Print User Guide
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1. Private Browsing Reset Safari Empty Cache XSE Services gt Hide Safari H Hide Others X3H Show All Yahoo Toolbar allowing pop ups 1 On the Yahoo Toolbar click the pop up blocker icon to see if Enable Pop up Blocker is checked If so click this line once to turn off pop up blocking eProtocol BBL Protocol Management System Microsoft Internet Explorer File Edit wiew Favorites Tools Help sak x g x B A P Search 5 Favorites E2 2 amp Gry Js 4 Address http bbapp bbl Ee Windows Live E O i what s New Profile Mail Photos Calendar MSN Sha Google sw 8 Search gt GB gt OQ O Q 3 v aa y Ea r 7 Y 0 o 6 re o e eProtocol BBL Protocol Mana f Play Sound When Pop Up Is Blocked Always Allow Pop Ups From Bb Bellberry Limited Total Pop Ups Blocked 6 Why am I still getting pop ups Pop Up Blocker Test More Help 2 When Pop up Blocker is correctly turned off it will show Enable Pop up Blocker as 7 Page unchecked Z eProtocol BBL Protocol Management System Microsoft Internet Explorer File Edit view Favorites Tools Help Q sack QJ x a A P Search Pp Favorites 4 3 ee La BE J l Address http bbapp bbl Y Windows Live O i What s New Profile Mail Photos Calendar MSN Sha Google vfa e G OFP DO B SG oro ea BR O e a Protocol BBL Protocol Mana f v Play Soun2. Please note that the file names used in the attachment section will be the document names that are listed in the approval letter as reviewed documents 17 Page A eProtoc SEE rnet Explorer Jeyx OE TTT ST Note denotes mandatory field Attachments Document Type Select One select One Advertisements Document Name Any other material to be considered by the Com Clinical Trial Agreement Schedule 7 Completed and signed Indemnity Forms Completed Site Approval Form Curriculum Vitae if not previously known to Bellbe Final Application Investigator Brochure Attachment ee Medical registration and personal medical insuran Sponsor Other Ethics Committees Approvals amp Rejections Application Information Patient Information sheets Consent Forms Return Notes Risk or Benefit Information iaieiiea Attachments Scientific Information ase click on Add to add Attachments B internet e Click on the Check for Completeness left hand menu option when you believe you have finished entering all of the necessary information You will see a message that will indicate which sections may be missing information NOTE The check for completeness feature cannot check to see if all of the necessary Supporting documents have been attached Be sure to double check that this has been done before you submit your application Clone an Application To create a new application from an existing protocol click
3. To delete a site click the check box next to a particular name then click the DELETE button To add additional sites simply click the ADD button again e Principal Investigator Declaration remember when completing the application form on page 6 of the Application Information the Declarations box must be ticked 16 Page HREC HREC Application Form Application ID 10 01 320 Atherton Michael 5 Application Title HREC Test Application lt Previous Next gt v sre Check alll Save X Close EF ey Declarations ES Will the consent process comply with the National Statement Item 5 2 16 Section a ERE ne Do you have any Conflict of Interest as per Section 3 3 4 of the National Statement Yes lf Yes please disclose Is the Investigators Brochure current relevant and are all relevant matters relating to OY the study covered in the application If Not why not Have you signed a Clinical Trial Agreement Yes fyes and Schedule 7 has been completed please attach a copy in the Attachments section The Principal Investigator has read and agrees to abide by the above Declarations Previous Next gt e Attachments Page 7 of Application Information This section allows you to attach documentation form the listing above Ensure that you save the document under the correct heading and that you save the file using a file name that describes the content e g for Protocols save file as ProtocolVersionNoxxDate
4. and you will see a small window open HREC Create Application Clone Application Delete Application Applications In Preparation Submitted Approved Applications Initial Last Approval Expiration Approval Date Date Date Application Application ID Principal Investigator Status Comments Type 10 01 3058 Atherton Michael 22 01 2010 22 01 2010 31 1 2 2999 APPROVED NEV 10 01 276 Atherton Michael 11 01 2010 11 01 2010 10 01 2011 APPROVED NEV 09 12 250 Atherton Michael 5 22 01 2010 22 01 2010 21 01 2011 APPROVED NEW 3 If the option to Start Amendment IB button as shown below is not available ie you cannot click on it then e You may not have EDIT access to this study Select Open in View mode and click on the left hand menu option Personnel Info Only those people listed in the first four roles Principal Investigator Administration Contact Co Investigator Other Contact have access to EDIT the application and start amendments e An amendment or extension may have already been started or is in process for this application Check on your HOME page in the Applications In Preparation Submitted section to see if the study is listed there Approved Application Decision Please select any one of the following Open in View Mode Application Details Start Amendmentib Start Ethics Approval Extension Start Final Report Form Start Progress ReportForm Start Adverse Event Report Form Start Protocol Deviat
