OCREB Online User Guide
Contents
1. 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 Ar RAR TSS SSS SS mr 1 ia FNO please contact ihe OCRES office Protocol number i e 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 have access to and can edit this application and will receive all notifications for his study Ontario Cancer Research Ethics Board Page 4 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 Once you have created your study 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 oh ly Jump To Save saves your work and keeps you on the same page 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 t2. 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 al Name 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 Ethics Board Page 6 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 The application forms are SmartForms which are designed to show or hide questions as they apply to your study 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 you were previously working on or to bypass a mandatory question that you are not ready to answer It is strongly recommended that you use the Continue button to move to the next page when you are filling in the application to avoid missing any mandatory questions and to trigger the SmartForm feature A ocreb Edit Initial Submission Pro00000080 lt Back Continue gt gt Save Exit Hide Show Errors Pri
3. to 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 rE all notifications for this study Demo Study Coordinator 1 Select Clear Select the main study coordinator who will receive all notifications 6 0 Other Study Staff at this centre requiring access to and ability to edit the REB materials for this study ED related to the provincial study Add any other Study Staff _ members requiring access to the provincial study including the ability to submit amendments renewals or reportable events Ontario Cancer Research Ethics Board OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 Page 5 of 21 2 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 non 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 gt yr the document if applicable and select Add again to upload Required K OK and Add Another Cancel Submit a Document This will open up another window Enter the title of the document and select Browse to OG sey sere es If not provided the name of the locate the document on your computer Select OK to upload the document to the _Browse _ appli
4. 38 PM Pre Submission Principal investigator 1 oF Pro00000002 DEMO_1b fr 03 02 2011 2 39 PM P Response Pending ull Board Review Principal Investigator 1 27 01 2012 y Prooo000006 DEMO _2a Py 03 02 2011 2 40 PM Pre Submission Principal Investigator 2 Ontario Cancer Research Ethics Board Page 15 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 2 5 Pl Response Pending 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 and the application is once again open to the Provincial Applicant and study staff for editing 2 5 1 Accessing the OCREB Review Letter When the REB review letter is issued the PI and main 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 from My Home page along with any other items requiring action by the study coordinator and PI 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 Corre
5. A ocreb OCREB Online User Guide Initial Provincial Application includes routing the application to the study sponsor and back Intended Users e Provincial Applicant Provincial PI Version 1 0 e Study Staff assisting with the Provincial Application e Sponsor or CRO Staff assisting with the Provincial Application Table of Contents 1 About OCREB Online sice cssescspsnctesiad eocuseietensucasnceceateneesensien evsuouepaedengsteuaaxeoeternunus eeocuaaesssseageesorseacteaednteseaeieens 3 jie ram Mende AUdONCO porna a oe ene ere eee eee ee ee ee ee eee eee 3 t2 PROCS SSC BN Ss By Se I aenn ters ace ateis enacted sansa E E EE A O E EAN 3 to TECNA DCIIS aree E E E E E E ES 3 TA OUPO a E E E E E E E nee nee eee 3 2 INtaNew Provincial SUY seisseen i a E ETa S N ia 4 2w Pe SUDNICE IOT nn e A aes NEEE EN A E EE ANE ENT N EE A 4 2i UpoddiNng DOCUMEN S aen E E E E E E E 6 ara OU NOK PO A E E E E E E E E T E E S 8 2 1 3 Routing the Provincial Application to the Sponsor or CRO in Pre Submission 9 2 1 4 Finalizing the Provincial AppliCation cccccccsssscccsssssececssssseceessseeecsesseeessssusesessseeeesseaeees 12 PA mne ONF ON Enema enn ence cee eee ene eee ee eee cee eee 13 23 0 9 419 2196 2 een ee een eee ene enn eee E E ee eer ee 14 2 4 Tracking the Progress of the AppliCatiOn ceccessccessssseccessseeccsssnseesssseeeesssseeeeeseseeseseeeeeeess 15 29 VERE SOON SS Pondi arioso are EE EEEE EE
