Investigator e-Protocol User Guide
Contents
1. amp etc Change Password If you wish to change your password click on the Change Password button on the Top Right Hand Corner of the Screen next to the Sign Out button It will prompt you to enter your existing password and then enter in your new password SAVE Investigator User Guide 14 June 2012 Page 5 Who can create applications A nominated contact from another organisation is able to prepare applications To do so approval must be sought from the Principal Investigator by completing the Nominated Contact Authorisation Form This form provides authorisation from the Principal Investigator for the nominated contact to create the application This form now covers all future studies for a PI as a blanket authorisation until otherwise advised by the Principal Investigator Therefore approval is not required for each study CRO s or Lead Sites for Multi Centre Applications You will need authorisation from the Principal Investigator as detailed above and a registration USER ID for each organisation Please use your surname and organisation name for the User ID i e Smith organisation name Please ensure that a nominated contact from the site is also included i e the Trial Co Ordinator System Requirements To access the eProtocol application you ll need a computer with an Internet connection e If on a Windows computer use Internet Explorer IE as your browser e If ona Macintosh computer us2. Internet Options 3 When Pop up Blocker is correctly turned off it will show Turn On Pop up Blocker Investigator User Guide 14 June 2012 Page 34 Z eProtocol BBL Protocol Management System Microsoft Internet Explorer File Edit view Favorites BEHS Mail and News gt Q Back J x Pop up Blocker Turn On Pop up Blocker EA Manage Add ons dns httpif bbapp bbl Synchronize 2 Windows Live Windows Update ew Profile Mail Photos Google l Windows Messenger i 2 E O dp O S Diagnose Connection Problems o e Blog This in Windows Live Writer vA x 7 a 9 Edit with XML Spy 6 z c Protocol BBL Protocol Mz 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 is checked If so click this line once to turn off pop up blocking g Fite Edit View Hisi About Safari Report Bugs to Apple Preferences of Block Pop Up Windows 3K Private Browsing Reset Safari Empty Cache X E Services gt Hide Safari 3H Hide Others XSH Show Al 3 When Pop up Blocker is correctly turned off it will show Block Pop up Windows as unchecked Investigator User Guide 14 June 2012 Page 35 File Edit View Hist About Safari Report Bugs to Apple Preferences 2 Block Pop Up Windows 3K Private Browsing Reset Safari Empty
3. Page 30 Repeat the steps as outlined in starting an Amendment and select Final Report Form from the Approved Application Decision Box Use the heading Final Report Form Attachments Only when attaching any documents to this form Complete required fields and once completed Submit 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 Investigator User Guide 14 June 2012 Page 31 A small window will open Please select any one of the 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 HEKE EARR 0000000000 00000000 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 If you are having difficulty with this function your Windows software may be blocking it Please go to the application page and Ctrl P to print individual pages Investigator User Guide 14 June 2012 Page 32 Trouble Shooting
4. 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 e 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 Co Investigator Nominated Contacts have access to EDIT the study application and start Ethics Approval Extension e An amendment or Ethics Approval Extension renewal may have already been started or is in process for this application Check on your HOME page in the Applications In Preparation Submitted sec
5. E mail Phone Fax Post Code Address User ID First Name Last Name Click here to add Other Personnel if you are sure the User ID does not exist for the person e A contact person cannot be listed twice However if you click on to the binoculars it comes up with the 2nd screen then click on the text in blue This will allow free text Add the company sponsor or who the tax invoice is made out to in the name section You can then add your email address or the sponsor contact Please also add the full postal address 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 Investigator User Guide 14 June 2012 Page 12 e Some special required fields will have a red asterisk T Name of the Site Physical Location of the Site e Check boxes mean that you may select more than one item from that group _ Australianflocal C International e Radio buttons mean that you may select only one item from that g
