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1. 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 button to generate an electronic signature 23 Page Australia Online Forms for Research Version 1 8 October 2015 Authorise Form Please enter your username and password and the details relevant to this authorisation Username 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 TheSubmission tab The Submission tab for applications submitted to New South Wales Queensland and South Australia generates a submission code but DOES NOT electronically submit the form To generate a Submission Code NSW QLD SA 4 5 1 Select the Generate submission code button on the Submission tab A new window will appear with the following mess
2. 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 3 tl My Project Navigate Documents Transfer Submission SSAs Project Progress National Ethics Application Form NEAF 4 NSW SSA Forms Click here to begin completing reviewing the form or click on the number for a specific section a atus 5 NSW SSA 994 Organisation N A Navigate by question numbers v O enabled O disabled 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 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 14 Page Australia Online Forms for Research Version 1 8 October 2015 a Diabetes and exercise under
3. 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 z t My Project National Ethics Application Form NEAF L3 NSW SSA Forms NSW SSA 994 Organisation N A Navigate by question numbers x Click here to begin completing reviewing the form or click on the number for a specific section 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 a 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 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 Page completed Navigate by question numbers 1 TITLE and SUMMARY of Project 1 2 2 RESE
4. Document Type Version Description Choose file to upload Please note that the fields Version and Description will be visible by the assessing organisation Navigate Documents E Save Transfer ae Suh Prea Propane Within which jurisdiction will your research application be submitted Remove Email History Australia Online Forms for Research Version 1 8 October 2015 If you have MODIFIED the answers in your application 6 Click Submit your application electronically if you are re submitting a revised application with or without new revised documents Click Submit to confirm Please contact the CAS to book in your application and obtain the HREC Reference Number Enter the HREC reference HR amp C 15 Vic Testy Verify Submit your application electronically e Provisional Approval Response This section allows you to submit your response to a request for further ee post approval documents Clicking the Submit Documents button will electronically send the new updated documents to the secretaria Submit Documents Save completed form as XML Submission Submission Code RII Application made a request for further information and clock AU 1 991A016 29 09 2015 11 29 stopped 29 09 2015 00 00 00 Generate PDF Save as XML Detailed information on status is available on the Project Progress tab If you have not modified your application and are
5. Governance Office of the new submission code To submit an application to VIC Electronic submissions are only available for applications submitted to Victoria Electronic submission is used for Victoria only projects and the Victorian part s of National Mutual Acceptance projects The electronic submission process is the same for all application forms NEAF SSA LNR VIC and LNR VIC SSA Once you have completed the form uploaded supporting documents and obtained all mandatory authorisations you must submit your application 4 5 8 Open the application and click on the Submission tab Navigate Documents Transfer Authorisation C Submission SSA Project Progress Email History will your research application be submitted Submission Code Date Submission Status atus is available on the Project Progress tab 25 Page Australia Online Forms for Research Version 1 8 October 2015 4 5 9 Click Victoria as the jurisdiction in which the research application will be submitted Navigate Documents Transfer Authorisation Submission Save Within which jurisdiction will your research application be submitted New South Wales Queensland South Australia Victoria Study Type Please select vi 4 5 10 Complete the screening questions Note some application types will require you to enter an HREC reference number and then click the Verify button Document
6. Project in the navigation tree to display the Transfer tab HREC Reference 1 Click My Project link Status Form Section N A Owner to open the Transfer tab Created On Signatures Last Modified On LJ My Project Project Filter Transfer Manage a LNR Please enter the recipient s e mail address in the box below au NSW LNR SSA Forms NSW LNR SSA 2269 Organisation N A This option is for transferring a form to a collaborator Recipient s e mail Include personal message Transfer To User In order to transfer the form to an e mail address the recipient must have an account on the online form system 4 3 6 Transfer the project as above to ensure the recipient accepts the forms Once the recipient has accepted the form you must go back into the application and click My Project in the navigation tree to display the Transfer tab and then click the Permanently transfer this form link 19 Page Australia Online Forms for Research Version 1 8 October 2015 3 oi My Project Project Filter Transfer Manage zj i LNR 4 NSW LNR SSA Forms 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 NSW LNR SSA 2269 Organisation N A NOTE Include personal message To permanently transfer this form to another user cli
7. applications as you like To create an account 5 Page Australia Online Forms for Research Version 1 8 October 2015 2 2 1 Goto https au ethicsform org 2 2 2 Goto the Create Account tab on the menu bar Australia A Online Forms Y LOGIN CREATE ACCOUNT in for Research HELP CONTACT US Welcome to the Online Forms webs 2 2 3 Enter your user details and click Register Most fields on this form are required including Fax a Create New User Account Title Forename Surname Organisation E mail Address User Login Confirm E mail Password Confirm Password Password must be at least 6 characters at least 1 of which must be a number Mailing address Suburb Town State PostCode Country Telephone Number Fax 2 2 4 An activation code will be emailed to you If you do not receive the automated email after 1 hour please check the Junk e mail folder of your email account or telephone the Helpdesk for assistance 2 2 5 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 2 3 Logging In To log into the Online Forms system 2 3 1 Enter your user login 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 6 Page Australia Online Forms for Resea
8. clicking the Submit button in the pop up window Note you cannot change an application submitted to Victoria between submission and approval unless the committee requests for further information See 6 below for recall Once submitted you will be able to print a clean copy of the application by clicking Generate PDF The option to Recall your application is available as long as the application is still pending registration by the committee Once successfully recalled you may amend the form upload supporting documents obtain authorisations and re submit the application If you are unable to recall the application please contact the committee The committee may choose to invalidate the application thus allowing Please contact the CAS to book in your application and obtain the HREC Reference Number Enter the HREC reference This HREC Reference is verified Submit your application electronically a Submission Code Date Submission Status No Submissions to display Detailed information on status is available on the Project Progress tab Navigate Documents Transfer Authorisation Submission Submit Application Selecting Submit will electronically submit the form and all supporting documents Important An application submitted without uploaded supporting documents may not be accepted by the reviewing organisation Recall your application The recall button will not work once the appli