6. amp Printer version E view SmartForm Progress My Activities F amp a Send For Sponsor l Review gt Withdraw Z Edit Email List Z Edit Guest List FE Send Email to REB Staff F Send Email to PI Z Edit Study Personnel Project Information Centres Provincial Study Credit Valley Hospital Study SPSR 001 Pro00001270 OCREB 12 100 Acronym Sponsor Review Full Title Preparing the training materials for routing the provincial applicantion to the sponsor Principal Test Principal Investigator Study Investigator 1 Coordinator Funding Sources Demo Sponsor Review Type Test Study Coordinator Attachments This area shows instructions and questions and important notifications regarding this Study Activity Author Activity Date K Submitted Sponsor Test John 02 03 2012 12 30 PM GMT Review 05 00 f Added CRO contact This responsibility has been delegated to the CRO The application should be routed to the CRO contact to assist in completing it Sent For Sponsor Study Coordinator Test 01 03 2012 5 03 PM GMT Change Log Initisl m Page 11 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 2 1 4 Finalizing the Provincial Application The study will remain in My Action Items until it is submitted Select E Et Application tg open the application and make edits at any time prior to submission Once you are back in the applicatio
7. EE 16 2 5 1 Accessing the OCREB Review Letter ccc cccssecssseessseeesssecesssecsseeeceeeesseeessseeessaeessaees 16 2 5 2 Accessing the OCREB Recommended Changes to the Consent Form s cc00 16 2 5 3 Preparing the Pl RESPONSE cccccsssssccessssseccessesecesssesecsesuseccsssessessesusecseseusecsessesseseesenses 17 2 5 4 Routing the Provincial Application to the Sponsor or CRO PI Response 06 18 Zee SUMNAR RE DOR O a E cee eee 20 2 5 6 Centre Application or Provincial Application Where am 1 ccecessceesseeeeseeeeeseeeens 21 Ontario Cancer Research Ethics Board Page 2 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 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 promp
8. al Applications Version 1 0 2012 Mar 10 2 2 Submission PI Only Only the PI has the authority to submit an initial provincial application The PI must log in 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 If an email was sent from the workspace the PI can use the link to be taken directly to the study workspace after login Review the application by viewing the Printer Version or review and edit the application by selecting S E Appiicauon When ready the PI selects Sum Stucy 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 required 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
9. cation Select OK and Add Another to al file will be used upload other documents or select OK until you return to the application form Required ok EN 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 No Title Windows Internet Explorer SE If the docu ment iS pas SWO rd protected you le https fo2 dev oicr on ca Dey_eREB ResourceAdministration Document FormForProperty postback 1 amp formID 08 b 4 must select Show Advanced Options and enter the password in the Description 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 Delete the document and then repeat the Add procedure to upload the correct document If you do not enter a document name in the Title field the Name will default to the filename 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 ConsentForms amp Other Study Participant Materials 4 3 Consent Forms amp Other Study Participant Materials
10. ce Workspaces are where you conduct your work or activities Workspaces are created for each type of submission and contain activity buttons that allow you to create view or work on submissions e g new provincial application post provincial approval activities such as amendments centre applications reportable events etc 1 State displays where your application is in the review process Monitor the progress by checking the current state which changes as the application moves through the review process 2 Edit Application takes you back to the application to make edits any time prior to submission 3 View Smartform Progress displays questions in the application as complete or incomplete 4 My Activities displays the 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 Send for Sponsor Review routes the application to the sponsor contact to allow them to assist in completing the application Submit Study is only available to the PI for initial provincial and initial centre applications Withdraw removes the study from REB review anytime after it has been submitted Edit the Email List to add others who should receive notices Edit Guest List to give others e g study monitors view only access to the study Send Email to PI sends an email from the system to the PI s regular email addres
11. cipal Test PI2 Study Test Study Investigator Coordinator Coordinator My Activities OCREB Test Ethics Coordinator Review Type Full Board Review H Withdraw Coordinator Select Submit Sponsor Review Edit Centre PI List Expiration Date 7 Feb 2013 Meeting Date 29 Feb 2012 to route the application back to the provincial applicant PI Fea Send Email to Study Contact Activity Author Activity Date a ee ne tE Sent For Sponsor Review Study Coordinator Test 05 03 2012 12 05 PM GMT ssigned To Committee Meeting 05 00 Attachments Contingencies ChangeLog Letters Submit Sponsor Review A Sponsor Review Sponsor Review Acknowledgement Acknowledgement window will When you have completed review of the application select OK to send the application back to the PI Study Coordinator for final review and submission appear Insert any notes or comments to the Pl Study Coordinator in the comment field below If the sponsor or CRO has edited Comments The appropriate edits have been made to the application form The revised the PI response letter it should consents have also been uploaded Please have the PI review the be uploaded in this window application for accuracy Select Add then Browse to find The revised draft PI Response Letter is attached below Please have the PI review the letter make any changes and sign it and upload the draft PI response Remember a signed _pdf copy of the letter must be attached at the time t