6. Cache XBRE Services gt Hide Safari 36H Hide Others XH 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 E eProtocol BBL Protocol Management System Microsoft Internet Explorer File Edit View Favorites Tools Help Q sack Q x a A pe Search Si Favorites A ee KS m as 4 a Address 6 http bbapp bbl 28 Windows Live Bing W 7 what sNew Profile Mail Photos Calendar MSN Sha Asah t a OPFP OO B A WEBSEARCH Z W Ce O E v Play Sound When Pop Up Is Blocked Google v 9 Protocol BBL Protocol Mana 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 unchecked Investigator User Guide 14 June 2012 Page 36 eProtocol BBL Protocol Management System Microsoft Internet Explorer File Edit View Favorites Tools Help Q sack Q ix a A pe Search Si Favorites g 2 ee LJ SL Fa Address E http bbapp bbl o l 2B windows Live f What sNew Profile Mail Photos Calendar MSN Sha Google visu O OF O B S 0 wasan 6 pe O ea Enable Pop Up Blocker v Play Sound When Pop Up Is Blocke
7. 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 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 Progress Report Ethics Approval Extension and click OK PLEASE NOTE If a Progress Report 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 Investigator User Guide 14 June 2012 Page 25 HREC HREC Application Form Application ID 2011 04 062 Marie Curie Application Title The study of radioactivity Next gt Spell Check Save Close Q QI PROGRESS REPORT ETHICS APPROVAL EXTENSION Progress Report Ethics App peee PROGRESS REPORT To be completed for annual monitoring requirements ETHICS APPROVAL EXTENSION Please note the following report is to be submitted with all requests for Ethics Approval Extensions Check For Completeness Requested Date of Extension From E3 To E3 Submit Fo
8. WB FB Personnel Information Declarations Study Sites Will the consent process comply with the National Statement Item 5 2 16 Section a ot If Not why not Print View Do you have any Conflict of Interest as per Section 3 3 4 of the National Statement Yes Ho lf Yes please disclose ls the Investigators Brochure current relevant and are all relevant matters relating to the study covered in the application Yes No If Not why not o K there any state specific legislation which should be considered during this study Yes No Have you signed a Clinical Trial Agreement Yes No ifyes 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 Investigator User Guide 14 June 2012 Page 15 e Attachments Page 7 of Application Information This section allows you to attach all documentation from the listing below Ensure that you save the document under the correct heading and that you save the file as a PDF using a file name that describes the content e g for Protocols save file as ProtocolVersionNoxxDate Please note that the file names used in the attachment section will be the document names that are listed in the approval letter If the documents are incorrectly named in the attachment section the Approval Letter will be incorrect therefore it is imperative that you name the docume
9. an Amendment and then select Adverse Event Report Form from the Approved Application Decision Box Select either 1 Individual Event or 2 Summary Report and then complete the relevant fields For Individual Event Select 1 and complete report as required For Summary reporting select 2 and attach relevant documents Ensure you use the heading Adverse Event Form Attachments Only when attaching any documents to the Adverse Event Form Once completed Submit Form If you are requiring a summary SAE template go to www bellberry com au and select Investigator and then Forms Investigator User Guide 14 June 2012 Page 28 Start Violation Report Form HREC HREC Application Form Application ID 2011 04 063 Marie Curie Application Title The study of radioactivity v Spell Check 2 Help Protocol Violation Report Beliberry requires reporting of all application deviations within 14 days of the event Report Form Principal Investigator Name Marie Curie Date of Report 03 04 2011 E The study of radioactivity Research Protocol Title Protocol No 123456 Participan s ID Date of Event fr Provide a full description of the application violation as well as why the violation occurred What happened when it happened where how and why it happened attach as many pages as necessary Describe the action taken in regard to the event Attach as many pages as necessary Describe the effe
10. applications The document names are the names of the documents that appear in the Approval Acknowledgement letters When updating versions or adding further documents do not delete documents If you do not want clean to appear in the document heading do not include it e If you are copying and pasting from another document into the Study Title when creating the application if there are or in the heading please delete these symbols and re enter these characters from the keyboard The software currently has an issue with these characters Who can log in Anyone wishing to submit an application must apply for a User ID and Password by registering on the eProtocol homepage A user ID should be surname then initial e g SmithA Ensure you include the Organisation Name and the site address Select the Register button and complete and submit the form Your application will be validated and an email with your access details will be emailed to you Please ensure that all people that will be involved in the study i e the Principal Investigator Co Investigator and any other nominated contact is registered As per the National Statement guidelines sponsors are unable to submit applications on behalf of the Investigator 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
