IRBear Study Staff User Manual - CTSI-CN
Contents
1. Attachments Reviewer Notes Pre Review Status Change Log Activity Author Activity Date boy Study Approved By Division Schweitzer MD Albert 6 19 2012 10 24 PM EDT e Use the Pre Review Status tab on the study workspace to view which division department and pre IRB submission ancillary reviews have been received and which are pending e Note that the Division Center approvals are called Department approvals under the Pre Review Status tab History Attachments Reviewer Notes Change Log Pending Department Approvals Department Name Ophthalmology Received Department Approvals Department Name Neurology Child Neurology Outstanding Issues The following Ancillary Committee Approvals are still pending Committees There are no items to display The following Ancillary Committee Approvals have already been recieved Committees There are no items to display Uploading and Attaching Document Files in IRBear There are four types of documents that you are asked to upload to specific items in the SmartForm application e Approval letters from other IRBs if applicable e The study protocol e Documents related to the informed consent process including o Consent parental permission forms o Assent forms o Waiver of consent parental permission and assent forms o Waiver of documentation of consent parental permission and assent forms o Information sheets e Recruitment materials The system allows you to upload P2. Children s National Medical Center Institutional Review Board Office for the Protection of Human Subjects Version 1 2 October 1 2012 Table of Contents WIEIGCOME 10 IRADOJ serisine rE Enea rar r KA ans ie eee YENE i 3 IRBear FEQUIFEINGIIS ssccavessvesaderecevesiexcnaredaneuanstavensanvauencualexaiossaienaneredevenseiaxssanesavess 3 Wna C anir Ber DOT seen eee emer eee eee ere ae eee eee eens 3 LOGOIMNO We el wert rcinace tarcesanestaicatoarndorennexavoxaioesatouaipe casterstnara texenaxndaxnoaxadarooucdexersxadexsteoiees 4 TOUR SSO FAG erisir nErenn erer Erare rE Erap epe Krepa a ciTe EEEren rit 5 Creating a New Study Application in IRBe f ccccccceecccseeeeceeeeeeseeeesseseeseaeeesaeeeeas 8 Types of SmartForm Questions cccceecccceeceeceeceeceececaeesecseeesseesessaueessaeeeseeeesaaes 9 Navigating IRBear SmartForms ccccceeccceeeeceeeeceeeeceeeeceueeseueceueeseuseseueesaneessees 12 o epee 66 626 et ne ee en ne ne er et ree tee rer er err 14 Assigning Study Staff ataccnancncacsenczcneuanerienerciesdeakenctaucnadesiammaeaiceenenenunnd akqeeuetceentnonenrenaraees 15 Selecting Members of the Study Staff cccccccsesceceeeeeceeeeeseeseeseeeeseeeeeseeeeeeas 14 Co Investigator Agreement to Participate cccccceccecseececeeeeeceeeeeeeeeeseeeeseeeeeeas 16 Tracking Co Investigator Agreement to ParticiPate ccccccceccseeeceseeeeeeseeeeaeeees 18 Required Division
3. El Printer version View SmartForm Progress My Activities FA Ja oa J303 S Submit Study Withdraw Edit Ancillary Approvals Change Workspace Template Copy Study Administration Edit Email List Edit Guest List Send Email to Study Team Send Email to IRBA Request To Investigator and Ancillary Department Support Add Supporting Documentation Submit Study Only the PI can engage this activity Withdraw Removes study application from the approval process Copy Study Saves a copy of the application that can be used as a template for future applications Edit Email List Add or remove individuals to the list of those who will receive email notifications regarding the study Edit Guest List Add or remove Guests who can view the study in IRBear but not alter it read only privileges Send Email to Study Team Communicate with members of the study team within the IRBear system Send Email to IRBA Communicate with the IRB Analyst within the IRBear system Agree to Participate Co investigators indicate their agreement to be part of the study team Request Co Investigator and Ancillary Department Support Prompts Co ls to agree to participate and Ancillary Departments to approve use of their resources Add Supporting Documentation Upload documents that are not uploaded within the application form study History Log Every action perfo
4. Workspace IRBear page containing basic information about the Study Amendment or Continuing Review Each type of transaction creates a separate and unique workspace with the Amendment and Continuing Review workspaces accessible through the parent Study workspace Includes a History of all actions in IRBear related to the transaction You must be in the correct workspace to view a transaction nm BO Appendix 2 IRBear States for IRBear Submissions In IRBear the State indicates a submission s status in the review and approval process It can be found in the upper left corner of each workspace and under the State column on your personal page Who Has Protocol State Control What Do I Need to Do Pre Submission Pl Study Staff Create new study Edit study application Request Co Investigator and Ancillary Department support e Co ls must Agree before submission can proceed to Division review Sign off by Investigational Drug Service Radiation Safety Committee and Institutional Biosafety Committee must be obtained before submission can proceed to Division Review Other ancillary departments e g Laboratory Medicine Medical Records must signoff before IRB approval letter can be released PI must click the Submit Study study activity to advance the submission to the Division Review state The submission stays in the Pre Submission state until all sign offs are completed Division Review Divis
5. Protocol State wool What Do I Need to Do Control In Facilitated Review IRB Reviewer Nothing The submission is under IRB control for processing COG Protocols IRB Analyst Nothing The submission is under IRB control for processing In Facilitated Review Admin Review WIRB protocols IRB Staff Review COG Protocols Pl Study Staff Edit study to make requested changes and or provide In Facilitated Review Carica en a PI Response Pending Submit requested clarifications changes PI only To view the clarifications WIRB protocols Changes Required by 1 Click the Reviewer Notes tab Then click the Jump To IRB link 2 Make a direct response under the Reviewer Note tab and within the editable study application Please note Any text that you enter in the green shaded area under the Review Note tab will not appear in the SmartForm application once the transaction has been approved by the IRB To change a response in the application you must enter it directly in the item 3 Once you have addressed all of the clarifications have the PI click Submit Changes to send your response back to the IRB for review the submission will transition to the In Facilitated Review Admin Review state THE SUBMISSION WILL NOT ADVANCE FOR FURTHER PROCESSING UNTIL THE SUBMIT CHANGES ACTIVITY HAS BEEN EXECUTED AG laa ora IRB IRB Analyst Nothing Facilitated review is complete cton COG protocols new protocol submission
6. Approvals and Ancillary Reviews cccsscccseeeeseeeeseeeeseeeeseeeesaees 19 DIVISION Approvals ccccccceccceeeceeecsececeeeceueesececeueceeesueeseeseeessueeseeesaeeteueeseeeneeesegs 19 Ancillary Reviews by IDS RSC and IBC cceeccecsseeeceeeeeseeseeseeeesegeesseeeeseaes 19 Other Ancillary ROVIQWS ccccccccccsssceceeececeeeeeceeeeeeecesseeeeseuseeseeeesseesessaseesseeesaaes 21 Tracking Division Approvals and Ancillary REVIQWS ccccssecseeeseeeeseeeseeeseeeens 22 Uploading and Attaching Document Files in IRBe ar ccccceeecseeeeeeeeeeeeeeeeeeeneees 23 ENTA ON Gc decent EEE E EEE E EEE EAEE 24 Joldading Rovised DOCUM N S sirisser ee ERER EER 24 Submitting an Pp a IN IR BCA erisir a aea eaaa EAE 26 IRBoar Application StalUS ene ee ee ene ee eee ee een 27 dF eS seereis e rea eeN EIEEE EE ESTERE ETEEN 27 SEE e EE A E EE 27 The Study WorkSpa0e cassac ects ca be case ca Secs ce ects ca be coon ce seks ES rE reira irine aeaiiai 28 DONG ainavanes rutunk skoranctnsavannuahiwanceaurtssan aunts sew mau averauavaveravsrovsvousrevavevsvixevincueratararam ants 29 PSS E E E E E E E 30 Sodai ea a ES e EE E E E A PE ee ee eer 31 Responding to Reguested UM cece tects acienee sence ccaceadencsaradiceanetandeassonsassesossoacssnsee 32 Accessing Change Requests act cher cies chet cictckarcieictcasietcheraialelerstenssauasdesciensdectsecsdestoes 32 a ojelgelicel Bole bl qiiclg Coen ee tr eer ee ee er eee rrr
