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OCREB Online User Guide

1. Control Panel 2 Select the Date Time Language and Regional Options category Z Windows Update J ECH Help and Support Network and Internet Connections User Accounts G Other Control Panel Options Add or Remove Programs Date Time Language and Regional d Options C Sounds Speech and Audio Devices Accessibility Options I a Performance and Maintenance Security Center 3 My Computer E Date Time Language and Regional Options A lax e File Edit view Favorites Tools Help 3 OH Back ba P Search Key Folders Et Address D Date Time Language and Regional Optic E Go Date Time Language and Regional Options See Also guage g H A Scheduled Tasks Pick a task E Change the date and time 3 Under Pick a task select Change the format of numbers dates and times Change the format of numbers dates and times ove ff ee D iii EA a a Change regional settings so that software which supports international data will correctly display languages numbers times and dates or pick a Control Panel icon a Date and Time x Regional and Language Options lt gt O Mr Computer O My Computer Regional and Language Options 1 fx Regional Options Languages Advanced Standards and formats This option affects how some programs format numbers currencies dates and time istom
2. EI New Provincial Study Quick Links E Fein My Amendments My Renewals My Reportable Events Filter by ID Advanced ID Name SmartForm H Date Modified Type Owner State Last State Change 2 9 2011 2 59 Initial Pre 2 9 2011 2 59 PM Ontario Cancer Research Ethics Board Page 9 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 My Action Items displays items requiring action by you When you log in this tab will show as your default view Once you complete your action the submission will move out of this area to the next step in the review process My Studies displays all studies that you are preparing to submit or have submitted Other columns show attributes such as current state application type provincial versus centre review type H name and expiry date etc 3 1 1 My Home Pag e a zla My Action Items My Studies My Amendments My Renewals My Reportable Events ch require action by the study team Click on links for more information ID G Pro00000917 e Pro00000916 G Pro00000915 G Ame2_Pro00000908 Amendment 2 for My Action Items My Studies i Name Test for Ready to Review 3 Feb 9 Test for Ready to Review 3 Feb 9 Test for Ready to Review Feb 9 OCRER Gite y Amendments SmartForm c z z Filter by D dl ID Name Pro00000884 Pro00000374 Pro00000829 DA03 ES Pro00
3. Enter any comments or information in the summary field in the pop up window select Add to upload the PI response letter and select OK The status of the study will change to REB Staff Modifications Review and Study Staff can no longer make changes to the application Submit Changes Please provide any other summary information for the reviewer The application has been revised in response to the OCREB review letter Attached is the PI response Please upload any other documents e g PI response No Title Windows Internet Explorer Submit a Document ge If not provided the name of the Title PI Response for SST 01 Train Study P bapa Show Advanced Options Required ok OK and Add Another Cancel S Doe interes m Ams z The REB Coordinator will guide the PI response revised application and consent forms through the final review process ensuring that the REB recommendations are adequately addressed An approval letter will be issued once all of the REB requirements are met at which time the study will move to the Approved state Access the approval letter by selecting the Letters tab of the study workspace and selecting View Correspondence Letter under the Activity column under Study Approved You can also access the letter under the History tab however over the life of the study this area is likely to become very long and busy istory Amendments Continuing Reviews Reportable Events A
4. GATIENTOAE nr toll froo RG The O2 team will create an account for each authorized O2 user and provide a user name and password If you already have your user name and password select the Login link in the top right hand corner of the screen to go to the login screen The first time you login you will be prompted to change your password 2 3 Registration A ocreb Coeur pasevednd Pips piped Flagge ch MH your pasted If you do not have a user name and password you will need to register To register select the Registration link in the bottom left hand corner of the OCREB home page complete the registration form and select Register to submit The OCREB office must have your access authorized e g by your manager before creating your account and providing you with a user name and temporary password Ontario Cancer Research Ethics Board OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 Page 5 of 43 2 4 User Profile Contact and Password Information When you login the first time you will be directed to your User Profile to verify your contact information Select Apply to save any changes John Smith Title Employer Demo Centre Honorific First Middle Last Business Mobile Home Fax Email 1 E mail 2 E mail 3 E mail Business Mobile Employer Demo Centre Title Addr 1 Addr 2
5. Ontario Cancer Research Ethics Board 4 5 2 Accessing the OCREB Recommended Changes to the Consent Form s OCREB Recommended Consent Form Changes Name Main Consent OCREB Recommended Changes Tissue Consent OCREB Recommended Changes The review letter will contain a link to the consent forms containing the REB recommended changes Attached Documents Other Contingencies Pil Response A d Page 23 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 4 5 3 Preparing the PI Response To prepare the PI response create a response letter on your local letterhead We recomment that you copy and paste the REB questions into the response letter from the REB review letter In addition to responding to the letter you must make the necessary changes directly in the application form which is a living document that should reflect the most current study information To edit the application right click on Edit Application and open the application for editing in a new window Resize and position your PI response letter window beside the application windows so you can view them side by side as you modify the application and your response The PI should sign the PI response letter GG Sih L lt p E Seren pe EE ee d j ge 8 INSTITUTIONAL LETTERHEAD 0 Are here ary teerutiment malerialat D yes C Ho Gar li YES chock all that apply and attach below FP Brochure Sar poster Femmes 20
6. are mandatory e lf you are the Provincial Applicant you must add your own centre as a study location in order to be able to submit your centre application e If you are the Provincial Applicant you will see all Centre Applications associated with that Provincial Study In other words as the parent you get to see the actions of all of your children e A session will time out if the system is idle for 60 minutes and the user will be prompted to enter their username and password to continue e Using the Jump To menu to navigate from page to page as you work through the application instead of Continue will override the SmartForm feature that shows or hides questions as applicable to your study However using the Jump To menu is a very good way to come back to a page that your were previously working on We strongly recommend that you use the Continue button to move to the next page when you are filling in an application e Pressing Finish does not show any errors or missing items in the application Always View SmartForm Progress to check for incomplete sections before submitting e The Study should always reflect the most current information Any changes to the Study application are considered amendments e New Amendment forms briefly describe what has changed After the amendment is created you must Edit Modified Study to make all of the changes associated with the amendment directly in the application which is a living document e The ori
7. the current state i e even those you are working on ore submission State REB Staff Modification Revi Name Amendment 1 for OCREB Study DEMO3_JAN18 e Pro00000884 r 1 28 2011 2 03 PM Amendment 1 for OCREB Study Pre Submission Test for Ready to Review 2 Jan 23 i My Renewals F FE SmartForm Date Modified Owner mi 2 26 2010 4 02 REB PMI Coordinator 1 Test REE Admin Test REB Coordinator 1 Test 1 27 2011 6 23 PM 1 27 2011 3 53 PM 1e1_Pro00000838 Amendment 1 for OCREB Study DEMO6_JAN18 Amendment 1 for OCREB Study DEMO C Assigned To REI Meeting 1e1_Pro00000801 My Studies My Amendments ly Reportable Events Advanced State Withdrawn Name 2010 Review for ProQoooo004 My Renewals displays a list of your renewal applications regardless of the current state 00003 2010 Review for Prodoodooo0s 2 26 2010 11 21 Withdrawn AM 4 19 2010 12 18 PM rd 2010 Review for Testing pil create study fa test ta see if changes are saved REBC REBA REBD My Amendments DUDU My Action kams My Studies My Renewal II My Reportable Events H LG Abanca SmantForm Date Modijed Owner 5 10 47 27 of Filter by Name State on 00074 REB _Adverse Event Fri No EOT 2010 My Reportable Events displays a list of all your reportable events including the type of reportable event Ontario Cancer Research Ethics Board Page 10 of 43 OCREB Online User
8. the study moves out of My Action Items and Study Staff can no longer make any changes ocreb Staging Of Home KGR Contes Researcher Profila leaps amp Support Project Propertios 2 Ge y Centre Study Demo Centre 12 Study DEMO_11c proper 7 reommen Full Thie Centres E view Senartronm Progresi ay Withdraw Principal Invesiigator F nding Bounces Edit Emad List LI Edit Guest List ey Seng Email to PI Auihar Geen e r Arinaty HETI Send Email to REB Staff Created Shudy Principal in Error Warning Messages Message This is a required field therefore you must provide a value This is a required field therefore you must provide a value Submit Canine pd Inetstiqator Anrett rt l agree with the abra statemeni IR Stony Coordinator D De VIEW Wipe cisae Date echigaion 13 Dema Field Name Jump To isParticipatingInSubstudies 2 1 General Study Information isDifferentStandardOfCareFromProvincial 2 1 General Study Information Close Once the PI submits the initial centre application it is automatically routed to the selected Department Approver The principal investigator must login to officially sign off on the initial centre application This activity cannot be delegated doing so is equivalent to forging a signature Regulatory inspectors auditors e g Health Canada FDA OHRP may ask investigators to login to O2 to demonstrate how the PI accesses his
9. 3 0 Associated Study Coordinators Study Coordinators Read access will be given to the coordinators on this list Select study coordinators Page 8 of 43 3 Navigating OCREB Online It is important to spend some time figuring out how to navigate this new system O2 consists of a variety of pages and workspaces The different pages help to organize and display information in a logical fashion and they act as gateways to specific study areas Workspaces are unique areas that contain activity buttons and are where you work on your various ethics applications eg on a new provincial study or on post provincial study approval activities such as amendments centre applications reportable events renewals etc 3 1 My Home Page Except for the first time you login every subsequent login will take you to your personal home page My Home If you have more than one role in O2 this page will differ slightly for each user role Selecting My Home in the upper right hand corner of the screen will bring you back to this page if you get lost My Home page contains 1 2 A system navigation bar with links to various pages This navigation bar is visible from any page or workspace in the system A user tool bar menu with links to your profile and your home page My Home You can link to your personal profile to review or update it at any time by clicking on your name This user tool bar menu is visible from any page o
10. A ocreb OCREB Online User Guide Complete Guide for Applicants For Study Staff including Study Coordinators Version 1 0 and Principal Investigators Table of Contents 1 About OCREB E UE 4 Ba Mende Ell E 4 ta PROCS SSC BS oy EE 4 to HOC IMIG A TST E EE 4 E Ee ele let Practice Fla EE 4 To OD E 4 2 E de Le Ai e D 5 GC EE ee lte e 5 2e Beie Tell e Mla E 5 GC ROOSE ON WE 5 2 4 User Profile Contact and Password Iniormaion 6 E a E ROOS eee en ee ee ee ee ne nee ene eee eee ee eee 7 ZO TRESS GIST e cearn E T E E A E 8 3 Navigating OCREB Een Un E 9 el NRM FAGO arria i E E E E E EEE E E EEE EEN E E E E 9 31 1 My Hom e Ee gall b 6 lt ee ee ee ee ETEN 10 Cele Frand YOUR SUD MINS SUC EE 11 e elek EE 11 Io OCS e EE 12 3 3 1 Amendments Renewals and Reportable Events Pages cccceesscccssteceessteeessteeeesneeens 12 SE e tee LE 13 CR By Gne e TE 13 4 Jonge NEW Provincial StUGY siesena E EEEE Tai 14 A PSUS O aeiae E EE E E EE EE A E E N E E 14 AET Be e te Voie DOCUMEN E 16 e SEENEN 18 4 1 3 Finalizing the Provincial Appitcaton 19 42 OUDMISSION P e 20 AS 18 4 lee Ee 21 Ontario Cancer Research Ethics Board i s lt is s lt lt a Page 2 0f 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 4 4 Tracking the Progress of the Applcaton ENEE 22 AD WPS Lelleg 23 4 5 1 Accessing the OCREB Review Letter cc cccsseccsseccsssecess
