" will appear. If you know they are available you may need to contact the person and ask them to update their availability so that you can proceed with your application. If an Ethics RM user has set their status as unavailable. A message will appear when they next login to remind the user to update their status "You are currently set as unavailable, go to Personal Details to change this".

I cannot see a project in my account from RED (legacy system) what do I do?

The owner of the project or form migrated from the RED system will be the applicant. If forms were not previously uploaded into RED then the owner will be the CPI or PI. For those with forms that were previously not visible in your Ethics RM account, we have resolved some of the issues, please go back into your account and check if the form appears. Please ask the owner of the project or form to use the Role action to share the form with you. If you still experience any issues please send through details of applications that need urgent action such as further information or amendments etc so that we can give you access to Helpdesk@infonetica.net with the following - - Reviewing Ethic Committee or Research Governance Office; - Project Title; - HREC reference number; - Submission code; - Coordinating Principal Investigator/Principal Investigator.

I cannot re-submit further information/modifications for a project migrated from RED (legacy system) what do I do?

A form migrated from RED (Legacy system) cannot be unlocked or re-submitted. This is a READ only form; even if the form has not been approved. All correspondence including documents and changes to the form should be sent via Correspondence or email.

I cannot open document in Amendments migrated from the legacy system what do I do?

The migration of projects from the legacy system is a 2 week process. Weekend 1 (10 August-13 August) included the migration of the application + a shell/placeholder for the documents. Weekend 2 will include the migration of the documents. If you try and open the documents you will get an error until the documents have been migrated across.

How do I delete a project?

Click on "Home" to get you back to the Work Area page. Click on the "Delete Project" Action's tile. Select the project you wish to delete and click "Delete" Note: A project that contains submissions cannot be deleted. Reconfirm by clicking "Yes" if you wish to remove the item.

What does duplicate project do?

Duplicating a project will create an exact copy of the project including all the associated forms, except for documents upload in the original forms and electronic signatures. NOTE: You cannot change the jurisdiction to which the form is pointing to. You should only duplicate a project if you are creating and submitting a new study with similar attributes to a previously generated project. You SHOULD NOT be duplicating a project to create subforms for the SAME project. All subforms should be created off the one project. If unsure, contact Helpdesk@Infonetica.net

What happens to my form if there is a newer version of the form?

If a newer version of the form is available for update you will be prompted to do so. If the questions in the form are unchanged, the data you have entered will remain. NOTE: Click "Update" Always print and save a copy of unsubmitted form(s) before updating. WARNING! Answers in the form may disappear as the question or dependency may have changed.

What do I do if a warning appears to update my project?

Always print and save a copy of the form(s) before updating. WARNING! Answers in the form may disappear as the question or dependency may have changed. "WARNING: The project owner must update your project in order to submit this form Update" The warning to update is because the jurisdiction has re-published their portfolio of forms, if the researcher is on an older version of the project then the project owner has to update the project. At this stage, it is recommended that the owner updates the project to ensure that applications and application rules are up to date as the jurisdictions are fine tuning their systems. Always print and save a copy of the form before updating. Note that the SUBMITTED form will not change, only if the form has not been submitted or if the form has been unlocked will the questions and/or rules change. The researcher needs to contact the owner of the form to update the project. "Note: This will update all forms within this project. Please note that if you have existing signatures within the project then they will be invalidated after updating" If the form has not been submitted and the owner updates the project, any new questions added to the form will invalidate any signatures received. You can decide to complete the signatures and submit the form without updating the project if you want, however this will mean any NEW questions added to the form or new rules will not apply to that version of the form. Always print and save a electronic copy of the form before updating. WARNING! Answers in the form may disappear as the question or dependency may have changed. "Note: There is a new version of the project." This is the message you will see if you are the owner of the project. At this stage, it is recommended that the owner updates the project to ensure that applications and application rules are up to date as the jurisdictions are fine tuning their systems. Always print and save a electronic copy of the form before updating. Note that the SUBMITTED form will not change, only if the form has not been submitted or if the form has been unlocked will the questions and/or rules change. When several versions of a project have been created, the jurisdictions may decide to no longer accept submissions from previous form versions in which case you/or the owner will need to update the project. Applicants may notice a new warning message when clicking into projects. : ‘This form is obsolete and can no longer be submitted’. This occurs because a form within the project, usually a DM HREC or an SSA MDF has been disabled and can no longer be submitted. No further action is required or can be undertaken. This message will not appear on forms that have not been disabled.

