eIRB User Manual for Research Staff
Contents
1. amp Printer version My Activities pr Submit Study P Notify Co Investigators to Agree to Participate cs Withdraw Once logged into your study they will be required to use the Accept Participation activity in order to complete an affirmation of involvement Before the application is submitted it will be validated to check for common errors The application is also validated when the Principal Investigator submits the application to the IRB Exit the Smart Form version of the study by selecting Exit This will bring you to the Study Workspace Version 3 12 8 7 2013 UTGERS THE STATE UNIVERSITY UF MEW JERSEY You can identify the workspace you are in by the bolded word listed above the study description RUTGERS ere Training Principal Investigator My Home Logoff THE STATE UNIVERSITY Sandbox OF NEW JERSEY Nee IRB STUDIES USER PROFILES IRB Studies gt Tissue Bank Test Current State rincipal Investigator Edit Stud en c os x x a y Funding Sou Study Tissue Bank Test Pro2013003193 E Printer version Co Investigators Who Have Not Acca There are no items to display EB View SmartForm Progress Study Tissue Bank Test Pro2013003193 New Brunswick Piscataway je hh Department i Review Pre Submission Br IRB Review Complete Clarifications Clarifications u i Requested Required bs nvestigators t Agree to Participate ss Withdraw2. The history is updated after a new activity is completed by anyone working on the study RUTGERS ai Sandbox BE ITEE Current iiaii Thay ni Pret pi iai riri a aM Pt Traarure Pragi Ira Ab rs Fender Pardi Oele Berk fer imira bye Enema E reer Per BE Ta ar Paepe arch Pironi ipamo Deparment Furie Emo Ci hc Hee Hot Accepi Parapat Core hao Bra Declined ParDopamor Fri ar a Art ba cay Eh Arbvies Ee pere z r a l _ Tal aaa ar EH ima Banii Deum Dipake ap Bie ne Lig l Filer by chy w Gs arlene iri Lh f kr Dis ree Attachments StampedDocuments DeparimentApprovals RevewerNotes Change Log Fitter by Acthtty ul Adanced Arty Athor Activity Date TA IRB Administrator Ownership Re assigned Punsal Jennifer M 8772013 302 PM EDT E Assigned to Jennifer Punsal Dept Study Approved By Departmen Reviewer Departmental Bi42012 129 PM EDT i vj FE 2nd Reminder ta Dept Chair Administrator System B22013 S03 PM EDT pr Say Submitted for Renten Prinapalimesigalor Training 5172013 11 40 AM EDT mien tw tm ome tee ee Version 3 17 8 7 2013 Responding to Requested Changes The study team will receive an automated email notification when the study is sent back to them for requested changes Within the study workspace you must click on the Reviewer Notes tab to see requested changes 1 Select the Click here to respond link to respond to these reque
3. get an ID so can use the elRB system Frequently Asked Questions elRB Basic Terminology What is a Project What is a Workspace Whatis an Activity What is a Form Whatis a State What is a Continuing Review What is a Reportable Event What does it mean when my project is in the Presubmission state Navigating the elRB System The protocol disappeared why can no longer see it How do figure out the status of my project received an email that needed to do something but when log in nothing is there Why am receiving a 1 error message Performing Actions in the elRB System How do add study team members not in the pick list How do withdraw my Protocol Continuing Review Modification How do make and submit changes How do create a Renewal or Final Report Study Closure How do create a Protocol Deviation or Reportable Event How do submit my project for review Questions Regarding Consent Forms and Attachments need to edit an approved consent form but it s locked Why are the approved consent forms locked can edit parts of the form but have a problem attaching documents receive a The page cannot be found error when trying to open an attachment Where can find consent form templates and other university forms v heepe ffeirb rutgers edu AIRB Rooms DizplayPsqes LayoutinitisleContsinerecom webridge antity Entity SBOIDASBC7FB37941 AAFTEEIFA2COIA 9F25426424 50 5D K10 Fr
4. IRB Administrator Review An IRB Administrator will be assigned to the study The IRB Administrator will conduct an administrative review and manage the scheduling of the study Step 4 IRB Review The IRB committee will review the application and provide an approval Committee decisions and approval letters are recorded by the IRB Administrator in elRB and sent to the PI Step 5 PI and Study Team e Conduct research e Report adverse events e Submit requests for continuing reviews e Submit modifications to initial submissions Version 3 7 8 7 2013 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Create a New Application and Specify Personnel Pape for lraining Principal Investigalor Windows Inlormel Explorer G Kir E htp ntgers edu x cwet ser Rives 2S E Page tur Tr airing Prep Investigator o R E SS a Pope Seye Tose Qe w RUTG RS IRB j Training Principal Invesbgator My Home Logot uwes Sandbox USER PROFILES Current Role Welcome to your Personal Page RESEARCH STAFF Current Rote Please note RESEARCH STAFF Rems appearing in your Inbox require your ir My Roles You Can monitor the progress of your submit My Roles e initiate a new study application by Chcking on When you are using eiRD you must pakenin a ROLE you In order Io update your contact information your fe When You are u sing el RB you must Research Stal tell the system which ROLE you Em Pog AB Studien Ab Submission