7. Assurances certify that all information provided in this application represents an accurate description of the intended study agree to follow and abide by all policies and procedures as well as by all federal state and local laws concerning the protection of human subjects in research including but not limited to Implementing no changes in the approved protocol or consent form without prior approval of the Institutional Review Board IRB Conducting the research using only the qualified personnel listed on the approved protocol Submitting a timely continuing report as requested by the IRB Notifying the IRB any adverse events that are unexpected serious and or more severe than anticipated within ten 10 working days Reporting all deaths regardless of causality within ten 10 working days Immediately notifying the IRB upon termination of the study or departure of the Principal Investigator from this Institution understand that as Principal Investigator assume full responsibility for the conduct of the study and for the protection of the rights and welfare of human subjects involved in this research Required Department Approvals GASTROENTEROLOGY MEDICINE lf you have finished filling out your application and selected the depariment s to review it then click OK After you click OK you will no longer be able fo edit the apolication You will receive emai when each aporoval is granted or refused and again when all the
8. Meester rere merr rrr errr terre reer ter 35 SPOe Or RETU TO oe ern een ne ee eee ene ane eae a Eei 35 PUGS SING Me Approval LIEN A cencdecccecctoncatadecanstaceosacacesauctadeesacsosenassoseunsedosusnseneste 35 Accessing Approved Consent DOCUMENTS cc sccccseeeeceeeeeceeseeseeseeseneeseaeeensaes 35 Appendix 1 Glossary of IRBear TermMS cscs techie Reseed Seneca ecaeet se deace hbase 37 Appendix 2 IRBear States for IRBear Submissions cccseeeeeeeeeeeseeeeseeeeesaaeeeeeees 40 Appendix 3 Office for the Protection of Human Subjects Contact Information 48 o Welcome to IRBear Children s National Medical Center uses the Institutional Review Board Electronic Application Review IRBear system to support the conduct of ethical and scientifically valid human subjects research In addition to ensuring compliance with the Federal regulations governing the protection of research participants the IRBear system provides a more efficient process for submitting approving tracking and managing IRB study submissions IRBear is a product of Click Commerce IRBear Requirements The IRBear system is accessible from anywhere at the Internet website www RBear org It is available 24 hours a day 7 days a week Most of the IRBear features you will use work on almost any browser that is current some users however have reported difficulties with some features when they use Chrome and Safari For best results one of
9. Population wios Editing an Application A study or grant application may be edited before it is submitted during Pre Submission or any time changes are requested by reviewers or the IRB The study will appear under the My Inbox tab in all of these occasions To open a study to make changes Current State 1 From your Personal Page click on the Bae title of the study you wish to select Pre Submission 2 In the study workspace click the Edit F Edit Study Study button The first study application screen appears in edit mode Printer Version 3 Make any necessary changes and save the study by clicking the Save or Continue button 4 View SmartForm Progress ee ee Assigni ng Study Staff Selecting Members of the Study Staff New study application section 1 Specify who has permissions to edit and view the study On the Study Identification screen you can select the Principal Investigator PI for the study submission If you are signed in as the PI this will default to your name Only the users specified as the PI able to edit and save the study ap permission to edit the study after i Personnel Change amendment to study coordinator and co investigators will be plication If you would like to give a new person t has been approved you will have to submit a add them When adding Other Study Staff Members to the application Item 10 0 be sure to specify their role on the study t
10. be a registered user to access the IRBear system e Please contact the Children s National Office for the Protection of Human Subjects OPHS 301 565 8452 to obtain your user name and initial password e You will be required to reset your password the first time you log in If you forget your password contact OPHS to have it reset Once you have an account go to www irbear org and click the Login link in the top right corner of the page 4 Home Microsoft Internet Explorer lax File Edit view Favorites Tools Help Phd Q sack Q x a A p Search 5 Favorites E A 2 2 M LJ rel maA Address https www irbear org eResearch Rooms DisplayPages LayoutInitial Container com webridge entity Entity OID AC482809EC03C442446F2C8EEC4D75D3 e l 7 National Medical Center Home E oo Links amp Logi Home Institutional Review Board H What s New 0 m General Information Welcome this site enables Children s National to manage all aspects of Research Administration from Institutional Review Board IRB compliance processes Related Links Contact Us Log n here Enter your User Name and Password on the next screen and click Login To help keep your information secure do not check the Remember me box F i j T TET E ft Ser i H a j UATR a iTi M Login AS User Name Password Login F Remember me After signing into this site you are bound by the terms and conditions
11. navigator bar to skip screens that are not applicable to your study TIP Throughout the application process you must Save what you have done before you use the Back button or Exit in your standard tool bar or it will be permanently lost ilei b innse ata 2 vg O Children r cc Beck Carrs gt gt Study Identification Information if E t I t ti a ai i f PLIJ Pat r Shiehy Humber Previous Study Humber Study Tile Lomg Study Tithe Abstract a0 Principal Investigator The protocol number will be assigned once the first screen is saved It will appear in the upper right corner of your screen ae Ge Types of SmartForm Questions IMPORTANT All questions marked with a red asterisk are mandatory Text boxes Answer text questions by typing directly within the form or by pasting in information from another application such as Word 3 0 Specific Aims single Person Selection 3 0 Principal Investigator FO Select Select Person Windows Internet Explorer le http uclairb webridge com UCLADEY CommonAdministration Choosers Entity Chooser targetType Per v Select Person e Click on the Select button to open a new window Last First Organization Abrahms Sam TUFTS UNIVERSITY e Use the Filter to narrow your search ou TEO Alverado Carmen GASTROENTEROLOGY o Type the first few letters of the Anslager Helmut IMMUNOLOGY person s l
12. required consent assent documents or applicable waivers in Item 1 2 on the following page lt lt Back Save Exit Hide Show Errors Print Jump To 8 Informed Consent Considerations 7 Reviewer Notes Delete Previous Next Filter by Type Go Clear Advanced Type Reviewe Trea IRB Staff Change Request sram l m 3 m m m Cbee Regarding the last question you indicated No however your study is not exempt Please change your answer from No to Yes click Continue and upload the required consent assent documents or applicable waivers in Item 1 2 on the following page E Change Request Completed Mohamad Jaafar MD 9 14 2012 12 41 PM Requested Change Completed Making and Submitting Changes Make changes to the SmartForm application by navigating to the relevant item and revising your response In addition enter a response under the Reviewer Notes tab within the green shaded area and select OK Comparison of Lemonide vs F i J Edit View E bttos cnmestage clickcommerce com CNMCstage ResourceAdministration Project ProjectEditar WizardPageOID com webridge entity Le My Add to Wish List F Windows Marketplace C Factoids C WORK 0 Jan C Imported From Firefox vs Children s Edit Study Pro00003295 a Peer a Madin aniar s i os WAE PLV ade iT R Tn Back Save Exit HiderShow Errors Printa Jump To 8 1 Consent Forms amp Process of C
13. set forth when you received your account The Children s National IT Department does not support IRBear If you have difficulties logging in or other technical issues please contact the OPHS fos Your Personal Page Your personal page displays your name and has links to items applicable to you Page for Marie Curie Windows Internet Explorer Pia https lickoommerce com File Edt View Favorites Tools Help x SS yConvert F Select sup Favorites ey fe Office for Human Research E Free Hotmail Get more Add ons Page for Marie Curie A 5 J a 2 Marie Curie My Home Logoff Ls i F Ss k ni rua tfr uik w li td P Home IRB Studies Page for Marne Cune siban Page for Marie Curie My Roles 1 Welcome to your Personal Page the starting point for all interactions with this site Note the following Dept Div Approvers AE a i ai a Inbox Items appearing in your inbox require immediate action by you to speed your submission through the Study Staff review process Click on the link to view the workspace for an item and take action Create 3 Manitor the progress of your submissions using the other tabs Items on these tabs do not require any action by New Study KOM Quick Links 4 Consent Forms Displays all IRB related items which require action by the study team Click on links for more information Filter by Name Go Clear Advanced Name Date Modified Type Owner State L