9. hand side of the screen k Miss Reda Red reda redi yahoo com au My Account Logout 33 Page Australia Online Forms for Research Version 1 8 October 2015 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 address 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 i J Forgotten Password Click here 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 Helpdesk who will assist you in reactivating your account 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 F
10. of the application process 7 Page Australia Online Forms for Research Version 1 8 October 2015 Australia 7 Miss Reda Red reda red1 yahoo com au x A Online Forms x b My Account Logout h Y for Research e HOME MY PROJECTS MY CONTACTS HELP CONTACT US a My Projects amp Project Categories Create New Project Import xml NEAF amp other forms New Projects 0 mi Projects Requests for Authorisation 10 Transfer Requests Manage Categories Form Title FormType Project Created On Form Status 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 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 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 page 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 n
11. 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 Authorisation applies to the ENTIRE form
12. 2015 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 Any electronic documents already uploaded against the NEAF Application Form will automatically be uploaded against the SSA Form Document ee Uploaded by Document Type Upload Date Version Size Assessing Date 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 72 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 documents This Multiple Document Upload feature is compatible with Firefox Safari Chrome Opera and Internet Explorer 10 and above 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 Type Version Date Description Remove Upload Files 4 2 1 Goto the Documents tab and click on the Upload sub tab 4 2 2 To select multiple documents in the ONE FOLDER click on the B
13. ARCHERS 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 side of the as cn 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 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 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 15 Page Australia Online Forms for Research Version 1 8 October
14. Australia infonetica aD Online Forms research solutions for Research Australia Online Forms for Research Software User Manual Version 1 8 Released October 2015 2 Page Australia Online Forms for Research Version 1 8 October 2015 Contents 1 Hale o Wey e p eeen tere a entree nen E 5 2 GEN StS ae et 5 2 1 System PEGUIFEIMENUS s a crai eene mis usas dix caa russa unas a anat dra ena cbe 5 2 2 Oreating am ACCOUNT uineis uis inteso a ta ulis cea tt oan a elt ens tee 5 2o EOOD I nere RU 6 2 AOOCING OU E MER 7 3 Navigaling arourid Ivy PFrOJeCIS i tessties teret ua Lesootua Dora siue Dues od ua bora oua Lue adea Eon o La oda Eod GR uA 7 Sell JS roject GaleO One scant dtu tdt totns ere A 8 3 2 Importing the NEAF from www neaf gov au cccecccececeeeceeeseeeseeeseeeseeeseeeseeeneeenes 8 9 9 The Projects TaD satan sssossepedsmuacnsuanntennsnuscoruceteoniaidecguentenniaiuecgtueatenniaivacgiuentnondanits 9 3 4 The Requests for Authorisation tab cccccccccsecseeeceeeeeeseeeseeeeeeeseeeseesseeseeeeaeees 10 3 5 The Transfer Requests tab cccccccseccseeceeeseeeceeeceeeseesseeeseeseeeseeeseeeseeeseeesaeees 10 26 Ne NOTMC ATOMS Lal cendo andoe uc ioc dnos oce ceres odit cnn iod ones 11 37 Creating aNew PIOJIBGGU ii rt or Miro I Peer tdt EC 11 3 0 The Manage la taverns spit neo eod xvin cp Ix atri pep x er epd x Ea rbzk aec epi Et pz 12 39 he Email IN
15. CSubmission gt SSA Project Progress Email History Within which jurisdiction will your research application be submitted Australia Online Forms for Research Version 1 8 October 2015 If you have MODIFIED the answers in your application 13 Click Submit your application electronically if you are re submitting a revised application with or without new revised documents Click Submit to confirm Please contact the CAS to book in your application and obtain the HREC Reference Number Enter the HREC reference 8 1 IC Test Verify Submit your application electronically e Provisional Approval Response This section allows you to submit your response to a request for further information post approval documents Clicking the Submit Documents button will electronically send the new updated documents to the secretariats Submit Documents Save completed form as XML Submission Submission Code Submission Status PDF XML Application made a request for further information and clock AU 1 991A016 29 09 2015 11 29 stopped 29 09 2015 00 00 00 Generate PDF Save as XML Detailed information on status is available on the Project Progress tab If you have not modified your application and are only submitting new revised documents 14 Go to the Provisional Approval Response section and click Submit Documents if you are submitting new revised documents only i e no change to application form The s
16. 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 The applicant cannot authorise their own SSA form if they are the Head of Department Head of Supporting Departments or Authority for Data Provision A Chief Investigator who is also the owner of the form can include their electronic authorisation on a form by clicking the Sign button 21 Page Australia Online Forms for Research Version 1 8 October 2015 Similarly the first 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 i My Project Navigate Documents Transfer Submission SSA Project Progress T Gather electronic authorisations for this NEAF form organisation submission The following electronic authorisations are available for this form type Electronic authorisation is available as an alternative to ink signatures The user must have a valid Online Forms username and passwo
17. MAS nS RON ad 36 Appendix A Quick Guide for e Submissions to Victorian Public Health Organisations 38 1 Submitting Applications to Victorian Human Research Ethics Committees or Victorian Research Governance OlTICeS eite tie oe st uds enue ees vus bees s ean Sues ds sue 38 2 Setting up email notifications for a project reviewed in Victoria essssse 40 3 Accepting declining email notifications for a project reviewed in Victoria 41 4 Following the progress of my submission and viewing email correspondence 41 5 Submitting a response for request for further information for an application reviewed in VICON Dane T 42 6 Submitting post approval documents in VICOLIA ccceecccseeeeceeeeeeeeeceeeesaeeeeseeeesseeeeeaes 44 7 Minimal Dataset Form for an NMA ethics application outside of NSW VIC QLD SA public Dnesl ordapisatloliSaietua nietutucdui netu desdntarseUna iodestetu iube n dede uU dM eL ia trR oadeines oie URPL UIN dd 46 4 Page Australia Online Forms for Research Version 1 8 October 2015 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 researchers is used t