5. application can apply for a User ID and Password by registering on the eProtocol homepage Select the Register button and complete and submit the form System Requirements To access the eProtocol application you ll need a computer with an Internet connection If on a Windows computer use Internet Explorer IE as your browser If on a Macintosh computer use Safari as your browser Pop up blocking software must be disabled pop ups must be allowed while using eProtocol See instructions for allowing pop ups in your browser 9 Page Access to Submitted Applications Once logged in to eProtocol you will have access to see all those and only those applications for studies on which you have been listed in the Personnel Info section You will only have access to edit those studies applications on which you are listed as either Principal Investigator Co Investigator Nominated Contact Tax Invoice You must have edit access for a particular study in order to start an amendment or Ethics Approval Extension application for that study e PLEASE NOTE If you are listed in the Other Personnel section of a study application you only have read access to that study When is independent ethical review needed For a definition of Human Research please click here http www nhmrc gov au publications ethics 2007_humans purpose htm d As per the National Statement on Ethical Conduct in Human Research 2007 in
6. checked to make sure it is complete and that it includes all of the necessary attachments etc Sometimes it is necessary to Return an application If you receive an email that your application was returned go into the application and check the Return Notes section to see why This releases the application back to you with full EDIT capability so that you may make any necessary adjustments Also the Application Status that displays on your HOME page will be Submission Returned You ll need to open the application and click the link in the left hand menu labeled Return Notes as shown below Application Information Check For Completeness This will open a small window with information regarding the reason your application was returned and instructions on how to proceed When you are ready to re submit the application you simply click the SUBMIT APPLICATION button just as you did for the initial Submission PLEASE NOTE The HREC Return Notes area is only used for instructions relating to returned applications and is not where you can see comments that were entered as part of the full HREC review 20 Page Application Review Process Once your protocol has been accepted it will be assigned to a specific Bellberry Committee A B or C for review and assigned a meeting date Check your email regularly You will receive an email for each major event in the review process You can also see the status by looking at the application listi
7. following Application Only Application with Comments Comments only Sections to Print Select Orientation All Portrait Landscape Personnel Information Study Sites Sponsor Rationale Participant Population Radiation Risks Ethics Committee Declarations Attachments 00000000000 OO O O00000 Select an option sections and their orientation and click OK The Adobe pdf file will be created and opened You may save it to your computer by clicking File then save as in the upper left hand corner of the window 34 Page Close a Study To Close a Study follow these steps 1 On your eProtocol HOME page the page you see when you first log in look at your Applications Active listing You may need to click the at the right side of the section header to expand this section Click on the desired application number A small window should open as shown below Approved Application Decision Please select any one of the following Open in View Mode Application Details Start Amendmentib Start Ethics Approval Extension Start Final Report Form Start Progress ReportForm Start Adverse Event Report Form Start Protocol Deviation Violation Report Form Close Application O O O O O O O Select Final Report and complete the application and submit to Bellberry You will see the option to Close Application as shown above Simply select Close application and click OK You ll see anothe
8. on the CLONE APPLICATION button in the upper right hand corner of your HOME page and follow the instructions on the page 18 Page Submit an application to Bellberry After completing your application form you can submit it to Bellberry by clicking on the SUBMIT APPLICATION button in the left hand menu of the Application Form as shown below You will need to have the application open in EDIT mode Select YES and the application will automatically be submitted to Bellberry Personnel Information Study Sites Sponsor Application Information Check For Completeness Submit Form Print Yiew Event History Please be patient after clicking submit The application will automatically check to make Sure that all parts of the application form are complete If the application is complete a small window will open thanking you for submitting your application If the application is not complete then a window will open indicating the portions of the application that remain to be completed Navigate to those areas and answer the questions before attempting to Submit again PLEASE NOTE Once an application is submitted you will not be able make edits or additions unless requested as part of the Bellberry HREC review process 19 Page Returned Applications After your application has been submitted it will undergo an initial check by the Bellberry office staff before it is assigned to a Bellberry Committee for review The application is