5. a Impiermentng no changes in be appre protocol or conserd form without poor appeal of the ivstethatonal Review Board RB Conducta the tesegcch unng nhy the quakbed personne isted on the approved protocol a Submilins a lim a Hotf ying the IRE working Jans Repaning al dag immediate not l agree with the above statement understand that as Prince Iresbgior assume full vegansiteey for the conduct of the siudy and fer the protecion of the mghts and welfare of human subpects ipec ved im this vesesech Required Depanm mene Approvals GAS TROEHIEROLOSY KEIEZINE M poU have mabed ing cof For ancab and Bach ite cdecartitaesiis fo rece oh ther chok OF After you cick CH you will mE Geert Seat Bele BS aes hep een Wd nell abe ed ee Tr ie eT ie jue Sees Se eee eel oe ee eet er fo Sete par an ches lal l agree with the above statement L Check the Status of the Application and Respond to Requested Changes Once the application has been submitted to the IRB the application is automatically routed to the required personnel in the review process As part of the study team you will receive notifications from the system indicating the completion of certain elements of the review process or requesting changes to be made to the application You can also check the progress of your application by opening the Study Workspace in elRB Receiving Progress Notifications and Update E mails The elRB system automat
6. proposed changes amendments study modifications end paper file conver Proms Tam Mew Podica t borm Study Contimuaticns end Final Reports study closures Ca New Continwing Rewiew Chic on Mew Reportable Ewent for LUnantiopeated Problems Advernse Event Protocol Deviations DOSE reports and JA dee ed Qe ent Reguests ri 1 Y Mew RE portabhe Event Appr Submit a Modification to the Study When you need to make a change to an approved study you must submit a modification to the IRB for approval When making changes the approved study application is the working document and all required changes must be made in the Modified Study which is a copy of the approved study When the IRB approves the modification the Modified Study becomes the approved version of the study All previously approved versions of the study are stored in the system for record keeping and audit purposes in the History folder Version 3 23 8 7 2013 Create a New Modification 1 Inthe approved study s workspace click the New Modification button on the left navigation pane to start the application for a new modification Complete the first page and click the Continue button lick on Mew Peboedificeaticom for proposed changes amendments study modifications end paper file conver Poms l Taa Mew Piodithoa tiorm Chick on Mew Continuing Review for Study Gontimustions and Firmel Reports study closures Ca New Continuing Rewie
7. The first study application screen appears in edit mode 3 Make any necessary changes and save the study by clicking the Save or Continue button training Windows Internet Explorer 68 gt E https rutgers edu gly Favorites S RUTGERS elRB l training 2 Ah TE AMY en Sandbox OF NEW Edit Study Pro2013003171 Save Exit Hide Show Erots Print Jump To 1 Study Identification Tes is the first step in wir Research Application You will be automatically quided to the appropriste forms needed to complete your submission 4 0 Select the type of submission for your study Research ProtocollStudy G Research Tissue or Data Bank Facilitated Review or NCI CIRB Independent Review Ee view Smartform Progress Emergency Permission My Activities Humanitarian Use Device HUD C Quality Assurance Quality Improvement Only Py Edit Study Edit Email List L Full Title of Research If Research Tissue or Data bank Describe where the research tissue OR data bank is physically located i e Institution Department Building Floor Room 0 Send Email to Study Team training sg Change IRB of Reco nial Short Title Study Name Principal Investigator Bank Administrator Training Principal Investigator Study Coordinator Contact Person Version 3 20 8 7 2013 THE STATE UNIVERS Y UF NEW JERSEY View the Approval Letter and Appro