18. OUNGATONS aD 2 35 99 9 0 10 9 0124s A OS NO diac 13 4 MY FOICCHILAV OU sisti isa carri infa saei bias ES bas epi dota tet bin eid ban FUIS baa elbl dan n FN EG DAE 14 4 1 The Navigate tab m 15 42 TheDocumen e taD a a a o ufu ub fure 15 AS The Transier taD REIR CR 18 AA TheA thonsaton taD iere a E E aer cedido 21 45 THE SUDMISSION TaD ei a a oh eie 24 46 TNE SSAJdaD usado tdt in e teo eo e tu et nu en tia toits 27 Ad RNGPrOlECl Progress TaD sudcsswbdsuueuidev usato mad fitsut owed mous o tuat tuf 30 AS The Ball PISIOPY AD si sans seis oa Dx ono R pa Rx Eon po R Pau O 30 5 IOI OM ACES toe sar E n 31 Dal Adding a Comac TETTE 31 92 Importing Contacts trom ODIIOOK eio HIR i tu EROR nu mmu ie EIS ieu dee oe eiE 32 59 01 1 6 A CONAC C UT T TOT ee ee eee eee ee 33 54 delendam tog lene neem ce eee defined E M 33 6 Managing WIV ACCOMM MM TREE TE UTERE 33 Gail Editino yor ACCOUN eses c T TTMTM 33 62 3ROFdOHUGT PASS Word arseenia aa eos Ub decus o eoa UE decus ouod daos bad outs 34 7 mile HG 34 8 CONAC USA EE 35 3 Page Australia Online Forms for Research Version 1 8 October 2015 9 mise mee I T m m 35 10 Other QOnlneForis PUrGHOE IS uvnsacwend nr oai elogia oro er va te reta uer beeen 36 TOSL NG OPES S CHOU OMS setis dabu asd cintenay Dann mE S ER da n
19. ab Submission Status 4 5 14 Submitting a response to a request for further information for an application reviewed in Victoria Once a Victorian application has been electronically submitted the submitted application form and supporting documents are READ ONLY unless the research office has requested for further information If the committee gives the decision of Request for Further Information Modification the applicant will be sent a system generated email The committee will send you separate correspondence detailing the specific information required Steps Screenshots 1 Open the project and click me meu vea sanae menn m nanus Emetre on the Navigate tab to lt O DUM modify the application if ITI ae required D 4 PRIOR REVIEWS 2 C ick O n th e Docu m e nts Navigate Transfer Authorisation Submission SSA Project Progress Email History tab to upload new revised Us Upload H 1 Any electronic d ts already uploaded against the NEAF Application F ill automatically be uploaded against the SSA F documents if required y electronic documents already uploaded against the pplication Form will automatically be uploaded against the orm Document loa Document Date Version Covering Letter 28 05 2015 01 05 2015 1 0 View Manage 27 Page Australia Online Forms for Research Version 1 8 October 2015 3 To update new versions of documents f
20. age Windows Internet Explorer If the Form has been completed and you are ready to submit select F OK A submission code will be generated and will appear on the printed Form and in the Submission History Selecting OK will nat electronically submit the Form to the assessing organisation EN NOTE generating a submission code DOES NOT electronically submit the form 24 Page Australia Online Forms for Research Version 1 8 October 2015 4 5 2 4 5 3 4 5 4 4 5 5 4 5 6 4 5 7 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
21. ame 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 u Manage Categories Category name Active Forms Edit Delete Drug D and Cancer Q version 2 0 In Progress Diabetes and exercise under 35 version 2 0 Transferred Out In Progress Add Category Move selected forms to 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 8 Page Australia Online Forms for Research Version 1 8 October 2015 If 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 Ma Create New Project Import NEAF from www neaf gov au IE Requests for Authorisation Manage CERLE d TE Projects Requests for Authorisation 3 Transfer Requests Manage Project Categories z Project Title Created On Drug D and Cancer Q 02 03 2010 In Progr
22. 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 rc RECIPIENT Project Title Transfered To Transfer Action Transfer Date Diabetes and exercise under 35 Miss Belinda Seeto Form Accepted 26 02 2010 18 02 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 10 Page Australia Online Forms for Research Version 1 8 October 2015 3 6 The Notifications tab The Notifications tab displays Email Notification requests for VIC applications The recipient will need to either accept or decline the Email Notification request Accepting allows the recipient to view the project status and correspondence for the ethics application and SSAs This table also keeps a history of all Email Notification requests Form titles that are not greyed out are available for the user to access You can view the project at any time by clicking on the underlined form title to open the project If you decline the project greyed out will remain in the table unless you click Delete Projects Requests for Authorisation 2 Transfer Reque
23. cation is being processed by the reviewing organisation Save completed form as XML Submission Code Submission Code Date AU 1 17BE115 28 05 2015 16 13 Application submitted pending registration by review body Detailed information on status is available on the Project Progress tab Submission Status Generate PD Save as XML Recall your application The recall button will not work once the application is being processed by the reviewing organisation Save completed form as XML Submission Code Submission Code Date AU 1 17BE115 28 05 2015 16 13 Application submitted pending registration by review body Generate PDF Save as XML Detailed information on status is available on the Project Progress tab Submission Status you to amend and re 39 Page Australia Online Forms for Research Version 1 8 October 2015 submit the form 2 Setting up email notifications for a project reviewed in Victoria The form owner of electronically submitted Victorian applications automatically receives all email notifications The ethics form owner can identify others whom they wish to be copied into email notifications and or view the project progress Steps Screenshots 1 Q pe n th e project a nd at My U Ke Project Filter Transfer Manage th e My P roj ect level cl ick i Please enter recipient s email address in the box below This option is for sending email notifications relating to the project status a
24. ck the Permanently transfer this form button Include personal message 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 4 3 7 4 3 8 4 3 9 4 3 10 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 Automated emails are generated advising the recipient and owner of the actions taken at various stages of the transfer 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 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 If an application has been permanently transferred to multiple users these users become third party recipients and acce
25. e that has been issued by the G NHMRC Information icon is information related to various functions on the Online 0 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 37 Page Australia Online Forms for Research Version 1 8 October 2015 Appendix A Quick Guide for e Submissions to Victorian Public Health Organisations 1 Submitting Applications to Victorian Human Research Ethics Committees or Victorian Research Governance Offices Electronic submissions are only available for applications submitted to Victoria Electronic submission is used for Victoria only projects and the Victorian part s of National Mutual Acceptance Projects The electronic submission process is the same for all application forms NEAF SSA LNR VIC and LNR VIC SSA Once you have completed the form uploaded supporting documents and obtained all mandatory authorisations you must submit you application Steps 1 Open the project and click on the Submission tab 2 Click Victoria as the jurisdiction in which the research application will be submitted 3 Complete the Victorian screening questions Note some application types will require you to enter an HREC reference number and then click the Verify button 38 Page Screenshots Authorisation SSA Project Progres