11. Bb Bellberry Limited supporting research and ethics bB bb Investigator e Protocol User Guide Updated 14 6 2012 Event History Changes Investigator User Guide 14 June 2012 Page 1 Investigator User Guide 1 Getting Started Before you Start Tips for Success Who can log in Access to Submitted Applications Understanding your e Protocol HOME page 2 Working with Applications Create a new Application Filling in an Application Form Clone an Application Submit 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 How do I allow pop up blockers Investigator User Guide 14 June 2012 Page 2 Getting Star
12. C Comment 1 Select Section Please add nominated contact details Response Necessary for Approval Suggestion Not Necessary for Approval it oo ee Sy Use the Show All Comments to list all the comments Use the print screen button and then right click on your mouse to copy into a word or email document You ll need to e make the adjustments to the application itself click the GET APPLICATION button to open up a new window with the application to add additional attachments you will need to go to the Attachments Page 7 and attach and SAVE e enter a response for each comment and SAVE e 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 the same for the CTN CTX Once received by Bellberry we will attach the signed copy to your application in the attachments section in eProtocol Once the application is officially approved in the system it will appear at the bottom of your home page under Approved Applications Investigator User Guide 14 June 2012 Page 20 Making Amen
13. R 1 oe Bellberry Administration 31 05 2012 HREC Responses sent Cycle 1 2012 05 832 Bellberry Administration 31 05 2012 HREC Comments sent Cycle 1 2012 05 832 Bellberry Administration Application Assigned to Committee 2012 05 832 Bellberry 31 05 2012 Administration 31 05 2012 New Application has been submitted 2012 05 832 Bellberry Administration 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 HREC Create Application Clone Application Delete Application Applications In Preparation Submitted y NEW y Principal Application ID Application Event Status Comments Panel Meeting Date Investigator 10 01 316 Eae Comments Received Cycle 1 IN PROGRESS BBL 28 01 2010 Investigator User Guide 14 June 2012 Page 19 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 Cn Comments Get Application Show All Comments Submit to HRE
14. all of the questions on the Amendment IB Form page see next 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 make updates to reflect those changes i e update the personnel section with additional contacts or attach updated Protocol Participant Information Sheet etc 8 ATTACHMENTS You will be redirected to the Attachments Section on Page 7 of your application PLEASE ENSURE YOU USE THE HEADING AMENDMENT IB UPDATE ATTACHMENTS ONLY THIS WILL ENSURE YOUR APPROVAL LETTER STATES THE CORRECT ATTACHMENTS TO APPROVE NOTE 9 Submit the amendment form when ready by clicking the SUBMIT APPLICATION option in the left hand menu Investigator User Guide 14 June 2012 Page 23 AMENDMENT FORM Protocol Title Principal Investigator Name Protocol No Date of Report m 1 Administration Other correspondence O Yes ONo Please use this section for any administrative change or correspondence thatis not related to a protocol Amendment Investigator Brochure Update or to other changes to approved documentation For example adding removal of study staff updating email addresses Indemnities Insurance CV updates etc For any study document change use section 2 3 or 4 Complete the box below outlining the changes required Ensure you make any necessary changes in the Person
15. ation 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 Progress ReporvEthics Approval Extension Start Final Report Form Start Adverse Event Report Form Start Protocol Violation Report Form OoOoOoO _ 4 Select Start Amendment IB and click OK Investigator User Guide 14 June 2012 Page 22 PLEASE NOTE If an Amendment 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 The Amendment Form was updated in October 2011 Please note the following changes required to complete an Amendment Form 5 Please use Section 1 For all Administration Changes Use this section for any change or correspondence that is not related to a protocol Amendment Investigator Brochure Update or to other changes to approved documentation For example adding removal of study staff updating email addresses Indemnities Insurance CV updates etc 6 FOR ANY STUDY DOCUMENT CHANGE USE SECTION 2 3 OR 4 ENSURE ALL DOCUMENTS THAT ARE ATTACHED IN THE ATTACHMENTS SECTION HAVE BEEN SAVED IN THE NAME THAT YOU WANT THAT DOCUMENT TO APPEAR IN THE APPROVAL LETTER 7 Answer
