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3. Navigating around My Projects
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2. m My Projects 4a Project Categories New Projects 0 _ Archive 7 Manage Categories Create New Project Import xml NEAF amp other forms Projects Requests for Authorisation 10 Transfer Requests Form Title FormType Project Created On Not named yet NEAF 19 07 2010 In Progress 3 6 2 A new project Not Named Yet is generated in the system and the My 3 6 3 3 6 4 Project tabs will appear Project Filter Transfer Manage You will know you are in My Project level because it will be highlighted in the navigation tree on the left In the Project Filter tab select which jurisdictions your application will be submitted to You may choose more than one jurisdiction select the ethics form types required NOTE Users submitting applications to NSW Queensland or Victoria have the option to choose the NEAF and or the application form for Ethical and Scientific Review of Low and Negligible Risk Research LNR Refer to the guidance in the Help tab 11 Page Australia Online Forms for Research Version 1 6 August 2014 3 6 5 Click on the ethics form type eg NEAF in the navigation tree on the left to open the application window or you can go to the My Projects page to view all projects and open the one you would like to work on In the NEAF the user can access the Navigate Documents Transfer Authorisation SSAs or Project Progress tabs similar tabs are also available for the other
3. S oil Australia infonetica a Online Forms research solutions for Research 9 Australia Online Forms for Research Software User Manual Version 1 6 Released August 2014 2 Page Australia Online Forms for Research Version 1 6 August 2014 Contents 10 Introduction Getting Started System Requirements Creating an Account Logging In Logging Out Navigating around My Projects Project Categories Importing the NEAF from www neaf gov au The Projects tab The Requests for Authorisation tab The Transfer Requests tab Creating a New Project The Manage tab My Project Layout The Navigate tab The Documents tab The Transfer tab The Authorisation tab The Submission tab The SSA tab The Project Progress tab My Contacts Adding a Contact Importing Contacts from Outlook Editing a Contact Deleting a Contact Managing My Account Editing your Account Forgotten Password Help Contact Us Helpline Other Online Forms Functions 10 1 Icon Descriptions 3 Page O 0 ON NO O OI OI Australia Online Forms for Research Version 1 6 August 2014 4 Page Australia Online Forms for Research Version 1 6 August 2014 1 Introduction This is the user manual for AU Online Forms for Research Online Forms Online Forms is not just a website that enables users to complete a licensed copy of the NHMRC s National Ethics Application Form electronically the project information that is entered by research
4. 3 Navigating around My Projects Once you have logged into the Online Forms system you will be taken to the My Projects page Any Project that you own old or new projects that are in progress or have been submitted to the reviewing body are stored on the Online Forms system and can be re visited at any stage of the application process You can always return to this page by clicking the My Projects link on the Main Menu bar at the top of the page or the Existing Projects link in the My Projects dropdown menu l J rs Online Forms x af Ta lt HOME MYPROJECTS MYCONTACTS HELP CONTACT US m My Projects x Project Categories Create New Project Import xml NEAF amp other forms New Projects 0 on aoe Projects Requests for Authorisation 10 Transfer Requests Manage Categories Form Title FormType Project Created On Not named yet NEAF 19 07 2010 In Progress The My Projects page is the first page you are directed to after you have logged in On this page you will also see a number of sections these include 3 1 Project Categories This section lists all the available categories in which you can store your projects this is similar to directories in a computer filing system When your account is created you will notice a default category to store your projects called New Projects You can use the Manage Categories page to rename or add Project Categories available to you in the My Projects pa
5. CUE ACSS Projects Requests for Authorisation 3 Transfer Requests Manage Project Categories Project Title Drug D and Cancer Q 02 03 2010 In Progress Diabetes and exercise under 35 21 12 2009 Transferred 3 2 1 From the My Projects page click the Import NEAF from www neaf gov au Website button to create a new project from the XML export of the NHRMC system 3 2 2 This will take you to the first import page On this page you will need to select a file from your local file storage area This file MUST be a valid XML export or the import will not succeed NOTE Save the XML file directly to your local computer as the OPEN button in this instance only allows you to view only 3 2 3 Select your file by clicking the Browse button and then use the file explorer box to find the target file Once you have found the file click on it and then click the Open button 3 2 4 Click the Upload button on the Online Forms webpage 3 2 5 Select the option to import the NEAF XML as a new NEAF and click the Next Step button 3 2 6 Click the Import Data button 9 Page Australia Online Forms for Research Version 1 6 August 2014 3 2 7 You can then view the form or import more forms 3 3 The Projects tab The Projects tab lists all forms within the selected project category The table lists the Project Title this is the short title from the NEAF or full title if there is no short title the Form Type the Proj
6. forms These tabs allow the user to navigate between the various form functions 3 C0 Mhy Project Project Filter Transfer Manage NEAF Within which jurisdictions will your research application be submitted tick all that apply E New South Wales Click the link to E Queensland open the form E South Australia Y Victoria Ethics Form Type E NEAF LNR VIC Victoria onby Each project may only have one NEAF and one LNR per Jurisdiction If you have created an ethics form type and no longer require the form you can deactivate the form by un checking the form 3 7 The Manage tab The Manage tab for ethics forms has been moved from application level to project level but still allows you to duplicate or delete a project The Manage tab for site specific forms has not changed and is still available The Duplicate Application button duplicates the ethics form and its site specific forms Most of the data from the original form s and can be edited and assigned its own submission code NOTE Electronic documents uploaded against the form will not be duplicated and must be uploaded manually The Duplicate Application button should only be used if you have a new project using the same similar information in the form You should not use this function to create a duplicate dummy original form to create site specific assessment SSA forms All SSA forms should be linked to one NEAF only The Delete Application button