12. form should be uploaded directly into the application form Ontario Cancer Research Ethics Board Test Study Coordinator My Home Logoff A ocreb 02 Home Studies Centres ResearcherProfile Issues amp Support my Edit Application E printer Version E gt View SmartForm Progress Mv Activitiee Principal Send For Sponsor Send Fors Review Investigator C Withdraw Funding Sources Z Edit Email List Z Edit Guest List E Send Email to REB l gt Staff This area shows instructions and questions and important notifications regarding this Send Email to PI Study Z Edit Study Personnel DEMY Anah Activity Date e Created Study Study Coordinator Test 01 03 2012 4 23 PM GMT 05 00 Project Information Wuk Centres Provincial Study Credit Valley Hospital Study SPSR 001 Pro00001270 OCREB 12 100 Acronym Sponsor Review Full Title Preparing the training materials for routing the provincial applicantion to the sponsor Test Principal Study Investigator 1 Coordinator Review Type Test Study Coordinator Attachments Change Log Send For Sponsor Review Instructions e This form allows you to send the provincial application to the sponsor for review and completion of the application if required The sponsor will be notified when you submit this form e Use the box below to add any comments to the sponsor e Click the Ok button to send this application to the spo
13. he letter The PI must sign the PI response is submitted to OCREB Thanks review letter Select OK to route the application back to the provincial applicant PI and study staff A ocreb Test Sponsor My Home Logoff 02 Home Studies Centres Researcher Profile Issues amp Support The State will change back to PI Response Pending and the provincial applicant and study Ena e Provincial Study Credit Valley Hospital staff can once again edit the El view Appiicat apinn Gi application The sponsor and gt sintlinateoni Acronym CRO now will have view access Full Title test for sponsor Principal Test PI2 Study Test Study on y Investigator Coordinator Coordinator gt Withdraw OCREB Test Ethics Coordinator Review Type Full Board Review Coordinator 1 Edit PI The cycle of routing the Ca E a Bes Expiration Date 7 Feb 2013 Meeting Date 29 Feb 2012 application to and from the 1 Send Email to Study Contact sponsor or CRO contact can be OS repeated as needed Attachments Contingencies ChangeLog Letters Activity Author Activity Date K Submitted Sponsor Sponsor Test 05 03 2012 12 47 PM GMT Review 05 00 f The appropriate edits have been made to the application form The revised consents Ontario Cancer Research Ethics Board Page 19 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 2 5 5 Submitting the PI Res
14. he form Back or Continue will take you to the previous page or to the next page of the application Edit Initial Submission Pro00000013 1 2 Funding Information Continue gt gt Under Study Locations amp Other Reviews select the PI at every centre that plans 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 1a If you start typing the last name first name or organization in the m fields in any application form that hela ES asks you to Select q person Principal Investigator 10 choices with similar names will appear for you to select from Principal Investigator 13 You also may Select and choose Principal Investigator 14 from a full drop down list Principal Investigator 15 Principal Investigator 16 Principal Investigator 11 Principal Investigator 12 Principal Investigator 17 Principal Investigator 16 First Demo Demo lem E Organization Demo Centre 1 Demo Centre 10 Demo Centre 11 Demo Centre 12 Demo Centre 13 Demo Centre 14 Demo Centre 15 emo Centre 16 emo Centre 17 emo Centre 18 have access to and can edit this application and will receive to and ability to edit the REB materials for this study DCREB approved study e g is a sub study or companion
15. ion select OK to send the application back to the Pl Study Coordinator for final review and submission Insert any notes or comments to the Pl Study Coordinator in the comment field below Comments A ocreb 02 Home Studies Centres ResearcherProfile Issues amp Support PSOR Jt JT John Test My Home Logoff h aed WLU AOGE euE Centres By view appiication Bescon Printer version Provincial Study Credit Valley Hospital Study SPSR 001 Pro00001270 OCREB 12 100 H View SmartForm Progress Acronym Sponsor Review R Full Title Preparing the training materials for routing the provincial applicantion to My Activities the sponsor 2 Withdraw Principal Test Principal Investigator Study Test Study 7 Edit Centre PI List Investigator 1 Coordinator Coordinator Funding Sources Demo Sponsor Review Type 1 Send Email to Study Contact Initial Gws A Attachments Change Log This area shows instructions and questions and important notifications regarding this Study Activity Author Activity Date K Submitted Sponsor Test John 02 03 2012 12 30 PM GMT Review 05 00 Added CRO contact This responsibility has been delegated to the CRO The application should be routed to the CRO contact to assist in completing it A ocreb Test Study Coordinator My Home Logoff 02 Home Studies Centres ResearcherProfile Issues amp Support m Edit Application