8. for use in the consent process These documents will be converted into a PDF file e The Clean and Strikethrough Copies of Consent Forms found in the Attachments tab will contain unstamped versions of the approved consent form These documents will be editable in MS Word and should be used if there is a future need to amend the consent forms e The remainder of the Stamped Documents tab displays any question in the application that allows you to upload a document or file Use the tab to quickly locate any document in the application Submit a Reportable Event for the Study Reportable events are used to report any of the following to the IRB e Acknowledgement Request e Unanticipated Event e Data Safety Monitoring Report e Protocol Deviation Version 3 22 8 7 2013 oe mi L gt iy OF N E W JERSEY Create a New Reportable Event 1 Inthe approved Study s Workspace click the New Reportable Event button to start the application for a new reportable event 2 Complete the first page of the application and select the type of reportable event 3 Click the Continue button and complete the rest of the application TIP If this reportable event requires you to also submit an amendment to the study click the Create Related Modification activity in the reportable event workspace 4 Amember of the study staff must submit the reportable event to the IRB using the Submit to IRB activity lick on hew Pebodificeationm for
9. later time you can use the Save button at the top of the screen Simply exiting will not save changes Navigation Edit View Windows Internet Explorer Ge gt hd e https rutgers edu v 4 ba 4 X Gs x Convert PR select Sr Favorites 5 5 gt r Edit View fay H v Pager Safetyr Tools 2 RU l GER FF Exit incon Ee Print Jump To 1 Study identification THE STATE aey OF NEW JER Edit Study Pro2013003194 d Save Exit Hide Show Errors Print Jump To 1 Study Identification Stud ificati Na 1 Study Identification Help lt lt Back 1 0 Study Identification IRB Newark This is the first step in your Research Application You will be automatically guided to the appropriate forms needed to complete your subm 12 IRB Researcher Training Records 1 3 Conflict of Interest Continue gt gt 1 0 Select the type of submission for your study Research Protocol Study 1 4 Required Departmental Division Reviews 1 5 Review Type O Research Tissue or Data Bank Facilitated Review or NCI CIRB Independent Review Emergency Permission 3 Review Type Risk Determination Humanitarian Use Device HUD 3 0 Review Type Risk Determination Quality Assurance Quality Improvement Only O Western IRB WIRB 4 Study Funding Clear 4 0 Funding 4 1 Adding Sponsors 2 0 Full Titl
10. ss Copy Study sg Edit Email List amp Send Email to Study Team cations regarding this study Filter by Activity v co Advanced sg Change IRB of Record Activity Author Activity Date 8 Created Study Principal Investigator Training 8 27 2013 3 33 PM EDT Initial Application Validation and Submission In the Study Workspace select Submit Study located in the left navigation bar Only the Principal Investigator on the study can submit the application The system will run a final validation check on the entire application before submission If there are any errors they will be displayed on the submission screen that opens up and your application will not be submitted The application must be error free and all co investigators must have agreed to participate before it can be submitted On the new screen that opens up read the Principal Investigator s assurances and check next to agree with the above statement Select the OK button at the bottom of the screen to submit the application for the study Version 3 13 8 7 2013 THE STATE UNIVERSITY OF NEW JERSEY Sime ben Inmesoigador Assurances I cerifyr Ghat all nenn peceded an thers application represents an accurste Gescnpien of the attended stuck l eoree 10 ioios and sbie by all policies are procedures 25 weli as by af federal slate and local fas concer the piece of human supects m research inchdeng bul not med 10
11. Mm v Pager Safety Toos RUTGERS eIRB THE STATE UNIVERSITY Sandbox OF NEW JER Training Principal Investigator My Home Logoff SRT edle IRB STUDIES USER PROFILES IRB Studies gt Tissue Bank Test Current State Study Tissue Bank Test Pro2013003193 New Brunswick Piscataway 2 PRE SUBMISSION 3 un Principal Investigator Training Principal Investigator Study Coordinator EI Edit Study a Funding Sources Department Funded E Printer version Co Investigators Who Have Not Accepted Participation There are no items to display Co Investigators Who Have Declined Participation There are no items to display H view Smartform Progress 5 Pre Submission IRB Review Department a Review My Activities EEE Review Complete Requested Required Requested amp Notify Co Investigators to 7 8 a Agree to Participate 9 ss W Nithdraw s Copy Study Attachments Change Log 5 Edit Email List This area displays instructions questions and important notifications regarding this study o Send Email to Study Team s Change IRB of Record Filter by Activity co Advanced Activity Author Activity Date Created Study Principal Investigator Training 8 27 2013 3 33 PM EDT Initial Internet Gr 100 The workspace displays important information about the study and contains links to help navigate to any information contained in the study 1 The current state displays the progres