26. ess Diabetes and exercise under 35 21 12 2009 Transferred Before you can import your NEAF you must open the application in www neaf gov au click Save to disk and select XML We suggest clicking SAVE AS so that you can choose the folder to which the file is saved to 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 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 3 2 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 Project 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 Progre
27. ich jurisdictions your application will be submitted to You may choose more than one jurisdiction 3 4 Select the ethics form types required e NEAF National Ethics Application Form for full ethics review e LNR State specific application form for Ethical and Scientific Review of Low and Negligible Risk Research LNR e MDF Minimal Dataset Form for an orphan SSA application must be completed and submitted if you wish to submit an SSA application for a HREC application that will 11 Page Australia Online Forms for Research Version 1 8 October 2015 not be reviewed by an HREC under the public health system in New South Wales Queensland South Australia Victoria or Mater Research Brisbane This dummy HREC application is created for the purposes of linking subsequent SSA applications under the public health system in New South Wales Queensland South Australia Victoria or Mater Research Brisbane to a parent application 3 7 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 forms These tabs allow the user to navigate between the various form functions My Project Project Filter Transfer Manage NEAF Withi
28. ine Forms system The following Research Ethics Database AU RED actions may appear depending upon the progress of the application in AU RED for applications submitted to NSW QLD and SA 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 The project progress tab for applications submitted to Victoria allows the researcher to not only view the history table to monitor the progress of the submission but there is now an Email History tab 4 8 The Email History tab The Email History tab is available for applications submitted to Victoria This displays email correspondence Email correspondence from the research office will appear on the Email History tab Click on the links to view the email and attachment s 30 Page Australia Online Forms for Research Version 1 8 October 2015 Subject Email Date Sent Attachments letter requesting Email Demo reda redi yahoo com au View Email 26 05 2015 further information docx 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 fill in contact details in a form by clicki
29. istory Upload Date Document Date Version System Vers sp File Size Pea detnr L AER n 28 05 2015 28 05 2015 2 current 28 05 2015 01 05 2015 1 View Uploaded File View Uploaded File Delete Authorisation Navigate Transfer Submission SSA Project Progress Email History Multi document upload 7 For Internet Explorer 10 or above Document Name Remove Upload Files Single document upload 7 For Internet Explorer 7 8 9 or Safari 5 1 1 5 1 7 for Windows Please select v Version Document date Document Type Description Choose file to upload Please note that the fields Version and Description will be visible by the assessing organisation Navigate Documents Transfer Authorisation CSubmission gt SSA Project Progress Email History H Save Within which jurisdiction will your research application be submitted Provisional Approval Response This section allows you to submit your response to a request for further information post approval documents Clicking the Submit Documents button will electronically send the new updated documents to the secretariats Submit Documents Australia Online Forms for Research Version 1 8 October 2015 7 Minimal Dataset Form for an NMA ethics application outside of NSW VIC QLD SA public health organisations CURRENTLY NOT FOR USE The Minimal Dataset Form MDF has been created in pre
30. k to log in NOTE If you are requested to sign electronically 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 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 4 4 12 4 4 13 4 4 14 4 4 15 4 4 16 a My Projects Project Categories Create New Project Import NEAF from www neaf gov au website New Projects 4 Manage Categories i Projects Requests for Authorisation 2 Transfer Requests REQUESTS SIGNED Short Title Request By Request Date Form Type Signature Type Sleep Aponea Study Ms Ainsley Martlew 31 01 2010 09 35 NEAF Principal Researcher Open Request Sleep Aponea Study No 2 Ms Ainsley Martlew 10 02 2010 11 34 NEAF Principal Researcher Open Request 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 arrow buttons
31. lready 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 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 18 Page Aus
32. mail 28 05 2015 UN iE History tab Click on the links to view the email and attachment s 5 Submitting a response for request for further information for an application reviewed in Victoria Once a Victorian application has been electronically submitted the submitted application form and supporting documents are READ ONLY unless the research office has requested for further information If the committee gives the decision of Request for Further Information Modification the applicant will be sent a system generated email The committee will send you separate correspondence detailing the specific information required BEEN Steps Screenshots 8 Open the project and click nee o el atria on the Navigate tab to REmg 0 MEM modify the application if UIDI IT RN OR RR GR required 0 4 PRIOR REVIEWS 9 x C iC k O n th e D O C Uu m e nts Navigate Transfer Authorisation Submission SSA Project Progress Email History tab to upload new revised us plead d OC u m e nts if req u red E Any electronic documents already uploaded against the Prin a will Eee be uploaded against the SSA Form Covering Letter 28 05 2015 01 05 2015 1 0 View Manage 1 0 E To u pdate new versi O NS Single document upload 7 of d OCU m ents fro m th e ee 7 8 9 or Safari 5 1 1 gt 5 1 7 ea A d 5 List tab cl ick Version 2 0 28 05 2015 View Manage for the selected document Update the version numbe
33. n and viewing email correspondence Steps Screenshots 1 Open the application Navigate Documents Transfer Authorisation Submission SSA Email History A 1 HREC Actions and click on the Project ERRORI AU 1 86BE111 Provisional Approval Response submitted 28 05 2015 28 05 2015 12 57 00 P rog re S S ta b z jj h e AU 1 86BE111 Application made a request for further information and clock stopped 28 05 2015 12 52 02 28 05 2015 12 52 00 h ISto ry t ab e WI al low AU 1 86BE111 Application decision given Decision Further information modification requested 28 05 2015 12 52 00 AU 1 86BE111 Application assigned to meeting Meeting Date 29 05 2015 08 00 00 28 05 2015 12 52 00 yo u to monitor th e AU I86BE111 Application received 28 05 2015 28 05 2015 12 52 00 AU 1 86BE111 Application marked as valid 28 05 2015 12 51 00 D rog ress of yo ur AU 1 86BE111 Application registered by review body awaiting validation VIC Test not for use HREC 15 VIC Test 29 28 05 2015 12 51 00 AU 1 86BE111 Application submitted pending registration by review body 28 05 2015 12 50 00 submitted application rE 41 Page Australia Online Forms for Research Version 1 8 October 2015 2 Em ail corres ponde nce Navigate Documents Transfer Authorisation Submission l SSA Project Progress from the research office letter requesting h Will appear on the Email Email Demo reda red1 yahoo com au View E
34. n which jurisdictions will your research application be submitted tick all that apply E New South Wales Click the link to F Queenstand open the form C South Australia v Victoria Ethics Form Type NEAF LNR VIC Victoria ont 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 8 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 of the original form to create site specific assessment SSA forms All SSA forms should be linked to only ONE ethics form The Delete Application button 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 s