11. Content Connections Programs Advanced Home page In the browser choose Internet Options from the Tools menu Click the Languages bu tton on the A To create home page tabs type each address on its own line General tab Click Ada to add another language to the list Make sure English Canada is at the top of the list oh Select OK https collaboration oicr on cafheshe http www google ca http www bing com Use default Use blank Browsing history Delete temporary files history cookies saved passwords and web Form information Search Language Preference Language Preference Add the languages you use to read websites listing in order of preference Only add the ones you need as some characters can be used to impersonate websites in other languages English Canada en CA English United States en us Move down Restart the browser Change search defaults You must also change the date format on your local computer see next section for Windows Change how webpages are displayed in Settings tabs Prefix and suffix options Do not add www to the beginning of typed web addresses Appearance a Eas Specify the suffix For example net that should be added to typed web addresses when you press Ctrl Shift Enter Suffix a Jl cece Ca To change the date format in Firefox Mac OS X 1 Choose Preferences from the Firefox menu 2 Click t
12. Guide for Study Staff Complete Version 1 0 2011 Feb 21 3 1 2 Finding Your Submissions Many views have a Filter feature to allow users to more easily find an item in a long list For example to find a study by sponsor protocol number select My Studies tab enter the exact protocol number in the Filter by Name field and press Go To find a PI Filter by First or Last name enter the name in the adjacent field and press Go Press Clear to return to the full list If you know the O2 system generated project PRO number filter by ID and use in front of last 3 numbers of the PRO number to find the project My Inbox My Amendments My Renewals My R Select One or More Persons Filter by Name DEMO z Gol _ciesr Ach 1 martForm Date Modified Owner Sti 31 01 2011 REB Ap Owner First Name 3 24 PM Coordinator State 1 Test Application Type Organization K d 26 500f254 gt Al Review Type P User ID Project ID Organization Expiration Date You can sort most columns in ascending or descending order If you move your cursor over the column heading it will change to a link if the column allows sorting Select the column heading to sort Select the column again to sort in the opposite direction Date Modified Date Modified Name pr EI Name JID or Se etc e g if you wish to display studies by the closest expiry date sort by ascending Expiration Date My Actio
13. Reportable Events Displays all items which require action by the study team Click on links for more information Filter by 17 el E Advanced Name SmartForm Date Modified Type TM 02 P Initial Pre Owner State Last State Change 2 9 2011 2 59 PM 2 9 2011 2 59 1 1 Study Identification This is the first step in your Human Research Ethic Application You will sutomatically be guide SSE a ee eeEe EN here Lee o ae ay See eee CS RES eee re re Szen STS FE feed eet E CH Dr sections needed to complete your submission Guidance notes will be in iteli Red ssterisks 7 a kussi Bear day ep Zare il ee seul rer Lull EE ES ST ER E raed e Submission of the soclication will be blocked unless sll mandatory questions sre answered Is this a multi centre cancer clinical trial OCREB s mandate is multi centre cancer clinical mals ie a inal conducted at more an one cenire in Ontano using OCREB Yes Cb CledD E Alex REENEN mr ME E FNO please contact the OCRES office Protocol number te sponsor protocol number enter EXACTLY as wnten on the protocol eg BR 29 not BR29 Pd Study acronym or other unique identifier or nickname OCREB number please contact the OCREB office at 416 673 6649 if you do nothave an OCRESB number Full Study Tithe enter exactly as written in protocol Provincial Applicant Investigator Test Principal Investigator 2 Study Co ordinator or Assistant itis person will ha
14. Review Principal Investigator 1 27 01 2012 oF Pro00000001 DEMO 1a fy 03 02 2011 2 38 PM Pre Submission Principal Investigator 1 oF Pro00000002 DEMO_1ib pi 03 02 2011 2 39 PM P Response Pending ull Board Review Principal Investigator 1 27 01 2012 G Prooo000006 DEMO 29 pi 03 02 2011 2 40 PM Pre Submission Principal Investigator 2 Ontario Cancer Research Ethics Board OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 Page 22 of 43 4 5 Pending PI Response Once the initial application has undergone REB review typically at a full Board meeting the REB will issue a review letter with any questions requests for clarifications recommendations or concerns Once the review letter is issued the state automatically changes to PI Response Pending 4 5 1 Accessing the OCREB Review Letter When the REB review letter is issued the PI and Study Coordinator both will receive an automatic email notice with a direct link to the study workspace The study also shows up in the My Action Items tab with any other items requiring action by you Select the study from the Name column to open the study workspace The application is now open to the Study Staff to edit in response to the OCREB review letter Find the review letter under the Letters tab and select View Correspondence Letter to open the letter To download a copy right click on View Correspondence Letter A ocreb OCREB WILTZ Centres Researcher Pro
15. g Ontario Institute Offers New Model of ed ett Eee Cancer Research Hee Mean be bt iSoee protocol or consent form and application i e coal reduce the size of the windows and drag a them together 9 3 Windows Computer Tips e Holding down the CTRL button on your computer keyboard and scrolling with a mouse wheel allows you to change the zoom level of a page displayed on your computer screen e Hold CTRL F to search within a document e Use ALT TAB to switch between windows 9 4 Reminders e lf you fail to successfully login after five 5 attempts the system will lock you out and you will need to call O2 Help to have your password reset e The first page of an application must be created and saved before the study record is created Ontario Cancer Research Ethics Board Page 40 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 e Once a reference number is generated the form can be saved and modified at any time until it is submitted Select Exit to save and exit without completing all mandatory questions on a page e Selecting Back or Cancel will allow you to exit from an activity before it is activated e You may copy and paste into application fields from external documents A field with a down facing arrow means that the field can be formatted Click on the arrow to open the formatting tool bars e Questions marked with a red asterisk
16. her REB study files Ontario Cancer Research Ethics Board OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 Page 28 of 43 5 1 4 Department Approvals Signatories Login and locate the initial centre application study in My Action Items Ensure that you select Dept Div Approvers from My Roles if you have more than one role in the system A PI cannot be Department Approver for his her own studies Select the study name to open the centre study workspace To review the application section by section select View Application Select Printer Version to print or to review the application as a single document To approve the application select Issue Departmental Approval To return the application to the PI select Changes Requested by Department Reviewer Check off the box in the bottom left hand corner and then select OK from the bottom right to submit the study This serves as the official Department Approver signature Once approved the application is automatically routed to the REB The state changes to REB Staff Review The PI or Study Coordinator can monitor the progress of the application by checking the State column in My Studies tab on My Home page The OCREB office will run reports to identify any submissions that have been stalled for two weeks or more Study Staff will be asked to remind the department approver to sign off on the appli
17. meeting and is ready for review by the REB members The REB meeting is finished and the study is awaiting the REB coordinator to draft either a review letter or an approval letter as applicable If changes are required by the REB a review letter is issued and the application is sent back to the Study Staff to respond to edit and resubmit Draft review or approval letters are under review by the Chair The Chair can send the letters back to the REBC for changes edit the letter or approve the letter and issue It to the PI which serves as the Chair s formal signature The modified application PI response is under review by a designated REB member The initial centre application has been submitted to the department head approver for review The department approver can approve the application which routes it directly to the REB or request changes which routes it back to the Pl Study Staff The submission meets the criteria for expedited review also referred to as delegated review and is under review by one or more REB members Initial centre applications default to expedited review unless concerns are identified during the review The REB reviews are complete and the REB Coordinator is drafting the final approval letter which is routed to the Chair for final review and approval OCREB has approved the submission Many types of submissions are acknowledged rather than approved e g reportable events
18. users using the Edit Guest List activity eg sponsor monitors on a study by study basis However the person must first register in O2 and be granted an O2 account before they will appear in the guest list e Select Printer Version to view the application in its entirety or to print it You can print to pdf to save a copy of the application forms locally on your computer e If renewal applications are not received by the expiry date ethics approval will expire a Suspension notice will be issued and no further activities will be available in O2 e Once OCREB acknowledges the study closure the study application cannot be reopened Ontario Cancer Research Ethics Board Page 41 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 9 5 Changing the Date Format 9 5 1 Changing the Date Format in the Brower Date formats in browsers such as Firefox Internet Explorer and Safari can be changed Depending on the browser there are different methods for changing the date format Safari s date formats are controlled by the OS X date format and language settings which can be found in the International Setting section of the Date Time system preference window Firefox and Internet Explorer date formats are controlled by the language set for each browser in the browser s preferences We recommend that you change your date formats to English Canada tel EAE ae AS AT tere deed EE stor VE rity Privacy
19. ut Newspaper ad D Telephon ak Dr Det Hotim E Wee Chat OCR slat IOL Coflegy Steet Eege Si IT Wues d be r apepd withoul zcpetz Termit Cape MIG DA FP Osher specify below Dex De Moolland I OTHER specify RE Vogel Li Sponge FPM Repase ty DCHER Review Lette ae ia Piae az be paaa i OCRER s pamm med concer below Pratanal 10 Lint the kay inchaian eriteria in poln form ia ie charactarisics thet man be med for Iniividveds io be anralled 1 Thea cha commbaned chine i stedy Please dr whether or oot phase fer he stecht conopltte JC phate complete pleie poovede the plise daia E Seese A gt Th d El ci BR Z H es Reps Phas la me sepies The phus 1 Arn ached SE gt Pleats dandy cory bec da becau h oje E E am De car d 3 k a ei Gi mg Repesane celami ebb bty wil be bed on The seleabze ka been Feat Maral Font Sie amp Pati relem Ger cetera li wdy i j o bag terai mp Ceaent Timakin Bea oan sl oeptseogd Goer pr eeleaei ef be Pl eopeeg Fiir DE voa kae su aethon on commen ents de act betie ba eel a soe Semcrenty on Ep dita PY pare der ambii Dh Peecpal mangaa e 4 E S GEZ Leg tice Pa ADS 2 T NA OOS Ac GE ow a m eae Editing the application usually includes uploading revised versions of documents i e consent forms For the clean version of each consent form i e with changes incorporated select Delete beside the appropriate consent form and upload th
20. 0 2011 Feb 21 2 5 Access Levels Roles Most O2 users will have only one O2 role i e Study Staff However if you are a PI and a department approver both roles will be added to your profile Although all Study Staff share the same role name your authorized activities e g view only make changes submit depend on the permissions set for your specific study staff role e g PI main study coordinator co investigator other study staff A ocreb If you have more than one user role switch between roles by selecting the appropriate role on My Home OCREB Studies Centres Rese page NB The role that you select will determine the information that is displayed on your screen and the activities you are allowed to execute DeptiDiv Approvers Study Staff Ontario Cancer Research Ethics Board Page 7 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 2 6 Researcher Profile The Researcher Profile link on My Home will take you to your researcher profile if you are a Pl ortoa list of profiles for all Pls that you are linked with if you are a study coordinator The Researcher Profile collects information similar to that in the OCREB New PI Form First time O2 users Select Edit Researcher Profile complete the fields and upload the Pl s most current CV This can be done by a study coordinator linked to a PI or by the PI A PI can add study coordinators to his her profile granting t