9. BB Bb Bellberry Limited supporting research and ethics DB Db Investigator e Protocol User Guide 1 Page I JULIA SOFTWARE Guides Investigator User Guide Master doc Investigator User Guide 1 Getting Started 2 Working with Applications Before you Start Tips for Success Who can log in Access to Submitted Applications When is Independent Ethical Review needed Understanding your e Protocol HOME page Create a new Application Filling in an Application Form Clone an Application Submit an Application Clone an Application Returned Applications Application Review Process Respond to Bellberry HREC Comments Submitting an Amendment Submitting Ethics Approval Extension Renewals Submitting Progress Reports Submitting Adverse Reports Submitting Protocol Violation Reports Submit Final Report Form Update Study personnel Print_an Application Close a Study 3 Troubleshooting I click on EDIT but application does not open I can t see my approved applications I can t find the application I need to amend The option to Start Amendment or Ethics Approval Extension is not available it appears grey I select Start Amendment and click OK but am brought back to the page where I started I received an error stating Session Expire I am trying to respond to HREC comments but it appears as if there are none I can t open the PDF of my study or approval letter 2 Page Getting Started Before You Start W
10. ant fields For Individual Event Select 1 and complete report as required For Summary reporting select 2 and attach relevant documents Once completed Submit Form 30 Start Violation Report HREC HREC Application Form Application ID 09 12 226 Atherton Michael S Application HREC Application Form Title oe Spell Check EJ Help Save x Close Protocol Deviation Violation Report Bellberry requires reporting of all application deviations and or application violations within 14 days ofthe event Protocol Deviation Violation Report Form Principal Investigator Name Michael Atherton Get Application Date of Report 14 12 2009 T3 HREC Application Form Research Protocol Title Protocol Na Participant s ID Date of Event Ts Provide a full description of the application deviation violation as well as why the deviation violation occurred What happened when it happened where how and why it happened attach as many pages as necessary Attachments Add Please click on Add to add Attachments Describe the action taken in regard to the event Attach as many pages as necessari Describe the effect the event had on the participant Describe the action taken to prevent any future recurrence ofthis protocol deviation Attach as many pages a necessary Who was the violation deviation reported to Sponsor O yes ONo ONA Date Notified C The Principal Investigator has read and agrees that the ab
11. ct more than one item from that group d Australianslocal F International e Radio buttons mean that you may select only one item from that group Yes No e Tables are used in parts of the application where you may need to add more than one item for example Additional Sites 15 Page HREC HREC Application Form Application ID 10 01 320 Atherton Michael 5 Application Title HREC Test Application lt 3Previous Next gt v Spell Check Help Save x Close Site Location Where will the study be conducted Studies being conducted within hospitals and or institutions must complete a Site Approval Form and attach a copy with this application Forms available on the website For multi centre studies please attach a list of each Investigator and the names and physical location of each Sponsor si site from which they will conduct the study Site Location f aaa Investigator Name Name of the Site Physical Location of the Site Print View C Simon Jones Bellberry Limited Dulwich if the Principal Investigator has responsibility for more than one siteJocation please advise on how supervision will take place at each site Previous Next gt When you click add a window will open where you enter the details related to the site To view or edit the detailed information click the Investigator Name link in this case Simon Jones This will re open the window where you had first entered the site details
12. cted Adverse Events SUSARS occurring at a Bellberry approved site Summary Report This form is to be completed for Summary Reporting ATTACHMENTS FOR SUMMARY REPORTS Attachments Please click on Add to add Attachments TT 1 REPORTING OF INDIVIDUAL EVENTS Date of Event Report No 1 Date PI learned of Event Description of Event Are there any ethical implications of the event on the conduct of the trial Principal Investigator s opinion re the relations of the event to the study drug device Definite Likely Possible Unlikely Uncertain Sponsors opinion re relationship of the event to the study drug device Definite Likely Possible Unlikely Uncertain Please indicate if any ofthe above adverse event s necessitates an Yes amendment to the Protocol and or the Patient Information Sheet Consent Form lfyes start and Amendment and reference this report Has the Sponsor or Data Safety Monitoring Board been notified of the event if relevant lfno please provide reasons Attach relevant documents Attachments Definitely Not Definitely Not No Please click on Add to add Attachments C The Principal Investigator has read and agrees that the above information is True 29 Page Repeat the above steps and select Adverse Event Report Form from the Approved Application Decision Box Select either of Individual Event or Summary Report and then complete the relev
13. d When Pop Up Is Blocked Always Allow Pop Ups From Bb Bellberry Limited Total Pop Ups Blocked 0 Why am I still getting pop ups Pop Up Blocker Test More Help Google Toolbar allowing pop ups 1 On the Google Toolbar click the pop up blocker icon to see if pop ups from his site are allowed If not Always allow pop ups from message is displayed Click this line once to turn off pop up blocking eProtocol BBL Protocol Management System Microsoft Internet Explorer File Edit View Favorites Tools Help pack amp x a A s Search Pp Favorites E2 A AN bans Bry FA rel 3s Address https bbapp bbl 2 Windows Live H 3 What s New Profile Mail Photos Calendar MSN Share By Google v 4 Search gt X O ope O BS 3 ea ro WEB SEARCH b GB amp et sno allow pop ups From bblapp eProtocol BBL Protocol Mana a 2 When Pop up Blocker is correctly turned off the button will show as shown below 8 Page eProtocol BBL Protocol Management System Microsoft Internet Explorer File Edit view Favorites Tools Help O Back QJ x a A pe Search 52 Favorites 4 2 es Address http bblapp bb E7 windows Live fF gt What s New Profile Mail Photos SO search I O Gp I 10 _ kesma 6 Eh We eProtocol BBL Protocol Mana 4h Google E Who can log in Anyone wishing to submit an