Why do I keep having to sign into Ethics RM?

The Researcher side (Forms) of the Ethics RM system is set to time out after 30 minutes. Please save your responses to the questions in the form regularly to avoid losing data.

Login issue - An error occurred while processing your request. Object reference not set to an instance on an object.

If you are experience the following error "An error occurred while processing your request. Object reference not set to an instance on an object." please try clearing the Cache and try logging in via a URL without any page extensions like this example https://au.forms.ethicalreviewmanager.com/Project/Index/000001 Use the following URL: https://au.forms.ethicalreviewmanager.com Scheduled outages also occur every Saturday lasting 5-10 minutes.

How do I clear my cache after a software update?

Most operating systems will automatically cache IP addresses and other DNS results, this is done in order to speed up subsequent requests to the same hostname. Sometimes bad results will be cached or code has been revised after an update and therefore needs to be cleared from the cache in order for you to communicate with the host correctly. All major operating systems allow you to force this process. Outlined below are the common steps you will need to follow in order to clear your cache - Chrome In the browser bar, enter: chrome://settings/clearBrowserData At the top of the "Clear browsing data" window, click Advanced. Select the following: • Cookies and other site data • Cached images and files From the "Time range" drop-down menu, you can choose the period of time for which you want to clear cached information. To clear your entire cache, select All time. Click CLEAR DATA. Exit/quit all browser windows and re-open the browser. Firefox From the History menu, select Clear Recent History. If the menu bar is hidden, press Alt to make it visible. From the Time range to clear: drop-down menu, select the desired range; to clear your entire cache, select Everything. Next to "Details", click the down arrow to choose which elements of the history to clear; to clear your entire cache, select all items. Click Clear Now. Exit/quit all browser windows and re-open the browser. Microsoft Edge In the top right, click the Hub icon (looks like star with three horizontal lines). Click the History icon (looks like a clock), and then select Clear all history. Select Cookies and saved website data, and then Cached data and files. Click Clear. After the "All Clear!" message appears, exit/quit all browser windows and re-open the browser. Opera From the Opera menu, select Settings, then Privacy & Security, and then Clear browsing data.... In the dialog box that opens, from the "Obliterate the following items from:" drop-down menu, select The beginning of time. Select the following: • Cookies and other site data • Cached images and files Click Clear browsing data. Exit/quit all browser windows and re-open the browser. Safari 8 and later From the Safari menu, select Clear History... or Clear History and Website Data.... Select the desired time range, and then click Clear History. Go to Safari > Quit Safari or press Command-Q to exit the browser completely.

Why can't I navigate to the next page of the form and why won't it save?

If you are completing the form and try to navigate to the next page of the form and it won't let you and the data will not save, you may have pasted data from MS-Word that the system does not accept, such as symbols. If you are pasting text from MS-Word, you must paste as plain text. This is to prevent the execution of malicious data/code. If you must use symbols, attach your response to the form in one of the document upload questions.

I don't have a submit button, what do I do?