21. 0 2011 Feb 21 3 3 Studies Page The Studies page is where you access all studies you are involved in Provincial top or Centre bottom This includes provincial applications where you are NOT the provincial applicant but your centre is participating or listed as potentially participating even if you have not yet submitted your centre application The various tabs link to Provincial and to Centre studies by their current state i e In Progress Approved Closed or to a list of All Studies regardless of their current state On the left hand side you will see a menu of Other Submission Types from where you can access all post approval provincial and centre submissions amendments renewals and reportable events related to all studies Think of these as subfolders of the study A OC reb Deve l O D me nt Test Principal Investigator 2 My Home Logoff OCREBR IR Centres Researcher Profile Issues amp Support Other Submission Types Studies 3 Amendments gt Renewals View all studies by In Progress Approved and Closed groupings Use the Wy Home link in the top right hand comer of your screen to see the z list of submissions related to you gt Reportable Events Ei Create Provincial aS eee ee Frovincial Approved Provincial Closed Provincial All Studies E New Provincial Study ID Mame SmartForm Date Created Jl Date Modified Owner State Review Type Provincial FI oe ProkhO0eT4 Ready To r 120
22. 000281 Test for Ready to Review 2 Jan 23 Oct21Test_CentreApproved6 01 333 Oct 7 Test Session My Renewals GI Date Modified 09 02 2011 3 45 PM 09 02 201 PM 09 02 201 PM 1 3 44 1 3 42 SmartForm Date Modified z z z z 16 02 2011 1 58 PM 06 12 2010 11 49 AM 13 01 2011 3 05 PM 06 10 2010 9 25 AM Type Owner nitial Submission nitial Submission nitial REB Submission 1 Test REB Amendment Cnanrdinatnar Pacnnancea My Reportable Events Owner State REB Coordinator 1 Test REB Coordinator 1 Test REB Assigned To Coordinator REB Meeting 1 Test REB Coordinator 1 Test Approved Approved Approved Coordinator lt State Pre ub re re p ission S Pre Subm p ubm Last State Change 09 02 201 PM 09 02 201 PM 09 02 201 PM 13 45 1 3 44 13 42 PM Application Type Review Type PI Provincial Provincial Provincial Provincial Full Board Review Prin Inve Expedited Full Board Review Expedited 0X Di D 1e 1_Pro00000847 My Studies My Renewals Advanced SmartForm Date Modified Owner r 2 1 2011 8 29 REB PM Coordinafor 1 Test REB Coordinator 1 Test REB Adr in Test REB Meeting Complei Coordinar Awaiting 1 Test I My Amendments My Reportable Events My Amendments displays all your amendment applications regardless of
23. 11 934 W2N2011 10 25 REB Assigned To Full Board Principal Review Test Al Al Coordinator REB Meeting Review Investigator 2 Mi Test Centre In Progress Centre Closed Centre All Studies SmartForm E Date Modified Owner State Review Type Centre FI Provincial Pl r W21V2011 3 45 REB Changes Expedited Principal Principal PM Coordinator Required by Investigator Investigator 1 Test Centre T 7 Department Amendments page displays a list of all provincial and centre amendment applications for all studies you are involved in OCRER iii Centres Researcher Profile lssues View all Amendments by In Progress and Completed groupings Tip look for the crumb trail or the page title to confirm D Renewals LG Reportable Events your location Centre Completed Study Expiratio D WILH er Submission R rtable E t Reportable Events page View all displays q list of all provincial Depe events by In Progress and Completed groupings Renewals and centre reportable event ak e orete su bmissions e g local SAE OE m protocol deviation safety ID Name Date Modified State Study H Reportable Event T update DSMB report for all Adv00000126 Reportable Event DEMO_D SEH 1 56 Changes Pro00000789 Principal Safety Update e g Required by Investigator DSMB report safet studies OU are involved in REB 1 summary report IN y i Committee action Dear doctor letter etc Adv00000136 Reportable Event D
24. 260 7945 or toll free 1 866 678 6427 Ext 7945 Ontario Cancer Research Ethics Board Page 4 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 2 Getting Started 2 1 02 Home Page On the O2 home page you will find the login link as well as links to other OCREB information such as policies and procedures templates user guides and OCREB meeting dates and deadlines A ocreb OCREB Online Home What s New About OCREB Policies and Procedures Deadlines and Meetings 02 Sandbox Forms and Templates Related Links Contact Us To create an account Registration 2 2 Logging In application preparation submission and review processes Ethics applications for new studies and post approval applications such as amendments renewals study closures and reportable events e g local SAEs safety updates DSMB reports protocol deviations are submitted via the online system by the principal investigator or by the designated study team member Applications are prepared using smart forms which dynamically show or hide questions depending on the applicability to the study The system automatically prompts for missing information thereby ensuring that the application form is complete before submission OCREB Online is available 24 hours a day unless otherwise indicated here 02 Support During business hours contact Simon Wong O2 Business Analyst Email ocrebonline at cicr on ca al
25. Addr 3 City Province Country Postal Code e To change your password at any time select your name from the user menu bar This will take you to your user profile Select the Account tab to access the password area A ocreb Staging O2 Home Studies Centres ResearcherProfile Issues amp Support Root John Smith Title Employer Properti f Account P ification Settings Password and Miscellaneous Editor Password Information E mail ostage ap CS Business 111 111 1111 Mobile Curent Password Hew Fassword Passwords must contain at least six 6 characters in an alphanumeric combination Passwords must not be shared or stored in a visible and accessible location i e written down Passwords must NOT contain e any words that could be found in a dictionary e any words or references to the type of work being performed in relation to the system on which the password is being deployed e any identifying user information such as birthdays spouse s birthdays anniversaries children s birthdays pet names or other similar types of identifying information e three or more consecutive characters from your username If you fail to successfully login after five 5 attempts the system will lock you out and you will need to call O2 Help to have your password reset Ontario Cancer Research Ethics Board Page 6 of 43 OCREB Online User Guide for Study Staff Complete Version 1
26. EMO_D 1 19 2011 11 26 Awaiting Pro00000789 Principal External non local AM REB Investigator Adverse Event EA Subscribe Ontario Cancer Research Ethics Board Page 12 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 3 4 Centres Page Selecting Centres in the navigation bar will take you to a link to your Centre profile Select the link to open the profile Only users at your centre and in the OCREB office will be able to view your Centre Profile A OC reb Dev e O p me nt Test Principal Investigator 2 My Home Logoff OCREB Studies eae Researcher Profile Issues amp Support Subscribe Help Centres Create Centre Profile You do not have have sutficient pnvileges fo creste Precis wath Centre Profiles Archived Centre Profiles ihis Project Crestor Component Filter by Name sl el Ces Date Crested Date Modified wm m ei IR wi ee m i EZ 25 Nw G BL iia has G eo ALA Carlo Fidani Cancer Centre s Profile IA 2200S 3 24 AM 1 2017 9 55 AM 3 4 1 Centre Profile The centre profile page allows you to view information pertaining to your centre including a List of Staff at your centre who are registered in the O2 system a place to store any relevant Centre Policies if you so choose a list of OCREB Approved Consent Form Changes a list of all Studies running at your centre and a list of all provincial studies created by your centre Provincial Studies Crea
27. The state changes to Acknowledged once REB review is complete Ontario Cancer Research Ethics Board Page 39 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 9 Tips This section contains tips to optimize the use of O2 Please forward any suggestions 9 1 Formatting Copying amp Pasting DRescribe procedures treatment or activities that are not considered part of the diagnostic or Whenever you see a down facing arrow in an application field it means that the field can be formatted Click on the arrow to open the formatting tool bars You can now format the text e g 7 0 Describe procedures treatment or activities that are not considered part of the diagnostic or therapeutic routine bullets numbers You may wish to E sure GIA ie AEA format the information in a Word a me document first or cut and paste into i EE EEL RTE g r or this field from the protocol or consent wm EES Ge form and then format the information directly in the application 9 2 Working with Multiple Windows It can be useful to display two windows side by side to see O2 and another document at the same time e g O2 and this guide Right click on links to open an item in a new window Manually resize and position the two windows If you have Windows 7 the two windows will snap together automatically MEWS To view two windows side by side e g Sea S Ge eege EES
28. View Application TE Printer version Centre Study Demo Centre SST 01 TRAIN Proo0000092 D View Differences Description Principal Investigator John Smith Study Coordinator Demo Study Coordinator Go to the Provincial Study Date Submitted 05 02 2011 Review Type Expedited workspace by taking the crumb ect ACRE Caardinatar Tas DER o onnan trail back to the parent from the Centre Study workspace If you are the Provincial Applicant you will see all of the Centre Studies Applications associated with that Provincial Study In other words as the parent you get to see the actions of all of your children Ontario Cancer Research Ethics Board Page 32 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 5 2 Amendments Any changes to the approved ethics application are classified as amendments A study must be in the approved state before an amendment can be submitted There are two types of amendments e Full Amendment for changes to the consent form or consent procedures a change in centre PI protocol changes investigator brochure updates etc e Administrative Amendment to correct spelling errors for changes in contact information for a change in provincial applicant for translation of approved materials and for changes in study Staff except for the centre PI Changes to centre PI must be submitted as a full amendment Only one request for review of an amendment is a
29. ator Brochures or Product Monographs unless the sponsor formally agrees to do so on my behalf will submit an OCREB Application for Approval of Centre Participation for review approval to conduct the study at my centre am aware that OCREB will provide the following study information to all Ontario oncology trial sites OCREB project _D sponsor name sponsor protocol REB review status name of provincial applicant e submitting Pl list of participating centres After you click OK you will no longer be able to edit the application You will receive email when each approval is granted or refused and again when all the required approvals are received if you are not ready to submit your application click Cancel I agree with the above statement DW orl Cancel The principal investigator must login to officially sign off on the initial provincial application This activity cannot be delegated doing so is equivalent to forging a signature Ontario Cancer Research Ethics Board Page 20 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 4 3 Contingencies Once your study has been submitted the Intake Coordinator at OCREB will review your application and send it back to you to edit or assign it to an REB Coordinator as applicable The REB Coordinator will review the application set contingencies as required and either assign it to a meeting assign it to an expedited reviewer or send the app