12. RUTGERS HE 51 F NE if eIRB User Manual for Research Staff 8 7 2013 herein AICE F NEW JERSEY RUTG Table of Contents EIRA EE are E A ee ee 3 LOE NOC Bonner res A einen 4 Overview of the eIRB Submission and Review PLOCESS ssssssssececcecssaeesseeececeeseuaesseseceeeessaagseess 7 Create a New Application and Specify Personnel ccscccccsssececesseceeeesecceseeseceeeeaeceseeeceeseeseeeeas 8 Na EA Once re 9 SUDMIE NE ABBIIE A ON ee te ee een 12 Application Validation and Submission cssccccssseccccesececcessececeusececceneceeeeusecessuaecesseeceeseneeeetas 13 Te SCO WV OF SCO ae ee ee omnes aig abneduaaenncsaniubssdeaennceacsate 15 Responding to Reguested Cla OSS needs 18 Submit a Reportable Event for the Study cccccceseccccsssececeeseceeeeneceeeeesecesseseceseeneceeseeeceeseeeeeetes 22 Submit a Modification tothe SUG ersehen 23 I When the Modification is complete the Pl must submit the modification to the IRB by using TRESUBEMIETONRB ACIYI ee ee ee 25 Submit a Continuing Review for the Study cccccscccccsssecccsesececcenececceeseceseeeceeeeeceseeeceeseneeeetes 26 Frequently Asked Questions u een 27 Roles and ADDreviatiOns cccccccccsssssssseecccccsceeeececcccessseeesseceseceessueusseeececeessauasseeeseeeessagaaseeeeeess 28 CONAN ee ree E eer tee 29 Version 3 2 8 7 2013 eIRB Access The website is available via any Internet connection anytime with a s
13. Staff 6 7 8 9 IRB Studies All Submissions My Profile Create E New Study Displays all items which require action by the study team Click on links for more information Quick Links Filter by i ear Advanced Consent Forms ID Name Date Modified Type Owner State Last State Change Campus Pro2013003193 Tissue Bank Test 8 27 2013 4 09 PM Study Pre Submission 8 27 2013 3 33 PM New Brunswick Piscataway Pro2013003192 See All Biopower Tissue Bank 8 27 2013 3 43 PM Study Pre Submission 8 27 2013 2 48 PM New Brunswick Piscataway Pro2013003185 Test Tissue Data Bank 8 27 2013 12 09 PM Study Pre Submission 8 22 2013 11 52 AM New Brunswick Piscataway Pro2013003188 Training 8 23 2013 11 16 AM Study Pre Submission 8 23 2013 10 16 AM Newark Pro2013003187 _Protocol Fri Aug 23 10 19 26 EDT 2013 8 23 2013 11 16 AM Study Pre Submission 8 23 2013 10 16 AM Newark Pro2013003189 training 8 23 2013 10 37 AM Study Pre Submission 8 23 2013 10 16 AM Newark Pro2013003184 8 14 2013 3 40 PM Study Pre Submission 8 14 2013 3 40 PM Newark Pro2013003150 Test 1234 8 13 2013 4 16 PM Study Pre Submission 5 29 2013 10 54 AM Newark Pro2013003182 RBS Tissue Bank 8 13 2013 3 00 PM Study Pre Submission 8 13 2013 2 15 PM New Brunswick Piscataway Pro2013003178 Trainer 8 9 2013 10 57 AM Study Pre Submission 8 9 2013 10 27 AM Newark Internet Sr 100 Left Navigation Bar 1 My Roles allows you to select between user roles if you have more than one Select the correct role as
14. e of Research If Research Tissue or Data bank Describe where the research tissue OR data bank is physically locat _ 4 2 Other Funding Source 4 33 Coverage of Study Related Costs 1 4 3b Coverage of Study Related Costs 2 v 3 0 Short Title Study Name Mi Internet f 100 e Use the Back and Continue buttons to move back and forward on the screen e The Save button will allow you to save any changes made to the application e gt Exit will close the application screen without saving changes Always save the application before exiting 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 by selecting a link from the drop down box Version 3 9 8 7 2013 RUTGERS ze STATE UNIVERSITY NEW JERSEY e Hide Show Errors will show any errors and mandatory fields not yet completed e 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 Error Warning Messages Message Field Name Jump To This is a required field therefore you must Full Title 1 Study Identification provide a value This is a required field therefore you must name 1 Study Identification provide a value This is a required field therefore you must Upload Management Plans 1 3 Conflict of Interest provide a
15. each role has its own inbox Your role determines your access level or what you are able to view edit 2 The Create New Study button allows you to start a new IRB application from scratch Version 3 5 8 7 2013 Top Navigation Bar 3 Your Name allows you to change personal information 4 My Home is the default user page which always returns you to this page view 5 Logoff ends your session and logs you out of the system Tabbed Area 6 The Inbox tab displays all studies you are a part of that require some task to be completed by the study team 7 The IRB Studies tab allows you to search through all respective IRB studies that you are a part of regardless of where the study is in the submission and review process 8 The All Submissions tab lists new studies continuing reviews modifications and reportable events you are listed on but do not require your attention 9 The My Profile tab allows you to edit and view your personal training profile and research certifications Version 3 6 8 7 2013 THE STATE UNIVERS Y UF NEW JERSEY Overview of the eIRB Submission and Review Process The following steps illustrate the basic application review process Step 1 PI and Study Staff Prepare and submit application Step 2 Dept Div Review The application is routed for approval and sign off e Department Review This is a blocking review where the IRB will not see the project until it has departmental approval Step 3