16. l The application will be sent to the following sponsor for revie assist with the responses eee TA Hello John Please assist in revising the application as per the OCREB review Remember to copy and paste the letter and as discussed have attached the draft PI response letter below It py p includes the OCREB questions and the draft responses Please revise these as REB questions from the review appropriate and attach the revised letter when you return the application to me letter into the response letter so Thanks that the questions and responses are in one location Select OK to send the application to the sponsor or CRO The state Bostnents will change from PI Response Pending to PI Response Pending Sponsor Review The provincial applicant PI and study staff will have View access only to the application until the sponsor routes it back Ontario Cancer Research Ethics Board Page 18 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 A ocreb Test Sponsor My Home Logo 02 Home Studies Centres Researcher Profile Issues amp Support The sponsor or CRO contact Project Information selects Edit Application to Provincial Study Credit Valley Hospital revise the application form 10000 Pro00001263 OCREB including adding and removing jes Acronym Full Title test for sponsor documents e g consent forms Ze view birterences Prin
17. l contain a link to the consent forms containing the REB recommended changes Attached Documents Other The consent forms with the REB ae recommended changes also can be Contingencies NOL ITA NE accessed from the Study workspace Select the Attachments tab and scroll down to Attached Documents Other Pl Response h a are a Ontario Cancer Research Ethics Board Page 16 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 2 5 3 Preparing the PI Response To prepare the PI response create a letter on your local letterhead Remember to copy and paste the REB questions from the review letter into the response letter so that the questions and responses are in one location In addition to responding with a letter the relevant changes must be made 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 must sign the PI response letter BEATE Z Yeo C No Cloar INSTITUTIONAL LETTERHEAD 70 Are here any recrutiment malerialaT vee C No Chew li YES chock all that apply and attach below Washim Guar cia ot poole Ponie 20 2001 i Telephone call
18. mation _PlResponse Pending _ assist in preparing the PI ay aramon Provincial Study Credit Valley Hospital response i e application edits r 12000 ae cronym and responses to questions Be STN E Tito fi h h test for sponsor sure to confirm the contact wit Principal Test PI2 Study Test Study the sponsor or CRO My Activities Investigator Coordinator Coordinator Send For Sponsor OCREB Test Ethics Coordinator Review Type Full Board Review Review Coordinator 1 A Send for Sponsor Review 21 Submit Changes Expiration Date 7 Feb 2013 Meeting Date 29 Feb 2012 window will appear showing the 5 Withdraw sponsor or CRO contact 7 Edit Email List Attachments Contingencies ChangeLog Letters Send Email to REB Staff Activity Author Activity Date Send Email to PI Sent Letter to PI Ethics Coordinator 1 17 02 2012 4 28 PM GMT Test 05 00 Z Edit Study Personnel 7 y f View Correspondence Letter Send For Sponsor Review Enter any notes to the sponsor or Instructions CRO in the Comments field e This form allows you to send the provincial application to the sponsor for review and completion of the a if required The sponsor will be notified when you submit this form Select Add then Browse to find e Use the box below to add any comments to the sponsor and add the draft PI response e Click the Ok button to send this application to the sponsor letter if the sponsor OF CRO wil
19. mmends downloading the applicable consent form templates i e main study genetic research etc and modifying where necessary Name Version Date Update Main Study Consent changes tracked February 6 2011 Delete Update Main Study Consent doc February 6 2011 Delete Update Optional Tissue Consent Form February 4 2011 Delete Include the tracked change versions of the consent form s to show the changes by uploading them Add to the tracked change consent form area of the application Upload all consent form s here MS WORD ONLY OCRESB strongly recommends downloading the applicable consent form templates i e main study genetic research etc and modifying where necessary Add Name Version Date There are no items to display Upload all consent form s with tracked changes MS WORD ONLY if applicable Ontario Cancer Research Ethics Board Page 17 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 2 5 4 Routing the Provincial Application to the Sponsor or CRO PI Response The provincial applicant or study staff can route the application to the study sponsor or to the CRO if applicable to assist in preparing the PI response A ocreb Test Study Coordinator My Home Logoff Select Send for Sponsor _o2Home EMIRA centres Researcher Profile Issues amp Support o Review to route the application to the sponsor or CRO contact to Project Infor