14. ease comment on the following 1 Maintenance and security of records held in relation to this study 2 Compliance of the study with the approved application consem procedures and documentation 3 Any new s informatior mtific information that may impact on the current conduct of the study Attach relevant Attachments table below 4 Any new risk or benefit information related to the research not previously reported to Bellberry Attach relevant information in Attachments table below 5 Compliance with any conditions of approval if relevant 6 Any unforeseen events new information that may affect continued ethical acceptability of the project 7 Any complaints from participants you have received in relation to the study ttachments ada Please click on Add to add Attachments C The Principal Investigator has read and agrees that the above information is True Repeat the above steps and select Progress Report Form from the Approved Application Decision Box Complete the required fields and once completed Submit Form 28 Page Adverse Event Report Form Adverse Event Report Form Submit Form Print View Get Application g Spell Check Adverse Event Report Form Protocol No Protocol Title Principal Investigator Atherton Michael S Select ONE of the following Individual Event amp Save Cx Close This form is to be completed for Local Serious Unexpected Suspe
15. ebsite for Bellberry Human Research Ethics www bellberry com au This website has the answers to many common questions and provides a wealth of information on regulations and guidelines It has information and links to help get you started Please visit often for news and updates Subscribe to News Contact Us gt search About Us Investigators Participants Committee Members Resources Quick Links Welcome to our new and improved website How to Apply Bellberry Limited is a national private not for profit organisation that provides streamlined scientific and ethical review of human research projects across Australia As a not for profit company Bellberry donates surplus Hel errorvocol ne p funds back into the research community Bellberry Human Research Ethics Committees HRECs are professionally managed and have been established Meeting Dates Log into eProtocol to exclusively service the research community Bellberry HRECs provide high quality and independent review and guarantee rapid turn around times for assessment of ethical and scientific research proposals Bellberry Human Research Ethics Committees comply with the strict guidelines as set by the National Health and Medical Research Council NHMRC and ensure that all kinds of research involving or impacting on humans conform to the highest standards of ethical practice and academic integrity Sitemap Disclaimer Privacy Policy About Com
16. el info nothing happens when you click CREATE then you have pop up blocking software on in your browser Even if you believe you have allowed pop ups there may be additional toolbars etc that are blocking your pop ups See User Tips Instructions for allowing pop ups in your browser Filling in an Application Form 13 Page Home Create Application a on VJ HREC HREC HREC Application Form Principal Investigator Note To enable this application to be processed ft is essential that proof of current medical indemnity for this research project is attached for each investigator and co investigator First time applicants to Bellberry HREC must also attach proof of medical registration and a copy of their Curriculum Vitae This is to include work history postgraduate training professional college affiliations publications listings and research trials experience Please Attach in the Attachments Section Name Degree MD PhD MS Title Atherton Michael S ESN E mail Phone Fax michael gqmail com 999 999 9999 999 999 9999 Post Code Co Investigator Note To enable this application to be processed ft is essential that proof of current medical indemnity for this research project is attached for each investigator and co investigator First time applicants to Bellberry HREC must also attach proof of medical registration and a copy of their Curriculum Vitae This is to include work history postgraduate training professi
17. he following to adjust your settings In IE7 click on Tools in the Menu Bar Choose Internet Options Click on the Security tab at the top of the window Click on the Custom Level button In the Security Settings Window make sure the following are set to Enable a ActiveX controls and plug ins Binary and script behaviors b ActiveX controls and plugons Automatic prompting for ActiveX controls c Downloads Automatic prompting for file downloads d Downloads File download 6 Click OK in the Security Settings Window 7 Click Yes to the Warning about changing security settings 8 Click OK in Internet Options Window a Now you should be able to open the PDF of your application or approval letter 37 Page