A submit button may not be available for the following reasons - 1. You have not been given permission by the Project Owner to SUBMIT the form (ASK the project owner or other collaborators with submit permission to submit the form). 2. The project requires an update and the Jurisdiction has prevented the existing version of the form from being submitted (ASK the project owner to update the project). 3. The form has been disabled and is no longer accepted by the jurisdiction. Eg QLD HIIRO has disabled the Amendments, Reports and Notifications (RGO only) form and has also disable the ability to submit this form. If you are submitting an SSA Amendment this must be created as a subform of the SSA application, by selecting Post Authorisation Notification Form. If you open two browsers you might be able to copy and paste the data from one to the other. Once you have submitted the new subform, you might want to do some housekeeping and select the redundant form and click Delete Form (AFTER you have submitted the Post Authorisation Notification form).

What is Form Side Track Changes?

An introduction to the new forms-side track changes feature. This feature allows applicants to compare their form as it was when they submitted it last in comparison to its current state. If the form has been submitted previously, and is currently unlocked, a new button is available at the top-right of each form page: Compare With Previous Submission After clicking this button, the system will save any changes on the page and compare them to the state of the form when it was submitted last. A new side bar on the right-hand side allows applicants to navigate through their changes. As well as some details of their submission, the side bar contains two tabs. A list of every change on the currently viewed page is provided under the “This Page” tab, whilst opening the other tab, “All Changes”, will trigger a comparison of the entire form against the previous submission, and allow changes on other pages to be viewed: On the “All Changes” tab, each page can be expanded to view changes within it, making it easier to quickly hop to different parts of the form to see changes there. Applicants are able to click on any question title, either on the currently viewed page or another page, to hop straight over to that question to take a look at it. They will be scrolled to the question they have clicked on, and it will be highlighted with a red outline to clearly denote the change in question. The main page itself also shows details of the changes. Any questions or responses that are new since the last submission are highlighted in green, whilst anything that is no longer present is highlighted in red. Changes to the text are noted to make it easy to see even relatively minor changes within text bodies. Deselected items are highlighted in red, such as the radio button shown above, whilst new questions appear highlighted in green to clearly denote that they need the attention of the applicant. Other question types such as lists, signatures and document questions are also compared against the previous submission to indicate any changes in their content.

What is the timezone setting set to?

The timezone setting is set to Australia Eastern Standard Time (AEST).

Reasons why a process may be slow

If an applicant is uploading/downloading a document this can be slow because the file is large. If an applicant is creating a HREA or submitting a HREA this can be slow because of the size of the HREA. When submitting, the system can be slow because it has to create the PDF, perform various actions and send notifications. If an applicant is updating a project this can be slow because it needs to check for updates for the form that the user is in and all the subforms. It then needs to replace the forms with newer versions. If an applicant accepts a transfer this can be slow because it has to update all the tables in the backend with the recipient’s details. NOTE: closing the tab or browser before an action has completed or saved successfully will break the communication and the process may be incomplete. Please wait for the confirmation message to appear.

Why do I see 'This form is obsolete and can no longer be submitted' message?

Applicants may notice a new warning message when clicking into projects. : ‘This form is obsolete and can no longer be submitted’. This occurs because a form within the project, usually a DM HREC or an SSA MDF has been disabled and can no longer be submitted. No further action is required or can be undertaken. This message will not appear on forms that have not been disabled.

Bookmarking

Please bookmark the splash page (https://au.forms.ethicalreviewmanager.com/) as opposed to the login page (https://au.forms.ethicalreviewmanager.com/Account/Login). This is because the splash page is where important notifications and changes are displayed.

Scheduled Outages

Scheduled outages will occur every Saturday for re-indexing. Outages will last for 5-10 minutes. If you're unable to login on Saturday's please attempt again after 10 minutes.

Internet Explorer

As of the 31st of July we will no longer be supporting the Internet Explorer browser, this will also include the old Microsoft Edge. If you are using an old version of Internet Explore or Edge we would advise you to update to the New Edge.

Ensuring emails from 'donotreply@infonetica.net' emails are received in Inbox | Whitelisting

A Whitelist will allow emails to be received from 'donotreply@infonetica.net' when signature requests are being sent out from Ethics RM. For assistance, contact the System Administrator of your organisation's IT Department to add the domain “infonetica’ to the organisation's Whitelist.