7. record of projects where electronic authorisation has been granted The Signed tab lists all forms signed by you or forms that you have requested others to sign 3 5 The Transfer Requests tab 10 Page Australia Online Forms for Research Version 1 6 August 2014 The Transfer Requests tab displays transfer form requests requiring action by the user i e a form has been transferred to them and they will need to either accept or reject the transfer This table also keeps a history of all transfer requests made as the owner of a form Projects Requests for Authorisation 3 Transfer Requests cco EN Diabetes and exercise under 35 Miss Belinda Seeto Form Accepted 26 02 2010 18 02 Project Title Transfered To Transfer Action Transfer Date The Transferred To column displays the name of the user to whom the form has been transferred The Transfer Action column indicates the current status of the transfer request and the Transfer Date displays the date and time of the transfer request 3 6 Creating a New Project To create a new project 3 6 1 Select the Create New Project in the dropdown list of My Projects or if you are already on the My Projects page click the Create New Project button at the top of the page Australia l a A j i g v ae Miss Reda Red reda red1 yahoo com au ES Online orms x My Account Logout he HOME MY PROJECTS MY CONTACTS HELP CONTACT US
8. user Forms username and password as this is used to authenticate the electronic authorisation Prior to sul sation is accepted by their organisation The user must have a registered account with this website a a Please click here for downloadable in electronic authorisations before you print the form for submission i y TE da redi yahoo P The following electronic authorisatii Sees re eee ee status As sa te ene een oe ee Signing U Acti Reda can you please review the form and S eer in nes Electronic Authorisations History Send Request gt gt No Electronic Authorisations to display 4 4 6 Automated emails are generated advising the recipient and owner of the actions taken at various stages of the authorisation 4 4 7 The owner has the power to recall the electronic authorisation request that has not been approved by selecting the Recall button 4 4 8 The owner also has the power to revoke an electronic authorisation that has already been approved by selecting the Revoke button 4 4 9 lf any data in the form is modified after electronic authorisation has been granted the authorisation becomes invalid and the applicant must again request electronic authorisation To action an electronic authorisation 4 4 10 As the authoriser of an electronic authorisation request you will receive an email requesting you to authorise a form with a link to log in NOTE If you are requested to sign electron
9. username and password NOTE Your user login and password are case sensitive that means you must use capitals on the same letters you did when you registered 2 3 2 Once you have entered the details click the Submit button and you will be taken to the My Projects page It is from this page you will be able to navigate into the data you maintain for each individual project you have on the system If you are a first time user of the Online Forms website please read the information on the help page before selecting the Create Account option from the menu at the top of the page Login four full e mail address Password Suen Forgotten Password Click here 2 4 Logging Out To log out of the Online Forms system 2 4 1 7 Page Click the Logout link on the top right of the page below your name and user login pan y u Miss Reda Red reda redi yahoo com au Lh My Account helpline In order to access your work again you will need to login The site will also log you off automatically after a period of inactivity It is therefore important that you save any unsaved form changes by clicking the Save Now link on the form page if you plan to leave your work inactive for any period of time If you have not logged off the site you may have difficulty navigating away from Online Forms Please ensure you log out before leaving the site Australia Online Forms for Research Version 1 6 August 2014
10. 4 55c 6 7a 3 RESOURCES 1 4 5 9 Below the main Online Forms menu bar are the following sections The Project Information Bar Also referred to as the project header This bar displays the basic information about the project The project s short title appears above the bar and all other information appears in the bar i e the current form section that is selected if any the status of the form owner of the project when it was first created and last modified and electronic signature notification Navigation Tree Underneath the Project Information Bar on the left you will find the navigation tree In this navigation tree you will find the ethics form eg National Ethics Application Form NEAF and or Low and Negligible Risk Research Application Form LNR and folders for any site specific forms It is from this navigation tree that you will navigate between individual forms by clicking on the form name a Diabetes and exercise under 35 HREC Reference Status Transferred Out In Progress Form Section N A Owner Miss Reda Red Created On 21 12 2009 Signatures Last Modified On 26 02 2010 18 39 08 4 My Project Navigate Documents Transfer Submission SSAs Project Progress National Ethics Application Form NEAF NSW SSA Forms Click here to begin completing reviewing the form or click on the number for a specific section Status O enabled O disabled NSW SSA 994 Organisation N A Navigate by question num
11. 5 When permanently transferring ethics forms you must transfer the whole project Select the application and click My Project in the navigation tree to display the Transfer tab HREC Reference g 2 z Status Form Section N A 1 Click My Project link Owner to open the Transfer tab Created On Signatures Last Modified On My Project Project Filter Transfer Manage j LNR Please enter the recipient s e mail address in the box below a 4s NSW LNR SSA Forms In order to transfer the form to an e mail address the recipient must have an account on the online form system pi y NSW LNR SSA 2269 Organisation N A This option is for transferring a form to a collaborator Recipient s e mail Include personal message gt gt Transfer To User lt lt 4 3 6 Transfer the project as above to ensure the recipient accepts the forms Once the recipient has accepted the form you can now click the Permanently transfer this form link z My Project Project Filter Transfer Manage a LNR 0 NSW LNR SSA Forms NSW LNR SSA 2269 Organisation N A This form has been transferred to another user To retrieve the form from this user s account the user will no longer have access to the form click the Retrieve Project button Include personal message gt gt Retrieve Project lt lt To permanently transfer this form to another user click the Permanently transfer this form but