14. will close and links to your files will appear in the application form gt No Title Windows Internet Explorer clickcommerce com Submit a Document Title f not provided the name of the file will be used File C Documents and Settings mrossi Desktop r Browse Show Advanced Options Required OK and Add Another 7 Cancel 1 2 Upload consent forms assent forms or information sheets here Add Name Modified Version Upload Revision Pro3279 Assent 12 17_8 29 2012 doc History 8 29 2012 1 08 PM 0 01 Upload Revision Pro3279 consent with hippa 8 29 2012 doc History 8 29 2012 1 08 PM 0 01 AFTER a ee Delete Delete Navigating IRBear SmartForms The SmartForm navigation pane appears at both the top and bottom of each screen Edit Study ProOO003279 Sontirue gt study Identlication Information This is the first step in your Human Research Application You will automatically be guided ta the appropriate forms needed to complete your Submits porns 1 0 Study Nunkber System Generated Prood003279 S sien Generated 4 0 Previous Study Number Stody Tithe Please limit to 250 characters or less Radiation Therapy in 2 Paediatric Population Long Study Title Lise the iong tibe only if your tithe will not fit in the ceguiar study Oihe box Please have the short ttle in the regula box and se ecbice hhe fA hee Bee Alstract mn a study on the use of rediatio
15. Analyst Nothing The submission is under IRB control for processing Admin Review In Exempt Review PI Pl Study Staff Edit study to make requested changes and or provide Response Pending clarification Submit requested clarifications changes PI only To view the clarifications 1 Click the Reviewer Notes tab Then click the Jump To link Make a direct response under the Reviewer Note tab and within the editable study application Please note Any text that you enter in the green shaded area under the Review Note tab will not appear in the SmartForm application once the transaction has been approved by the IRB To change a response in the application you must enter it directly in the item Once you have addressed all of the clarifications have the PI click Submit Changes to send your response back to the IRB for review the submission will transition to the In Exempt Review Admin Review state THE SUBMISSION WILL NOT ADVANCE FOR FURTHER PROCESSING UNTIL THE SUBMIT CHANGES ACTIVITY HAS BEEN EXECUTED In Exempt Review IRB Reviewer Nothing The submission is under IRB control for processing Awaiting IRB Analyst Nothing The submission is under IRB control for processing Correspondence Exempt Certified Review your approval letter on the main study workspace under Letter of Approval Review your consent documents under the Documents tab A5 Facilitated Review COG PCIRB and WIRB Protocols
16. DF files Word documents spreadsheets emails presentations and html files using the following steps 1 Navigate to a question in the smart form application that requires a file upload 2 Click the Add button on the left had side of the question A new web page will open 1 2 Upload consent forms assent forms or information sheets here Add Name Modified Version There are no items to display 3 If you are asked to accept a certificate from Click Webridge click the Always or Yes button The file upload process requires a small java applet to be downloaded to your computer Accepting the certificate allows this process to occur 4 Enter a title for the file in the Title field This can be something like Consent Form lf you leave the title box blank the name of the file will be used as the title me Oe No Title Windows Internet Explorer Sis x http webrps02 webridge com Rx ResourceAdministration Document FormForProperty formID O0 amp postback 1 amp valueField Pa Submit a Document Help Title Po If not provided the name of the file will be used Show Advanced Options Required Ww F kd Internet T ioo 5 Click the Browse button on the right hand side A Choose File window will appear 6 Navigate to the desired file select it and click the Open button You may only select one file at a time 7 Click the OK button The file will be uploaded to the se
17. Smartform Progress Edit Study Opens the SmartForm application for editing or viewing You will not be able to edit the application when it is in a State that is controlled by someone else Examples Division Review IRB Staff Review In Expedited Review Printer Version Consolidates all of the study application input into a single document which can be printed View SmartForm Progress Provides a pop up view of all the possible sections in an application and whether they are Complete Not Required or Incomplete see below SmartForm Progress Pop up Click on the section name to navigate directly to an incomplete section Progress Section 1 Study Personnel amp Funding 2 Study Objectives amp Design Description Progress Complete Complete 3 Methods amp Procedures Social amp Behavioral Not Required 4 Methods amp Procedures Bio Medical Not Required 5 Methods amp Procedures Data Collection Not Required 6 Study Population 7 Risks amp Benefits 8 Informed Consent amp Recruitment Incomplete 9 Data Privacy amp Confidentiality Complete 10 Data Safety amp Monitoring Plan Not Required 11 Biosafety 12 Radiation Safety 13 Submission Complete Complete Complete Not Required Not Required Complete ap amp Activities The activities that are available to you will vary based on the current state of the study and your role Current State C Edit Study
18. action has been approved by the IRB To change a response in the application you must enter it directly in the item 3 Once you have addressed all of the clarifications the PI must click Submit Changes to send your response back to the IRB for review the submission will transition to the IRB Staff Review state THE SUBMISSION WILL NOT ADVANCE FOR FURTHER PROCESSING UNTIL THE SUBMIT CHANGES ACTIVITY HAS BEEN EXECUTED ne A Full Board Review Who Has P Protocol State Control What Do Need to Do Assigned to IRB IRB Analyst Nothing The submission is under IRB control for processing Meeting Meeting in Process Meeting Complete IRB Analyst Nothing The submission is under IRB control for processing Awaiting Correspondence IRB Chair IRB Reviewer Nothing The submission is under IRB control for processing If Correspondence changes are requested by the IRB the state will change to Review Changes Required by IRB Edit study to make requested changes and or provide Clarification Submit requested clarifications changes PI only Changes Required by IRB Pl Study Staff To view the clarifications 1 Click the Reviewer Notes tab Then click the Jump To link Make a direct response under the Reviewer Note tab and within the editable study application Please note Any text that you enter in the green shaded area under the Review Note tab will not appear in the SmartForm application once the transac
19. al Drug Service IDS the Review Radiation Safety Committee RSC or the Institutional Biosafety Committee IBC as applicable to the protocol These are called pre IRB submission ancillary approvals and are required before the new study application can transition to the IRB Staff Review state Other ancillary approvals are required from departments whose resources are needed for the successful conduct the study or who review recruitment materials These approvals are required before the new study application can be reviewed by the IRB members Breadcrumb Shows the user s path to their current location Also allows the user to Navigation navigate to where they started from as from an Amendment workspace Bar to the Study workspace for the same protocol CITI Collaborative Institutional Training Initiative Online education program providing training in human subject protections at www citiprogram org Required modules must be completed prior to obtaining a new IRBear user account Continuing Process for obtaining continued IRB approval for a study beyond the Review current expiration date Federal regulations limit the IRB approval period to a maximum of one year History Area within the Study Amendment or Continuing Review workspace that displays in reverse chronological order all actions related to the transaction that occurred in IRBear Inbox Area within the IRBear user s Personal Page that displays all
20. ant to add Gorelik Yana IRB Heidebrecht Murray Click Commerce Dept App Richard GASTROENTEROLOGY Co Investigators Co Investigator Jin GASTROENTEROLOGY dd ar Michelle IRB Last Name First Name Martha RADIOLOGY Barton RN K lt I 1 230f23 H Lo Sti DOr oa Co Investigators NA Cancel amp Internet AFTER 100 Yes No Radio Buttons 3 0 Will this study include non English speaking participants C Yes C No Clear Select One Answer Radio Button Requested Review Type C Exempt C Expedited Facilitated Review Full IRB Review Clear mA select Multiple Answers Check Boxes Indicate the types of consent that will be involved in this study check any or all that apply Written signed consent by subject Written signed consent by a legally authorized representative for an adult Written permission for a minor by a parent or legal guardian Written Signed Assent by Minor N A Upload Documents Documents must be saved on your computer or flash drive for you to upload them into IRBear Upload consent forms assent forms or information sheets here Modified Version BEFORE e Click on the Add button to open a new window e Use the Browse button to find the file you want o Select OK and Add Another if you want to upload multiple files o Select the OK button when you have finished uploading files e The window