How to transfer a project when the current owner is not contactable.

Complete the Departed Colleague Transfer Request Form in Help, Templates and send it to Helpdesk@Infonetica.net. It is here https://au.forms.ethicalreviewmanager.com/Personalisation/DownloadTemplate/112

What does the term Project mean?

A project refers to a study. It contains a main form such as the HREA or a LNR application and all the associated forms.

How do I create a project?

Click on the "Home" link. Click on the "Create Project" tile within the Actions pane on the left side of the page. Enter a Project Title for your application. Select the Jurisdiction that the application will be submitted to. Select the form to be created and click the green "Create" button to continue.

How do I transfer a project?

When an individual is leaving an organisation it is very important that the handover process should include, where applicable, the transfer of projects in Ethics RM to a new project owner. If you are the current owner of the project: Wishing to transfer ownership to another Ethics RM account holder, click on the "Home" link and click "Transfer" in the Actions pane on the left side of the screen. Enter the email address of the person you wish to transfer to: Select the projects you wish to transfer and click "Transfer".

How do I transfer a form/sub-form between jurisdictions?

Transferring the ownership of forms and sub-forms to users in different jurisdictions is the same as how you would transfer a form to someone in your own jurisdiction. But there are some differences you should be aware of: Just transferring the form alone will not provide the new owner access to themselves to grant access to additional users to the form - the ability to grant access via the "Roles" action will not be available to them automatically. For the new owner to have access to this function the original project owner will need to provide access to the form using the Roles from their own Ethics RM account before transferring ownership. Using the Role share option allows the new form owner to see the extended Project tree. Using the Share option will only grant them access to the single form.

How do I cancel a transfer request?

If you have transferred the project but wish to recall the request - 1. Select your project from the project list. 2. In the project tree, click on the top most tier of the project tree. 3. Four tabs will appear in the centre of the page, click on the Transfers tab. 4. Click the cancel button to cancel the transfer.

How do I share the project with other researchers on this project?

If you only want to share the application in question, click on the "Share" tile within the Action pane and enter the email address of the person you wish to share the form with. NOTE: they will not be able to view up the branch of the project. If added by Share the Permissions are editable. If you want them to view the application in question and applications up the branch, e.g. to be able to read the sub-form and make changes etc. AND be able to view the main form, click on the "Roles" tile within the Action pane, select the level of access and enter the email address of the person you wish to share the forms with. Once you have shared a form using "Roles" you can click on the Collaborators tab to check the permissions given. The importance of using "Roles" is to give the recipient read access to the main form. Once the Role is shared the Edit Permissions button is greyed out if the shares are added by Roles. In order to change the Permissions for a collaborator who has permission given by a Role you will need to run Roles again and then “Remove” the Role. “Remove” and “Remove all Permissions” does the same thing. After “Remove” the Share Roles page stays up and allows for the adding of a different Role.

How do I complete the application form?

Click on any question within the Navigation tab to open up the form. Click on "Save" in the Action pane on the left of the page to save your work. Clicking on the next and previous will also save your work. NOTE: the text fields only allow simple text entry, so try to avoid complete formatting. Use the space bar or insert a line break between paragraphs or sections. If you need to include tables, figures or special characters, these should be referenced and uploaded to the Documents section of the form.

Can I submit a sub-form before submitting the main form?

No. The main form must be submitted before a sub-form can be submitted

How do I upload supporting documents?

Click on the blue "Upload Document" button. If the question allows, you can click on the "Upload Document" button multiple times if you have more than one document to upload for that question. The Document Name can be modified and the date of submission and version are usually mandatory. Note the date of submission is not customisable…for mm/yyyy or yyyy or formats the format MUST be dd/mm/yyyy. The recommendation if the 'day' is not known is to use '01'. The recommendation if the 'month' is not known is to use January / '01' Note - Date can be not mandatory however the date is not customisable for each committee/form." Please convert Rich Text Files to Word Documents before uploading.