35. nd correspondence for the ethics O n th e m ail N otif j catio n S as le i MEAE project will automatically receive all email tab ET Email Addresses to be notified email address Send Email No data to display ee ee the person who you wish to receive email Please enter recipient s email address in the box below This option is for sending b email notifications relating to the project status and correspondence for the ethics notifications and then click application and SSAs The owner of the project will automatically receive all email the Add Recipient button notifications and view all email history opis rider Email Addresses to be notified email address Send Email No data to display 3 Click on the Submission N Ema Noticaton tab access checkbox if you wish for the recipient to have read only access to the project to view the applications documents and status Click OK to eal nagar e Io eee pier application and SSAs The owner of the project will automatically receive all email Update submission tab access Allow reda red2 yahoo com au access to the submission tab notifications and view all email history confirm Email Addresses to be notified Submission Tab Access Submission Tab Status Note an automated email niis dor nd iced Delete will be sent to the recipient asking them to accept or decline the invitation The recipient must be an Online Forms u
36. ng 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 a 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 3 EA 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 Page completed Navigate by question numbers 1 TITLE and SUMMARY of Project 1 2 2 RESEARCHERS INVESTIGATORS 2 3 4 55c 6 7a 3 RESOURCES 14 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
37. ng on the Add Contact Details d icon whenever it is 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 d Add New a 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 V Contacts Filter by First Name Position Organisation Action Prof Jane Black Haematologist Emerald Hospital View Delete Dr Joseph Bloggs Clinician Emerald Hospital Delete Ms Ainsley Martlew G Manager Infonetica Delete Miss Belinda Seeto PD Manager Infonetica Delete q ddContact 31 Page Australia Online Forms for Research Version 1 8 October 2015 9 1 2 5 2 If you have entered a contact into zem 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 Before deciding whether to select Update existing contact or Add new contact view exact first name and surname matches by clicking the b
38. o 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 au ethicsform org 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 10 or later e Mozilla Firefox 36 or later e Google Chrome 4 0 or later 2 1 8 Browser plug ins e Adobe PDF Reader Ensure that you have the latest version 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 To access the forms you must have registered and verified your account You only need to register once you can then complete as many
39. o unsuccessful unfinished forms 12 Page Australia Online Forms for Research Version 1 8 October 2015 could be moved to a new folder category This function will not appear if the project has a Submission code 3 9 The Email Notifications tab The form owner of electronically submitted Victorian applications automatically receives all email notifications The Email Notifications tab for VIC applications allows the owner of an application form to identify others whom they wish to be copied into email notifications and or view the project progress 3 9 1 Open the project and at the My Project level click on the Email Notifications tab C My Project Project Filter Transfer Manage Email Notifications NEAF Please enter recipient s email address in the box below This option is for sending email notifications relating to the project status and correspondence for the ethics application and SSAs The owner of the project will automatically receive all email notifications and view all email history Add Recipient Email Addresses to be notified email address Send Email No data to display 3 9 2 Enter the email address of the person who you wish to receive email notifications and then click the Add Recipient button Project Filter Email Notifications Please enter recipients email address in the box below This option is for sending email notifications relating to the project status and corre
40. only submitting new revised documents 7 Go to the Provisional Approval Response section and click Submit Documents if you are submitting new revised documents only i e no change to application form The system will check for new revised documents and indicates the number of documents electronically sent to the research office 4 6 The SSA tab Please contact the CAS to book in your application and obtain the HREC Reference Number Enter the HREC reference IC Test 231 Meee Submit your application electronically Provisional Approval Response This section allows you to submit your response to a request for further information post approval documents Clicking the Submit Documents button will electronically send the new updated documents to the secretariats Submit Documents 4 Save completed form as XML po wig Submission Code Pair eer og Application made a request for further information and clock AU 1 991A016 29 09 2015 11 29 stopped 29 09 2015 00 00 00 Generate PDF Save as XML Detailed information on status is available on the Project Progress tab This tab only appears in the ethics form ie NEAF or LNR action tabs NOTE An SSA form must 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 Asses
41. orms 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 check for updates periodically e FAQs page will include frequently asked questions and answers This page is currently unavailable 34 Page Australia Online Forms for Research Version 1 8 October 2015 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 35 Page Australia Online Forms for Research Version 1 8 Octobe
42. ount with this website Please click here for downloadable The following electronic authorisati 7 95 redigyahoo com au Prin Include personal message Reda can you please review the form and as contact me on 02 8448 2069 Electronic Authorisations History Send Request gt gt Date No Electronic Authorisations to display age Project Progress Forms username and password as this is used to authenticate the sation is accepted by their organisation in electronic authorisations before you print the form for submission Request Sign 22 Page Australia Online Forms for Research Version 1 8 October 2015 4 4 6 4 4 7 4 4 8 4 4 9 Automated emails are generated advising the recipient and owner of the actions taken at various stages of the authorisation The owner has the power to recall the electronic authorisation request that has not been approved by selecting the Recall button The owner also has the power to revoke an electronic authorisation that has already been approved by selecting the Revoke button If 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 4 4 11 As the authoriser of an electronic authorisation request you will receive an email requesting you to authorise a form with a lin
43. paration for national mutual acceptance It will allow the form owner to generate and submit an MDF parent application so that Site Specific Applications SSAs can be generated and submitted to NSW VIC QLD SA public health organisations Within which jurisdictions will your research application be submitted tick all that apply New South Wales Queens land South Australia Victoria Ethics Form Type NEAF lir rosaceo ARR CURRENTLY NOT FOR USE 46 Page Australia Online Forms for Research Version 1 8 October 2015