16. epted Participation There are no Hens to display Codmmestigators Who Have Declined Participation There are no hems In display dan Summary of Changes SS Print Friendly Study Do CE List of im Edit Modification Print Friendly Modification Ph Edit Modified Study El Print Friendly Study My Activines Fa Submit logfication 8 Netty Co lnvestigators to Aprea i Parana Withdraw fa send Email to Study Team Pap Submin Taste Activity Date a 11 38 AM EDT You can also Edit the Modification in this workspace Printer Friendly views of both the Modification and the Modified Study allow you to print and view in their entirety The View Changes button opens a window showing changes made to the original submission When the Modification is complete the Pl must submit the modification to the IRB by using the Submit to IRB Activity Version 3 25 8 7 2013 Submit a Continuing Review for the Study e Anemail notification will be sent to the Principal Investigator and Study Coordinator 60 days prior to the Continuing Review due date to the IRB A second reminder email notification will be sent 30 days prior to the Continuing Review due date to the IRB if the Continuing Review has not yet been completed You should begin preparing an application for continuing review before your IRB approval expires Create a New Continuing Review In the approved study s workspace click the New Co
17. equently Asked Q Inbox Microsoft Ou wt Committee member u wi eIRB Use Manual for untitled Paint Jop 1 55 PM Version 3 27 8 7 2013 RUTGERS RSET Roles and Abbreviations Principal Investigator PI A principal investigator is the individual who assumes full responsibility for a research project including the supervision of any co investigators research assistants house staff and students The Institutional Review Board only recognizes one principal investigator per human subjects research study Co Investigator SS Co Investigators are individuals involved with the PI in the scientific development or execution of a project A co investigator typically devotes a specified percentage of time to the project and is considered key personnel Study Coordinator SS An individual who organizes and coordinates the study and study documentation under the supervision and direction of a PI Study Staff SS All individuals involved in research processes under a proposed or approved research study for which a RUTGERS IRB is the IRB of record are considered study staff These personnel may include individuals who will have responsibility for the consent process interactions or interventions with subjects data collection data analysis etc or those who will have access to identifiable private information for research purposes Department Approvers DEPT DIV Department Division Approvers are the individua
18. ere to respond ieee IRB Staff Change Request Tr Te i hung Te 6 21 Radiation Safety Reson Agdimuinishrad or bjezis wall be exposed to during ihe course of thes stuchy Change REB of Record A i o are brie Sirattend IRB Administra Jia SAT A k Re ae wand Click here to respond We require that Pis name sites which are not UMDHJ we should offer the same opportunity for UMDHL sites a5 im check of other and then indicate MAME O e You have 90 days to respond to the requested changes or your study will be automatically withdrawn from the system e If you know that you will need more than 90 days you may request an extension from the IRB by selecting the Request Extension activity to call for another 90 days to respond e The IRB will receive your request and either approve or deny you another 90 days You may apply for up to 3 extensions or an additional 270 days to respond Version 3 19 8 7 2013 RUTGERS ls STATE UNIVERS NEW JERSEY Edit an Application A study application may be edited before it is submitted during Pre Submission or any time if changes are requested by reviewers or the IRB The study will appear under the My Inbox tab in allthese occasions To open a study to make changes 1 From your Personal folder My Home click on the title of the study you wish to select listed in My Inbox 2 Inthe study workspace click the Edit Study button