21. ast State Change GF Radiation Therapy in a Pediatric 8 29 2012 9 23 Study Pre 6 29 2012 9 23 Population AM submission AM 5 2010 Click Commerce Inc 1 My Roles Allows you to select between user roles if you have more than one Principal investigators co investigators and study coordinators all have the role of Study Staff 2 Top Navigator Available on almost all screens Has links to your Name My Home always brings you back to this page your personal page and Logoff ends your session and logs you out of the system 3 Create New Study Allows you to start a new IRB application from scratch 4 Quick Links Gives access to the templates for the Informed Consent Parental Permission and Assent forms 5 Inbox tab Displays all studies you are a part of that require some action to be taken by the study team 6 Studies tab Allows you to search through all of the IRB studies that you are part of regardless of where the study is in the submission and review process 7 Templates tab Displays a listing of the submissions that you have chosen to save as templates for future studies Dd 5 rw Click on the Studies tab to display studies that you are a part of that do not require any action on your part Home IRB Studies Page for Marie Curie cow Page for Marie Curie My Roles Welcome to your Personal Page the starting point for all interactions with this site Note the following Dept Div App
22. ast name and click Go Arm Comm Chair Richard IMMUNOLOGY Arnot Norma IMMUNOLOGY Select the correct person and Bulkload Michelle GASTROENTEROLOGY click the OK button DiMalgio Vincent IMMUNOLOGY Duvette Daniel ONCOLOGY Gorelik Yana IRB Heidebrecht Murray Click Commerce Ing Dept App Richard GASTROENTEROLOGY Kim Co Investigator Jin GASTROENTEROLOGY Leonard Michelle IRB Mears Martha RADIOLOGY v IN V 1 230f23 gt W wj Internet 100 Multiple Person Selection 3 0 Co Investigators Add Last Name First Name There are no items to display Investigators NA I aiti aaa ins Select Person Windows Internet Explorer Joe B E FO R E http fuclairb webridge com UCLADEV Commonadministration Choosers Entity Chooser targetType Per v Select Person Filter by Last v B Advanced e Click on the Add button to open a J new window Last First Organization Ead Abrahms Sam TUFTS UNIVERSITY Use the Filter to narrow your search Allen Steven Click Commerce Alverad C GASTROENTEROLOGY o Type the first few letters of the Se ae last name and click Go Anslager Helmut IMMUNOLOGY person s Arm Comm Chair Richard IMMUNOLOGY o Select the correct person and Amot Norma IMMUNOLOGY click the OK button Bulkload Michelle GASTROENTEROLOGY DiMalgio Vincent IMMUNOLOGY e Repeat these steps for each person Duete ET ep you w
23. dited Review PI Response Pending To view the clarifications 1 Click the Reviewer Notes tab Then click the Jump To link Make a direct response under the Reviewer Note tab and within the editable study application Please note Any text that you enter in the green shaded area under the Review Note tab will not appear in the SmartForm application once the transaction has been approved by the IRB To change a response in the application you must enter it directly in the item Once you have addressed all of the clarifications have the PI click Submit Changes to send your response back to the IRB for review the submission will transition to the In Expedited Review Admin Review state THE SUBMISSION WILL NOT ADVANCE FOR FURTHER PROCESSING UNTIL THE SUBMIT CHANGES ACTIVITY HAS BEEN EXECUTED In Expedited Review IRB Reviewer Nothing The submission is under IRB control for processing IRB Analyst Nothing The submission is under IRB control for processing The submission is under IRB control for Nothing The submission is under IRB control for processing Correspondence Approved Review your approval letter on the main study workspace under Letter of Approval Review your consent documents under the Documents tab 44w Exempt Research Who Has P Protocol State Control What Do I Need to Do In Exempt Review IRB Reviewer Nothing The submission is under IRB control for processing In Exempt Review IRB
24. eam For example Obtain informed consent administer survey review medical Principal Investigator Mare Curie Sebect Clear Primary Study Coordinator Clara Barton RN Select Clear Secondary Study Coordinators Add Last Name First Name There are no items to display Responsible Investigator Select Responsible Investigator MA M Co Investigators Add Last Name Furst Name Barton RN Clara Co Investigators NA I Study Research Nurse If applicable Select Study Research Nurse NA W Other Study Staff Members Add Name Organizaton There are no items to display charts data analysis Department Profile Remove Profile aioa Co Investigator Agreement to Participate All individuals listed as co investigators on a new study SmartForm application must electronically confirm their agreement to be a member of the study staff before the application can be submitted by the PI e Select the Request Co Investigator and Ancillary Department Support activity on the study page to obtain the co investigators agreement to be part of the study team The new study application is simultaneously routed electronically to each co investigator s IRBear Inbox e Each Co Investigator uses the Edit Study button in the study workspace to open the application and review it ss gt Request Co i Investigator and lt Pre Submission D EJ Edit Study jE Printer versio
25. ent 12 17_8 29 2012 dac History 9 11 2012 3 25 PM 0 01 Delete Upload Revision Pro3279 consent with hippa 8 29 2012 dac History 9 11 2012 3 25 PM 0 01 Delete Upload Revision Pro3279 Waiver of Assent form doc History 9 11 2012 3 28 PM 0 01 Delete Name Modified Version Uploading Other Documents Documents that are not requested within the application form for example Investigator Brochures questionnaires etc should be uploaded using the activity Add Supporting Documentation which is found under My Activities on the study workspace Fi Add Supporting Documentation nm Ob Submitting an Application in IRBear e Inthe study workspace select Submit Study Only the Principal Investigator on the study can submit the application My Activities fpr Submit Study e The system will run a final validation check on the entire application Any errors are displayed on the submission screen that opens e Before the application can be successfully submitted o The application must be error free o All co investigators must have agreed to participation o The Investigational Drug Service Radiation Safety Committee and Institutional Biosafety Committee must approve the study when applicable e Read the principal investigator s assurances and check the box next to agree with the above statement Click the OK button at the bottom of the screen to submit the application for the new study Submit Study Investigator
26. es to send your response back to the IRB for review the submission will transition to the IRB Staff Contingency Review state THE SUBMISSION WILL NOT ADVANCE FOR FURTHER PROCESSING UNTIL THE SUBMIT CHANGES ACTIVITY HAS BEEN EXECUTED IRB Analyst Nothing The submission is under IRB control for processing Carespondene a IRB Reviewer Nothing The submission is under IRB control for processing eview Approved Review your approval letter on the main study workspace under Letter of Approval Review your consent documents under the Documents tab Disapproved According to Children s IRB policy RA HRPP 05 14P Disapprovals and Appeals you may appeal the IRB s decision to disapprove the protocol by responding in writing to the IRB This response must state that an appeal is being made and include a description of the rationale for the appeal Contact the OPHS for more information mA Expedited Review Who Has P Protocol State Control What Do I Need to Do In Expedited Review IRB Reviewer Nothing The submission is under IRB control for processing In Expedited Review IRB Analyst Nothing The submission is under IRB control for processing If Admin Review changes are requested by the IRB the state will change to In Expedited Review PI Response Pending Pl Study Staff Edit study to make requested changes and or provide Clarification Submit requested clarifications changes PI only In Expe