16. ave 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 on the CLONE APPLICATION button in the upper right hand corner of your HOME page and follow the instructions on the page This function only works for the same Principal Investigator i e you can not clone applications between Investigators 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 ad
17. ct the event had on the participant Describe the action taken to prevent any future recurrence of this protocolNiolation Attach as many pages anecessary Who was the violation reported to Sponsor O Yes O No O NA Date Notified Attachments Add Please click on Add to add Attachments O The Principal Investigator has read and agrees that the above information is True Save x Close Repeat the steps as outlined in starting an Amendment and then select Start Protocol Violation Report from the Approved Application Decision Box For any Attachments please use the Protocol Violation Attachments Only heading Complete required fields and once completed Submit Form Investigator User Guide 14 June 2012 Page 29 Start Final Report Form ensure that this form is only completed once all sites included in the study sites section of the Application that the PI is responsible for have been finalised as this report can only be submitted once HREC HREC Application Form Application ID 2011 03 061 Marie Curie Application Title The study of radioactivi Spell Check close FINAL REPORT FORM Final Report Form Please note the following report is to be submitted for completed studies SSS Print View ane ee 123456 Get Applicatio Research Application Title The study of radioactivity Principal Investigator Marie Curie Date of Study Approval 03 04 2011 Date Study Closed 3 Has the r
18. cuments based on the approved documents PREPARING SITE SPECIFIC APPLICATION e Go to your home page e Click on the Application ID e Open in Edit mode e Go to Application Information eft hand side blue table e Click on Page 7 top of the screen e Attach site documents based on the approved documents from lead site This includes the PISCF and any other site relevant documents which may include advertisements and any state specific requirements e SUBMIT Form left hand side blue table ADDITIONAL SITE REVIEW The application will be sent to the HREC for an expedited review based on the approval of the lead site This will be conducted outside a meeting It will therefore not be necessary to a book a meeting date for additional sites APPROVAL If the Committee raises any questions they will be sent to the Principal Investigator for response If there are no comments or once Committee comments are addressed the approval will be completed The approval letter will appear on the site s application Investigator User Guide 14 June 2012 REMINDER Please name any attached document as you would like it to be listed in the Approval Letter and where applicable following the format of the lead site IMPORTANT NOTE If the additional site application is submitted AFTER lead site approval a copy of the latest version of ALL approved documents should be submitted in addition to t
19. d eProtocol BBL Protocol Mana f Always Allow Pop Ups From Bb Bellberry Limited cnn sina 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 Q sax Q x a A Search Sie Favorites g2 2 ga LJ E2 72 rel 33 Address https bbapp tbbl 2 Windows Live o ka what s New Profile Mail Photos Calendar MSN Share A X Google Jae t o O F Ole A o a O ili Re B iS AF Son soc pop ups From bblapp eProtocol BBL Protocol Mana ae 2 When Pop up Blocker is correctly turned off the button will show as shown below E eProtocol BBL Protocol Management System Microsoft Internet Explorer File Edit view Favorites Tools Help Q Back a A 2 Search Pe Favorites 4 B te Address http bblapp bb Y windows Live H 3 What s New Profile Mail Photos SB search t B O dee Dn v oro Dema go i D Google v 3 eProtocol BBL Protocol Mana ae Investigator User Guide 14 June 2012 Page 37
20. ditions unless requested as part of the Bellberry HREC review process Investigator User Guide 14 June 2012 Page 17 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 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 Investi
21. dments 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 Please note that you will be unable to submit another Amendment until you have received approval You can add multiple changes etc to the one Amendment For studies approved prior to eProtocol these have now been added to the system under the Principal Investigators Name To add additional nominated contacts to these studies the PI will be required to login and complete an Amendment Form see below updating study personnel Update Study personnel email addresses If there has been a change addition to the personnel related to a particular study or an administration change i e change of email address you ll need to include these changes as part of an Amendment or Ethics Approval Extension application 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 Approval Extension instead As part of the Ethics Extension application you may include any proposed changes to the application Please note that approval letters are not generat