12. F the Form has been completed and you are ready to submit select ae OK A submission code will be generated and will appear on the printed Form and in the Submission History Selecting OR will not electronically submit the Form to the assessing organisation NOTE generating a submission code DOES NOT electronically submit the form selecting OK generates the Submission Code which then appears on the Submission tab the most recent Submission Code will also appear against the project on the My Projects main page The date and time that the Submission Code was generated is also displayed You will then be able to generate a PDF of the form this is a clean copy of the form which will contain the Submission Code in the bottom right hand corner or save the form as an XML file You may be asked to make changes to a form that has already been submitted to an HREC or RGO If you make changes to a form with a submission code edit the form as required and save the changes Request electronic authorisations where required Remember to confirm with the HREC that electronic authorisation is allowed Go to the Submission tab and select the Generate submission code button to generate a new submission code Print a hard copy for submission and notify the HREC Coordinator and Research Governance Office of the new submission code 4 6 The SSA tab This tab only appears in the ethics form ie NEAF or LNR action tabs NOTE An SSA form mus
13. allows E the user to insert symbols that are not on your keyboard Text History icon in the forms provides you with a history of all text changes Text history is only available on certain fields within the NEAF and some SSA forms When you click onto the icon a window will appear listing text history the name of the person who made the text change and the date and time of the text history sorted chronologically e New text is highlighted in BLUE e Old text is in black and is not highlighted e Deleted text is in RED and has a red strikethrough line NOTE When you generate a pdf of the form there is an option to include the last three saved text changes Add Contact Details icon allows you to add an existing from your Contacts database Save Contact Details icon This gives you the option to either Add a new contact from the Form or Update an existing contact which overwrites ALL existing details including Summary of qualifications and relevant expertise AND General competing interests Guidance icon in the NEAF is guidance that has been issued by the NHMRC Information icon is information related to various functions on the Online Forms system Helpline icon in the top right corner provides you with information on who you can contact for technical assistance and State specific guidance This page has a print button for your convenience 31 Page Australia Online Forms for Research Version 1 6 August 2014
14. and password authentication process for electronic signatures follows the FDA guidelines on electronic signatures CFR 21 Part 11 Electronic authorisation gives applicants the option of obtaining electronic signatures rather than ink signatures for the Chief Investigator Principal Investigators Associate Investigators Heads of Department Heads of Supporting Departments and Authority for Data Provision on forms generated on the Online Forms system This avoids the need to take or post paper copies of forms to the various individuals who need to authorise the application forms More than one electronic authorisation may be requested at the one time though the persons authorising the form must have an Online Forms account Electronic authorisation is an option that may be used where convenient but ink signatures may still be used where preferred There is no need to obtain both ink signatures and electronic authorisation Prior to submission please confirm with your HREC RGO that electronic authorisation is accepted by their organisation Where applicants are using electronic authorisations as an alternative to ink signatures they must obtain the relevant authorisation before generating a submission code This is a different order to the process used for ink signatures Applicants need to obtain their electronic authorisations first so that all the authorisations are included in the form which is then saved and printed NOTE 20 Page Au
15. at window Click Next 5 2 1 4 Select Comma Separated Values DOS Click Next 5 2 1 5 Select the Contacts folder Click Next 26 Page Australia Online Forms for Research Version 1 6 August 2014 5 2 1 6 Select the location where you wish to save the exported file Click Next then click Finish 5 2 2 From the My Contacts page click on the Import Contacts from Outlook link 5 2 3 Click the Browse buiton to find and select the exported file from MS Outlook with contacts click Open and then click the Upload File button My Contacts Your Contacts Database allows you to create and store your colleagues contact details Contacts that are created and saved here can be inserted into any Form wherever you see the insert contact icon ts Contacts Upload Outlook Contacts Choose file to upload c Users seetob Desktop yahoo ab csv Select All Deselect All upload rie cane 5 2 4 To upload the entire list click on the Select All link to ensure that all boxes are checked and click Upload File 5 2 5 To upload selected contacts use the Deselect All link to uncheck the boxes and then check the boxes to mark the contacts to save then click Save selected contacts Choose file to upload Browse select All Deselect All Dr Jon Who Hospital X jwho fake com 4 Mr Jon Mann Hospital M jon mann hosp com C Mr Waine rusev Hospital M w rusev fake com Mr Clive Stefchov Hospital M c