19. heart to work in Fater by ID E D ast State Change Campus ef Pr02013003193 Tiss mk Test 22702013333 PM New Brunswick Piscataway oF Pro2013003192 See All Biopower Tissu Create 5272013248 PM New BrunswickPiscataway Quick Links oF Fro2013003 185 est lissue Uats Bank W2272013 11 52 AM New Brunswick iscataway oH 102013003188 Training E9 New Study 232013 10 16 AM Newark ee 6102013003187 Pr Fri Aug 23 10 Y22013 1016 AU hewark amp Pr02013003189 reining a o 3242013 10 16 AM Newark F Fro2013003184 8 14 2013 3 40 FM Y Fre Submission 12013 340 PM Newark P 02013003150 Test 1234 8320134 15 PM Pre Submission 5292013 1054 All Nerzuk oF Pr02013003182 RBS Tissue Dari 3132013 3 00 PM Pre Submission 8132013 215 PM New Brunswick Piscataway om Pro2013003178 Trainer 8972013 10 57 aM Pre Submission 882013 1027 AM e Create a new study by using the New Study button in your personal folder This will open a new application so you can fill in the identifying information for this study e Once the smart form opens enter at least the required fields those marked with a red asterisk are mandatory e You can answer the text questions by typing directly within the form or by pasting in information from another application such as Word e Select the Continue button in the navigation bar to save and move to the next screen Version 3 8 8 7 2013 RUTGERS ls STATE UNIVERS NEW JERSEY e If you need to finish an application at a
20. ically generates email notifications and sends them to the study team when significant events have occurred in the review process The study team will always receive a notification when a reviewer requests changes be made to the application In addition the study team will receive notifications at the following times Version 3 14 8 7 2013 pe u g ur dei Ur NEW j E ESET e Confirmation that the application has been submitted e Receipt at the IRB office e Official action letter from the IRB Since the system uses this email address to send notifications about review progress it is important that your email address recorded in the elRB system is current e You can update your information by returning to My Home and selecting the My Profile tab e Select your name to open your profile e Choose Edit Profile located in the left navigation bar e Change any outdated contact information e Select Save Exit to return to My Home The Study Workspace Every study created in the elRB system is assigned a folder or workspace When you click on a study to view it from your My Inbox the study s workspace is opened Version 3 15 8 7 2013 THE STATE UNIVERSITY OF NEW JERSEY Tissue Bank Test Windows Internet Explorer Ge https bsandbox rutgers edu cIRB F x convert PP select Aus Eu ted Sites gt T E r amp Tissue Bank Test x Page for Ariella Finly ff gt N
21. ls within each department division who have signatory authority for a department division Version 3 28 8 7 2013 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Contact Us Office Locations HSPP Office 973 972 1149 FAX 973 972 1598 65 Bergen Street SSB 507 Newark NJ 07107 RBHS Newark IRB Office 973 972 3608 FAX 973 972 0906 65 Bergen Street SSB 511 Newark NJ 07107 eMail IroNWK ca rutgers edu RBHS New Brunswick IRB Office 732 235 9806 FAX 732 235 9810 390 George Street Suite 700 New Brunswick NJ 08901 eMail IroNB ca rutgers edu Version 3 29 8 7 2013
22. m and the IRB Log in to eIRB You can log into the elRB website using your core username and password Login as After signing into this site you are bound by the terms and conditions set forth when you received your account Version 3 4 8 7 2013 UTGERS THE STATE UNIVERSITY OF NEW JERSEY Personal Folder Your elRB experience is personalized allowing you access to all of the studies you are listed on When you log into elRB you are taken to your personal folder which displays links to items applicable to you Page for Training Principal Investigator Windows Internet Explorer x ll dE Pe Ss S Suggested si Page for Training Principal Investigator fay x A m r Pager Safety Tools RUTG E RS eIRB Training 3 ana ema Home oy THE STATE UNIVERSITY Sandbox OF NEW JERSE gt EIRB SANDBOX HOME IRB STUDIES USER PROFILES Page for Training Principal Investigafor Welcome to your Personal Page the starting point for all interactions with this site RESEARCH STAFF Please note e Items appearing in your Inbox require your immediate attention My Roles e You can monitor the progress of your submissions using the other tabs Items on these tabs do not require any action by you e Initiate a new study application by clicking on the Create New Study activity When you are using elRB you must bei u re tact infor our firsts lick on the My Profile tab Research
23. ntinuing Review button to start the application for a continuing review 1 Complete the first page of the application and select the status of the study 2 Click the Continue button and complete the rest of the application 3 When the continuing review is complete any member of the study team may submit the continuing review to the IRB using the Submit to IRB activity Version 3 26 8 7 2013 GERS THE STATE UNIVERSITY OF NEW JERSEY Frequently Asked Questions Visit the eIRB Home Page for answers to frequently asked questions Frequently Asked Questions Windows Internet Explorer fe x JS v gj https eirb rutgers edu elRB Rooms DisplayPages LayoutInitial Container com webridge entity Entity SBOID SBC7FB3794 1 AA 7EESFA2C044 7F25426424 5D 5D Google p 2 Google vit search 0 8 O dr Share gt D Sidewiki Sp Bookmarks Check al Translate E AutoFill gt onei Convert P Select w k Frequently Asked Questions m Mr dh gt ir Page Toos LITGERS 1 4 gt a Stratford PI My Home Logoff elRB Home Halligen tn E US a TE elRB Home gt Frequently Asked Questions Departmental Approvers System Requirements Frequently Asked Questions elRB Personal Account Questions Institutional Review Board How can I obtain my elRB username and or password Related Links What can do if forget my password do not work at RBHS How do