44. pload Multi document upload For Internet Explorer 10 or above Browse No files selected Document Name Version Description Remove Upload Files Single document upload For Internet Explorer 7 8 9 or Safari 5 1 1 gt 5 1 7 for Windows Document Type Please select v Version Document date Choose file to upload No file selected Please note that the fields Version and Description will be visible by the assessing organisation Upload File 17 Page Australia Online Forms for Research Version 1 8 October 2015 4 2 4 2 8 4 2 9 Click on the Upload tab select the document type from the dropdown list Enter the version number and document date of the document This will help you keep track of the latest version of the document 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 4 2 11 the target file Once you have found the file click on it and then click the Open button 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 document has a
45. r document date description and browse to Upload New Version j Delete Cancel upload a new version of cover letter Description Choose file to upload Please note that the fields Version and Description will be visible by the assessing organisatiop gt History th e f i o a n d th e n cl ick th e Upload Date Document Date Version System Vers sp File Size Anh ep ale U D load New Version 28 05 2015 28 05 2015 2 came IS b u tt O n 28 05 2015 01 05 2015 1 View Uploaded File Delete 42 Page Australia Online Forms for Research Version 1 8 October 2015 11 To upload new documents go to the Upload tab Enter the document type version number document date description and browse to upload the file then click Upload File 12 Once you have modified the application form and or uploaded new revised documents click on the Submission tab 43 Page Authorisation Submission SSA Project Progress Email History Multi document upload 7 For Internet Explorer 10 or above Upload Files Single document upload 7 For Internet Explorer 7 8 9 or Safari 5 1 1 5 1 7 for Windows Document Type Version Description Choose file to upload Navigate Documents 1 Save Please select Iv Please note that the fields Version and Description will be visible by the assessing organisation Remove Document date E Transfer Authorisation
46. r 2015 10 Other Online Forms Functions 10 1 Icon Descriptions There are various icons used in the Online Forms system 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 generates 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 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 v icon again The form is not affected if you choose not to use this feature Complete 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 o pages of the form Previous Mext The Page Index allows you to click on a chosen page rather than having to scis go back to the Navigate page or to click the Previous and Next button numerous times to get to the
47. rch Version 1 8 October 2015 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 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 four full e mail address Password Forgotten Password Click here 2 4 Logging Out To log out of the Online Forms system 2 4 1 Click the Logout link on the top right of the page below your name and user login f m I ed reda red1 yahoo com au Lb ore Logout aout 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 3 Navigating around My Projects 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
48. rd as this is used to authenticate the electronic authorisation Prior to submission please confirm with your HREC RGO that electronic authorisation is accepted by their Please click here for downloadable step by step instructions on electronic authorisations You must obtain electronic authorisations before you print the form for Status Authorisation Type Status Signing User Action Chief Researcher Not requested Sign 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 Request buiton 4 4 4 and click the Send Request button Principal Researcher and click the Enter the email address of the authoriser and include a personal message if necessary 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 requests i An Authorisation History at the bottom of the page keeps a record of all authorisation Navigate Documents 1 m Gather electronic authorisations for Enter e mail address ofthe 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 user electronic authorisation Prior to sul The user must have a registered acc
49. reenshots Navigate Transfer Authorisation Submission SSA Project Progress Email History List Upload Any electronic documents already uploaded against the NEAF Application Form will automatically be uploaded against the SSA Form Covering Letter 28 05 2015 01 05 2015 1 0 Australia Online Forms for Research Version 1 8 October 2015 2 To update new versions of documents from the List tab click View Manage for the selected document Update the version number document date description and browse to upload a new version of the file and then click the Upload New Version button 3 To upload new documents go to the Upload tab Enter the document type version number document date description and browse to upload the file then click Upload File 4 Once you have uploaded new revised documents click on the Submission tab 5 Go to the Provisional Approval Response section and click Submit Documents The system will check for new revised documents and indicates the number of documents electronically sent to the research office 45 Page Single document upload For Internet Explorer 7 8 9 or Safari 5 1 1 gt 5 1 7 for Windows Document Type Covering e v Version 2 0 28 05 2015 E Document date EH cover letter Description Ld Choose file to upload Browse Please note that the fields Version and Description will be visible by the assessing organisatiop 2 H
50. required page Clicking the allows the user to display pages before or after the page numbers displayed This feature only appears on the electronic form opell 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 allows the user to 36 Page Australia Online Forms for Research Version 1 8 October 2015 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 New text is highlighted in BLUE Old text is in black and is not highlighted 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 es icon allows you to add an existing from your Contacts database oave Contact Details A 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 guidanc
51. rom the List tab click View Manage for the selected document Update the version number document date description and browse to upload a new version of the file and then click the Upload New Version button 4 To upload new documents go to the Upload tab Enter the document type version number document date description and browse to upload the file then click Upload File 5 Once you have modified the application form and or uploaded new revised documents click on the Submission tab 28 Page Single document upload 7 For Internet Explorer 7 8 9 or Safari 5 1 1 5 1 7 for Windows Document Type Covering es v 28 05 2015 E Version 2 0 Document date cover letter Description Choose file to upload Browse Please note that the fields Version and Description will be visible by the assessing organisatiop LESE Upload New Version gt History Upload Date Document Date Version System Vers sp File Size VERS pra L A n 28 05 2015 28 05 2015 28 05 2015 01 05 2015 1 2 current Navigate CDocuments Transfer Authorisation Submission SSA Project Progress Email History a View Uploaded File View Uploaded File Delete Multi document upload 7 For Internet Explorer 10 or above Document Name Upload Files Single document upload 7 For Internet Explorer 7 8 9 or Safari 5 1 1 5 1 7 for Windows Please select Iv Document date