How do I collect signatures?

BEFORE YOU REQUEST FOR A SIGNATURE OR ELECTRONICALLY SIGN, YOU MUST ENTER ALL THE NAMES FOR THOSE SIGNING THE DECLARATION SECTION AS THE FORM IS LOCKED ONCE YOU SIGN OR REQUEST A SIGNATURE. If requesting a signature, click the blue "Request" button, enter the email address to request a signature. If the person you are requesting a signature from has never used Ethics RM they will need to create an Ethics RM account before you can send them a signature request. If you are signing off the application, click the "Sign" button, enter your login information and click "Sign". Ensure to not close browser or navigate away from page before banner displays signature is successful. REMINDER: Do not sign the application or request a signature until it is complete, including all documents and the names of the signatories in the declaration section. After the application has been signed it will locked from further editing (and possibly automatically submitted, depending on the form's setting).

The email address for the signatory does not exist. How do I invite a new user?

If the email address for the signatory does not exist in Ethics RM - 1. Check if the email has been entered correctly. 2. Check what email address the signatory uses in Ethics RM. 3. If the user does not exist on the system: - i. Ask the user to create an account by going to: https://au.forms.ethicalreviewmanager.com and clicking the NEW USER button, OR; ii. Go to the Share action tile, enter the signatory's email address and click the INVITE button. An email will be sent to the signatory inviting them to create an Ethics RM account. - Once invited and a new user creates their new account, if you want them to view the application in question and applications up the branch, e.g. to be able to read the sub-form and make changes etc. AND be able to VIEW the main form; click on the "Roles" tile within the Action pane, select the level of access and enter their email address. Once you have shared a form with them using "Roles", you can click on the Collaborators tab to check the permissions given. The importance of using "Roles" is to give the recipient read access to the main form. If the 'share(s)' is added by Roles, once the Role is shared, the Edit Permissions button is 'greyed out'. In order to change the Permissions for a collaborator who has permission given by a Role you will need to run Roles again and then “Remove” the Role. “Remove” and “Remove all Permissions” does the same thing. After “Remove” the Share Roles page stays up and allows for the adding of a different Role.

How do I cancel a signature request?

If you have requested an Ethics RM user to electronically sign your form but wish to recall the request - 1. Select your project from the project list. 2. In the project tree, click on the specific form that you wish to recall the signature request. 3. Seven tabs will appear in the centre of the page, click on the Signatures tab. 4. Click the cancel button for the signature request you wish to cancel.

How do I submit an application?

Once you have completed your form, uploaded all your documents and have electronically signed or received notification that all signature requests are complete, then go to the Submit button in the Action pane on the left. The system will run a completeness check to ensure all mandatory questions are complete before asking you to click the submit button.

I just submitted the application but realised I have forgotten something what do I do?

Click on the "Recall" [or Withdraw] tile in the Action pane to take back your application. You cannot recall your submission if the review body has started to process your submission. NOTE: Any changes you make to your submission will INVALIDATE all electronic signatures and you will need to collect all required signatures again.

How do I unlock a form?

You can only unlock a form if it has not been submitted. Unlocking a form will allow you to edit the form. To unlock the form, researchers will need to enter into the form and click the unlock button. NOTE: if you unlock a form all signatures will be revoked.

How do I replace a supporting document with a new version?

Go to the submission and find the document question. A delete button will appear in the question where the document has been uploaded. Note: documents cannot be modified if the submission is locked. Please convert Rich Text Files to Word Documents before uploading.

How do I submit applications to Mater?