18. he same for the CTN CTX Once the application is officially approved in the system it will no longer appear on the top of your home page in the Applications In Preparation Submitted section but will be visible in the Applications Active section To see the listing of your approved applications you ll need to select Applications Active from the menu bar at the top of the screen Making Amendments and Investigator Brochure Updates to Approved Applications studies If you would like to make changes to a study that has already been approved you will need to submit an Amendment Investigator Brochure Form and wait for Bellberry Approval before implementing the change Before you begin an Amendment you should consider the date that the current approval will expire Keep in mind that once an amendment is submitted you will not be able to start an Ethics Approval Extension Renewal application until the amendment has been reviewed and approved If the expiration date of your study is near you should start an Ethics instead As part of the Ethics Approval Extension application you may include any proposed changes to the application To start follow these steps 1 On your eProtocol HOME page the page you see when you first log in look at your Applications Approved listing You may need to click the at the right side of the section header to expand this section 23 Page 2 Click on the number of the study you wish to amend
19. ion Violation Report Form Close Application 4 Select Start Amendment IB and click OK PLEASE NOTE If an Amendment Form does not open when you click OK then you 24 Page have pop up blocking software on in your browser Even if you believe you have allowed pop ups there may be additional toolbars etc that are blocking your pop ups See instructions for allowing pop ups in your browser Answer all of the questions on the Amendment IB Form page depending on whether it is an update to the Investigator Brochure Protocol or Other Describe the changes that you wish to make You will also need to go to the appropriate sections in the application form and update your answers to reflect those changes Submit the amendment form when ready by clicking the SUBMIT APPLICATION option in the left hand menu 25 Ethics Approval Extension Renewals To start an Ethics Approval Extension Renewal application follow these steps 1 On your eProtocol HOME page the page you see when you first log in look at your Applications Active listing You may need to click the at the right side of the section header to expand this section 2 Click on the desired application number A small window should open as shown below Approved Application Decision Please select any one of the following Open in View Mode Application Details Start Amendmentib Start Ethics Approval Extension Start Final Report Form Start Progress Re
20. ions In Preparation Submitted NEW Application ID Principal Application Event Status Comments Investigator 10 01 316 Atherton Comments Received Cycle 1 IN PROGRESS Michael S HREC Create Application Clone Application Delete Application v v v v Panel Meeting Date BBL 28 01 2010 Click on the link in the Application Status column to access the comments page A sample of what the comments page looks like is shown below Home Comments Application ID 10 01 316 Atherton Michael Cycle 1 Comments Comment 1 Get Application Show All Comments Select Section Please add nominated contact details Response Necessary for Approval Suggestion Not Necessary for Approval Response Submit to HREC 22 Page You ll need to make the adjustments to the application itself click the GET APPLICATION button to open up a new window with the application enter a response for each comment and SAVE click the SUBMIT TO HREC button to send your responses back to Bellberry PLEASE NOTE SAVE will save your responses to the comments However these responses are not sent to the HREC until you click the SUBMIT TO HREC button Once Application is Approved You ll receive an email notification when your application is approved with instructions on how to access the approval letter on line You will be required to print the letter and sign and send the original copy to Bellberry Please do t
21. lems Blog This in Windows Live Writer JA eS Cop s Edit with XML Spy a z Reset Web Settings Internet Options 3 When Pop up Blocker ts correctly turned off it will show Turn On Pop up Blocker 5 Page eProtocol BBL Protocol Management System Microsoft Internet Explorer File Edit View Favorites Mail and News am a wv Q Back gt Di Pop up Blocker Turn On Pop up oda Manage dd ons l dd ES ina s http ji bbapp bol Synchronize E7 Windows Live windows Update ew Profile Mail Photos Windows Messenger Go le d A F n 8 Diagnose Connection Problems O aP O Blog This in Windows Live Writer i 2 Fae Edit with XML Spy 5 ie Protocol BBL Protocol M Reset Web Settings Internet Options Safari allowing pop ups 1 Start Safari 2 On the Safari menu look to see if Block Pop up Windows ts checked If so click this line once to turn off pop up blocking ii About Safari Report Bugs to Apple Ect View Hisi Preferences 3 of Block Pop Up Windows 3K Private Browsing Reset Safari Empty Cache X E Services gt Hide Safari 32H Hide Others xH Show AH 3 When Pop up Blocker is correctly turned off it will show Block Pop up Windows as unchecked 6 Page File About Safari Report Bugs to Apple Edit View Hist Preferences 3 Block Pop Up Windows 3K
22. m the list to have the option to view the most recent approved version of the application or to start an amendment or Ethics Approval Extension Remember the option to start an amendment or Ethics Approval Extension is only available to those listed on the application in a personnel role that grants EDIT access Working with Applications Create a new Application There are two ways you can create a new application from scratch or from a copy of an existing application study LOGIN to eProtocol at www bellberry com au Bb Bellberry Limited CPROT enabling paperless re eProtocol v Investigator gt Approved Applications Clone Application Delete Application Investigator Home Non Active Applications Create Application Clone Application Delete Application Search Application y 12 Page Create a new application from scratch To create a new application simply click on the CREATE APPLICATION button in the upper right hand corner of your HOME page or click on CREATE APPLICATION option in the menu You will need to enter basic information such as Protocol Title Personnel Information before your application form is generated a Bellberry Reference number assigned and the initial information that you have entered is saved Once you have your application number you may continue to complete the application or exit the system and return at a later time to complete PLEASE NOTE If after entering the title personn