27. eviews New study application section 2 0 item 3 0 part 2 e Authorization to conduct the proposed study may be required by your departmental research committee or from departments whose resources you are requesting If so select the applicable entities from those listed e While the application is still in the Pre Submission state i e before the PI clicks the Submit button select the Request Co Investigator and Ancillary Department Support activity on the study workspace You need only select this activity once to request both ancillary department support and co investigator agreement to participate e The application is simultaneously routed electronically to the selected entity ies for review Exception Requests for review and approval of recruitment materials must be submitted to Public Relations and Marketing outside of IRBear Please email these materials directly to Emily Hartman at EHartman childrensnational org e The PI may submit the new study application while these ancillary approvals are still pending Approval sign off from these entities must be received before the IRB will complete its review Ancillary Reviews Committee must verify the study prior to IRB Committee Meeting M Medical Records Nursing Research Council PR amp Marketing Pathology Laboratory Medicine ao Ol ee Tracking Division Approvals and Ancillary Reviews e Sign off approval by a Division Center is recorded in the study History
28. fication will contain a link to the workspace for the study with requested changes Click on the link and the IRBear login page will open Once you log in you are taken directly to the relevant workspace OR Log in to your personal page and select the appropriate item from your IRBear Inbox Click on the study title to open the Study workspace Folder for Marie Curie Welcome to your Personal Page the starting point for all interactions with this site Note the following Inbox Items appearing in your inbox require immediate action by you to speed your submission through the review process Click on the link to view the workspace for an item and take action Monitor the progress of your submissions using the othertabs Items on these tabs do not require any action by you Inbox Studies Templates Profile Displays all IRB related items which require action by the study team Click on links for more information Filter by Name Go Clear Advanced Name m Date Modified Type Owner State Last State Change Radiation Therapy in a 11 7 2010 10 32 Study ee ees ieee 11 7 2010 10 32 N Pediatric Population AM AM Sa BD Ea Once you are in the study workspace click on the most recent item in the History log to see comments from the requester or of the changes Study Radiation Therapy in a Pediatric Population Prooo003279 Description This is a study on the safety and efficacy of radiation treatment in childre
29. formation and possible actions Activities available to the user Users with multiple roles must select the correct One in order to access the IRBear Inbox and Activities relevant to that role Roles and Their Abbreviations Study Staff SS Includes the PI co investigators and study coordinator Principal Investigator PI Division Department Approvers Dept Includes Division Chiefs and Center Sr Vice Presidents Directors IRB Analyst Administrator IRBA Designated Reviewer DR IRB Committee Chair or Vice Chair CCH IRB Committee Member CM Ancillary Committee ANC Includes Investigational Drug Service Radiation Safety Committee and Institutional Biosafety Committee SmartForm IRBear electronic submission form Replaces paper submission form Determines which questions you see next based upon your responses to previous questions State The status of your submission in the review process Examples Pre Submission Division Review IRB Staff Review Changes Required by IRB Approved see RBear States for IRBear Submissions table for a complete list of states and their definitions Studies Area within the IRBear user s Personal Page that displays all of the user s studies that do not require some action by the user Tools Features available to the user within each Workspace to facilitate the Submission process Examples Edit or View Study Printer Version View SmartForm Progress View Differences
30. ion Chief or If the PI is also the Division Chief he she cannot provide CRI Center division approval for his her own submission The application Director must be reviewed by the Center of Excellence Senior VP or CRI Center Director Please contact the OPHS at 301 565 8452 for assistance e Click Changes Requested by Division Reviewer activity to request clarifications or changes transitions to Clarification Required Division Review state or e Click Issue Division Approval activity to approve as submitted transitions to IRB Staff Review state 40 Clarification Required Pl Study Staff Edit study to make requested changes or provide clarification Division Review Submit requested clarifications changes PI only Nothing The submission is under IRB control for processing If changes are requested by the IRB staff the state will change to Changes Required by IRB Staff IRB Staff Review IRB Analyst Changes Required by Pl Study Staff Edit study to make requested changes and or provide IRB Staff clarification Submit requested clarifications changes PI only To view the clarifications 1 Click the Reviewer Notes tab Then click the Jump To link 2 Make a direct response under the Reviewer Note tab and within the editable study application Please note Any text that you enter in the green shaded area under the Review Note tab will not appear in the SmartForm application once the trans
31. ions appended to this manual The Study Workspace Every study created in the IRBear system is assigned a folder or workspace When you click on a study to view it the study s workspace is opened vs Childrens Maryann Rossi My Home Clipboard Projects Logoff AS as Vas H T KH preempt ie Home Committees IRB Studies Researcher Profiles Reports Issues Site Administration IRB Studies gt Radiation Therapy in a Pediatric Population 4 Layout Current State Study Radiation Therapy in a Pediatric Population Prec0003279 Pre Submission Description 3 This is a study on the use of radiation in the treatment of children E Eat stuay Edit Study Principal Investigator Marie Curie Study Coordinator Clara Barton RN Previous Study Number amp Printer version Study Type Social Behavioral Review Type E gt View SmartForm Progress Funding Type There are no items to display My Activities PI Submit Study ss Withdraw real Edit Ancillary Approvals 8 Change Workspace lt Template ss Copy Study 7 8 Administration Attachments Change Log Pending Agreements amp Approvals Ss Edit Email List This area shows instructions and questions and important notifications regarding this Study Activity Author Activity Date fss Edit Guest List W Created Study Curie Marie 8 29 2012 9 23 AM PDT Send Email to Study Team o Send Email to IRBA ss Request Co Investigator and Ancillary De
32. n Ee View Smartform Progress Ancillary Department Support My Activities ss Withdraw cc Copy Study ss Edit Email List ss Edit Guest List E Send Email to Study Team Send Email to IRBA to respond to the request A new window opens e The Co selects the Agree to Participate activity ss Agree To Participate e Next the Co I checks the response box and e Request Co ss TAESMIGERUP AI clicks OK see next screenshot Ancillary Department support Ei Add Supporting Documentation iO https Avww irbear org eResearch ResourceAdministration Activity form Activityl ype com webridge Microsoft I BEE We eS Agree To Participate You have been identified as a co investigator on this protocol If you agree to participate in this research study please indicate your support by checking the box below You may alsa add optional comments and documents to this form If you do not wish to participate in the research please cancel out of this activity and contact the study coordinator or principal investigator directly Once you have been removed from the team this study will disappear from your inbox Comments Attach documents here Add Name Version There are no items to display By checking this box I am indicating my agreement to participate in this study ee Wa Tracking Co Investigator Agreement to Participate e Each co investiga
33. n Patients ages 5 through 17 will be recruited time of treatment A follow up visit will be scheduled every year for three years Principal Investigator Marie Curie Study Coordinator Clara Barton RN Previous Study Number Study Type Bio Medical Review Type Full IRB Review Funding Type There are no items to display History Attachments Reviewer Notes Pre Review Status Change Log Activity Author Activity Date Trea Changes Requested by IRB Staff McGee Guthrie Michele 9 15 2011 11 16 AM EDT zl 2 Reviewer Notes Logged Good Morning The administrative review of your submission is complete and clarifications are necessary prior to revie Click the Reviewer Notes tab Then click the Jump To link 2 Answer each clarification and make any necessary changes to the appropriate st of the application 3 Once you have addressed all of the clarifications have the PI click Submit Changes to send your response back to the IRI Next select the Reviewer Notes tab for details of the request Click on the section link following Jump To to open the corresponding page of the SmartForm application History Attachments Reviewer Notes Pre Review Status Change Log Filter by Type Go Clear Advanced Type Reviewer Modified Michele 9 12 2012 11 1 McGee Guthrie Regarding the last question you indicated No however your study is not exempt Please change your answer from No to Yes click Continue and upload the