30. cation Demo Department Head 12 My Home Logoff P ocreb Staging 02 Home Studies Centres Researcher Profile Issues amp Support Page for Demo Department Head 12 My Roles Welcome to your Personal Folder Use the following guidelines to process your Studies Dept Div Approvers e Review all submissions in your Inbox You can Approve the submission for your department or Request Changes that the study team My Action Items G DEMO_11c P Departments Approve For Demo Centre 12 Studies Date Modified State PI 19 02 2011 5 56 PM 20 02 2011 2 21 AM Centre Department Review Principal Investigator 12 martForm Date Created Staging OCREB OT Centres Researcher Profile Issues Project Properties Centres Centre Study Demo Centre SST 01 TRAIN Provo000082 Description Principal Investigator Jotin Smith Date Submitted wO2Z 201 1 OCREB Coordinator T Gb View Application ZA Printer Version 3 View Differences Study Coordinator sel EEN Review Type fey Issue Departmental Approval Lac Changes Requested by Department Reviewer EE IR Attachments Autnor Smith Jonn Activity c Centres 1S r Review orn entre Study Submitted for Review J Activity Date Issue Departmental Approval DEPARTMENTIDIVISION OR INSTITUTIONAL APPROVAL e am aware of this proposal and support its submission for ethics review consider it to be feasible and appropriate e attest that any internal D
31. dd the new Centre PI Amendment Type 1 From the Centre Study workspace create a Centre New Amendment form Select Full KEEN Amendment then select Change in Centre PI OPAN AR NET ee Le Te ee ee ae EAA from the Type of change options a ee E Select the amendment type below select all that may apply NOTE To change the provincial applicant to another investigator from the same centre please change your centre investigator Don t forg et to select A dministrative through a Centre Amendment first Once your amendment has been approved submit an Administrative Provincial Amendment Amendment as well and choose Study Staff here to set your new centre investigator as the new provincial applicant Changes if the Study Coordinator will also change Full Amendment A ocreb Development Edit Initial Submission MS2_Pro00000798 Save Exit Hide Show Errors Print Jump To 1 1 Study Personnel 2 Edit Modified Study to make the change to the new PI directly in the application form EE This includes uploading a revised Board of Record Study Agreement signed by the new Race a a Centre PI 2 0 Centre Principal Investigator Test Principal Investigator ZU Zelez Study Coordinator or designated contact Change Centre PI Select the new Centre PI E Change Centre PI Reminder Please do not submit this amendment After making your selection here the new investigator will have to accept th
32. ds section of the application will result in the appearance of questions relating specifically to biological specimens If you are collecting biological specimens in your study and you don t see the related questions go back to ensure that you made the appropriate selections in the Research and Methods section Once the application is finished double check that it is complete before submitting it if you are the Pl or before contacting the PI to submit if you are the study coordinator Selecting View Smartform Progress will open up a Progress window showing whether the sections are complete or incomplete If a section is incomplete it means that at least one of the mandatory questions was not answered Select the item from the Section column to go directly to that section Progress Description Progress Provincial Incomplete 2 0 Study Objectives amp Design Provincial Incomplete 3 0 Research Methods and Procedures Provincial Incomplete 4 0 Study Population Recruitment and Consent Provincial Incomplete 5 0 Risks and Benefits Assessment Provincial Incomplete 6 0 Data Privacy Confidentiality amp Security Provincial Incomplete 7 0 Data amp Safety Monitoring Plan Provincial Incomplete 8 0 Budgets Costs amp Contracts Provincial Incomplete Once you have determined that the application is complete if yeu are the study coordinator you can inform the PI from within OCREB Online by pressing the L activ
33. e 9 EXT RA STE P select the position and submit the amendment to complete the process activity and select the new Centre PI The PI will receive an email notice Accept Centre PI Position 4 EXT RA STE P Thei Incom j ng i m ust logi In and To accept the centre PI position please don t forget to complete these remaining steps 1 Selec Aaka endment and finish the application smartform 2 Selec res Submit Amendment from My Activities er Submit Amendment 5 DIFFERENT STEP the incoming PI must to officially accept the role When changing to a new Centre PI the modified centre application must include be modified to reflect the change in PI In addition a new Board of Record Study Agreement signed by the incoming PI must be uploaded Ontario Cancer Research Ethics Board Page 36 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 5 3 Reportable Events Reportable Events is a broad term covering multiple safety related submission types Reportable Events may include local SAEs protocol deviations and privacy breaches at the centre level and safety updates DSMB reports IND Action letters and external SAEs at the provincial level Multiple reportable events can be submitted at one time however only one type can be submitted per reportable event form The Provincial Study must be in the Approved state before provincial reportable events can be submitted The Centre S
34. e Study Staff SS at various stages states in the review process Emails are automatically generated with the following activities e When the REB issues requests for changes or clarifications the SS at the submitting centre are notified e When the initial provincial study application is approved SS at all centres listed as participating are notified e When provincial amendments are submitted SS at all participating centres are notified e When formal decisions are issued e g approved expired SS at all participating centres are notified e When there is a change in provincial applicant or change in Centre PI the incoming PA or PI is notified so that he she can login and officially accept the role T Issues amp Support Select Issues amp Support from the navigation bar and then Ask a Question to submit an issue Or check the FAQs tab for questions and answers submitted by other users Selecting the Ask a Question activity will open up a new issue form Please be as specific as possible if you are describing an issue e g where you were in the system and the time what activity you were performing or tying to perform and what happened You can also upload screenshots or documents Screenshots are always helpful in characterizing an issue Ontario Cancer Research Ethics Board OCREB Studies Centres Researcher Profil Issues Ask a Question K i Ask a Question Links No items to d
35. e for Study Staff Complete Version 1 0 2011 Feb 21 To upload revised documents e g protocol consent form IB with your amendment i e moditied study Delete the version in the application and Add to upload the revised version A record is always retained of the previously submitted versions To add new documents e g Consent Update forms summaries of changes to the protocol or summaries of changes to the investigator brochure select Add to upload to the relevant section of the application If you have multiple protocol amendments with one submission you must upload each amendment amended protocol and protocol summary separately and clearly name each document per the sponsor s assigned name number letter and add the appropriate version date of each document in order for each document to be displayed appropriately in the approval letter You must manually revise the date in the Version Date each time you upload a revised document because once the application is approved this date field transfers directly into the approval letter as the version date of the approved document 5 2 1 Opting Out of a Provincial Amendment All previously approved participating centres will receive approval of the amendment simultaneously with the approval of the provincial amendment If the amendment does not apply to your centre your centre can Opt Out of the approved amendment 5 2 2 Centre Specific Amendments Amendments a
36. e revised version 4 3 Consent Forms amp Other Study Participant Materials 1 0 Upload all consent form s here MS WORD ONLY OCREB strongly recommends downloading the applicable consent form templates e main study genetic research etc and modifying where necessary S Name Update Main Study Consent changes tracked Update Main Study Consent doc Update Optional Tissue Consent Form Version Date February 6 2011 Delete February 6 2011 Delete February 4 2011 Delete Add the tracked change versions of the consent form s by uploading them in the tracked change consent form area of the application Upload all consent form s here MS WORD ONLY OCREE strongly recommends downloading the applicable consent form templates e main study genetic research etc and modifying where necessary Add Name There are no items to display Version Date Upload all consent form s with tracked changes MS WORD ONLY if applicable Ontario Cancer Research Ethics Board Page 24 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 4 5 4 Submitting the PI Response Now that the PI response letter has been reviewed and signed by the PI the modifications have been made to the application form and the revised consent form s with the new version date s have been uploaded directly into the application you are ready to select Submit Changes which sends the updated application to OCREB
37. e section of the SAE reportable event form 5 4 Renewals Ethics approvals are granted for one year unless otherwise indicated Study Staff will receive email reminders when renewal deadlines are approaching 60 30 15 and 1 day in advance of the expiry date Centres must submit individual centre renewal applications In addition to their centre renewal application the Provincial Applicant Study Staff must submit a provincial renewal application If renewal applications are not received by the expiry date ethics approval will expire a Suspension notice will be issued and no further activities will be available in O2 Study Staff will need to contact the OCREB office for further instructions regarding requirements for initiating a re approval for the study Ontario Cancer Research Ethics Board Page 37 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 ring 5 5 Study Closure The Close Study activity will appear when your study is approved and there are no outstanding amendments renewals or reportable events All participating Centres must submit their study closure application and be closed by the REB before the Provincial Study closure application can be submitted and the study officially closed by the REB Once OCREB acknowledges the study closure the study application cannot be reopened 6 System Notifications The O2 system automatically generates email notifications to th
38. eecssssecssseessseeessseeessseeeeseeessaees 23 4 5 2 Accessing the OCREB Recommended Changes to the Consent Fomis 23 AS Preparing ING gel 24 45 4 Submitting the Pl RESPONSE EE 25 3 EE lege E e E 26 5 1 Initial Centre Application New Centre Study 00 cccccccsccsssecesseecesseecesseesseeseseeessseeeesseeenes 26 cS rai es EE ee K O ee o pre ee senna ete nn nner a N 27 5 1 2 Finalizing the Centre A pplilGAQtlOn EE 27 5 1 3 Submitting the Centre Application Principal Investigator Only 28 5 1 4 Department Approvale ionatores 29 SE EE ee ln Te ere 20 5 1 6 Accessing Centre Approval Letters and Approved Documents 31 5 1 7 Centre Application or Provincial Application Where am IV 32 eee RAINS ONC EE 33 5 2 1 Opting Out of a Provincial Amendment ccccessccssecsssecssssecssssecsseecssetecseasecseatecssaneseanes 34 5 22 GeNire SPSGIIC une Tun soecniereripaniirner e T E alee 34 5 2 3 Amendments Involving a Change in Provincial Applicant and or Centre Hl 35 E Hmmm ee eeler 37 54 RENOWAl Snaren enee a a N e a nla neala ena T 37 S5 OUV e EE 38 EE un elteren EE 38 Ee EE 38 E eet ere WE 39 S MNS E 40 Ot elen Eege BR Copying Sc Pasting BEE 40 9 2 Working with Multiple WiNdOWS ssssssoeeesssessessseessssseesssseesssssersssressssrerssseressssreesssreesssrersssereesssrees 40 93 dl tee lune TEE 40 oes EENEG 40 9 59 hanging Ine Date FORM EE 42 Ontario Cancer Research Ethics Board i i
39. epartment requirements will be met e attest that the PI is qualified and has the experience and expertise to conduct this research e attest that the PI has sufficient space and resources to conduct this research agree with the above statements on behalf of the following department division or institution H Demo Centre Z ocreb Staging D Home Shediet Centres Retoarches Prois lamens E Sippari Stith Sta Page for Demo Study Coordinator 11 me bo youd Herseangal Folkia sindy sisi Process ai iubmeimana n yow Inbox hems pening bere ame immedma achon by you i seed your subtamen uh ihe iine process Cati on ink io protease a Mordor the progees of pour subeniedions Gart the ler late ems of Shige labs do no iogan ay action by you Croats Provincial O nee ince Sage a My engen Quick Linis L Faportatle Everts The Department Approver must login to officially sign off on the initial centre application This activity cannot be delegated doing so is equivalent to forging a signature Ontario Cancer Research Ethics Board Page 29 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 5 1 5 Contingencies Once your study has been submitted the REB Coordinator will review the application set contingencies as required and assign it to an expedited reviewer or send it back to you to edit If the application is sent back to the Study Staff you will receive an emai