22. e Safari as your browser e Pop up blocking software must be disabled pop ups must be allowed while using eProtocol See instructions for allowing pop ups in your browser 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 e Principal Investigator e Co Investigator e Nominated Contact You must have edit access for a particular study in order to start an amendment or Ethics Approval Extension application for that study Investigator User Guide 14 June 2012 Page 6 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 mmm M y Applications In Preparation Submitted NEW ae Principal EEEN P z Application ID Investigator Application Event Status Comments Panel Meeting Date 10 01 318 Atherton Michael 5 Responses Sent Cycle 1 IN PROGRESS BBL 28 01 2010 10 01 316 Atherton Michael S SUBMITTED TO HREC IN PROGRESS BBL You can expand or collap
23. ed for administration changes 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 2 Click on the number of the study you wish to amend and you will see a small window open Investigator User Guide 14 June 2012 Page 21 Home HREC Create Application Clone Application Delete Application Applications In Preparation Submitted z Approved Applications Application ID Principal Investigator pera Date rae Approval a ation Status Comments laa 10 01 308 Atherton Michael 22 01 2010 22 01 2010 31 12 2999 APPROVED NEW 10 01 276 Atherton Michael 11 01 2010 11 01 2010 10 01 2011 APPROVED NEW 09 12 250 Atherton Michael S 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 Nominated Contacts Co Investigator 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 prepar
24. endent 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 Come and see us at the ARCS Conference in Sydney May 2011 formation about the Sitemap Disclaimer Privacy Policy About Investigators Participants Committee Members Contact Us Internet f 100 i start Inbox Microsoft Out A eProtocol Training eProtocol Training m Investigator Guide w t Multi Site Process Inv Investigator User Guide 14 June 2012 Page 3 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 V 6 amp 7 If you are on a Mac machine use Safari e 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
25. esearch project discontinued prior to its expected completion date Please explain Number mments 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 in relation to this study 2 Compliance of the study with the approved application consent procedures and documentation 3 Any new scientific information that may impact 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 Attachme Please click on Add to add Attachments O The Principat investigator has read and agrees that the above information is True Investigator User Guide 14 June 2012
26. gator User Guide 14 June 2012 Page 18 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 listing 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 Each form type is allocated a number for easier tracking ee COI Pei ation Date Application ID Status View Attachments Letters 31 05 2012 2012 05 832 NEW FORM CREATED 31 05 2012 2012 05 832 NEW FORM SUBMITTED Application Information 31 05 2012 2012 05 832 NEW FORM PANEL ASSIGNED Print View 31 05 2012 2012 05 832 NEW FORM REVIEWER S ASSIGNED 31 05 2012 2012 05 832 NEW FORM SUBMITTED CYCLE 1 31 05 2012 2012 05 832 NEW FORM APPROVED 31 05 2012 2012 05 832 PVR 1 DEVIATION 1 FORM CREATED 31 05 2012 2012 05 832 PVR 1 DEVIATION 1 FORM SUBMITTED View Attachments 31 05 2012 2012 05 832 A 1 AMENDMENT 1 FORM CREATED 31 05 2012 2012 05 832 A 1 AMENDMENT 1 FORM SUBMITTED View Attachments Email Date Email Type Attachments 31 05 2012 Amendment IB Form has been submitted 2012 05 832 A 1 Bellberry Administration Protocol Violation Report has been submitted 2012 05 832 PV
27. he site specific documents This is to ensure that any post approval amendments are included TROUBLESHOOTING Once an application is submitted to Bellberry you cannot add any further documents until the application is returned to you If the application is submitted and the Investigator requires further documents to be added Contact Bellberry Depending on the stage at which the application is at the application will be returned to you to add the documents or you will be requested to email the document s and they will be attached into the eprotool application by Bellberry Page 10 Filling in an Application Form Home Create Application MHREC HREC HREC Application Form Principal Investigator Note To enable t application to be processed it 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 tr g professional college affiliations publications listings and research trials experience Please Attach in the Attachments Secti Name Degree MD PhD MS Title Atherton Michael S 9 E mail Phone Fax michael gmail com 999 999 9999 999 999 9999 Post Code Co Investigator Note To enable this application to be processed it is essential that p