34. n in the treatment of children Enlarged view of Navigation Pane lt lt Back Save Exit Hide Show Errors Print Jump To 1 Study Identification Continue gt gt e Use the Back and Continue buttons to move back or forward one screen respectively e The Save button will allow you to save any changes made to the application e Always use the Save button BEFORE exiting the form Simply selecting Exit will close the application screen without saving changes e Hide Show Errors will show any errors and mandatory fields not yet completed e Print will produce a printer friendly view that can be printed e Jump To allows you to select a screen within the application process and go there directly e Click the Continue button in the navigator bar to save and move to the next screen E OES Below is an example of the results of Hide Show Errors This can be used to gauge your progress and determine any additional fields that will need to be completed in the application Sere Exit Het Error Pii j J Help we oooh S Shuidy bdhentification Information This rs the frat step in pour Human Research Appbcaton You will sofomaticaly be guided to the appropriate forme needed to complete your submiaaeons 1 0 Tithe Lung Rehabilitation in Treating Patients Vinh Chronic Obsiructre Pulmonary Disease iho Are 2 0 Desorption Lung Rehabilitation in Treating Patients Wah Chronic Obstructre Pulmonary Disease Who Are U
35. ndergoing Surgery for Lung Cancer Freon Piani Meida gii Nips sage Field Mame Jump Ta This is a required field therefore you must provide a value Reve Type Requested 2 1 Requeed Revwews This ts a required field therefore you musi prowde a value Research Calegor 2 3 Research Calegones G Theis a required feki therefore you must prade a value lnveatagator Rusk Assessment T Risks A Benes Assessment This is a required field therefore you must praade a value HIPAA Sunmar 2 1 HFAA amp This is a required Said therefore you must proade a value Plan Option IU Data Satety Monitoring Pian To use the Jump To feature open the drop down box on the navigation pane Click on the title of the desired section of the SmartForm to open that page Edit Study Prodd0d044 1 Study Personnel Funding Study Identhcaten 1 1 Federal Research Definbon L2 IRE Recebre Triund Recorda 1 0 Pleace select the Primary Source of Funding for this Project 1 3 Funding Sources PATENTEN 1 39 Secondary Source of Funding for Your Study PERE AH 1 4 Conflict of Interest State or Local Government 1 5 Study Locations in Doerr tal Primary Source of Funding lor Your Study aie a Foundahon Nom Prohig Z Study Objectives A Design 2 0 Regured Reward 2 01 Expedited QGualificabon 2 1 Study Summary Hf Other Please Describe ne 2 Research Categones intemal Award intemal Department Funds mp jis aiji MOoUOUU 6 Study
36. nter Each Division Center you select must approve your new study application before it will transition to the IRB Staff Review state TIP Adding one Division Center is generally sufficient especially for minimal risk research You may want to add multiple Divisions Centers if for example major responsibility for the conduct of the research will be shared by different divisions within different centers Your application will be routed to the appropriate Divisions Centers simultaneously Required Division Approvals Add Center for Cancer amp Immunology Research Children s National Medical Cent Ancillary Reviews Committee must verify the study prior to submission to IRB Vo Investigational Drug Services r Radiation Safety Committee M Institutional Biosafety Committee Ancillary Reviews Committee must verify the study prior to IRB Committee Meeting M Medical Records Nursing Research Council PR amp Marketing Pathology Laboratory Medicine Ancillary Reviews by IDS RSC and IBC New study application section 2 0 item 3 0 part 1 e f your protocol requires review and approval by the Investigational Drug Service IDS the Radiation Safety Committee RSC or the Institutional Biosafety Committee IBC select the appropriate box es These are called pre IRB submission ancillary approvals e While the new study application is still in the Pre Submission state i e before the PI clicks the Submit button selec
37. nts will also be accessible under the History tab study Comparison of Lemonide vs Flovent in the treatment of Asthma Proooo03281 Description Training example Principal Investigator Train PIO1 Study Coordinator Train SC20 Previous Study Number PI Proxies There are no items to display Expiration Date 6 30 2013 Letter of Approval View Funding Type Federal NIH Review Type Expedited Suspension Type Facilitated Review Type History Amendments Continuing Reviews Reportable Events Documents Change Log Activity Author Activity Date Study Aporoved McoGee Guthrie Michele 8 31 2012 7 28 AM PDT Recorded Decision and Expiration Dates McGee Guthrie Michele 8 31 2012 7 25 AM PDT Study Approved By Division Coppes MD Max 6 31 2012 7 04 AM PDT Study Submitted for Review FIOL Train 6 31 2012 6 57 AM PDT Created Study PIO1 Train 8 31 2012 6 17 AM PDT PEL Kl dJ 1 7of7 gt A Appendix 1 Glossary of IRBear Terms Activities Actions available to the IRBear user Activities vary based on the user s Role and the State of the submission Examples Edit Study Send Email to Study Team Agree to Participate Submit Study Send Email to IRB Analyst Submit Changes Amendment Process for changing the method procedures consent documents PI or any other aspect of an approved study EXCEPT a change in study Staff other than the PI See Personnel Change Amendment Ancillary Review and approval by the Investigation
38. of the studies that require some action by the user IRBA IRB Analyst or Administrator Member of the OPHS staff maT IRBear Institutional Review Board electronic application review system Internet based application used for the submission review and tracking of human research protocols Notification Automated Outlook email message from the IRBear system generated whenever an action by the user is required and at significant transition points in the review process Outlook notifications come from eResearch childrensnational org OPHS Office for the Protection of Human Subjects at Children s National Provides regulatory educational and administrative support to the IRB Personal The user s home page Accessed at login and when the My Home link Page is used Contains the user s IRBear Inbox Personnel Process for adding or removing members of the study staff EXCEPT the Change PI Amendment Pre IRB Approvals that must be received before a new study application can Submission transition to the IRB Staff Review state Includes review and approval Ancillary by if applicable the Investigational Drug Service IDS the Radiation Approvals Safety Committee RSC and the Institutional Biosafety Committee IBC Reviewer Area in the Study Amendment or Continuing Review workspace that Notes displays the reviewer s requests for changes to or clarification of the corresponding submission Identifies the types of in
39. onsent Continue gt gt ww Reviewer Notes Filter by Type Go Clear Advanced Type Reviewer f Modified IRB Staff Change Request Question 1 2 Practice uploading revised documents Change Request Completed Change Request Completed Change Request Not Completed Train PILO 9 26 2012 4 39 PM m Inf tian Onl IREA Lee Se Jan Martinez 9 2 2012 1 06 PM Done ok Cancel Fre ooooos 4 F Consent Forms amp Process of Consent at Instructions 1 1 Download the applicable consent form template to your machine and modify this where applicable E CMH Assent Form Ages 12 17 Save and Exit the SmartForm application when you are finished Select Submit Changes from the My Activities list in the study workspace This activity must be executed in order for the changes to be sent to the requester A new window will open where you may enter comments Click OK when you are finished The application will transition back to the state from which the changes were originally requested pr Submit Changes TIP Any member of the study staff listed in the application can make the changes to the SmartForm However only the Principal Investigator can submit changes BAe Approval Documents Sponsor Required Text New study application section 1 Item 12 0 lf the study sponsor requires specific language in the IRB approval letter enter the text EXACTLY as you want it to appear in the le