40. er Kod 1081 for your study y y OK Cancel Ontario Cancer Research Ethics Board Page 26 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 5 1 1 Consent Principles OCREB approval of your centre application authorizes your centre to use the provincially approved documents The provincial templates e g consent forms wallet cards will appear in the provincial documents section of the centre application Select View to open and save the document s locally on your computer You can also access the documents directly from the Provincial Study workspace by selecting View Application and using the Jump To menu to go to the appropriate section s Make your local administrative changes to the consent e place it on institutional letterhead add local contact information and include any OCREB pre approved institutional changes Pre approved consent changes will automatically populate from your Centre Profile into the centre application form and the approval letter No other changes except spelling or formatting are authorized without consulting with OCREB with the exception of the pre approved language The version date of the approved centre consent form will therefore remain the same as the provincially approved consent form You will not submit your localized consent form s with your centre application However OCREB may request a copy at any time Copies of centre consent form s are required at the time o
41. f renewal 5 1 2 Finalizing the Centre Application A ocreb Staging Demo Study Ceonfnsior 11 MyHome Lago Project Proparties Cantras d Centre Study Demo Centre 12 crom Double check that the application is complete by st selecting 4 View SmartForm Progress Flt Tie P Timcspal Jnvezstdeoatog Funding Souwreea Change Leg Histary Altachments Activity Author ZJ Actraty Die fay Created Study Principal lnesiigator 13 Deng Progress This will open up a Progress window showing whether each section is complete or incomplete If a section is incomplete it means that at least one of the mandatory questions was not answered Section Description Progress 1 0 Study Identification Funding amp Locations Provincia Not Requirec 2 0 Study Objectives amp Design Provinc Not Required 3 0 Research Methods and Procedures Provinc Not Required 4 0 Study Population Recruitment and Consent Provinc Not Required Select the item from the Section column to go directly to that section to complete it Note because the Progress menu is shared between the provincial and centre applications you will see both types listed You only need to review the progress of the centre sections when submitting a centre application Ontario Cancer Research Ethics Board 5 0 Risks and Benefits Assessment 6 0 Data Privacy Confidentiality amp Security 7 0 Data amp Safety Monitoring Plan 8 0 Budgets Costs amp Cont
42. ff will not receive the notifications Ontario Cancer Research Ethics Board Page 15 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 4 1 1 Uploading Documents i i i fe Edit Add D t At various points in the application you will susie ery be prompted to upload relevant documents SEH Uploading a document is a two step process C Selecting Add will open up an Edit Add Version Date Document window Enter the version date of III the document and select Add again to upload i Required orl OK and Add Another Cancel Submit a Document This will open up another window Enter the title of the document and select Browse to ac In Bass Eee if not provided the name of the locate the document on your computer Select OK to upload the document to the _Browse _ application Select OK and Add Another to j file will be used upload other documents or select OK until you return to the application form Required oul Cancel Edit Add Document a Protocol Version Date as written on protocol b Upload the protocol here PDF ONLY If the document is password protected please enter the password under advanced options d iption None No Title Windows Internet Explorer SE If the docu ment iS pas SWO rd protected you c An nendment le https o2 dey oicr on ca Dey_eREB ResourceAdministration Document FormForProperty postback 18formID 0 amp he a will need t
43. file Issues CH Edit Application Printer version E View Differences Description Principal Investigator OCREB Coordinator Expiration Date EH Submit Changes Withdraw Z Edit Email List Send Email to PI Send Email to REB Staff History View Assigned To Committee Meeting Review Letters Activity Sent Letter to PI Attachments Last Issued Letter Demo Principal Investigator 1 My Home Logoff Project Information Information Provincial Study Demo Centre 1 DEMO_ 1b Proo0000002 This is the full title for test study DEMO1b Demo Principal Investigator 1 Study Coordinator Demo Study Coordinator 1 Test REB Coordinator 1 Review Type Full Board Review Meeting Date amp Time 11 02 2011 11 00am Contingencies Change Log Author REB Chair Test Activity Date 27 01 2011 1 50 PM GMT 05 00 CO View Correspondence Letter The REB recommended consent changes will be tracked directly in the consent forms Download copies to your computer to review and accept or reject the changes as agreed with the PI and sponsor Change the version date and be prepared to upload the revised consents to the edited application to submit with the PI response The consent forms with the REB recommended changes also can be accessed in the same area as Contingencies from the Study workspace select the Attachments tab and scroll down to Attached Documents Other
44. ginal approved submission and all subsequent approved versions are accessible in the Amendments tab of the Study workspace e To upload revised documents e g protocol consent form IB with your amendment i e modified study Delete the version in the application and Add to upload the revised version A record is always retained of the previously submitted versions e You must manually type in the Version Date each time you upload a revised document because once the application is approved this date field transfers directly into the approval letter as the version date of the approved document e Only one request for review of an amendment is allowed at a time This means that one amendment must be processed completely approved rejected withdrawn before another New Amendment can be created However one amendment can include multiple changes If a renewal application is open you will not be able to create a new amendment e Amendments are submitted from the amendment workspace e You can provide your contracts office personnel with access to the study from the centre application e When changing to a new Centre PI the modified centre application must be revised to reflect the change in PI In addition a new Board of Record Study Agreement must be signed by the incoming and uploaded in the modified application e API cannot give department approval for his her own studies e You can grant and remove read access to other
45. he Languages button on the General tab 3 Click Add to add another language to the list Make sure the desired language is at the top of the list 4 Restart the browser To change the date format in Firefox Windows 1 Choose Options from the Tools menu 2 Click the Advanced icon and choose the General tab 3 Click the Choose button to select the desired language 4 Click Add to add another language to the list Make sure the desired language is at the top of the list 5 Restart the browser To change the date format in Safari Mac OS X 1 Choose System Preferences from the Apple menu and click Date and Time 2 Click the Open International button 3 Set the language with the desired format at the top of the languages list 4 Verify that the desired format appears on the Formats tab If it does not switch the Region or click the customize button to modify the format 5 Restart the browser Ontario Cancer Research Ethics Board Page 42 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 9 5 2 Changing the Date Format in Windows amp Control Panel Sele gt File Sdt View Favorites Tools Help Baci ka ES Search E Folders PE e Go Address D Control Panel v4 Control Panel x Pick rs category D Switch to Classic View Wi ee Appearance and Themes Printers and Other Hardware See Also 3 a a From the Starf menu go to the
46. he revised application with your PI response Alternatively you can attach and send them in a regular email to the REB Coordinator Owner of your study If the items are sent by email the REB Coordinator will upload them to the contingency area and change the contingency to completed This now will allow the approval to be issued Because the REB office cannot modify your application this is where you find any contingency documents it they are received separately from your application Ontario Cancer Research Ethics Board Page 21 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 4 4 Tracking the Progress of the Application A unique feature of the OCREB Online system is that you can easily track the progress of your application through the entire ethics review process If you look at the top left hand side of the Study workspace highlighted in yellow is the current State your application is in For example before you submit the study the state of your application is called Pre Submission After you submit the study it will change to REB Administrative Review and to REB Staff Review once assigned to an REB Coordinator Upon submission the State changes from Pre Submission REB Administrative Review You can track the progress of your application by viewing the State column on My Home page Filter by iD Go cles Advanced SmartForm la Date Modified Ow
47. hem permission to update the Researcher Profile add the PI to new ethics applications to create an ethics application to add or remove study coordinators from individual studies and to submit post approval applications e g amendments on his her behalf The Researcher Profile link on My Home page links to the PI profiles Select Edit Researcher Profile to make changes Select Printer Version to view or print the full profile Complete the profile fields and upload the Pl s most current CV Select relevant study coordinators from a pop up list to add to this PI s profile Press Finish to complete Ontario Cancer Research Ethics Board OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 Test Study Coordinator OCREB Studies Centres Researcher Profile issues amp Support Researcher Profile A ocreb d Development OCREB Studies Centres WT digdsGoulcn Issues amp Support Test Principal Investigator 1 s Profile SM Edit Researcher Profile ee E Date Created 1423 2009 11 06 AM Printer Version Date Modified 2 1 2011 6 52 PM ump lo 2 0 Investigator Information v Basic Profile Information Test Principal Investigator 1 Please upload your CV here Browse view Delete Medical License Number 42444042 How long have you been conducting research as a Principal Investigator PI Name 1 lt 1 year Save Exit Hide Show Errors Print Jump To
48. i History Attachments Change Lag 2 Edit Email List This area shows instructions and questions and important notifications regarding this Study Edit Guest List Activity Author Activity Date Created Study Smith John 03 02 2011 10 46 PM GMT 05 00 El Send Email to PI El Send Email to REB Staff Wd ei b La Initial Ontario Cancer Research Ethics Board Page 18 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 4 1 3 Finalizing the Provincial Application The study will remain in My Action Items until it is submitted Select Fi Application tg open the application and make edits at any time prior to submission Once you are back in the application select Eege continue section by section or use the YMP T9 11 Study Identification menu to go to a specific section or sections These two options can be found at the top and the bottom of the application As you Continue from page to page an error message will appear if any of the mandatory questions on that page have not been answered Could not update the Initial Submission due to one or more errors Please review the page and correct any errors REMEMBER that using the Jump To menu will override the SmartForm feature that shows or hides questions as applicable to your study For example if the collection of biological specimens is included in your study selecting Biological Specimens in the Research and Metho
49. ial Study This is accessible from a variety of places including Researcher Profile Studies page and My Home page You must complete and Save 1 the first page of the application form before the study record is created When you are finished with the current page select Continue 2 to move to the next page Questions marked with a red asterisk are mandatory You will not be allowed to continue to the next page unless these questions have been answered However at any point after the study is created you can Exit and come back to work on it later by selecting e Edit Application from the study workspace A ocreb i John Smith My Home Logoff 02 Home Studies Centres Researcher Profile Issues amp Support Dept Div Approvers Study Staff Create Provincial E New Provincial Study Quick Links Consent Forms Page for Demo Principal Investigator Welcome to your Personal Folder the central resource s your applications or managing your applications Use the following guidlines to proces e Process all submissions in your Inbox Items appearing here require immediate action by you to speed your submission through the review process Click on link to process an item The system will automatically notify you when action is required by you Monitor the progress of your submissions using the other tabs Items on these tabs do not require any action by you USCH My Studies My Amendments My Renewals My