20. n select Jump To 1 1 Study Identification E mti a ous fto continue section by section or use the 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 Methods 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 Hide Show Errors from within the application or Ese view SmartForm Progress from the workspace will open up a Progress window showing whether the sections are complete or incom
21. nces Appication Typa Review Type Fi Expiration Date Full Board Review Smith Demo Study Coordinator My Home Log Study Staff Demo Study Coordinator My Home Log Study Coordinator Review Type Demo Study Coordinator Expedited Demo Study Coordinator My Home Log Study Coordinator Review Type Demo Study Coordinator Expedited The Provincial Applicant 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 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 Page 21 of 21
22. nsor The application will be sent to the following sponsor for review John Test Comments Hello John As discussed am routing the provincial application to you to assist in completing it Thanks Documents Add Name Version There are no items to display Page 9 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 A ocreb Test Study Coordinator My Home Logoff Once you select OK the state will change from Pre Submission to Pre Submission Sponsor Review The provincial Project Information Centres applicant PI and study staff will Provincial Study Credit Valley Hospital have View access only to the Ep pamervesion Study SPSR 001 Pr000001270 OCREB 12 100 application until the sponsor EF view SmantForm Progress Acronym Sponsor Review routes it back Full Title Preparing the training materials for routing the provincial Eyes applicantion to the sponsor Activities Principal Test Principal Study Test Study Edit Email List Investigator Investigator 1 Coordinator Coordinator j ocrepd John Test My Home Logoff 02 Home Centres ResearcherProfile Issues amp Support O2Home Studies Centres ResearcherProfile Issues amp Support The sponsor or CRO contact will receive a notice from ocrebonline S Page for John Test and the study will be sitting In Welcome to your Personal F
23. nt Jump To 4 3 Consent Forms amp Other Study Participant Materials 1 0 Study Identification Funding ALe 1 1 Study Identification 4 3 Cons 1 2 Funding Information 1 30 Contact Information 1 5 Study Locations and Other Reviews Upi con _ 2 0 Study Objectives amp Design 2 1 Study Objectives amp Design UPS 3 0 Research Methods and Procedures Plea 3 1 Research Methods and Procedures 489 3 7 Clinical Trial 4 0 Study Population Recruitment and Consent L A 4 Otiuich Daniulatinon Save Exit Hide Show Errors Print Jump To 4 3 ConsentForms amp Other Study Participant Materials Because the system auto generates a different Pro number for the initial provincial study and each initial centre application until this is fixed a single OCREB number will be assigned to the overall project The format will be the first two numbers of the current year followed by a 3 digit number e g 11 001 Until this process is automated when you are ready to submit your application please contact the OCREB office 416 673 6649 for your OCREB number Enter the assigned OCREB number in the relevant question on the first page of the application Ontario Cancer Research Ethics Board Page 7 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 2 1 2 Study Workspace When you Finish or Exit the application you exit to a Study Workspa
24. nts 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 Leiter 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 History Amendments Continuing Reviews Reportable Events Attachments j Letters j Last Issued Letter View Activity Description Author Activity Date Study Approved REB Chair Test 27 01 2011 2 40 PM GMT 035 00 Ti View Correspondence Letter Ontario Cancer Research Ethics Board Page 20 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 2 5 6 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 There are many different ways to tell if you are in or accessing the provincial application study or the centre application study NOTE Name in this system is the sponsor protocol number The provincial applicant will see the same study listed more than once in lists of studies The Application Type column will show which one is Provincial and which one