52. rowse button Documents Transfer Authorisation Submission SSA Project Progress Upload Multi document upload For Internet Explorer 10 or above No files selected Document Name Version Description Remove Upload Files 16 Page Australia Online Forms for Research Version 1 8 October 2015 4 2 3 4 2 4 4 2 5 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 Click the Open button 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 G For Internet Explorer 10 or above Document Version Description Name Investigator s Doci docx Investigators Brochu 1 0 01 08 2014 Brochure v1 0 for drug x Upload Files 4 2 6 Click the Upload Files button on the Online Forms system Note Going back into the 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 oafari 5 1 1 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 List U
53. s Navigate Documents Transfer Email History E Within which jurisdiction will your research application be submitted New South Wales Queensland South Australia Victoria Submission Code Date Submission Status No Submissions to display Detailed information on status is available on the Project Progress tab Authorisation Navigate Documents Transfer Submission H Save O New South Wales Queensland O South Australia Victoria Study Type Please select Within which jurisdiction will your research application be submitted Navigate Documents Transfer Autnonsation submission SSA Project Progress Emau History 1 Save Within which jurisdiction will your research application be submitted New South Wales Queensland South Australia Victoria Study Type Clinical trial of a device v Choose the statement which best describes this ethics application single site application one health service only multi site application If you are unsure about which statement best applies to your application please contact your Research Office for advice Please contact the CAS to book in your application and obtain the HREC Reference Number Enter the HREC reference verity Australia Online Forms for Research Version 1 8 October 2015 4 Click the Submit your application electronically button and then confirm by
54. s Transfer Autnonsation Submission ssa Project Progress Eman History Save Within which jurisdiction will your research application be submitted Victoria Study Type Clinical trial of a device v Choose the statement which best describes this ethics application single site application one health service only multi site application If you are unsure about which statement best applies to your application please contact your Research Office for advice Please contact the CAS to book in your application and obtain the HREC Reference Number Enter the HREC reference E 4 5 11 Click the Submit your application electronically button and then confirm by clicking the oubmit button in the pop up window Note you cannot change an application submitted to Victoria between submission and approval unless the committee requests for further information See below on how to recall an application Please contact the CAS to book in your application and obtain the HREC Reference Number Enter the HREC reference This HREC Reference is verified Submit your application electronically a Submission Code Submission Code Date Submission Status No Submissions to display Detailed information on status is available on the Project Progress tab Navigate Documents Transfer Authorisation Submission Submit Application Selecting Submit will electronically submit the form and all supporting documents Importan
55. ser 40 Page Australia Online Forms for Research Version 1 8 October 2015 3 Accepting declining email notifications for a project reviewed in Victoria Steps Screenshots 1 i L O g int O P Ja Australia o S S Gb Ms Reda Red reda red1 yahoo comau Logout Online Forms http au ethicsform or Ren and click on the Notifications tab C SS Se Archive 7 eee Requests tor Authorisation 2 Transier Requests CRosficaions FIT Incomplete Suspended 0 E Cancer Projects 0 The owner of an application form has requested that you have access to information about the below projectis Form Title form Type Project Crested On Manage Categories 2105 2015 Submission Code AUS F2BE119 21 05 2015 Submission Code AU T D2BE 110 14 05 2015 Submission Code AUAn S2BE110 2 Click on Accept or a o ronadanedntraiovicocinas b i helpine My Account Logout Online Forms for Research Decline My Projects If you decline the project a ma greyed out will remain in cereus Senna R the table unless you click sn sat og ee roa eames Delete 1 ae ee 3 Once you have accepted you can view the project at any time by clicking on the underlined form title to eee oo nh open the project eat cain ST Manage Categorias 2105 2015 Submission Code AW1 D2BE 110 14 05 2015 Submission Code ALUAT 5 BE 110 4 Following the progress of my submissio
56. sment form specific for that State e Access Request form New South Wales only Form No SSA Forms to display 1 81 1 13 9 R1123 mis wa Please type the number of forms you wish to create in one go Navigate Documents Transfer Authorisation Submission SSAs Manage ProjectProgress Status Action 29 Page Australia Online Forms for Research Version 1 8 October 2015 4 6 1 Enter the number of forms you wish to create and then click the Create a new SSA Form button 4 6 2 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 4 6 3 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 4 6 4 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 may 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 Onl
57. spondence for the ethics application and SSAs The owner of the project will automatically receive all email notifications and view all email history reda red2 yahoo com au x Add Recipient Email Addresses to be notified email address Send Email No data to display 3 9 3 Click on the Submission tab access checkbox if you wish for the recipient to have read only access to the project to view the applications documents and status Click OK to confirm Note an automated email will be sent to the recipient asking them to accept or decline the invitation The recipient must be an Online Forms user Project Filter Transfer Manage Email Notifications Update submission tab access Allow reda red2 yahoo com au access to the submission tab Please enter recipients email address in the box below This option is for sending email notifications relating to the project status and correspondence for the ethics application and SSAs The owner of the project will automatically receive all email notifications and view all email history Add Recipient Send Email Submission Tab Access Submission Tab Status Email Addresses to be notified reda red2 yahoo com au Not Requested Delete 13 Page Australia Online Forms for Research Version 1 8 October 2015 4 My Project Layout What is the difference between My Projects and My Project My Projects is like a filing cabinet listi
58. ss or whether it has been transferred 9 Page Australia Online Forms for Research Version 1 8 October 2015 Requests for Authorisation 10 Transfer Requests Form Title FormType Project Created On Form Status Not named yet NEAF 19 07 2010 In Progress 20100715 NEAF 23 03 2010 In Progress No Title Status 1 SSA 2230 No PI typed No research organisation t In Progress 2 SSA 2231 No PI o research organisation 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 Short Title Request By Request Date eian 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 q Miss Belinda 08 02 2010 Open Request PEANUT vus 01 20 NEAF Principal Researcher Open Request Miss Belinda 26 02 2010 n It also keeps a 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 The Transfer Requests tab displays transfer form requests requiring action