28. inciple Investigators and sites for multi centre studies To view or edit the detailed information click the Investigator Name link in this case Prof Marie Curie This will re open the window where you had first entered the site details 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 For a Principal Investigator who is conducting a study at multiple sites use the second box as detailed above e Adding additional sites once application is approved Create an Amendment as detailed in the User Guide Open the Amendment Form complete section 1 detailing the additional site information and then open the application Click on Application Information Study Sites and add the site SAVE SUBMIT if you do not wish to add any further documents etc to the Amendment e Please make sure you enter the Protocol Number correctly This number will automatically alert Bellberry when a multi site application is received Investigator User Guide 14 June 2012 Page 14 e Principal Investigator Declaration remember when completing the application form on page 6 of the Application Information the Declarations box must be ticked The Principal Investigator electronically signs the application form by pressing this tick box e Signatures are legally binding and have the same intent affect and authority as the use of a manual signature W A D B amp
29. institutions or individuals at one or more sites Multi Site Research A research project undertaken b a single institution at more than one location as outlined by the NHMRC Investigator User Guide 14 June 2012 Page 8 Multi Centre Research Procedure CREATE A NEW APPLICATION this form is completed in the same way as any new application Click on the CREATE APPLICATION button upper right hand corner of home page or CREATE APPLICATION option in the menu Enter basic information such as Protocol Title Personnel Information Application Form will then be generated Bellberry Reference number will be assigned Initial Information will be saved FILLING IN AN APPLICATION FORM see page 11 of Investigator Guide Please complete ALL details for Principal Investigator Co Investigator if applicable Nominated Contact s and Tax Invoice TROUBLESHOOTING If after entering the title and personnel information nothing happens when you click CREATE check pop up blockers are turned off there may be more than one toolbar TIP Once you have the application number you may continue to complete the application or you can exit the system and return later to complete the application TIP It is recommended that you have at least one additional Nominated Contact to allow for access to studies if one contact is not available A new contact can only be created by someone who already has access to the
30. ion from scratch or from a copy of an existing application study LOGIN to eProtocol at www bellberry com au Bb Bellberry Limited C PRO enabling paperless re _ Protocol v Investigator Create Application Clone Application Delete Application y Search Application Applicat ABES BATEE 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 Study Title Personnel Information before your application form is generated a Bellberry Reference number assigned and the initial information that you have entered is saved TIP make sure you include the Protocol Number in the Study Title This will ensure it appears on your page header in the system 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 personnel 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 Multi Centre Site Applications Multi Centre Research A Research project undertaken by a group of
31. more information on configuring your browser to allow pop ups or see the Troubleshooting section e Avoid using your browser s BACK button This will avoid taking you out of the system instead use the menus and links 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 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 Investigator User Guide 14 June 2012 Page 4 e Creating Application Tips e Ensure you create the application under the correct Investigators Name e Don t delete documents when updating versions in the Attachments section e Ensure you use the correct document heading when you attach your document particularly for multi site
32. nel Information section of the Application Attach relevant documents in the Attachments section using the document heading name Amendment Attachments 2 Protocol Amendment O Yes No Version No Date E Are changes required to the Participant Information sheet O Yes O No Attach relevant documents in the Attachments section using the document heading name Amendment Attachments If not please explain 3 Investigator Brochure Update O Yes No Investigator User Guide 14 June 2012 Page 24 Progress Report Ethics Approval Extension Renewals To start a Progress Report 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 2 at the right side of the section header to expand this section 2 Click on the desired application number A small window should open see below Approved Application Decision Please select any one of the following Open in View Mode Application Details Start AmendmentiB y Start Progress ReporvEthics Approval Extension Start Final Report Form Start Adverse Event Report Form Start Protocol Violation Report Form OC 3 Ifthe option to start a Progress 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