16. ay differ 4 7 The Project Progress tab This tab allows you to be able to monitor the progress of your application when various actions have been performed where an organisation processing your application has a direct link into the Online Forms system The following Research Ethics Database AU RED actions may appear depending upon the progress of the application in AU RED Application Checked In Application Decision Given Application Marked Valid Application Marked Invalid Application Clock Started Application Clock Restarted Clock Stopped Application Assigned To Meeting Removed From Meeting 5 My Contacts The My Contacts link on the main menu bar takes you to your personal contact database This is designed to help you if you are filling out many forms and often refer to a contact multiple times Once a contact is in your contact database you can quickly 25 Page Australia Online Forms for Research Version 1 6 August 2014 fill in contact details in a form by clicking on the Add Contact Details icon whenever itis available You will find this icon on most questions that ask for contact information 5 1 Adding a Contact 5 1 1 You can add contacts from the My Contacts page by clicking on the Add New link and filling in the appropriate details HOME MY PROJECTS MY CONTACTS HELP CONTACT US Add N My Contacts A Act ee Your Contacts Database allows you to create and store your colleague
17. bers izl 13 Page Australia Online Forms for Research Version 1 6 August 2014 Form Action Tabs The form action tabs is to the right of the navigation tree The tabs correspond to the highlighted form in the navigation tree The available tabs will be different depending on which form you have selected and what permissions you have as the owner the electronic authoriser or the recipient of a transferred form Each tab plays an important role in the completion of your application a Diabetes and exercise under 35 HREC Reference Status Transferred Out In Progress Form Section N A Owner Miss Reda Red Created On 21 12 2009 Signatures Last Modified On 26 02 2010 18 39 08 r im My Project National Ethics Application Form NEAF E NSW SSA Forms Click here to begin completing reviewing the form or click on the number for a specific section NSW SSA 994 Organisation N A Navigate by question numbers Status O enabled O disabled 4 1 The Navigate tab This tab is available on all forms It allows you to navigate to the form either by question number or page number Inactive questions are shaded blue and cannot be clicked on Active questions have a white background and clicking on them will take you directly to those questions in the form Questions are activated and deactivated depending upon your answers to the questions in the form The Navigate tab also displays a green tick beside the completed pages Not
18. ck for updates periodically e FAQs page will include frequently asked questions and answers This page is currently unavailable 8 Contact Us The Contact Us link on the main menu bar will provide a list of all the suitable contacts for the various forms controlled by the system This page will assist you in contacting the correct organisation Please remember that the Helpline is only responsible for technical queries and general help More specific queries and procedural questions should be addressed to the appropriate organisation in this list 9 Helpline If you are having trouble with any aspects of the system and this manual does not help clear up the issue please contact the Helpdesk The contact information can be found by clicking on the Helpline link on the right hand side of the main menu bar Please indicate to the Helpdesk that you have an issue with the Online Forms system and they will then assist you with any problems you may have 29 Page Australia Online Forms for Research Version 1 6 August 2014 10 Other Online Forms Functions 10 1 Icon Descriptions There are various icons used in the Online Forms system Incomplete O Previous Mest Page 1 of 62 30 Page Navigate icon in My Project takes you back to the Navigate page of a specific form Print Draft icon in My Project generates a pdf of the form with a DRAFT watermark Do not use this copy for your submission Export icon in My Project g
19. ck on it and then click the Open button 4 2 11 Click the Upload File button on the Online Forms system NOTE Any electronic documents uploaded against a NEAF will appear in the Documents tab of accompanying SSA Forms These NEAF documents can only be deleted from the NEAF by the owner Also the document cannot be deleted if the 17 Page Australia Online Forms for Research Version 1 6 August 2014 document has already been uploaded by the HREC Coordinator or Research Governance Officer onto their Research Ethics Database system For Online Forms users submitting SSA forms to a Research Governance Office within New South Wales electronic documents from the NEAF appearing in the SSA documents tab are for the Online Forms user only The applicant will be required to upload NEAF supporting documents and the NEAF PDF into the SSA documents tab if these are required by the RGO From Friday 17 May 2013 researchers submitting SSA forms to a Research Governance Office RGO within Victoria and South Australian public health system will no longer need to upload the NEAF supporting documents and NEAF PDF into the SSA Any electronic documents already uploaded against the NEAF Application Form will automatically be uploaded against the SSA Form ready for import by the RGO This also applies to researchers submitting SSA forms to a Research Governance Office RGO within Queensland from Nov 2013 The Ethics Committee MUST upload the submission code to
20. ddress as this may prevent you from receiving transfer requests authorisations requests notifications 6 2 Forgotten Password If you have forgotten your password you can get a reminder by using the Forgotten Password link that can be found at the bottom of the login box Please Login If you are a first time user of the Online Forms website please read the information on the help page before selecting the Create Account option from the menu at the top of the page Login Your full e mail address Password 6 2 1 Enter your user login username and click on the Submit button Your user login is your full email address 6 2 2 A Lost Password Reminder email will be sent to you with your password NOTE If for some reason you have forgotten all your account details please contact the Helodesk who will assist you in reactivating your account 28 Page Australia Online Forms for Research Version 1 6 August 2014 7 Help The Help link on the main menu bar lists tools to help you get around the Online Forms system e Welcome page outlines the purpose of the Online Forms system e Guidance page includes State specific guidance for researchers e User Manual page includes detailed step by step instructions for the Online Forms system e How To page includes a list of electronic tutorials on key functions of the Online Forms system e Updates page includes a list of major changes to the Online Forms system Remember to che