18 December 2018 When creating forms, selecting the Mater Misericordiae Ltd option on the list of jurisdictions will submit to the Mater HREC and/or Mater Research Governance Office in Brisbane, Queensland. For new Ethics Applications to Mater Misericordiae Ltd (MML) HREC: • create a new project • select jurisdiction Mater Misericordiae Ltd • select HREA as the Main Form For new SSA submissions to Mater RGO (from Monday 22nd October 2018 onwards) where the reviewing HREC is an ERM user (i.e. MML HREC, Queensland Health and Health Victoria Ethics Committees): • create a sub-form of the HREA • select jurisdiction Mater Misericordiae Ltd • select Mater Site Specific Assessment For new SSA submissions to Mater RGO (from Monday 22nd October 2018 onwards) where the reviewing HREC is not an Ethics RM user: • confirm your project does not already exist in Ethics RM (contact the Mater Research Governance Office) • create a new project • select jurisdiction Mater Misericordiae Ltd • select MDF as the Main Form, complete and submit • create the Mater SSA form as a sub-form of the MDF All post-approval forms (Amendments, Progress and Final Reports, Serious Adverse Event forms and other safety reports) for submission to Mater are created as sub-forms of the main form in Ethics RM (HREA or MDF or DM HREC). If submitting to both MML HREC and Mater RGO, only a single submission is required for review by both offices.

How do I create a QLD SSA form and a QLD Amendment, Reports and Notifications (RGO) form?

6 August 2018 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 ERM. 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 ERM. 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 your QLD SSA form has been submitted AND AUTHORISED, you can create a sub-form off 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).

What do I do if the numeric field give an error/warning?

A numeric field only allows you to enter numbers. Remove all letters and symbols such as $ or . or AUD etc.

What do I do when I get an error/warning in the contacts question?

The most likely issue is that address line 2 is blank. As the address field is mandatory, the system requires both lines to contain data. Please enter data in address line 2 and save. It can be as simple as a full-stop in the address line 2 field.

What do I do if I get an error message when trying to submit?

Before you contact the Helpdesk, check that the amount of characters (char) in the Contact questions do not exceed the following: Title 50 char Firstname 100 char Surname 100 char Organisation 150 char Department 150 char Faculty 150 char Campus 150 char Address 100 char County/State 100 char If a field does exceed the character limit, the system is unable to submit the form. You will need to unlock the form to reduce the number of characters in the field. Note: this will invalidate signatures and these will need to be re-obtained. Infonetica are looking for a solution to prevent this from occurring in the future.

How to view status of forms without having to click through project tree?

As opposed to clicking through the project tree to determine which forms require action to be taken (i.e. annual reports, resubmission). researchers can view this information in the project overview. To locate the project overview, researchers can click on the project name in the project tree. Within the project overview, there is a forms tab which provides a status overview of forms in the project. For a Researcher/Investigator to know the Signature Status of their Forms without having to go through each Form: At the specific Project level; Click on the (Form) History Tab; Using 'Search' function type in 'sign' in the search window. What will appear is the complete History/Status of Form Signatures within the specific project.

What does the 'View as Table' button do?

For grouped questions that are repeatable, researchers have the ability to view the question responses in the form of a table, where this feature has been switched on. To action this, researchers must click on the Save action once all fields have been answered. This will enable the 'View as Table' button to be clicked and the question responses to be transitioned into a table format. Click the 'View as Form' button to return to the form view and the ability to modify responses.

Why can't I find or create the required sub-form from a DM HREC or SSA MDF form?

Applicants who are unable to create the required sub-form off a DM HREA or SSA MDF, will need to update their project. If there is no update project message, create any sub-form possible and the update project message should display. Delete the dummy sub-form once project has been updated.

How is the HREA in Ethics RM different to hrea.gov.au?

The HREA form in Ethics RM is a licensed copy of the application developed by the NHMRC. There may be visual or functional differences between Ethics RM and the HREA located in hrea.gov.au.

How do I import the XML file from hrea.gov.au?