25. older the central resource or managing your applications Use the his her My Action Items tab following guidlines to process your applications Sponsor e Process all submissions in your Inbox Items appearing here require immediate action by you NOTE the study will remain in auier inks eo the My Action Items section of Consent Forms the provincial applicant P and study staff with view only permission until the sponsor routes the application back to the My Action Items Displays all items which requir action by you Click on links for more information Filter by D i Advanced rovincial applicant Date Last State p pp ID Name smartForm eee Type Owner State Change e Pro00001270 SPSR 001 f0 01 03 2012 Initial Pre 01 03 2012 5 03PM Submission Submission 5 03 PM Sponsor h t A ocreb John Test My Home Logoff 02 Home Studies Centres ResearcherProfile Issues amp Support The sponsor or CRO contact must select Edit Application to Gems Centres edit the application form ay Edit Application J Provincial Study Credit Valley Hospital Selecting Printer Version opens Ei Printer version StUdy SPSR 001 Pro00001270 OCREB 12 100 int friend i fth Acronym Sponsor Review a prin nen y version o Full Title Preparing the training materials for routing the provincial applicantion to application the sponsor Principal Test Principal Investigator Study Test Study Investigat
26. or 1 Coordinator Coordinator When finished the sponsor or Submit Sponsor Funding Sources Demo Sponsor Review Type CRO contact must select the i Submit Sponsor Review activity Contact Attachments Change Log to route the application back to REA This area shows instructions and questions and important notifications regarding this Study the provincial applicant PI Activity Author Activity Date Sent For Sponsor Study Coordinator Test 01 03 2012 5 03 PM GMT Review 05 00 f Hello John As discussed am routing the provincial application to you to assist in completing it Thanks AA Created Study Study Coordinator Test 01 03 2012 4 23 PM GMT Ontario Cancer Research Ethics Board Page 10 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 A Sponsor Review Acknowledgement window will appear Enter any relevant comments or notes and select OK to route the application back to the provincial applicant PI and study staff The State will change back to Pre Submission and the sponsor or CRO contact now can view the application only The provincial applicant and study staff can once again edit the application The cycle of routing the application to and from the sponsor or CRO contact can be repeated as needed Ontario Cancer Research Ethics Board Submit Sponsor Review Sponsor Review Acknowledgement When you have completed review of the applicat
27. or Test 01 03 2012 4 23 PM GMT 05 00 Initial Ontario Cancer Research Ethics Board Page 8 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 2 1 3 Routing the Provincial Application to the Sponsor or CRO in Pre Submission The provincial applicant or study staff can route the application to the study sponsor or to the CRO if applicable to assist in the completion of the initial provincial application The sponsor or CRO contact must be in O2 in order to be able to route the application to them Be sure to send the person s full contact information to O2 Support to have them added to the system and set up with an account Be sure to check with the sponsor or CRO contact before adding them to the system or routing the application to them Select Send for Sponsor Review to route the application to the sponsor or CRO The sponsor or CRO contact that will assist with the application must be entered in the appropriate section of the application Only one CRO or sponsor contact can be selected to assist with the application Be sure to confirm the contact with the sponsor or CRO A Send for Sponsor Review window will appear The selected sponsor or CRO contact will appear in this window Enter any instructions or information for the sponsor or CRO contact in the Comments field Documents typically should not be added to this notice All study related documents e g consent
28. or by regular email 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 you can find any contingency documents received separately from your application under the Attachments tab Ontario Cancer Research Ethics Board Page 14 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 2 4 Tracking the Progress of the Application A unique feature of the OCREB Online system is that you can 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 all of your applications by viewing the State column on My Home page Filter by iD Go _ciear Advanced ID Name SmartForm Date Modified Owner State pplication Type Review Type Pl Expiration Date mg Pro 0o00080 SST 01 Fal 05 02 2011 4 51 REB As
29. or toll free at 1 866 678 6427 Ext 6649 Email ocrebonline oicr on ca or e After business hours send an email to ocrebonline oicr on ca Ontario Cancer Research Ethics Board Page 3 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 2 Initial New Provincial Study 2 1 Pre Submission 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 the documents in an easily accessible area on your computer or local network To start a new provincial application select New Provincial Study This is accessible from a variety of places including the 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 oy Edit Application from the study workspace A ocreb i John Smith My Home Logoff 02 Home Studies Centres Researcher Profile Is