40. partment Support cf Add Supporting Documentation IN J i iofi D Wi The workspace displays important information about the study and contains links to help navigate to any information contained in the study 1 Breadcrumb Navigation Bar Shows the user s path to their current location Also allows the user to navigate to where they started from 2 Current State Displays the progress of this study in the review process Description Displays summary information about the study IRB protocol number Refer only to the last four digits wnen communicating with the IRB OPHS Example 3279 Tools Used to access the SmartForm application once it has been created My Activities Lists all of the available actions you can perform on the study Click on them and complete the opened screen to perform the action 7 History Records all actions performed on the study Each action is recorded with the date time and person performing the action Click on the name of the activity to see the system details 8 Attachments All documents that were uploaded to the application form study protocol draft informed consent parental permission and assent documents recruitment materials can be accessed here OB w Tools The tools provide two ways to access the information entered in the SmartForm application and an easy method to find sections that are incomplete Current State EF Edit Study jE Printer version R View
41. required approvals are received If you are not ready to submit your application chek Cancel agree with the above statement C Once the application has been submitted to the IRB the application is automatically routed to the Division Chief or Center Director for review mm OF IRBear Application Status Email Notifications Members of the study team will receive Outlook email notifications from the system whenever they are required to complete an action related to the protocol review and at significant transition points in the review process IRBear generates notifications at times such as e The study application is ready for submission e A reviewer requests changes be made to the protocol application e Official action letter has been issued by the IRB e Continuing review submission to the IRB is due e IRB approval has expired TIP RBear notifications will come to your Outlook e mail address from eResearch childrensnational org Do not reply to these emails The email notifications contain a link to the relevant workspace Click on the link and the IRBear login page will open Once you log in you are taken directly to the relevent page Current State You can also check the progress of your application by opening the study workspace in IRBear and looking at the Current State listed at the top of the column on the left TIP For a complete list of States refer to the document RBear States for RBear Submiss
42. rmed on the study is recorded in the history log under the History tab e The actions you have permission to see are arranged in chronological order most recent on top e Each activity is recorded in the history log with a data time stamp and the name of the person performing the activity e Click on the name of the activity to view the system details Study Comparison of Lemonide vs Flovent in the treatment of Asthma Preo0003280 Description Training example PI Train F101 IRB Analyst Austin Grace Committee Committee A Review Type Full IRB Review Type of Research Bio Medical Sponsor There are no items to display Attachments Reviewer Notes Pre Review Status Change Log Activity Author x Activity Date Study Approved By Division Coppes MD Max 8 31 2012 7 23 AM PDT Study Submitted for Review PIO1 Train 6 31 2012 7 22 AM PDT Issue Ancillary Committee Approval Choi Henry 6 31 2012 7 20 AM PDT Requested Co Investigator and Ancillary Department Support PIO1 Train 8 31 2012 5 52 AM PDT Created Study P L Train 8 31 2012 4 47 AM PDT me OA ee Responding to Requested Changes The study team will receive automated Outlook email notification from eResearch childrensnational org when the application is sent back to them for requested changes or clarifications Changes clarifications may be requested by e Division Chief Center Director e IRB Analyst e IRB Accessing the Requested Changes The email noti
43. rovers Inbox tems appearing in your inbox require immediate action by you to speed your submission through the review process Click on the link to view Study Staff the workspace for an item and take action Create Monitor the progress of your submissions using the other tabs Items on these tabs do not require any action by you E New Study Quick Links Templates Profile Displays IRB related studies you are associated with but do not require any action by the study team at this time Consent Forms Filter by 10 7 Go Clear Advanced ID Name Date Modified State ExpDate PrevNumber Prot0d03327 Clinical Outcomes in a Cohort of Pediatric Patients 9 3 2012 12 52 PM Pre Submission Prot0dd3279 Radiation Therapy in a Pediatnc Population 9 3 2012 11 12 AM Pre Submission Pro00001234_ A Randomized Double Blind Trial oft 1 2012 2 40 Approved Click on RB Studies to view all studies cow Page for Marie Curie My Roles Welcome to your Personal Page the starting point for all interactions with this site Note the following Dept Div Approvers Inbox tems appearing in your inbox require immediate action by you to speed your submission through the review process Click on the link to view Study Staff the workspace for an item and take action Create Monitor the progress of your submissions using the other tabs Items on these tabs do not require any action by you E New Study Quick Links Templates Profile Displa
44. rver and will appear in the question on the smart form You can use the OK and Add Another button to upload multiple files Editing Attached Files 1 Navigate to the file upload question in the SmartForm application 2 Ifyou need to make changes to the existing document click on the name of the file to view it Then save it to your desktop and make the desired changes Uploading Revised Documents 1 When replacing documents previously loaded in the SmartForm applications with modified documents do not click Add button Instead the click the Upload Revision box to the left of the file you wish to change A new web page will open 2 Click the Browse button and select the new version of the file Click OK 3 The new version of the document with a new version number will replace the old file 4 To see documents that were replaced old version click on the History tab in the study workspace NOTE For Consent Form documents upload a track changes version AND a clean version Be sure to indicate in the document title whether it has track changes or is clean Once a study is approved only the current forms approved by the IRB should be uploaded in this section of the application ra Ds Consent Forms Opens a window where you can attach consent documents with track changes and approved clean copy consent documents 1 2 Upload consent forms assent forms or information sheets here da Upload Revision Pro3279 Ass
45. s only Pending acceptance of a Facilitated Review Acceptance Form FRAF by CIRB Operations Office WIRB protocols Find your Authorization for Protocol Review by WIRB under the History tab IRB Analyst Nothing The submission is under IRB control for processing Correspondence Correspondence IRB Reviewer Nothing The submission is under IRB control for processing Correspondence Facilitated Review COG PCIRB protocols Completed Review your approval letter on the main study workspace under Letter of Approval Review your consent documents under the Documents tab Approved WIRB protocols Children s National IRB has received notification from WIRB that the study is approved Additional IRBear Protocol States Administratively Transaction has been withdrawn by IRBear system This occurs when the PI does Withdrawn not respond to IRB contingencies within 30 days Complete Study has been closed by the PI All research activities are complete No further action required IRB approval has expired No research activities may take place Expired IRB approval has expired however a continuing review has been started or Continuation in submitted Complete the pending continuing review Contact the OPHS for more Progress information Suspended All research activity has been suspended by the study sponsor regulatory agency or the IRB Contact the OPHS for more information Withdrawn Transaction has been wi
46. t the Request Co Investigator and Ancillary Department Support activity on the study page You need only select this activity once to request both ancillary department support and co investigator agreement to participate The application is simultaneously routed electronically to each of the selected entity ies for review mow Current State C Edit Study 8 Printer Version E View SmartForm Progress My Activities g Request Co pr Submit Study Investigator and Fs Withdraw Ancillary Department ss Copy Study support ssi Edit EMail List ssi Edit Guest List C Send Email to Study Team O Send Email to IRBA ss Request Co Investigator and Ancilary Department Support T Add Supporting Documentation e Use the Pending Agreements and Approvals tab on the study workspace to view which ancillary reviews have not been completed IDS RSC and IBC approval must be received before the application can transition to IRB Staff Review History Attachments Change Log Pending Agreements amp Approvals The study cannot be submitted until all listed Co Investigators and Responsible Investigator have agreed to participate and all required ancillary committees have indicated their approval The following people are still pending agreement to participate Clara Barton RN The following pre IRB submission ancillary approvals are still pending Radiation Safety Committee 20 Other Ancillary R