24. rutgers edujelk E Resource dministrationt Activity iForm Activity Type com webridge entity Entity 3560056623564953 METIE Select Person I lt 1 25 of 26 D D Last First Organization Approver NB UMDMA Chair Test Medicine Cortez Pedro UMOJ Dadas Andrea Institutional Review Board Dean Test New Jersey Medical School Demo Stratford Health Systems and Policy Stratford Camden HSAP Elizes Romerl UMDNJ Fahmy Eanass Institutional Review Board Fell Hill Nancy Institutional Review Board Ferguson Andy Health Systems and Policy Stratford Camden HSAP Forst Cheryl Institutional Review Board Gates Melissa Family Medicine Hoagland Donna Institutional Review Board D DO D D D D D D Lallier Amy Institutional Review Board we Kk JS 1 25 07 26 EF Pl Cancel Internet 100 Version 3 11 8 2013 RUTGERS PEW TERE ERS AS Y NEW JERSEY Submit the Application I e Please note you are required to include the Department s Division s for each study team member involved in this application This is completed in section 1 4 Required Departmental Division Reviews Please note that all Co investigators listed in your study must agree to participate in the study prior to submission An email with a direct link to your study can be sent directly to your co investigators by clicking on the Notify Team Members to Agree to Participate button as seen below Current State
25. s of this study in the review process 2 The panel displays summary information about the study The amount of information will change depending on the study s progress through the review process 3 The IRB number for the study 4 The Edit Study icon will open the application smart forms 5 The Printer Version icon will open all of the relevant smart form screens in one easy to print window 6 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 Version 3 16 8 7 2013 RUTGERS ls STATE UNIVERSI MEW JERSEY 7 The History tab records all actions performed on the study Each action is recorded with the date time and person performing the action You may click on the name of the activity to see the system details 8 The Attachments tab contains all documents for a study 9 The Change Log tab lists all changes made to a submission The Study History Log Every study has a detailed history log For auditing purposes every action performed on the study is recorded in the history log This information is viewable under the History tab This is sorted in chronological order and displays only the actions you have permission to see Each activity when performed is recorded in the history log with a date time stamp and the name of the person performing the activity You can click on the name of the activity to view the system details
26. sts 2 Navigate to the smart form application and make any needed changes Remember to save the changes before exiting the application 3 When you are ready to submit your response navigate back to the study workspace and click the Submit Changes activity 4 Paste the requested changes you copied into the text box Write your response after each requested change detailing the change made or your reason for disputing it When finished click the OK button Version 3 18 8 7 2013 THE STATE UNIVERSITY OF NEW JERSEY Stratford Pi My Home Li 1 E oe om un Jom ts Klierobial amp Hest Markers for Suscegtibaity Study Localized Aggressive Periodontitis Microbial amp Host Markers for Susceptibility Pro2010000740 Stratford Camden REVISIONS PENDING Description Ve are examining students to find their level of gum disease A whether they harbor the 4a bactena Principal Investigator Saratford Pi IRB Administrator Sratford IRB Administra E view study Type of Submission Research Protocol Study Review Type Full IRB Review E Primer version Committee New Brunswick Executives Meeting Date amp Tint FISD T2no0n Colnvestigators Who Have Not Accepted Colinvestiqaiors Who Have Declined View Differences Participation There are no rem to Participation There are no tems to display daplay nen IRB Staff Change Request Jump To 6 21 Radiation Safety Review ha Response Required Click h