30. p to you again 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 Type Descri ae sit YP SCnPUC completed Created View Health Canada 1 26 2011 Contingencies NOL ITA NHF Clinical Trial 1 26 2011 Registration View Study Budget 1 26 2011 Name Version Modified Description There are no items to display OCREB Recommended Consent Form Name Version Modified Description Changes There are no items to display Name Version Modified Description There are no items to display PI Response To submit any outstanding contingency items upload them to the application if they are available at the time of preparing the revised application with your PI response Alternatively if the application is no longer open to you to edit you can attach the documents and send them by email to the REB Coordinator Owner of your study The email can be sent from within the study workspace in O2
31. plete 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 Section Description Progress 1 0 Study Identification Funding amp Locations 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 you are the study coordinator you can inform the PI from within the study workspace by pressing the activity button or 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 NOTE emails sent from the study workspace will contain study identifiers and the sender s name as well as a direct link to the study workspace after login however the emails will be From ocrebonline and not the person sending the email Ontario Cancer Research Ethics Board Page 12 of 21 OCREB Online User Guide for Initial Provinci
32. ponse 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 Enter any comments or information to OCREB in the summary field in the pop up window select Add to upload the PI response letter and then 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 Bi No Title Windows Internet Explorer ere are nc HE https o2 staging oicr on ca stg_eREB Resource Administration Document FormForProperty postback 18fo Submit a Document Title PI Response for SST_01 Train Study Saa the name of the Show Advanced Options Required Ok OK and Add Another Cancel g be rnme 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 requireme
33. roval 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 i 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 O 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 13 of 21 OCREB Online User Guide for Initial Provincial Applications Version 1 0 2012 Mar 10 2 3 Contingencies Once your study has been submitted and assigned to an REB Coordinator REBC The REBC will review the application set contingencies as required and either assign it to a meeting assign it to an expedited reviewer or send the application 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 notice with a link to the study The study also will be located under the My Action Items tab which means it now requires action by you At this point it is opened u
34. s e Send Email to REB Staff sends an email to the selected person in 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 A ocreb Test Study Coordinator My Home Logoff 02 Home Bavtl ee Centres Researcher Profile Issues amp Support aa euE Centres Provincial Study Credit Valley Hospital Study SPSR 001 Pro00001270 OCREB 12 100 View SmartForm Progress Ee Acronym Sponsor Review Full Title Preparing the training materials for routing the provincial 4 applicantion to the sponsor E ae For Sponsor Principal Test Principal Study Test Study eview Investigator Investigator 1 Coordinator Coordinator 2 Withdraw Edit Email List Edit Guest List 6 Send Email to REB Staff This area shows instructions and questions and important notifications regarding this study HeJ Send Email to Pl Activity Author Activity Date Edit Study Personne bi vity Created Study Study Coordinat
35. s are Centre When accessing a Provincial Study Provincial Study will be displayed in the Provincial Study workspace under the Project Properties tab To access the list of participating centres select the Centres tab When accessing a Centre Study Centre Study will be displayed in the Centre Study workspace under the Project Properties tab If you see the study name twice in the crumb trail you are in the Centre Study workspace Go up one level to the Provincial Study workspace by taking the crumb trail back to the parent from the Centre Study workspace Paty nina My Studies Fitter by Bo com Advanced SmanFonm 2 Daie Miiied Owner FAIRY ral BODO 104 PM PERC iinaior 2 T 4 5 A H a id 4 s A h a My Amendments My Renewals My Reportable Events Hame OCREB BjvGilt Centres Researcher Profile Issues Project Properties EE Latest Submissions Provincial Provincial Study Demo Centre TRAIN E Printer Version p view Differences Protocol ID SST 0 Centres Researcher Profile Issues OCREB iit Centres my View Application Project Properties E Printer Version 2 view Differences ee Pro00000092 Description Principal Investigator John Smith Date Submitted 05 02 2011 m View Application Centre Study Demo Centre SST 01 TRAIN Pro00000092 Description dems a Investigator John Smith E Printer Version J View Differe