21. deletes the entire project leaving no record of the forms Applications should not be deleted unless the form has been generated by accident It is recommended that you have a record of all your projects so unsuccessful unfinished forms could be moved to a new folder category This function will not appear if the project has a submission code 12 Page Australia Online Forms for Research Version 1 6 August 2014 4 My Project Layout What is the difference between My Projects and My Project My Projects is like a filing cabinet listing all your research applications and My Project without the s is the project folder holding project information for a single project which includes the ethics form and the associated site specific forms NOTE An SSA form must be linked to the ethics form eg NEAF that will be has been sent to the HREC An SSA Form cannot be created without an ethics form ie a NEAF or an LNR Not named yet HREC Reference Status In Progress Form Section N A Owner Miss Reda Red Created On 18 07 2010 Signatures Last Modified On 19 07 2010 10 39 41 al EH My Project Navigate Documents Transfer Authorisation Submission SSA Project Progress NEAF Click here to begin completing reviewing the form or click on the number for a specific section Status O enabled O disabled vPage completed Navigate by question numbers 1 TITLE and SUMMARY of Project 1 2 2 RESEARCHERS INVESTIGATORS 2 3
22. e browse function before clicking the Upload button will replace the current selection You must therefore upload the files before adding other files to the documents list You can remove files that you do not wish to upload The single document upload facility is for browsers Internet Explorer 9 and below or Safari 5 1 1 gt 5 1 7 for windows The single document upload facility is also used to upload new versions of a document To upload a single document Multi document upload For Internet Explorer 10 or above No files selected Document Name Description Upload Files Single document upload For Internet Explorer 7 6 9 or Safari 5 1 1 gt 5 1 7 for Windows Document Type Please select Version Document date PY E Description Choose file to upload No file selected Please note that the fields Version and Description will be visible by the assessing organisation Upload File 4 2 7 Click on the Upload tab select the document type from the dropdown list 4 2 8 Enter the version number and document date of the document This will help you keep track of the latest version of the document 4 2 9 Enter the description This is useful for identifying documents of the same document type e g Investigator CV J Bloggs Investigator CV C Brown 4 2 10 Select your file by clicking the Browse button and then using the file explorer box to find the target file Once you have found the file cli
23. ect Created On date and the Form Status i e whether the form has been given a submission code whether it is still being completed and therefore In Progress or whether it has been transferred Requests for Authorisation 10 Transfer Requests Form Title FormType Project Created On Form Status Not named yet NEAF 19 07 2010 In Progress O 20100715 NEAF 23 03 2010 In Progress No Title Status 1 SSA 2230 No Pl typed No research organisation typed In Progress 2 SSA 2231 No Pl typed No research organisation typed In Progress selecting the symbol on the left hand side expands the table to display any site specific forms that have been created for a particular project Click on the form title to open the form 3 4 The Requests for Authorisation tab The Requests for Authorisation tab displays information related to any outstanding requests for electronic authorisation i e electronic signatures es Projects Requests for Authorisation 3 Transfer Requests EES seneo Short Title Request By Request Date As Signature Type Action NSW SSA 1009 No PI typed No research Miss Belinda 29 01 2010 NSW Head of Supporting organisation typed Seeto 12 17 SSA Department P q Miss Belinda 08 02 2010 ar PEANUT as 01 20 NEAF Principal Researcher Open Request Miss Belinda 26 02 2010 noi Open Request blueberry aie 06 18 NEAF Principal Researcher Open Request lt also keeps a
24. enerates a copy of the form in XML file format The Incomplete Page features can help you identify which pages in the project are complete and which need further information and are therefore incomplete Each page of the form is marked as Incomplete by default When the page is complete the user clicks the incomplete icon The icon changes to a Complete icon To change back to incomplete just click the icon again The form is not affected if you choose not to use this feature If we go back to the Navigate page you will see that a green tick means that the user has confirmed that the page is complete Save icon in My Project saves changes Undo icon in My Project undoes any typing changes that you make The system automatically saves when you go to the next or previous page Next and Previous Page icon in My Project allows you to move between pages of the form The Page Index allows you to click on a chosen page rather than having to go back to the Navigate page or to click the Previous and Next button numerous times to get to the required page Australia Online Forms for Research Version 1 6 August 2014 Clicking the allows the user to display pages before or after the page numbers displayed This feature only appears on the electronic form Spell Checker icon in the forms identifies any bad words in the text box and provides suggestions where applicable Insert Symbols and Special Characters icon in the forms
25. ers is used to populate the various forms needed for the relevant approvals for both ethics and research governance This is also facilitated by the ability to import and export information in xml format The website hosts a licensed copy of the NHMRC s National Ethics Application Form NEAF as well as the NSW Health Qld Health SA Health and Victorian Site Specific Assessment SSA Forms User manual updates are based on system upgrades Please visit the website https www ethicsform org au to download the latest version of the user manual Further information is available on the website regarding the specific processes and information required to apply to each of the jurisdictions 2 Getting Started 2 1 System Requirements For optimum usage we strongly recommend that the following settings are used whilst using Online Forms This will ensure all features display correctly 2 1 1 Operating System e Windows 7 e Windows Vista e Windows XP e Windows Server 2003 e Windows 2000 2 1 2 Internet Browser e Internet Explorer 7 or later e Mozilla Firefox 3 5 or later e Google Chrome 4 0 or later 2 1 3 Browser plug ins e Adobe PDF Reader Ensure that you have the latest version 5 Page Australia Online Forms for Research Version 1 6 August 2014 2 1 4 Screen resolution e Our content displays best at a screen resolution of 1280 pixels x 768 pixels 2 2 Creating an Account When you access the Online Forms sy