50. ill be under the Letters tab f GC Gan The provincial ocreb Staging documents will appear in the provincial ie Project Properties oee O L Submission Susy a ESTIS Centren Beseacher Profile suen E Sapin the centre application Select View to open and save the consents wallet cards etc on your computer You can also access the documents directly from the Provincial Study workspace by selecting View Application and using the Jump To menu to go to the appropriate section s Make any administrative and pre approved changes for use at your centre Ontario Cancer Research Ethics Board Page 31 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 5 1 7 Centre Application or Provincial Application Where am I The Provincial and the Centre Studies will have the same name which might seem confusing at first Think of the Provincial Study as the parent and the study name as the parent s last name Each Centre Study becomes a child with the same last name NOTE Name in this system is the sponsor protocol number There are many different ways to tell if you are in or accessing the provincial application study or the centre application study As a provincial applicant you will see the same study listed more cr My Studies than once in lists of studies The peeji all Z io aavancea D Name Smanronm C Date Modified Owner Appication Typa Review Type Fi Expirati
51. isplay A ocreb Staging Submit a Question or Comment Shon Question Tithe enie wari iri OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 Our most frequently asked questions about the O2 Demo Principal Investigator 1 My Home Page 38 of 43 Lc 8 Application States Anyone with access to O2 can monitor the progress of an application by viewing the current state of the application The state changes as the application moves through the ethics review process Below is a table of many but not all of the possible states and a description of the state The application has been created by the Study Staff but not submitted to the REB In this state Study Staff can continue to edit the application The application has been received by the REB office and is under review by the Intake Coordinator Study Staff can no longer edit the application The REB Coordinator reviews the application and sends it back to the Study Staff for changes or assigns it to a meeting if full Board review required or toa designated REB member if it meets the criteria for expedited review as applicable The REB Coordinator identifies concerns during review of the application and sends it back to the Study Staff to edit and resubmit The modified application is under review by the REB Coordinator responsible for the study Owner The application has been assigned to an REB
52. ity button you can send an email outside the O2 system using your institutions email system e g Outlook or you can simply call the PI or tell the PI in person that the study is ready for him her to submit Ontario Cancer Research Ethics Board Page 19 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 4 2 Submission PI Only Only the PI has the authority to submit an initial provincial application The PI must login and locate the study in My Action Items on his her home page and select the study Name to open up the provincial study workspace The PI can review the application by viewing the Printer Version or review and edit Edit Application When ready the PI selects Il H the application by selecting If the application is incomplete an error message will list all questions that are incomplete Selecting the link in the Jump To column will take the PI directly to the application page in question The PI will not be terribly happy if this error message pops up at this stage Error Warning Messages Message Field Name Jump To This is a required field Funding Type 1 2 Funding Information therefore you must provide a value This is a required field Investigator Initiated Study 1 2 Funding Information therefore you must provide a value This is a required field Funding from USA DHHS 1 2 Funding Information therefore you must provide a value This is a re
53. ize to choose your own e formats English Canada Select English Canada from the drop down menu Select Apply Restart the computer Number 123 456 789 00 Currency 123 456 789 00 Time 6 28 57 PM Short date 45 02 2011 Long date February 15 2011 SEN Location To help services provide you with local information such as news and weather select your present location Canada Ontario Cancer Research Ethics Board Page 43 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21
54. l with a link to the study The study will be located under your My Action Items tab which means it now requires action by you At this point it is opened again for you to edit A contingency will always be set for the Board of Record Study Agreement because the OCREB authorized signature is always pending at the time of submission To view the contingencies from the Study workspace select the Attachments tab and scroll down to Attached Documents Other Note that the Date Completed column is blank until the REB Coordinator sets the contingency as completed Attached Documents Other te Date fompleted Created Contingencies View Board of Record pending 06 02 2011 Agreement at the Centre level ee ae ET Name Version Modified Description PP R ge There are no items to display OCREB Recommended Consent Form Name Version Modified Description Changes There are no items to display PI Response S27 JI Moalied Description The REB office will upload the fully executed Board of Record Study Agreement i e containing the signatures of all three parties to the Agreement to the contingency area and change the contingency to completed This will allow approval to be issued Because the REB office cannot modify your application this is where you can access a copy of the fully executed Agreement should you need to download a copy Alternatively you can give your contracts office personnel access to the study lf a provincial ame
55. lication back to you to edit as applicable If the application is sent back to the Study Staff you and the PI will receive an email with a link to the study The study will be located under the My Action Items tab which means it now requires action by you At this point it is opened up for you to edit A contingency is an item that was not included at the time of initial submission but must be submitted before approval can be issued The Health Canada authorization e g NOL ITA NHP the study budget and the Clinical Trial Registration number are all possible contingencies for provincial initial applications To view any contingencies from the Study workspace select the Attachments tab and scroll down to Attached Documents Other Note that the Date Completed column is blank indicating that these items must be received by OCREB before approval can be issued Attached Documents Other Date Date Completed Created View Health Canada 1 26 2011 Contingencies NOL ITA NHP View Clinical Trial 1 26 2011 Registration View Study Budget 1 26 2011 Type Description Name Version Modified Description There are no items to display OCREB Recommended Consent Form Name Wersion Modified Description Changes There are no items to display Mame Version Modified Description PI Response P There are no items to display To submit these outstanding items upload them to the application if they are available at the time of submitting t
56. llowed at a time This means that one Amendment must be processed completely approved rejected withdrawn before another New Amendment can be created However one amendment can include multiple changes If a renewal application is open you will not be able to create a new amendment From the Studies page or My Studies Z ocreb Staging tab open the approved Provincial Study ee and select New Amendment e Propp mi atersakermg E pour box He EE gem EE Ee Applicant can create and submit provincial zen amendments An amendment has 3 steps ocreb Staging 2 ocreb Staging 1 Complete a New Amendment form Select Full Amendment or Administrative amendment or both and Finish An amendment number is assigned A ocreb Staging The Study now is considered to be ee ERIE E Ph Edit Modified Study sich to update the application with the amended information This includes uploading new versions of any updated documents modified 3 Submit the amendment 0 S Amendments are submitted from the amendment workspace The Study should always reflect the most current information After a new amendment is created You must Edit Modified Study to make all changes associated with the amendment in the application The original and all subsequent approved versions of the application are accessible in the Amendments tab of the Study workspace Ontario Cancer Research Ethics Board Page 33 of 43 OCREB Online User Guid
57. ments renewals reportable events and study closures 1 2 Accessing the System To access the live O2 system go to https ocrebonline ca Review the Terms and Conditions for restrictions on and authorized use of O2 and for privacy security and confidentiality details 1 3 Technical Details e O2 is best viewed on Microsoft Internet Explorer version 7 or higher recommended e O2 will also work on Mozilla Firefox Apple s Safari Mac and Google Chrome e Sun Java will be required for downloading files from O2 which can be obtained from www java com en If you have firewall or downloading restrictions you may need local IT assistance to download this onto your work computers e O2 uses pop ups and multiple windows You will need to allow pop ups for the O2 website so that these windows are not blocked e The display of system generated date fields is dependent upon the settings on the computer that you are accessing the system with as well as the browser you are using See page 42 1 4 Sandbox Practice Area Users can familiarize themselves with O2 in the Sandbox at htips o2 staging oicr on ca The Sandbox is a practice environment where users can test drive the system without using real data Contact the O2 Help for a user name and password for the Sandbox 1 5 O2 Help e Submit issues or questions via the Issues amp Support page from within the O2 system e Email ocrebonline oicr on ca or e Phone 647
58. n tems My Studies My Amendments My Renewals My Reportable Events SmartForm Date Modified Owner State z Application Type Review Type PI Expiration Date HO ZC AT d M eu If there are more items than can be displayed on one page a bar at the bottom of the page will show the total number of items in the entire list as well as how many items are displayed on the current page M d 1280852 gt Hl To go to the next page select Select H to go to the last page 3 2 Navigation Bar The navigation bar is visible no matter where you are in the system with links to 1 O2 Home takes you to the OCREB Online home page without logging you out 2 Studies links to a page listing all provincial and centre studies that you are associated with 3 Centres links to your centre profile page that includes a list of staff at your institution in the system a list of all of the studies your centre is participating in and other centre specific items d Researcher Profile links to your researcher profile if you are a Pl or to a list of Profiles for all Pls that you are linked with if you are a study coordinator See page 7 for details 5 Issues amp Support links to a page where you can submit questions or issues to the OCREB Online team and access User Guides and Frequently Asked Questions FAQs Ontario Cancer Research Ethics Board Page 11 of 43 OCREB Online User Guide for Study Staff Complete Version 1
59. ndment 1 From the Provincial Study workspace create a E l Provincial New Amendment form Select 1 1 Administrative Amendment General Information Administrative Amendment and then select Change in Provincial Applicant from the Type of administrative change a options You will almost D Please select the type s of administrative change s you wish to make certainly need to select Study Staff Changes to A change the Study Coordinator to the Provincial Gerd Applicant s centre as well Adding a Centre to the Provincial Application Change in Sponsor contact information Correction of typographical or grammatical errors specify below This step IS the same aS it IS with any amendment Change in CRO contact information RED KI entres Researcher Profile ssues amp SUPPO 2 Once you Finish the amendment form you will exit Current State Provincial Amendment Carlo Fidani to the Provincial Amendment workspace You now DSS Amendment 1 for OCREB Study TES must Edit Modified Study to make the changes Tj ea amenamem 11 P emie Investigator 2 directly in the application form to reflect the new Print Frienaly amendment Amendment Ame1_Pro00000879 Provincial Applicant PA and new Study Staff if derer EE i CD Edit Modified Study applicable eessen Changes made in List of Changes this Amendment Change in Provincial View Changes Applicant This step is the same as it is with any amendment My Activi