47. thdrawn by the Pl study staff No further action required wares Appendix 3 Children s National Medical Genter Main Office 801 Roeder Road Suite 801 Tel 301 565 8452 Fax 301 565 8456 Personnel IRB Chair Naynesh Kamani MD nkamani childrensnational org SZ Campus Tel 202 476 2169 Silver Spring Tel 301 565 8486 Education and Accreditation Manager Maryann Rossi PhD CIP mrossi childrensnational org Tel 301 565 8485 IRB Committee A Analyst Michele McGee Guthrie CIP mmcgeegu childrensnational org Tel 301 565 8489 IRB Committee C Analyst Suzanne Cardy BA scardy childrensnational org Tel 301 565 8479 January 2013 Office for the Protection of Human Subjects Contact Information SZ Campus Satellite Office Research Floor 3 5 Room 232 Tel 202 476 3472 Hours Mon Thurs 9 00 a m 4 00 p m Director Research Regulatory Affairs Adriana Brigatti JD MPH LLM CIP abrigatt childrensnational org Tel 301 565 8488 Project Coordinator Kay Ayers BS kayers childrensnational org Tel 301 565 8452 IRB Committee B Analyst Jan Martinez BA CIP imartine childrensnational org Tel 301 565 8542 Exempt Research Facilitated Reviews Austin Grace BS agrace childrensnational org Tel 301 565 8541
48. the following Internet browsers is recommended e Microsoft Internet Explorer 7 0 or higher preferred e Firefox 5 or higher For all Internet browsers you must have client side JavaScript enabled To use the document upload feature and some reporting features you may be asked to allow Java applets or Active X to run in your browser You will need to accept the certificate to upload files ClickCommerce Webridge Incorporated certifies all items It is suggested you use a screen resolution of 1024 x 768 for the optimal display of the IRBear website What Can IRBear Do With IRBear you can e Create and edit an electronic application for IRB review e Add co investigators and other study personnel to the research team e Attach scanned or electronic documents to the submission e Print out or view the application in a printer friendly version e Validate the application before submission to catch common mistakes and reduce the number of changes required after submission e Submit an application to the IRB electronically e Track the progress of the application through the review and approval process e Receive email notifications whenever some action by the study staff is required e Access the approval letter and stamped consent documents online for download anytime e View atime stamped log of all changes made to the application and any correspondence sent between the study team and the IRB in IRBear oO es Logging into IRBear e You must
49. tion has been approved by the IRB To change a response in the application you must enter it directly in the item Once you have addressed all of the clarifications the PI must click Submit Changes to send your response back to the IRB for review the submission will transition to the IRB Staff Contingency Review state THE SUBMISSION WILL NOT ADVANCE FOR FURTHER PROCESSING UNTIL THE SUBMIT CHANGES ACTIVITY HAS BEEN EXECUTED IRB Staff Contingency IRB Analyst Nothing The submission is under IRB control for processing Review Designated Reviewer Designated Nothing The submission is under IRB control for processing If Contingency Review Reviewer changes are requested by the IRB the state will change to Contingencies Pending AO Contingencies Pending Pt Study Staff Edit study to make requested changes and or provide clarification Submit requested clarifications changes PI only To view the clarifications 1 Click the Reviewer Notes tab Then click the Jump To link Make a direct response under the Reviewer Note tab and within the editable study application Please note Any text that you enter in the green shaded area under the Review Note tab will not appear in the SmartForm application once the transaction has been approved by the IRB To change a response in the application you must enter it directly in the item Once you have addressed all of the clarifications the PI must click Submit Chang
50. tor s agreement to participate is recorded in the study History Change Log Attachments Reviewer Notes Pre Review Status Activity Author Activity Date cs Agreed To Participate Mitty MD Walter 8 11 2012 1 50 PM EDT e Use the Pending Agreements amp Approvals tab on the study page to view which co investigators have not responded to your request for their support The application cannot be submitted until all co investigators have agreed to participate History Attachments Change Log Pending Agreements amp Approvals The study cannot be submitted until all listed Co Investigators and Responsible Investigator have agreed to participate and all required ancillary committees have indicated their approval The following people are still pending agreement to participate Clara Barton RN The fallowina pre IRB submission ancillary approvals are still pending Radiation Safety Committee B x Required Division Approvals and Ancillary Reviews Division Approvals New study application section 2 0 item 2 0 Add the name of the PI s Division If the Pl is the Division Chief you must select a higher level of review This could be the PI s Center of Excellence or Research Center The PI cannot approve his or her own protocol When the new study application is complete and the PI clicks the Submit button the submission will automatically be routed electronically to the designated approver for the selected Division Ce
51. tter IRBear inserts your response as is directly into the approval letter Does the sponsor require the Approval Letter to contain specific references i e protocol version 01 dated January 1 2011 or references to updated investigator brochure diary cards etc Yes No Clear If yes add the required text here Protocol Version 1 0 dated 31 August 2012 Investigator Brochure for Lemonide Version 1 0 dated 30 August 2012 Package Insert for Flovent dated 25 July 2012 Accessing the Approval Letter Once the proposed study has been approved by the IRB the approval letter will be posted in the study workspace Current State and available for download at anytime View the approval letter 1 From your Personal Page select the Studies tab and click on the title of the approved study 2 In the study workspace the Current State will show Approved The summary panel will now have an item for Letter of Approval Click on the View link to the right 3 The approval letter will open in a new window You can then print the letter by selecting File Print from the menu bar The approval letter will also be saved for recordkeeping in the history log under the activity Accessing Approved Consent Documents 1 Once your study has been approved the informed consent parental permission and assent forms will be accessible from the study workspace under the Documents tab 2 The approved informed consent docume
52. ys IRB related studies you are associated with but do not require any action by the study team at this time Consent Forms Filter by fib l o Clear Advanced ID Name Date Modified State ExpDate PrevNumber Prot0dd3327 Clinical Outcomes in a Cohort of Pediatric Patients 9 3 2012 12 52 PM Pre Submission Prot0d03279 Radiation Therapy in a Pediatric Population 9 3 2012 11 12 AM Pre Submission 2010 Click Commerce Inc Use the Filter by function to find a particular study IRB Studies View all studies by In Progress Approved and Archived groupings Use the My Home link to see the list of submissions related to you In Progress Approved Archived GgLAlear Advanced Date Modified Owner State Review Type PrevNumber PI 9 11 2012 4 06 PM Pre Submission Full IRB Review Curie Owner First Name sn a Pro00003 cto s in a Cohort of Pediatric Patients 9 3 2012 12 52 PM Pre Submission Curie Review Type PreyNumber PI TIP Use as a placeholder for the Filter by function For example to find protocol number PRO00003279 enter 3279 Creating a New Study Application in IRBear e Select the New Study button on your personal page A new application form will open for you to complete My Roles en e IRBear uses SmartForms The system determines which aA questions you see next based upon your responses to previous questions Quick Links e When you fill out the application use the Continue button Consent Forms on the
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