26. ge 3 1 1 To add a new category click on the Add Category link at the bottom of the page This will add a new category which you can name using the Edit link attached to the new entry 3 1 2 To move a project into a new category expand the category the project is stored in and tick the project you want to move 8 Page Australia Online Forms for Research Version 1 6 August 2014 a Manage Categories Category name Active Forms Edit Delete Drug D and CancerQ version 2 0 In Progress Diabetes and exercise under 35 version 2 0 Transferred Out In Progress Add Category Move selected forms ta category Active Forms Go 3 1 3 Once this is done go to the bottom of the page and select the category you need to move the project into from the dropdown list then click Go which is next to the dropdown 3 1 4 You can delete categories by clicking Delete but only if you do not have any projects stored in it 3 2 Importing the NEAF from www neaf gov au lf you are submitting an application to the public health system in New South Wales Queensland South Australia Victoria or Mater Research Brisbane and have completed the NEAF from the www neaf gov au website you can import your ethics proposal HOME MY PROJECTS MY CONTACTS HELP CONTACT US Existing Projects Create New Project Q eS Create New Project __ Tort Near om win neor gov ou v eonte NEAF from www neaf gov au websi Requests for Authorisation Manage
27. ically you should only sign for the section that you are responsible for If you receive a request for electronic authorisation with an incorrect research personnel title authorisation type reject the form and immediately notify the owner of the request 4 4 11 When you the authoriser log into the Online Forms system the main My Projects page the Requests for Authorisation section will now display any outstanding requests for authorisation under the Requests tab and a history of all electronic authorisations previously granted not granted under the Signed tab a My Projects Project Categories 7 Create New Project Import NEAF from www neaf gov au website New Projects 4 Manage Categories Projects Transfer Requests REQUESTS SIGNED Short Title Request By Request Date Form Type Signature Type Action Sleep Aponea Study Ms Ainsley Martlew 31 01 2010 09 35 NEAF Principal Researcher Sleep Aponea Study No2 Ms Ainsley Martlew 10 02 2010 11 34 NEAF Principal Researcher 22 Page Australia Online Forms for Research Version 1 6 August 2014 4 4 12 4 4 13 4 4 14 4 4 15 4 4 16 4 4 17 4 4 18 4 4 19 In the Requests tab click the Open Request of the form you wish to authorise The Authorisation tab is now visible click the Review Requested Form button to check the data in the form in read only format Navigate through the form by clicking the Next and Previous a
28. ission please confirm with your HREC RGO that electronic authorisation is accepted by their organisation Please click here for downloadable step by step instructions on electronic authorisations You must obtain electronic authorisations before you print the form for submission The following electronic authorisations are available for this form type Authorisation Type Signing User Chief Researcher Not requested siga O Principal Researcher Not requested 4 4 3 The tab will indicate all the electronic authorisations that are available for that particular form Select the relevant type of authoriser E g Principal Researcher and click the Request button 4 4 4 Enter the email address of the authoriser and include a personal message if necessary and click the Send Request button NOTE the authoriser s email address must be their AU Online Forms username Applicants should check this with authorisers before attempting to request electronic authorisation 4 4 5 An Authorisation History at the bottom of the page keeps a record of all authorisation requests 21 Page Australia Online Forms for Research Version 1 6 August 2014 Navigate Documents i enema age Project Progress Gather electronic authorisations for Enter e mail address of the person from whom you wish to obtain an electronic authorisation and press Send Request An Electronic authorisation is available emailed request will be sent to the
29. ments This Multiple Document Upload feature is compatible with Firefox Safari Chrome Opera and Internet Explorer 10 and above 15 Page Australia Online Forms for Research Version 1 6 August 2014 Guidance has been included on the Upload page indicated by the icons Multi document upload For Internet Explorer 10 or above No files selected Document Name Version Description Upload Files 4 2 1 Go to the Documents tab and click on the Upload sub tab 4 2 2 To select multiple documents in the ONE FOLDER click on the Browse button Upload Multi document upload For Internet Explorer 10 or above Wa files selected Document Name Version Description Remove Upload Files 4 2 3 Using the file explorer box find the target file Once you have found the file click on it Press the Ctrl key when selecting more than one file 4 2 4 Click the Open button 4 2 5 Enter the version date and description This will help you keep track of the latest version of the document These fields are mandatory Multi document upload For Internet Explorer 10 or above Document Version Description Remove Name Investigator s Doct docx Investigators Brochu 1 9 01 08 2014 Brochure vi 0 for drug x P Upload Files 4 2 6 Click the Upload Files button on the Online Forms system 16 Page Australia Online Forms for Research Version 1 6 August 2014 Note Going back into th
30. named yet HREC Reference Status In Progress Form Section N A Owner Miss Reda Red Created On 18 07 2010 Signatures Last Modified On 19 07 2010 10 39 41 z My Project Navigate Documents Transfer Authorisation Submission SSA Project Progress NEAF Click here to begin completing reviewing the form or click on the number for a specific section Navigate by question numbers ee O enabled O disabled vPage completed 1 TITLE and SUMMARY of Project 1 2 2 RESEARCHERS INVESTIGATORS 2 3 4 5 5c 6 7a 3 RESOURCES 1 4 5 9 4 1 1 The Click here link takes you directly to the first question on the form 4 1 2 Once in the form to navigate between pages on the forms click on the Previous or Next buttons located at the top and bottom right hand side of the forms 4 1 3 Alternatively click on the Navigate button on the top and bottom left hand A 1 side of the form to return to the Navigate tab NOTE The forms do not need to be completed in one session as the system will save your progress every time you finish a page If you are typing large quantities of text into 14 Page Australia Online Forms for Research Version 1 6 August 2014 the forms you can click the Save Now button regularly to avoid losing data should your internet connection time out Alternatively text can be cut and pasted from your word processor 4 2 The Documents tab This tab allows you to attach any electronic documents