You can only import an XML file from hrea.gov.au (The XML file from au.ethicsform.org WILL NOT import into the HREA form in ERM). In hrea.gov.au, once you have completed the HREA form you will need to navigate to the Download Application Attachments option and click "All Application Forms and Attachments" zip file. Save the file and extract the XML file and all supporting documents from the zip file. [Detailed instructions on how to obtain the XML file from hrea.gov.au – 1. Log into hrea.gov.au 2. On your Applications page, find your completed form. 3. Click on the 3 vertical dots in the left most column of the completed HREA form. 4. Select Download application attachments. 5. Click on the hyperlink “All application forms and attachments (.zip)" 6. Click on the downloaded zip file or go to File manager/Downloads to find the zip file. 7. Open the zip file, select the XML file and document file and click Extract to. 8. Select a destination folder or create a new folder for the documents.] See FAQ, how to create a project. Complete the Ethics RM filter questions then click the "Navigate" tile in the Action pane on the left side of the page. Click on the "Import XML" tile, click Browse, select your XML file from your file manager and click "Open". Click on the "Completeness Check" tile in the Action pane to identify mandatory questions that need to be completed before you obtain signatures and submit. NOTE: Documents will need to be uploaded to the HREA in Ethics RM and signatures will need to be collected again.

How do I include additional document in my HREA application?

In the HREA form, go to the Generate HREA Document section. On the Upload page, Q4.2 allows you to upload all remaining documents into the form.

NMA

National Mutual Acceptance (NMA) is a national system for mutual acceptance of scientific and ethical review of multi-centre human research projects conducted in publicly funded health services across jurisdictions. The Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria, Western Australia and Northern Territory participate in NMA. Single ethical and scientific review for a multi-centre human research project can be provided across the seven participating states/territories. The scope of NMA includes any form of human research as defined in the National Statement on Ethical Conduct in Human Research (NHMRC, 2007) for which an application must be made to a Human Research Ethics Committee (HREC). For information on how to make an NMA Ethics application and NMA research governance/site specific assessment (SSA) application, go to https://www.clinicaltrialsandresearch.vic.gov.au/__data/assets/pdf_file/0016/171133/NMA-Ethics-and-Governance-Matrix.pdf

How do I flag my project as NMA?

When completing your HREA, if you have selected YES at Q4.6, click on the "Navigate" action and then click on the "NMA Project" in the Actions pane on the left prior to submitting the form. This action will not be available if you have already submitted the form. Your research office can modify the status, if required. If you have submitted your HREA form (or the DM HREC MDF has been migrated into ERM) as Project not for NMA AND your project needs to be changed from Project not for NMA to Project for NMA, you can change this if you are creating and submitting a new subform. This will change the NMA status for the entire project.

The National Statement hyperlink in v1-3 does not work, where can I see the latest version?

The National Statement hyperlink in HREA v1-3 will not be updated in the form. For HREA applications (v1-3) please refer to National Statement on Ethical Conduct in Human Research (2007) - Updated 2015 https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research. For HREA v1-4, please go to https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018 for the latest version of the National Statement.

HREA

Human Research Ethics Application. This is a licensed copy of the HREA developed by the NHMRC.

MDF

MDF is a minimal dataset form to create SSAs for non-ERM HRECs (eg ethics approved outside of Queensland, Victoria, or Mater). You should only use this form if directed by HREC/Research Governance Office. Only one MDF is required for a research project. The MDF is NOT sent to a committee for processing. The MDF is NOT an ethics application form and it does not need an approval or processing (it is just noted in the backend of the system). The MDF allows you to create Site Specific Assessment (SSA) forms to address research governance at sites in Queensland and/or Victoria. Mater SSA forms will be available later in the year.

LNR

Low and Negligible Risk Application.

VSM

Victorian Specific Module

DM HREC MDF/DM SSA MDF/DM HREC PAF/DM SSA PAF/DM HREC AMENDMENT/DM SSA AMENDMENT

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 ERM. • 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.

Update Summary

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.

Must Read

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.

Where are User Guides?

User guides can be found in templates page under Help section. Link: https://au.forms.ethicalreviewmanager.com/Personalisation/DisplayPage/50