36. scnpls Dr Jack Bodied Char DOCAL IOL College Stent Foe H Termin Daime MIG UAS Der Dr Holmi lf OTHER specify RE RED 11 123 9pm Pe Rapa to ORED Ringe Letter ie Gtody eile Plage fe tee mapasa e CREB y pam menina med era cam below Prateral 30 List thee kay inchalen eriari in point form pLa the charactarietics ihai must be med for inefieidomls in be anrelied l Tian rimbo phie i stocty Please darcy whether or oot phie fr iha oohredy diipi Lf phate oo complete pleie prove the plise daia El besse ILA TAGA ee M Repanse Phase 1 i mye melee The phus 1 dn is mehed Pidde ar laa da boi h oje E E am mimi eae 3 i 2 ba E a a a z r Bespeoge celami bebibty wil be bed on The ippleibaa bin been Fame Masal Fant Sie a oye Baisi pred eer Bar el Ana Sie a eee rehing Ceairni 3 i Tbe ecekted ooeace Serta sn d oa toed ee eaei m be Pl ccipenis Fiii DE yora heave my cpeethioed or commen ents de act betile o oe et oe Semoreny BF pare der Tr Priacal mreng ohee SOO EEFE T a Editing the application includes uploading revised versions of documents i e consent forms Delete the initially submitted document e g consents and upload the clean version i e with changes incorporated of the revised consents to the application 4 3 Consent Forms amp Other Study Participant Materials 1 0 Upload all consent form s here MS WORD ONLY OCREE strongly reco
37. signed Provincial Full Board Smith TRAIN PM coordinato To REB Review Meeting or the State column on the Studies page P ocreb Demo Principal Investigator 1 My Home Logoff OCRE Baer ics entres ResearcherProfile Issues studies V Studies gt Amendments 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 fo you gt Reportable Events l Create Provincial C New Provincial Study Provincial Approved Provincial Closed Filter by ip x al clear Advanced Provincial All Studies Provincial In Progress ID Name SmartForm 4 Date Modified State Review Type Provincial P Expiration Date ef Pro00000008 DEMO 2c fy 27 01 2011 2 41 PM Approved ull Board Review Principal Investigator 2 27 01 2012 oF Pro00000016 DEMO 3c fy 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 4 31 01 2012 oF Pro00000033 DEMO 5c fy 31 01 2011 3 24 PM Approved ull Board Review Principal Investigator 5 31 01 2012 oF Pro00000057 DEMO_19 fay 01 02 2011 1 45 PM Approved xpedited Principal Investigator 19 31 01 2012 oF Pro00000003 DEMO ic ful 03 02 2011 9 30 AM Approved ull Board Review Principal Investigator 1 27 01 2012 oF Pro00000001 DEMO 1a py 03 02 2011 2
38. spondence Letter A ocreb Demo Principal Investigator 1 My Home Logoff OCREB itO Centres Researcher Profile Issues _pinesponserenaing D E Edit Appiication Provincial Study Demo Centre 1 DEMO __1b Pro00000002 pree Crer version Description This is the full title for test study DEMO1b j View Differences Principal Demo Principal Investigator 1 Study Coordinator Demo Study Coordinator 1 Investigator OCREB Coordinator Test REB Coordinator 1 Review Type Full Board Review Expiration Date 27 01 2012 Meeting Date amp Time 11 02 2011 11 00am eS Submit Changes D Withdraw History Attachments Contingencies Change Log Z Edit Email List g Send Email to PI Last Issued Letter View Send Email to REB Staff Assigned To Committee Meeting Review Letters Activity Author Activity Date Sent Letter to PI REB Chair Test 27 01 2011 1 50 PM GMT 05 00 4 View Correspondence Letter 2 5 2 Accessing the OCREB Recommended Changes to the Consent Form s The REB recommended consent changes OCREB Recommended Consent Form Changes will be displayed in the consent forms mame O Download copies to your computer to make Main Consent OCREB Recommended Changes the changes as agreed with the PI and Tissue Consent OCREB Recommended Changes sponsor Change the version date and delete the initially submitted consents and upload the revised consents to the application The review letter wil
39. sues 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 UEG My Studies My Amendments My Renewals My Reportable Events Displays all items which require action by the study team Click on links for more information Filter by D K E Advanced Name SmartForm Date Modified Type TM 02 c 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 Ethics Application You will sutomatically be guide AAA a ee here hee o ae ay See eee CS RES eee re re ae STS ree Se eet Be eee Of sections needed to complete your submission Guidance notes will be in iteli Red ssterisks 7 a ee eee Hn cs Fite ES ee se erie sere rears ear raed is Submission of the soclication will be blocked unless sll mandatory questions sre answered
40. ts for missing information thereby ensuring that submissions are complete before submission 1 1 Intended Audience This guide is intended for the Provincial Applicant or Provincial PI and the Study Staff assisting with the provincial application It is also intended for the study sponsor or CRO staff who may assist with the completion of the provincial application 1 2 Accessing the System To access the live O2 system go to htips 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 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 Please refer to the Getting Started user manual to adjust date settings 1 4 O2 Support e During business hours contact O2 Support at Tel 416 673 6649
41. you must provide a Other Reviews lf the 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 e attest that the information in the application is complete and accurate to the best of my Knowledgte 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 Investigator 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 app
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