59. ss becomes limited For the final recipient to have FULL ACCESS the application must be transferred back to the original owner and for the original owner to transfer to the final recipient Infonetica Helpdesk can assist in the transfer if the owner is no longer involved in the project To carry out your request to transfer ownership of an Online Application we need an Email from the Chief Investigator or Sponsor of the research named on the form The email must come from the email address entered on that project form for the Chief Investigator Sponsor named If it does not we cannot validate that the person asking is in fact the Chief Investigator Sponsor of this project and we cannot carry out the request 20 Page Australia Online Forms for Research Version 1 8 October 2015 The email should begin with a confirmation that you are not able to contact the original owner and have them carry out the transfer for you It should also include explicit permission to carry out the transfer and contain the following required information e Your name Whether you are the chief investigator or the sponsor Short title of the Project Chief investigator as named in the Project Registered e mail address of an existing user of Online Forms from whom you wish to transfer the Project e Registered e mail address of an existing user of Online Forms to whom you wish to transfer the Project 4 4 The Authorisation tab The username and password authentication
60. sts Notifications 3 The owner of an application form has requested that you have access to information about the below project s Form Title Form Type Project Created On Form Status Status Action Shingles a andthe NEAF 21 05 2015 Submission Code AU 1 F2BE119 Accepted elderly NEAF 21 05 2015 Submission Code AU 1 D2BE110 Declined NEAF 14 05 2015 Submission Code AU 1 52BE110 Requested 3 7 Creating a New Project To create a new project 3 7 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 JA A Australia A v Miss Reda Red reda red1 yahoo com au x Online Forms x b i a amp My Account Logout Y for Research he HOME MY PROJECTS MY CONTACTS HELP CONTACT US m My Projects ux Project Categories E Create New Project Import xml NEAF amp other forms New Projects 0 ni ar in Projects Requests for Authorisation 10 Transfer Requests Manage Categories Form Title FormType Project Created On Form Status Not named yet NEAF 19 07 2010 In Progress 3 7 2 Anew project Not Named Yet is generated in the system and the My 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 3 7 3 Inthe Project Filter tab select wh
61. t An application submitted without uploaded supporting documents may not be accepted by the reviewing organisation 26 Page Australia Online Forms for Research Version 1 8 October 2015 4 5 12 Once submitted you will be able to print a clean copy of the application by clicking Generate PDF Recall your application The recall button will not work once the application is being processed by the reviewing organisation Save completed form as XML Submission Code Submission Code Date AU 1 17BE115 28 05 2015 16 13 Application submitted pending registration by review body Generate PD Save as XML Detailed information on status is available on the Project Progress tab s mM Submission Status 4 5 13 The option to Recall your application is available as long as the application is still pending registration by the committee Once successfully recalled you may amend the form upload supporting documents obtain authorisations and re submit the application If you are unable to recall the application please contact the research office Recall your application The recall button will not work once the application is being processed by the reviewing organisation Save completed form as XML Submission Code Submission Code Date AU 1 17BE115 28 05 2015 16 13 Application submitted pending registration by review body Generate PDF Save as XML Detailed information on status is available on the Project Progress t
62. t All link to uncheck the boxes and then check the boxes to mark the contacts to save then click Save selected contacts 32 Page Australia Online Forms for Research Version 1 8 October 2015 Choose file to upload select All Deselect All W Dr Jon Who Hospital X jwho fake com lV Mr Jon Mann Hospital M jon mann hosp com L Mr Waine rusev Hospital M w rusev fake com Mr Clive Stefchov Hospital M c stefchov hosp com Ms Tina Long Johns Hospital S tina lj 9fake com O v Mr Quinn Taylor Hospital B g taylor hospital com Upload File Save selected contacts 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 5 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
63. tralia Online Forms for Research Version 1 8 October 2015 Documents Transfer Authorisation Navigate 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 bloggsGhospitalx com Include personal message Dear Joe Please confirm that you have the approval to use the MRI machine from gt gt Transfer To User lt lt Transfered From Transfered To Transfer Action No Transfers to display To transfer an ethics form temporarily at NEAF level 4 3 1 Transfer Date 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 4 3 2 various stages of the transfer 4 3 3 The transfer actions are listed in the transfer history 4 3 4 Form button To permanently transfer a project is a 3 step process Automated emails are generated advising the recipient and owner of the actions taken at The owner has the power to retrieve the transferred NEAF by selecting the Retrieve 4 3 5 When permanently transferring ethics forms you must transfer the whole project Select the application and click My
64. utton to expand the contact details to ensure you are updating the correct contact Importing Contacts from Outlook You can upload the entire MS Outlook contact list or save selected Outlook contacts 9 2 1 9 2 2 9 2 3 5 2 4 9 2 9 5 2 6 9 2 7 5 2 8 9 2 9 Before you are able to import the contact list you must generate the Outlook csv file Go to Contacts in your MS Outlook Select File Import and Export from the Main Menu bar A new window will appear Select Export to a File from that window Click Next oelect Comma Separated Values DOS Click Next select the Contacts folder Click Next oelect the location where you wish to save the exported file Click Next then click Finish From the My Contacts page click on the Import Contacts from Outlook link Click the Browse button 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 V Contacts Upload Outlook Contacts Choose file to upload c Users seetob Desktop yahoo ab csv Select All Deselect All 5 2 10 To upload the entire list click on the Select All link to ensure that all boxes are checked and click Upload File 5 2 11 To upload selected contacts use the Deselec
65. ystem will check for new revised documents and indicates the number of documents electronically sent to the research office Please contact the CAS to book in your application and obtain the HREC Reference Number Enter the HREC reference IC Test Verify Submit your application electronically Provisional Approval Response This section allows you to submit your response to a request for further information post approval documents Clicking the Submit Documents button will electronically send the new updated documents to the secretariats Submit Documents 4 Save completed form as XML po wig Submission Code Pair eer og Application made a request for further information and clock AU 1 991A016 29 09 2015 11 29 stopped 29 09 2015 00 00 00 Generate PDF Save as XML Detailed information on status is available on the Project Progress tab 6 Submitting post approval documents in Victoria Once an application has been approved in Victoria the submitted application form will be READ ONLY No modifications can be made to an approved form The applicant can submit amendments progress reports revised protocols etc as new revised documents Go to http www health vic gov au clinicaltrials application instructions htm for post approval templates The templates are revised on an ongoing basis always use the most recent version Steps 1 Click on the Documents tab to upload new revised documents 44 Page Sc

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