23. mittee Members investigators Participants Contact Us Resources eProtocol 3 Page User Identification Password In order to access the eProtocol application you ll need a User Name and Password If you do not have one click on the registration button complete and submit the form Your application will be validated and an email with your access details will be emailed to you When you log on to the system for the first time you will be asked to change your password Passwords will need to be a minimum of 8 characters with 3 or 4 of the following Lowercase Uppercase Numbers Symbols amp etc Here are some Tips for Success in eProtocol e Use a recommended browser eProtocol is compatible with the most popular browsers including Internet Explorer Safari and Mozilla Firefox However if you do not have a strong browser preference we recommend the following If you are on a Windows machine use Internet Explorer If you are on a Mac machine use Safari Allow pop up windows Pop up blocking software prevents the eProtocol application from opening certain windows You ll need to make sure that your browser has all pop up blocking software disabled while using eProtocol See link to e protocol tips in the website for more information on configuring your browser to allow pop ups e Avoid using your browser s BACK button This will avoid taking you out of the system instead use the menus and link
24. ng on your HOME page in the eProtocol Application Event column as above To view the Event History select the relevant application and from the menu on the LHS last option select Event History HREC HREC Application Form Application ID 09 12 245 Atherton Michael 3 Application Title HREC Application Form HREC Application Form HREC Application Form HREC Application Form HREC Application Form HREC Application Form HREC Application Form HREC Application Form HREC Application Form HR Spell Check Help Save x Close Event History Date Status View Attachments Consent Forms Letters 15M 2 2009 APPLICATION CLONED 15 12 2009 SUBMITTED Sponsor 25 01 2010 RETURNED Application Information Email History cease eesti Submit Form 25 01 2010 HREC Protocol Returned 09 12 245 Atherton Michael S eee a 16M 2 2009 HREC Protocol has been submitted 09 12 245 Michael Atherton 15M 2 2009 HREC Protocol has been submitted 09 12 245 Michael Atherton 21 Page Respond to HREC comments Once your application has been accepted it will be assigned to a specific Committee A B or C for review and assigned a meeting date Check your email regularly You will receive an email for each major event in the review process alerting you to when you need to log into the system and take a particular action You can also see the status by looking at the application listing on your HOME page in the eProtocol application Applicat
25. onal college affiliations publications listings and research trials experience You can add muttiple Co Investigators in the Personnel Information section of the Application Form Name Degree MD PhD MS Title E mail Phone Fax Post Code Nominated Contact Clear Please provide nominated contact name and address for correspondence from the committee Name Degree MD PhD MS Title E mail Phone Fax Post Code Tax Invoice Clear Please provide contact name and address for whom should receive the tax invoice if different from above Name Degree MD PhD MS Title E mail Phone Fax Post Code e Enter in the details Once completed select Create If the Principal Investigator PI is also the Nominated Contact then the PI section only needs to be completed 14 Page e Navigate using the arrow icons in the upper right corner of page or jump straight to a particular section using the left hand menu e Each time you advance a page the application form will be automatically saved You can also save by clicking the save icon image of a diskette in the upper right hand corner of the page NOTE If you are working on a particular page for a long time you ll need to save frequently to avoid losing work The program will time out after 30 minutes on one page without Saving e Some special required fields will have a red asterisk a Name of the Site Physical Location of the Site e Check boxes mean that you may sele
26. ove information is True Repeat the above steps and select Start Protocol Violation Report from the Approved Application Decision Box 31 Page Complete required fields Once completed Submit Form Start Final Report Form HREC HREC Application Form Application ID 09 10 175 Atherton Michael S Application BBL Test HREC Study Title Title Spell Check Save Cx Close FINAL REPORT FORM Please note the following report is to be submitted for completed studies Final Report Form Protocol No me Solace Tae BBL Test HREC Study Title Principal Investigator Michael Atherton Date of Study Approval 29 10 2009 Date Study Closed c3 Has the research project discontinued prior to its expected completion date Please explain Number Comments Number of Participants screened Number of Participants enrolled Number of active Participants Number of Participants withdrawn Number of Local Serious Adverse Events Reported to HREC Please note that enrolled includes all participants who signed a consent form whether they were later deemed ineligible Reason for participant withdrawal Adverse events leading to withdrawal Serious Adverse Events Please comment on the following 1 Maintenance and security of records held relation to this study 2 Compliance of the study with the approved application consent procedures and documentation 3 Any new scientific information that may im