27. upported browser htto eirb rutgers edu Getting Help If you have problems need help or have questions about the elRB please contact your local IRB office Using the new eIRB website you can e Create and edit an electronic application for IRB studies e Add other investigators and study personnel to assist in editing the study application e Prepare the study application via SmartForms that present only those sections that are applicable and relevant to your study e Attach scanned or electronic documents to the study e Print out 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 a single application electronically to the IRB e Track the progress of the application as it is automatically routed for review and signoff to the appropriate organizations department heads before being received by the IRB e Receive email notifications anytime a reviewer sends the application back for requested changes Version 3 3 8 7 2013 RUTGERS THE STATE UNIVERSITY UF NEW JERSEY e Receive the approval letter via email once the study is approved A copy of the approval letter and approved consent forms will be posted online with the study and available for download at anytime e View atime stamped log of all changes made to the application and any correspondence sent between the study tea
28. value This is a required field therefore you must Do study investigators have a financial interest 1 3 Conflict of Interest Version 3 10 8 2013 RUTGERS ls STATE UNIVERSIT MEW JERSEY Assign Study Personnel As the creator of a new study application you will specify who has permission to edit and view the study On the Study Identification screen you can select the Principal Investigator 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 study coordinator co investigators or other study staff will be able to edit and save the study application If you would like to give a new person permission to edit the study later on you will have to add them to one of these sections at that time Principal Investigator Study Cogrding Principal Investigator Stratford PI Co Investigato Last Name First Name Department Division On Probation Co Investigator Stratford Community Health Co Investigator 2 Stratford Health Systems and Policy Stratford Camden HSAP Other Study Staff Name Department Interaction or Access to Individuals On Probation There are no items to display By clicking the Select button a search page will open that will allow you to search for a person by last name first name organization project ID or user ID An example search is shown below Select Person Windows Internet Explorer i B https eibsandbox
29. ved Consent Forms When your study has been approved by the IRB you will receive an email notification containing the approval letter The approval letter will also be posted in the study workspace and will be available for download at anytime View the Approval Letter 1 From your Personal My Home folder select the IRB Studies tab and click on the title of the approved study 2 Inthe study workspace the summary panel will now have an item for Letter of Approval Click on the View link to the right Study Test_004_ZachH Pro2009000458 Stratford Camden Description Summary Principal Investigator Stratford P Study Coordinator Expiration Date 12 25 200 etter of Approval view Funding Sources view Other Letter of Approval 3 The approval letter will open in a new window You can then print the letter by selecting File Print from the menu bar 4 The approval letter will also be saved for recordkeeping in the history log under the activity as Study Approved You can view the letter by clicking on this link then View Approval Letter in next window Version 3 21 8 7 2013 View the Approved Consent Form 1 Once your study has been approved the consent forms will be accessible from the study workspace under the Stamped Documents tab All documents from the approved application will be available under this tab 2 The Approved Consent Forms section will list all of the consent forms approved
30. wr Tlic on Mew Peeportable Ewent for Lnantiopeated Problems Adverse Events Protocol Ceevietions DSHS reports and Acknowledgement Requests F 1 i Mew Pe portabhhe Event e NOTE The elRB system only allows one modification to be in process at a time All Modifications must be approved rejected or withdrawn before a new one is created 2 Provide justification for any changes that need to be made in the study application 3 When finished explaining the changes save and exit to the Modification Workspace 4 All changes to the study MUST be made in the modified study Edit the Modified Study 1 Inthe Modification Workspace click the Edit Modified Study button to open the study smart forms e Note this is a copy of the approved study that can be used to make your changes 2 Make all the changes you detailed in the modification application 3 To return to the modification workspace click the Exit button Version 3 24 8 7 2013 THE STATE UNIVERSITY OF NEW JERSEY RUTGERS xe Sandbox See a RE STUDIES Ge i THE STATE UNIVERSITY OF MEW DERSEY IRE Ste Training gt Mydlicaton 2 lor RE zei Training Principal Ivestigalor Uy Home Logot ate bby LINKED MOG no PRE SUBMIS SHON Pt Training Principai Inveshgaloy Coordinator Modification F Mode 1 3000312 Degree of Change Minor Non Substanive Change pain Created 1122013 11 38 AN Dada Submitted Lnsobenimed o mestigators Who Have llot Acc
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