33. nts as you want them to appear in the Approval Letter Please remember to also attach a scanned copy of the signed Investigators acceptance declaration page of the Final Protocol Documents requiring signatures eg CTN CTX indemnities are required to be sent by standard mail These documents will be returned to the Principal Investigator unless otherwise notified Please specify nominated contact details if different from the PI Note denotes mandatory field Attachments Document Type Attachment 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 Bellbg Document Name a eee Medical registration and personal medical insuran Sponsor Other Ethics Committees Approvals amp Rejections Patient Information sheets Consent Forms ca Return Notes x Risk or Benefit Information Attachments Scientific Information Please click on Add to add Attachments Investigator User Guide 14 June 2012 Page 16 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 h
34. oose Internet Options 3 Click on the Security tab at the top of the window 4 Click on the Custom Level button 5 Inthe 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 Now you should be able to open the PDF of your application or approval letter How do I allow pop up blockers 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 ime Mail and News a gt Q Back 7 ix Pop up Blocker Turn Off Pop up Blocker Manage Add ons Pop up Blocker Settings Address fon http bbapp bbl Synchronize 2 Windows Live Windows Update ew Profile Mail Photos Windows Messenger Google gt 2 OPF OD X Diagnose Connection Problems o a O Blog This in Windows Live Writer GB ne Edit with XML Spy BBJ eProtocol BBL Protocol Ma Reset Web Settings
35. rm Protocol No 123456 Print Vi ee Research Protocol Title The study of radioactivity Principal Investigator Marie Curie Date of Study Approval 03 04 2011 Date of Study Progress Report ce 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 Bellberry Reason for participant withdrawal Adverse events leading to withdrawal Serious Adverse Events Please 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 consent procedures and documentation 3 Any new scientific information that may impact on the current conduct of the study Please attach relevant documents in the Attachments section under the heading Progress Report Ethics Approval Extension Attachments Only 4 Any new risk or benefit information related to the research not previously reported to Bellberry Please attach relevant documents in the Attachments section under the heading Progress Report Ethics Approval Extension Attachments Only 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 Please a
36. roof 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 Thi to include work history postgraduate training professional college affiliations publications listings and research trials experience You can add multiple 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 Ca Please provide nominated contact name and address for correspondence from the committee Name Degree MDPhDMS Title E mail Phone Fax Post Code Please provide contact name and address for whom should receive the tax invoice if different from above Tax Iny Name Degree MDPhDMS 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 Investigator User Guide 14 June 2012 Page 11 e Input of Tax details B neces temmes ERE WR ee T E Protocol Bellberry Limited Tax Invoice Windows Internet Explorer Note denotes mandatory field Tax Invoice Please provide contact name and address for whom should receive the tax invoice if different from above Name Degree MD PhD MS Title
37. roup Yes O No e Tables are used in parts of the application where you may need to add more than one item for example Additional Sites 7 Application ID 2011 02 059 Bellberry HREC HREC Application Form a Fira Application Title TEst application Previous Next gt Site Location Ahere will the study be conducted Personnel Information Studies being conducted within hospitals and or institutions must complete a Site Approval Form and attach a Study Sites Sapte 5 copy with this application Forms available on the website Sponsor 1 Multi Centre Studies please detail in the table below the Principal Investigators and the names and physical location of each site from which the study will be conducted Application Information Print View Event History Location investigator Name Name of the Site Physical Location of the Site wg qasdsad w 2 Multi Site Studies If the Principal Investigator is conducting the study at more than one site ocation please list all locations and advise how supervision will take place at each site he Principal Investigator has responsibility for more than one site location please advise on how supervision Multi Centre will take place at each site One PI at multiple sites Investigator User Guide 14 June 2012 Page 13 Multi Centre Sites Applications e When you click add a window will open where you enter the details related to the site and all Pr