27. pact on the current conduct of the study Attach relevant information in Attachments table below 4 Any new risk or benefit information related to the research not previously reported to Bellberry Attach relevant information in Attachments table below 5 Compliance with any conditions of approval if relevant 6 Any unforeseen events new information that may affect continued ethical acceptability of the project 7 Any complaints from participants you have received in relation to the study Attachments c Please click on Add to add Attachments C The Principal Investigator has read and agrees that the above information is True 32 Page Repeat the above steps and select Final Report Form from the Approved Application Decision Box Complete required fields Once completed Submit Form Update Study personnel If there has been a change in the personnel related to a particular protocol you ll need to include these changes as part of a Modification Revision or Continuing Review Renewal application Follow the instructions on the top of the Personnel Info page in the application form Print an Application You may generate an Adobe pdf file of your application form that can be printed or saved on your computer In the left hand menu of the application form click on the Print View option shown below Application Information A small window will open 33 Page Please select any one of the
28. port Form Start Adverse Event Report Form Start Protocol Deviation Violation Report Form Close Application 3 If the option to start an Ethics Approval Extension is not available you cannot click on it then o You may not have EDIT access to this application Select Open in View mode and click on the left hand menu option Personnel Info Only those people listed in the first four roles Principal Investigator Admin Contact Co Investigator Other Contact have access to EDIT the application and start an Ethics Approval Extension o An amendment or Extension may have already been started or is in process for this application Check on your HOME page in the Applications In Preparation Submitted section to see if the application is listed there 4 Select Ethics Approval Extension and click OK PLEASE NOTE If an Ethics Approval Extension application form does not open when you click OK then you have pop up blocking software on in your browser Even if you believe you have allowed pop ups there may be additional toolbars etc that are blocking your pop ups See instructions for allowing pop ups in your browser 26 Page HREC HREC Application Form Application ID 09 12 250 Atherton Michael 3 Application Title HREC Application Form Spell Check Q Help Save x Close AmendmentiB Submission Form Protocol Title HREC Application Form Amendment IB Application Information Principal Investigator Name Michael A
29. r window in which you ll confirm that the application should be closed 35 Pag D Trouble Shooting I click on EDIT but application does not open You have pop up blocking software on in your browser Even if you believe you have allowed pop ups there may be additional toolbars etc that are blocking your pop ups See instructions for allowing pop ups in your browser I can t see my approved applications Your approved applications appear on your eProtocol HOME page the page you see when you first log in in the section labeled Applications Approved It should appear towards the middle of your page You may need to click the at the right side of the section header to expand this section I can t find the application I need to amend Please refer to the instructions for Amendments if you do not see an application listed in your Applications Approved section it may be that you were not listed as personnel on the study The option to Start Amendment or Ethics Approval Extension is not available it appears grey You may not have EDIT access to this application Select Open in View mode and click on the left hand menu option Personnel Info Only those people listed in the first four roles Principal Investigator Admin Contact Co Investigator Other Contact have access to EDIT the study application and start Ethics Approval Extension An amendment or Ethics Approval Extension renewal may have al
30. ready been started or is in process for this application Check on your HOME page in the Applications In Preparation Submitted section to see if the application is listed there I select Start Amendment and click OK but am brought back to the page where I started You have pop up blocking software on in your browser Even if you believe you have allowed pop ups there may be additional toolbars etc that are blocking your pop ups See instructions for allowing pop ups in your browser I received an error stating Session expire Your application was left idle for longer than 30 minutes and has timed out Close all of your browser windows and log back in to eProtocol 36 Page I am trying to respond to HREC comments but it appears as if there are none You might be confusing the HREC Return Notes item in the left hand side of the application form with the HREC Comments page which is used during the official review cycle If you are attempting to access comments from the HREC for an application that has already been assigned to a meeting date please see the instructions on how to respond to HREC comments If your application was returned please see instructions for returned applications I can t open the PDF of my application study or approval letter Recent changes in security may require Internet Explorer 7 users to change settings to download PDFs using the Print View or View Approval Letter function in eProtocol Please do t