60. ndment is in progress depending on the timing i e where the amendment is in the review process your centre approval may include newly approved provincial documents that were not approved at the time you submitted your application Ontario Cancer Research Ethics Board Page 30 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 5 1 6 Accessing Centre Approval Letters and Approved Documents You will receive an email notice when your centre application is approved The email will contain a link to the Centre Study workspace where you can access the approval letter ocreb Staging Sue TTE D Heme Studies Contes Herenichar Profile heuri amp Support DECHE Page for Demo Study Coordinator 1 Access the approval i e Welcome to your Petsonal Foldet etter by se ecti n g My 2pudh sen a Brocess all submissices e yout Inbox ees appearing here require imediate aclion by you io speed yow submission through ihe rppguw process Chek on link to process an fem Thi H s 5 Monitor the progress of pour submissions wing the other tabs hems on thasa tabe do not regui any action by you tu ies rol l y ome Create Provincial E iem Provinciat Study page and locating the Ze wl Hmmm mmm mmm Approved Centre study se Fee m al leen Hama regio Lade Ma died Denger SG Stale Apel Type Hiei ype Fl Expiration Dale Select the relevant study to go to the Centre Study workspace The letter w
61. ner State wll 05 02 2011 4 51 REB Assigned PM Coordinatoy To REB 7 Meeting ID Name pplication Type Review Type Pl Full Board Smith Review Expiration Date rovincial G Prooo000080 SST 01 TRAIN or in the State column on the Studies page Demo Principal Investigator 1 My Home Logoff A ocreb Other Submission Types gt Amendments Studies gt Renewals View all studies by In Progress Approved and Closed groupings Use the My Home link in the top right hand corner of your screen to see the list of submissions related to you gt Reportable Events Create Provincial E New Provincial Study Provincial In Progress Provincial Closed Filter by iD Jl ES Clesr Advanced Provincial Approved Provincial All Studies ID Name SmartForm 4 Date Modified State Review Type Provincial P Expiration Date G Pro00000008 DEMO 2c fy 27 01 2011 2 41 PM Approved ull Board Review Principal Investigator 2 27 01 2012 oF Pro00000016 DEMO 3c fu 28 01 2011 2 56 PM Approved ull Board Review Principal Investigator 3 28 01 2012 G Proo0000022 DEMO_4c fy 31 01 2011 10 12 AM Approved ull Board Review Principal Investigator A 31 01 2012 G Pro00000033 DEMO Sc P 31 01 2011 3 24 PM Approved ull Board Review Principal Investigator 5 31 01 2012 oF Pro00000057 DEMO_19 P 01 02 2011 1 45 PM Approved xpedited Principal Investigator 19 31 01 2012 oF Pro00000003 DEMO jr fyi 03 02 2011 9 30 AM Approved ull Board
62. nization in the m irst Organization fi elds in any appli cati on form th at Frincipal Investigator 1 Demo Demo Centre 1 have access to and can edit this application and will receive ask you to Select a person choices with similar names will appear for you to select from Frincipal Investigator 13 D emo Centre 13 You also may Select and choose Principal Investigator 14 D emo Centre 14 from a full drop down list Principal Investigator 15 D emo Centre 15 Principal Investigator 16 D emo Centre 16 Principal Investigator 10 Demo Centre 10 Principal Investigator 11 Demo Demo Centre 11 Principal Investigator 12 D emo Centre 12 3 to and ability to edit the REB materials for this study Principal Investigator 17 D emo Centre 17 DCREB approved study e g is a sub study or companion Principal Investigator 18 D emo Centre 18 t0 a pilot study provide the study title and protocol number 5 0 Study Co ordinator or Assistant this person will have access to and can edit this application and will cet all notifications for this study Select the main study coordinator Demo Study Coordinator 1 SE EE who will receive all notifications related to the provincial study e Other Study Staff at this centre requiring access to and ability to edit the REB materials for this study Add any other Study Staff members requiring access to the provincial study including the ability to submit amendments renewals or reportable events These additional sta
63. o select Show Advanced Options SES and write the DasSSwoO rd in the Descri ption If not provided the name of the Required file will be used field Browse Po You should now see the uploaded document s and the version date s Select Update to correct the version date If you have uploaded the wrong document select Delete and then Add to upload the correct document If you do not enter a document name in the Title field the File name will default to the name you gave to the original document This means that if you have already clearly named your documents you can skip entering the Title field in the upload procedure Save Exit Hide Show Errors Print Jump To 4 3 Consent Forms amp Other Study Participant Materials 4 3 Consent Forms amp Other Study Participant Materials 1 0 Upload all consent form s here MS WORD ONLY OCREB strongly recommends downloading the applicable consent form templates i e main study genetic research etc and modifying where necessary Version Date Update Main Study Consent Form January 13 2011 Update Optional Tissue Consent Form February 4 2011 Please upload any other materials that will be distributed to study participants Sal Hame Version Date There are no items to display Save Exit Hide Show Errors Print Jump To 4 3 Consent Forms amp Other Study Participant Materials Ontario Cancer Research Ethic
64. on Date Application Type column will of Proooooooeo rn TRAN H 080212011 1016PM_ Szeen Test Approved 3 n show which one is Provincial and 00000 nn ee ese EEN Cet Run which ones are Centre My Amendments My Renewals My Reponable Events Demo Study Coordinator My Home Lo When you link to a Provincial Study through a Provincial tab on the Studies page you will see Provincial Study in the Project Properties ntres Latest Submissions Study Staff Provincial Study workspace eagles 7 under the Project Properties ae gt Provincial Study Demo Centre tab FE view Differences Protocol ID SST 01 TRAIN A ocreb Stag f ng Demo Study Coordinator My Home Log AA Ae e sues E wes through a Centre tab on the Studies page you will see REB Staff Review eaS Project Properties Centre Study in the Centre Fa view appnicaion Printer Version Centre Study gemo Centre Study workspace under the Ss apy mitt Project Properties tab BEER Fee Principal Investigator John Smith Study Coordinator Demo Study Coordinator My Activities Date Submitted 05 02 2011 Review Type Expedited NANPDED Caardinatar Tact DER Coordinator 9 Centres D A ocreb Stag I n g Demo Study Coordinator My Home Log If you see the study name twice in the crumb trail you are in the Centre Study workspace Project Properties Centres fay
65. ontact the OCREB office if you will be ioe conducting the study and your centre was not included in the provincial application You must complete and Save the first page New Initial Submission before the study record is created and a Sms sam DN unique identifier assigned Select Continue to move to the next page Questions marked with a red asterisk are mandatory You will not be allowed to continue to the next page unless these questions have been answered 0 Provincial PI Name Provincial Centre Name Centre Principal Investigator Add any other Study Staff members requiring access to the application including the ability V Study Coordinator or designated contact his person will have access to and can edit the REB application for this study at this centre will be able to submit to su bm it amend m ents renewals or mendments renewals and Safety updates and will receive all notifications of REB activity related to this submission reportable events or those who need read access only These additional staff will not receive the notifications SS Save Print For initial centre applications only you must down list If the Pl is the primary Department Approver a delegate must be selected 1 1 of 1 If the primary Department Approver is absent a Last First Organization select the delegate Approver Ensure that 7 Department Head Demo Demo Centre Approver selected is the appropriate Approv
66. quired field Funding CRO Involved 1 2 Funding Information therefore you must provide a value This is a required field Previous REB review 1 5 Study Locations and therefore you must provide a Other Reviews If application is complete the Provincial Applicant PI Agreement window will appear Check off the box in the bottom left hand corner before selecting OK to submit the study This serves as the official Provincial Applicant PI signature Once submitted the study moves out of My Action Items and Study Staff can no longer make any changes Submit Study PROVINCIAL APPLICANT INVESTIGATOR AGREEMENT e attest that this application as submitted is in compliance with the Tri Council Policy Statement ICH Good Clinical Practice Consolidated Guidelines Division 5 Canadian Food and Drug Regulations and the applicable laws and regulations of Ontario attest that the information in the application is complete and accurate to the best of my knowledate attest that this application contains the current and complete protocol including and sub studies am aware the the OCREB review materials i e provincial application form correspondence between the PI and OCREB approval letter will be shared with all Ontario sites participating in this study As provincial applicant acknowledge that am responsible for reporting to OCREB any proposed modifications or amendments to the protocol all external non local SAEs and updated Investig
67. r workspace in the system My Roles which allows you to toggle between user roles by selecting the applicable user role if you have more than one role A E new Provincial Study l activity button which will open a new Provincial application to allow you to prepare to submit a new study This button is available from most pages and workspaces My submission tabs which display items requiring action by you My Action Items and other tabs where you can monitor the progress of your studies and the different types of submissions related to your studies details on page 9 My submission tabs show only those studies and their related submissions that you are directly involved in Quick Links for example to OCREB templates A ocreb John Smith My Home Logof 02 Home Studies Centres Researcher Profile Issues amp Support Page for Demo Principal Investigator Welcome to your Personal Folder the central resource or managing your applications Use the following guidlines to Kees process your applications Dept Div Approvers Study Staff e Process all submissions in your Inbox tems appearing here require immediate action by you to speed your submission through the review process Click on link to process an item The system will automatically notify you when action is required by you Create Provincial e Monitor the progress of your submissions using the other tabs Items on these tabs do not require any action by you
68. racts 1 0 Study Personnel amp COl Centre 2 0 General Study Information Centre 3 0 Recruitment amp Consent Centre 4 0 Budgets Cost amp Feasability Centre 5 0 Data Privacy Confidentiality amp Security Centre 6 0 Contract Centre Application Completed OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 Provinc Provinc Provinc Centre Centre Centre Centre Centre Centre Provincial and Centre Complete a a a a a a Not Requ Not Requ Not Requ se Complete Complete Complete Complete Complete red red red Incomplete Page 27 of 43 5 1 3 Submitting the Centre Application Principal Investigator Only Only the PI has the authority to submit an initial centre application Review the application by viewing the Printer Version You may review and edit the application by y Edit Application selecting a When you are ready f Gs submit Centre Study lf the application is incomplete an error message will list all questions that are incomplete Selecting the link in the Jump To column will take the user directly to the application page in question lf the application is complete the Investigator Agreement window will appear Check off the box in the bottom left hand corner then select OK to submit the study This serves as the official PI signature Once submitted