38. se these two sections by clicking on the arrows on the right of the grey section bar as shown above 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 The application number has been recently updated The number will have a letter and number after the form to assist in event tracking of the document submitted A 1 Amendment 1 FR 1 Final Report 1 AER 1 Adverse Event 1 PRE 1 Progress Report Extension 1 PVR 1 Protocol Violation Report 1 Applications Approved Think of this as your work completed area It displays a listing of your approved applications Click on an application number from 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 Investigator User Guide 14 June 2012 Page 7 Working with Applications Create a new Application There are two ways you can create a new applicat
39. study an existing investigator or Contact TIP If the Principal Investigator is the Nominated contact then only the PI section needs to be created Once the form is completed select CREATE Are you the lead site COMPLETE THE APPLICATION Site Location Details Sponsor Application Information pages 1 6 Application page 7 SUBMIT the application COMPLETE THE APPLICATION Site Location Details Sponsor Application Information pages 1 6 Application page 7 No documents will need to be attached until the lead site is approved IMPORTANT NOTE tt is very important that the protocol number information be entered in exactly the same format as the Protocol number of the lead site this includes capital letters spaces and dashes The study title should also be the same as the lead site study title The Protocol number creates the link to the lead site application IMPORTANT NOTE Please name all attachments as you would want them named in the approval letter Where possible name documents that are common to the lead site in the same format as the lead site Investigator User Guide 14 June 2012 Page 9 After Approval of the Lead Site LEAD SITE Will receive notification of approval and the approval letter will be attached in eProtocol ADDITIONAL SITE Will receive notification through eProtocol that the lead site has been approved and a request to submit the site specific do
40. ted Before You Start Please log on to www bellberry com au and you will be able to access the eProtocol log in button on the RHS of the screen Be sure to click and subscribe to ensure you receive Bellberry news and eProtocol updates The Bellberry website has the answers to many common questions and the Investigator section provides a wealth of information on regulations guidelines and Bellbery Policies It has information and links to help get you started Please visit often for news and updates le Bellberry Limited For the monitoring and review of ethics in human research Windows Internet Explorer fe J a belberry com au xex 9 pl File Edit View Favorites Tools Help Favorites B O Free Hotmail s s Bellberry Limited For the monitoring and review of et i 8 z v Page Safety gt Toos Subscribe to News gt Contact Us gt search About Us Investigators Participants Committee Members Resources Welcome to Bellberry Quick Links 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 funds back into the research community Bellberry Human Research Ethics Committees HRECs are professionally managed and have been established to exclusively service the research community Bellberry HRECs provide high quality indep
41. tion 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 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 Investigator User Guide 14 June 2012 Page 33 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 the following to adjust your settings 1 In IE7 click on Tools in the Menu Bar 2 Ch
42. ttach relevant documents in the Attachments section under the heading Progress Report Ethics Approval Extension Attachments Only Investigator User Guide 14 June 2012 Page 26 5 Answer all of the questions on the Ethics Approval Extension Form page 6 Add any attachments under the heading Progress Report Ethics Extension Form Attachments Only 7 Submit the form when ready by clicking the SUBMIT APPLICATION option in the left hand menu Adverse Event Report Form Please note Form has been Updated October 2011 ADVERSE EVENT SAFETY REPORT FORM Bellberry Ref No Protocol No Protocol Title Principal Investigator 1 Select ONE of the following O Individual Event This form must be completed for Local Serious Unexpected Suspected Adverse Events SUSARs occurring at a Bellberry approved site and can be used for other individual event reporting Date of Adverse Event Participant ID if applicable Date PI learned of Event Did the event occur at a Bellberry approved site O Yes ONo Description of Event Principal Investigators opinion re the relations of the event to the study drug device Definite Likely Possible Unlikely Uncertain Definitely Not Sponsors opinion re relationship of the event to the study drug device Definite Likely Possible Unlikely Uncertain Definitely Not Investigator User Guide 14 June 2012 Page 27 Follow the steps as outlined in starting
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