31. s within the application to navigate e SAVE frequently eProtocol will time out after 5 minutes of inactivity Only actions which cause the page to refresh or reload such as saving or navigating to a new section are indications to the system that your session is active e Read the Instructions Help 4 Page Many pages in the application offer instructions right on the page to help guide you and answer the most common questions e Be patient Some processes can take a minute to run Although data is loading your browser may not indicate activity e Sign Out when done Always click Sign Out and shut down your browser completely close all browser windows when you are finished using eProtocol This will not only help keep your information secure but will also release any edit locks you may have had on protocols and allow your colleagues on the project to open the protocols in edit mode Internet Explorer allowing pop ups 1 Start Internet Explorer 2 On the Tools menu click Pop up Blocker and select Turn Off Pop up Blocker eProtocol BBL Protocol Management System Microsoft Internet Explorer File Edit View Favorites Mail and News lt A Q Back 7 x Pop up Blocker Turn OFF Pop up Blocker y a Manage Add ons Pop up Blocker Settings address Te http bbapp bbI Synchronize FY windows Live Windows Update ew Profile Mail Photos Windows Messenger O O OB Diagnose Connection Prob
32. stitutions are responsible for establishing procedures for the ethical review of human research That review can be undertaken at various levels according to the degree of risk involved in the research see Section 2 Themes in Research Ethics Risk and Benefit Consent responsibilities and Chapter 5 2 Responsibilities of HRECs other ethical review bodies and researchers Research with more than a low level of risk as defined in paragraph 2 1 6 page 20 must be reviewed by an HREC Research involving no more than low risk may be reviewed under other processes described in paragraphs 5 1 18 to 5 1 21 page 92 Institutions may also determine that some human research is exempt from ethical review see paragraphs 5 1 22 and 5 1 23 page 93 A judgment that a human research proposal meets the requirements of this National Statement and is ethically acceptable must be made before research can begin 10 Page For review requirements of activities such as quality assurance or improvement and clinical audit click here When does quality assurance in healthcare require independent ethical review NHMRC 2003 http www nhmrc gov au publications synopses e46syn htm All applications for studies must be submitted to Bellberry via e Protocol Approval must be granted before recruitment and data collection may start Click here to access more information that is available on the National Health and Medical Research Council Website link
33. therton Check For Completeness Protocol No 33 Date of Report 1 Protocol Amendment Yes No version No Date Attach Relevant Documents Attachments Select Yes to add Attachments 2 Investigator Brochure Update Yes No Investigator Brochure Name Version No Date 3 Other Amendment Summarise the proposed changes Are changes required in the Participant Information yes Sheet Attach tracked copy If not why not Attachments Please click on Add to add Attachments 5 Answer all of the questions on the Ethics Approval Extension Form page 6 Submit the form when ready by clicking the SUBMIT APPLICATION option in the left hand menu 27 Page Completing a Progress Report HREC HREC Application Form Application ID 10 01 276 Atherton Michael S Application HREC Application Form Title D Spell Check Progress Repon To be completed for an Protocol No ual monitoring requirements Submit Form ae Cot Research Application Title HREC Application Form Principal Investigator Atherton Michael S Date of Study Approval 11 01 2010 Date of Report Ts Number Comments Number of Participants screened Number of Participants enrolled Number of active Participants Number of Participants withdrawn Number of Local Serious Adverse Events Reported to HREC Reason for participant withdrawal Adverse events leading to withdrawal Serious Adverse Events Pl
34. www nhmrc gov au Understanding your eProtocol HOME page The first page you encounter after logging in to eProtocol is your HOME page Your HOME page has two main sections that display all of the studies on which you have been listed in the Personnel Info section This is how the sections appear Home Show hide sections by clicking on these arrows HREC Create Application Clone Application Delete Application Applications In Preparation Submitted NEW Application ID Pr incipe Application Event Status Comments Panel Meeting Date Investigator 10 01 318 Atherton Michael 5 Responses Sent Cycle 1 IN PROGRESS BBL 28 01 2010 10 01 316 Atherton MichaelS SUBMITTED TO HREC IN PROGRESS BBL You can expand or collapse these two sections by clicking on the arrows on the right of the grey section bar as shown above 11 Page Applications In Preparation Submitted Think of this as your work in progress area It displays all of your applications that are not yet approved This includes applications you have just begun working on new amendments Ethics Approval Extension as well as those that have been submitted and are in various stages of the Bellberry HREC review process Applications will be displayed here until they are officially approved in the system Applications Approved Think of this as your work completed area It displays a listing of your approved applications Click on an application number fro
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