31. rrow buttons Alternatively click the Reject Request button to reject the form prior to review if for some reason you cannot sign the form After reviewing the form click the Navigate icon and then the Authorisation tab Click the Authorise Form bution to generate an electronic signature Please enter your username and password and the details relevant to this authorisation Password Job Title Post Organisation Email Enter your username and password this acts as an extra layer of security to ensure that only the registered authoriser can electronically authorise an application as well as your Job Title Post Position and Email these details will appear on the declarations page on the form then click the Sign button Your electronic authorisation will appear in the form as long as it is valid Alternatively select the Reject Request button to reject the form The applicant will receive a confirmation email and should liaise directly with the authoriser to resolve any issues 4 5 The Submission tab The Submission tab replaces the Lock for Submission button on the old Online Forms website To generate a Submission Code 4 5 1 Select the Generate submission code button on the Submission tab A new window will appear with the following message 23 Page Australia Online Forms for Research Version 1 6 August 2014 4 5 2 4 5 3 4 5 4 4 5 5 4 5 6 4 5 7 Windows Internet Explorer e
32. s contact details Contacts that are created and saved here can be inserted into any Form wherever you see the insert contact icon ips Contacts Filter by First Name hd Position Organisation Prof Jane Black Haematologist Emerald Hospital View Delete Dr Joseph Bloggs Clinician Emerald Hospital View Delete Ms Ainsley Martlew G Manager Infonetica View Delete Miss Belinda Seeto PD Manager Infonetica View Delete q Add Contact 5 1 2 If you have entered a contact into a form and wish to update the details into the Contact list click the Save Contact Details icon This gives you the option to either Add a new contact from the Form or Update an existing contact which overwrites ALL existing details including Summary of qualifications and relevant expertise AND General competing interests 5 1 3 Before deciding whether to select Update existing contact or Add new contact view exact first name and surname matches by clicking the button to expand the contact details to ensure you are updating the correct contact 5 2 Importing Contacts from Outlook You can upload the entire MS Outlook contact list or save selected Outlook contacts 5 2 1 Before you are able to import the contact list you must generate the Outlook csv file 5 2 1 1 Goto Contacts in your MS Outlook 5 2 1 2 Select File gt Import and Export from the Main Menu bar A new window will appear 5 2 1 3 Select Export to a File from th
33. stefchov hosp com Ms Tina Long Johns Hospital S tina j fake com poseeeceesececececsesecceseceseccesesssececcesesececcesssesesesseceseeesessececessssesoceseesosecescesssecesescesecesesessssesesescosecesesessecesesessecesosesee e E E E E o R R 5 3 Editing a Contact 5 3 1 To find the contact person in My Contacts use the Filter By dropdown field to filter by First Name Last Name or Organisation the contacts are sorted alphabetically 5 3 2 To edit a contact in your contact list simply click the View link and then the Edit Details button 5 3 3 Once you have finished editing the details click the Update button to save the changes 5 4 Deleting a Contact 5 4 1 To delete a contact in your contact list simply click the Delete link 27 Page Australia Online Forms for Research Version 1 6 August 2014 9 4 2 You will be asked to confirm the deletion before the contact is actually deleted from the database Select OK to continue 6 Managing My Account 6 1 Editing your Account To edit your account details 6 1 1 After you have logged in click the My Account link at the top right hand side of the screen Th k Miss Reda Red reda red1 yahoo com au My Account Logout 6 1 2 Change your details and click the Save button Changing your E mail address will change your user login Please notify your colleagues research personnel Research Office of any changes to your details especially your new email a
34. stem you will first encounter the Login Screen To access the forms you must have registered and verified your account You only need to register once you can then complete as many applications as you like To create an account 2 2 1 Go to https www ethicsform org au 2 2 2 Go to the Create Account tab on the menu bar Australia A Online Forms for Research a LOGIN CREATE ACCOUNT HELP CONTACT US a Welcome to the Online Forms websi 2 2 3 Enter your user details and click Register Most fields on this form are required however if you are missing any required information the system will remind you when you click the Register button a Create New User Account Title Mailing address Forename Surname Organisation Suburb Town E mail Address State User Login Confirm E mail PostCode Password Country Confirm Password Telephone Number Password must be st least 6 characters Fax at least 1 of which must be a number 2 2 4 An activation code will be emailed to you If you do not receive the automated email after 1 hour please telephone the Helpdesk for assistance 2 2 9 The email you receive will contain a link Click on the link to complete the registration process NOTE This is a secure system Do not disclose your password to anyone 6 Page Australia Online Forms for Research Version 1 6 August 2014 2 3 Logging In To log into the Online Forms system 2 3 1 Enter your user login