69. re almost always at the Provincial Study level only However there are occasions when centre specific amendments are appropriate e g change in Centre PI From the Centre Study New Amendment _ workspace select NSW Amendment and proceed with your centre amendment submission Access amendments from Latest Submissions Study So the Amendments DE submission type on the Studies page from the Amendments tab in the Provincial Study workspace or from the My Amendments tab on My Home page Once a study is amended all subsequent amendments will be found in the ma See Bee D amendment workspace re Anni 1 OCREB Sty FEM along with the originally approved application Ontario Cancer Research Ethics Board Page 34 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 5 2 3 Amendments Involving a Change in Provincial Applicant and or Centre PI Amendments involving a change in the Provincial Applicant or in the Centre PI are slightly different If your Centre PI is also the Provincial Applicant PA and you need to change both eg PI has left your centre you must change your Centre PI through a full Centre Amendment first Once the Centre Amendment is approved submit an Administrative Provincial Amendment to select your new centre PI as the new provincial applicant 5 2 3 1 Change in Provincial Applicant PA A change in Provincial Applicant PA is considered an administrative ame
70. s Board Page 16 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 The application forms are designed to show or hide questions as they apply to your study SmartForms Using the Jump To menu to navigate from page to page as you work through the application instead of Continue will override this feature However using the Jump To menu is a very good way to come back to a page that your were previously working on We strongly recommend that you use the Continue button to move to the next page when you are filling in the application A ocreb Edit Initial Submission Pro00000080 lt lt Back Save Exit Hide Show Errors Print Jump To 4 3 Consent Forms amp Other Study Participant Materials A 1 0 Study Identification Funding ALe 1 1 Study Identification 4 3 Cons i 1 2 Funding Information 1 30 Contact Information 1 5 Study Locations and Other Reviews Uplq con 2 0 Study Objectives amp Design 2 1 Study Objectives amp Design Upd 3 0 Research Methods and Procedures Plea 3 1 Research Methods and Procedures 2 3 7 Clinical Trial 4 0 Study Population Recruitment and Consent L A 4 Sich Daniulatinn Save Exit Hide Show Errors Print Jump To 4 3 ConsentForms amp Other Study Participant Materials Because each type of submission eg initial provincial initial centre amendment reportable event is issued a different sy
71. ss lt i lt SO Page 308 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 1 About OCREB Online OCREB Online O2 is a transparent secure web based system designed to automate and streamline the preparation submission and review processes for ethics applications submitted to OCREB by institutions in Ontario authorized to use OCREB Ethics applications for new studies and post approval applications such as amendments renewals study closures and reportable events e g local SAEs safety updates DSMB reports protocol deviations are submitted via the online system by the principal investigator or by the designated study team member Applications are prepared using smart forms which dynamically show or hide questions depending on the applicability to the study The system automatically prompts for missing information thereby ensuring that submissions are complete before submission 1 1 Intended Audience This guide is intended for applicants to OCREB in particular study coordinators and principal investigators Pls It also contains information for department approvers The guide provides users with useful information on the overall OCREB Online system as well as how to navigate the system and how to submit and track submissions to OCREB The guide is structured so that if follows the most likely order of submissions new provincial initial study application initial centre applications amend
72. stem generated number a standard OCREB number will be assigned to the overall project file The format will remain the same as the current numbering system i e the first two numbers of the current year followed by a 3 digit number e g 11 001 Until this process is automated please call the OCREB office 416 673 6649 for your OCREB number before completing your application Enter the assigned OCREB number in the application in the relevant question A column displaying the OCREB number will be added to every submission listing view Ontario Cancer Research Ethics Board Page 17 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 4 1 2 Study Workspace When you Finish or anytime you Exit the application you end up in the Study Workspace 1 State displays where your application is in the ethics review process The state name will change as the application is routed through the review steps You can monitor the progress of your study by looking at its current state Edit Application takes you back to the application to make edits any time prior to submission View Smartform Progress displays questions in the application as complete or incomplete My Activities shows all activities that you can execute in this state e g Pre Submission Activities will change as the state changes with the various steps of the review process e Submit Study is only available to the PI for initial pro
73. ted By The History tab will display the history of all changes made to your centre profile the date the changes were made and by whom Select the appropriate tab to view the relevant information C Modify Centre Policias Carlo Fidani Cancer Centre s Profile 123 TEST st Address Unite 123 Toronto ON MiRZIG Centre Policies Approved Consent Form Changes Studies Provincial Studies Created By Histon E Mail g testirgokT on ca o 1 O2tEStINAOICT Cup Ca ottesting aicr an Ca o testinjoicr on ca Principal Investigator 2 eo O2testingghoicr on ca Principal Investigator 5 m Study Coordinator 2 diana auEDekT on ca LE UI UI HI UI UI UI ul rE rt r r er r j Study Coordinator 2a O2testingghoicr on ca user registers regussar cam Are you ready to dive in and prepare a provincial submission Ontario Cancer Research Ethics Board Page 13 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 4 Initial New Provincial Study 4 1 Presubmission Before you begin prepare your submission documents protocol IB and or PM study budget consent forms NOL if available other patient materials etc You will be directed to upload these documents at appropriate places in the application Clearly name and organize them in an easily accessible area somewhere on your computer or local network To start a new provincial application select New Provinc
74. ties Ferd Submit Amendment Change Provincial Applicant Se f gt Change Provincial Select the Centre PI to become the Provincial Applicant 3 EXTRA STEP select the ae C a Principal Investigator 20 Demo Centre 20 activity A Change in Provincial Applicant Window ee will appear with a list of Pls at all of the centres that EE Wa eminder Please do not submit this amendment After making your selection here the new applicant are participating in the study Select the new PA will then have to accept the position and submit the amendment to complete the process from the list The new PA will receive an email notice orl Cancel el ocreb 4 EXTRA STEP The incoming PA must login and SE gt Accept Provincial Applicant Position pp Submit Amendment 5 DIFFERENT STEP the incoming PA must to officially accept the role Ontario Cancer Research Ethics Board Page 35 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 5 2 3 2 _ Change in Centre PI The centre amendment workspace will display an activity to Change the Centre PI The process for changing your Centre PI is similar to changing the Provincial Applicant except that a change in Centre PI is done from the Centre workspace and it is considered a full amendment During the review process the REB Coordinator will need to remove the outgoing Centre PI from the provincial list of participating centre Pls and a
75. ttachments Letters B k Last Issued Letter View Activity Description Author Activity Date study Approved REB Chair Test 27 01 2011 2 40 PM GMT 05 00 i View Correspondence Letter Ontario Cancer Research Ethics Board Page 25 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 5 Post Approval Activities Once a study receives provincial approval all follow on L New Reportable Event missions ar nsider approval activities Th sub ssions are co side ed post approval activities These E New Centre Studay New Centre Study include submissions of provincial amendments reportable events and renewals or submissions of initial centre applications Pi New Amendment reportable events and renewals New activity buttons will appear 7 in the appropriate workspaces for relevant activities iA New Continuing Review 5 1 Initial Centre Application New Centre Study Once a provincial application is approved all A ocreb Staging centres listed as participating are Centres Researcher Profile Issues automatically notified Select the link in the email or Studies in the navigation bar to open the relevant provincial study You can View Application to view and the application and access all attached documents Sege In the provincial study workspace select E Gd E New Centre Study spo Latest Submissions Study Statt Study Title to create your initial centre application C
76. tudy must be in the Approved state before centre reportable events can be submitted A ocreb Staging naxx From the Provincial or Centre workspace as applicable submit centre or provincial reportable 414 Reportable Event Wormalln events by selecting i Hew Reportable Ewent A Reportable Event Information form will appear Once it is saved the reportable event is created and a unique number is assigned Select Continue to complete the ocreb Staging e NR reportable event form Different wb sunatan comptes questions will appear depending on the type of reportable event 1 2 Safety Update 10 Type of safety update C ita amp ateiy amd M A reportable event workspace is created Access reportable events from the Reportable Events submission type on the Studies sal page from the Reportable Events DEE report tab in the Study workspace or ID Name SmartForm LG Date Modified Owner State Study PI Reportable Event Type from the My Reportable Events ry 06 Pre Pro00000080 Smith Safety Update e g DS Event PM Coordinator Submission report safety summary l tab on My Home page SST N1 A Tect IND artinn Near dn The local SAE form requests the system organ class SOC of the event and links to either the NCI Common Terminology Criteria for Adverse Events CTCAE v 3 0 or v4 0 for guidance on correctly naming the SAE Upload a copy of the sponsors reporting form signed by the PI in the appropriat
77. ve access to and can edit this application and will receive all notifications for his study Ontario Cancer Research Ethics Board Page 14 of 43 OCREB Online User Guide for Study Staff Complete Version 1 0 2011 Feb 21 Once you have created your study new menu options will appear and the top right hand corner of the screen will now display a unique identifier assigned to your application Menu options 1 Save saves your work and keeps you on the same page If any mandatory questions on that page are not yet answered you will not be able to save however you can Exit Exit takes you out of the application to the study workspace Hide Show Errors will display a list of mandatory questions that have not been answered Jump To is a drop down list that allows you to jump directly to other sections of the form Back or Continue will take you to the previous page or to the next page of the application a E Edit Initial Submission ProO0000013 Jump To 1 2 Funding Information Continue gt Under Study Locations amp Other Reviews select the centres Pls that plan to participate in the study obtain this information from the study sponsor You must add your own centre as a study location in order to be able to submit your centre application Full Study Title enter exactly as written in protocol This is the title for test study DEMO ja If you start typing the last name first name or orga
78. vincial and initial centre applications e Withdraw removes the study from REB review anytime after it has been submitted e Edit the Email List to add others in addition to the Hl and main study contact who should receive notices e Edit Guest List to give others read access to the study e Send Email to PI sends an email from the system to the PI s regular email address e Send Email to REB Staff sends an email to the REB office 5 Project Properties tab displays information about the study This information auto populates from the application form and upon completion of other system activities Centres tab shows a list of potential centres participating in the study 6 History tab displays an ongoing list of study activities some of the REB activities will not be displayed to study staff for confidentiality reasons 7 Attachments tab in one location provides a listing of and access to all documents that were uploaded to the application e wN P ocreb John Smith My Home Logoff OCREB Aitite Centres Researcher Profile Issues GIE OST TEEN Centres Provincial Study Demo Centre study S3STM 1 Pro00000080 Full Title Training materials for Study Staff Principal Investigator John Smith Study Coordinator Demo Study Coordinator Funding Sources Review Type JL Printer Version View SmartForm Progress My Activities E Submit Study Il Send For Sponsor Review 7 z

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