35. stralia Online Forms for Research Version 1 6 August 2014 e Authorisation applies to the ENTIRE form If one authoriser requires changes to data that has been authorised by others all the authorisations will need to be requested again before the form can be submitted e The applicant cannot authorise their own SSA form if they are the Head of Department Head of Supporting Departments or Authority for Data Provision e A Chief Investigator who is also the owner of the form can include their electronic authorisation on a form by clicking the Sign button e Similarly an authoriser who also needs to enter information into a transferred application can have a form transferred to them and then select the Sign button This avoids the need for a separate process for completing and authorising information To request an electronic signature from another user 4 4 1 As the applicant requesting an electronic signature of an authoriser select the relevant form that requires authorisation from the My Projects page e g the NEAF 4 4 2 Select the Authorisation tab 3 EI my Project Navigate Documents Transfer authorisation Submission SSA Project Progress Gather electronic authorisations for this NEAF form LNR Electronic authorisation is available as an alternative to ink signatures The user must have a valid Online Forms username and password as this is used to authenticate the electronic authorisation Prior to subm
36. t be linked to the NEAF that will be has been sent to the HREC Selecting this tab allows you to create a new Site Specific Assessment SSA for your project Depending on the Location you select the SSA Form type list may include e Site Specific Assessment form specific for that State e Access Request form New South Wales only 24 Page Australia Online Forms for Research Version 1 6 August 2014 Navigate Documents Transfer Authorisation Submission SSAs Manage Project Progress 4 6 1 4 6 2 4 6 3 4 6 4 4 6 5 No SSA Forms to display 1 Please type the number of forms you wish to create in one go Form Status Action Enter the number of forms you wish to create and then click the Create a new SSA Form button Select the form you wish to open on the SSAs tab or expand the SSA Forms folder in the navigation tree on the left hand side and click on the desired SSA form Under the Location tab you are prompted to choose the relevant State in which the research is being conducted in order to determine which SSA Form to display Once you have chosen the relevant location you will be prompted to nominate the type of form you wish to create The navigation tree on the left hand side is updated and the new SSA Submenu tabs Navigate Documents Transfer Authorisation Submission and Project Progress become available NOTE Depending on the SSA Form Type you choose the number of submenu tabs m
37. the ethics database in order for the NEAF supporting documents to be linked to the SSA otherwise the applicant will need to upload the NEAF supporting documents into the SSA Form 4 3 The Transfer tab This tab allows you to transfer either the NEAF and or accompanying SSA forms to another Online Forms user NOTE The recipient of a transferred form must have an account with the Online Forms website Navigate Documents Transfer Authorisation Submission SSA Project Progress Please enter the recipient s e mail address in the box below In order to transfer the form to an e mail address the recipient must have an account on the online form system This option is for transferring a form to a collaborator Recipient s e mail joe bloggs hospitalx com To transfer an ethics form 4 3 1 Enter the email address that the other Online Forms user is registered with in order for the system to locate the other user Include a personal message to the recipient if necessary and click the Transfer to User button 18 Page Australia Online Forms for Research Version 1 6 August 2014 4 3 2 Automated emails are generated advising the recipient and owner of the actions taken at various stages of the transfer 4 3 3 The transfer actions are listed in the transfer history 4 3 4 The owner has the power to retrieve the transferred NEAF by selecting the Retrieve Form button To permanently transfer a project 4 3
38. to your forms The List tab displays any electronic documents already uploaded The View Manage link allows the applicant to view the document or replace the current version of the document keeping a history of all versions Note if you update a newer version of the document via View Manage the research office can refresh their documents If you add a NEW document the research office can pull the document into the ethics database using the last submission code made available to the research office If you upload new revised document AND modify the form then you must generate a new submission code and provide the submission code to the research office Project Progress Any electronic documents already uploaded against the NEAF Application Form will automatically be uploaded against the SSA Form Document Type germs pe erie Version Size oy nad aid Date ate Organisation Covering Letter none CTN Form none CTX Form none Drug data sheet none GP Consultant Information Sheets none Interview Schedules Topic Guides none Investigator CV 12 08 2014 01 08 2014 1 0 T2 KB View Manage Investigators Brochure none Letter from Sponsor none Letter Of Intention To Appeal none Letter of invitation to participant none Master Consent Form none Master Participant Information Sheet none Other none Participant Information Sheet Consent Form none Peer Review none The Upload tab allows you to upload any new electronic docu
39. ton Include personal message gt gt Permanently transfer this form lt lt NOTE Once the form has been permanently accepted by the recipient you will no longer be the owner of the form and the person to whom the form was transferred will have full access to all management functions such as being able to transfer the form to other users or to generate a submission code To transfer an SSA form 19 Page Australia Online Forms for Research Version 1 6 August 2014 4 3 7 Enter the email address that the other Online Forms user is registered with in order for the system to locate the other user Click the Transfer to User button 4 3 8 Automated emails are generated advising the recipient and owner of the actions taken at various stages of the transfer 4 3 9 When an SSA form is transferred by the original owner the form is transferred with full access to all management functions The recipient is usually the Principal Investigator for the site The transfer to persons thereafter will be the standard transfer with limited access 4 3 10 The Principal Investigator can transfer the SSA form to the original owner by clicking on the Return Ownership button NOTE If only the SSA form is transferred the recipient can still view the NEAF but as a read only version If the user wishes to transfer the NEAF and all accompanying SSA Forms they must do so from My Project Transfer 4 4 The Authorisation tab The username
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