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eIRB User Manual

1. uuu A MA 43 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY eIRB Access The website is available via any Internet connection anytime with a supported browser http eirb rutgers edu Confidentiality While PHI is typically not included in eIRB studies there are study designs ideas methodology and other proprietary information for which IRB members are responsible for safeguarding Precautions should be taken to protect Rutgers information in eIRB Please protect this information in the following ways e Do not select the Remember Me feature of the eIRB log in page from laptop home computers as this may compromise the security of confidential information e Do not share your eIRB password e Do not leave your computer unattended while working in eIRB e If possible do not print the Investigators Brochure the protocol or other study materials e If you do print from eIRB take precautions to destroy the paper upon completion of your review Getting Help If you have problems need help or have questions about elRB please contact your local IRB office RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Designated Reviewer Workflow elRB enables IRB members to conduct review of new studies progress reports study modifications continuations and reportable events in an electronic environment that improves record keeping and reduces environmental impact There are three ways t
2. EIRE HOME IRE STUDE 5 USER PROFILES IRH Studies gt The Validity od New Ballard Sobra tor Gestational Ag Modified Sheddy The Validity of Hew Ballard Score tor Gestaponal Age Assessment in Narcotic E xposed Neonates M52 Pro 2001855 Newark The goal of fnis study ig To debermine Ee validity of using the Hew Ballard Scone Tor assessing gestational age in a specific group of neonagbes who hyat Den exposed to narcotics The hypothesis is hal narcoticexposed infants arg inappropriately assigned an older gestational age using the New Ballard score compared to ether methods of dating as tesut of MODIFICATION OPEN exposure in utero affecting neuromuscular development suay The speci amp c aims as follows Study Ta determine if the New Ballard Assessment ts comparatively higher than dating based an either last menstrual period or ultrasound dating in narcatic axpased neonates 7 bj determine if neuromuscular score of Ballard Score comelates with time to withdrawal symptoms ar length of trestment time for withdrawal in narcotic exnosaed neonates in Nareobe Expesed Current State Fh printer version Principal investigator Ener Omad Study Coordinator Expiration Date 2 2013 Modification Letter ActiviBes eee View Differences a Activity Author Activity Date Change Log 3 3 Con Bain Junnite
3. Stratton IRB Admaintrator 5 19 2010 1 10 PM PDT Schedule Far Assigned to Board 7 on 5 2 2010 Sirmid IRE 519 2010 1 10 POT masa Changed Review Stratford RS Administrate 5 19 2010 1 09 PM PDT New Full IRE Review f Fur assign Owner Route 5 19 2010 1 05 PM POT Susbacted IRA Comrmntiee 5 15 2010 1 05 PM PDT 3 Assigned to Stratford Board 1 Submit Sraid Pi 5 19 2010 12 57 PM POT Created Continuing Renew Stratford 5 10 2010 10 57 AM 18068 Done 100 If you Acknowledge the continuing review box will open allowing you to make comments add documents Click to begin the review process EX a one mn Acknowledge Reviews Comments Add Documents Mame Description There are no items to display Cancel Done Internet E 10095 V 19 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY When you view the Continuing Review in its smart form version you can use the Jump to menu and add reviewer notes in the same way as a new study After you have added all your reviewer notes tothe smart form exitthe study and submit Any Additional notes Add any documents Select Review Motion Check off Review Complete Submit review by selecting OK gt IRB
4. x icone P seet E Suggest w O m Pem wre Toh RUTGERS IRB Sandbox d J OF Hrw IFESTEY IRB Commitee My Home Lagon BRE SAHDBOX HOME USER PROFILES IRB Studies Tinin Current State Study Training Proz 13003147 Newark NREUEW Dencription Training Training Principal Iresligalos IRB Admin Pur al Commitiea Blue Review Type Expaditad pa of Submissi n Research Protecaliatudy ponsi Department Funded 39 wien IGEDE rneestigators Who Have Hot Accepled Participation Co Investigabors Who Have Declined Paartscipalion There are lems te display There are t display view Study ar T N assisiaril w Display PAR Checklist Disptay Reviewer Mates Lon Private Comment attachments Stamped Documents DeparmentApprovals RevewerNotes RewWews ChangeLog Filter by d eo Advanced Activity Authat 2 Activity Dule EM Submitted Review Acree with concdilians Committee Member IRE 452013 2 55 EDT Completed Reviewer Checklist Waiver Informed Consent Committee Member IRS 8 5 2013 247 PM EDT 1 CGnmgpleiad hadit Fer miia Fn Cnmmitop 247 PM EDT ca Completed Hewewer Checklist for Research Involving Pregnant Women Commitee Member IRE HERTS 247 EDT bw Curmgleted
5. A Co hrecessligators Who Hane Hot Acceplec Participation Who Hart Dicini Participan There are items to display There are nc items ip display I My Activities eit E a vier Checklist dificatice Fon Submit Ren Dale Reviewer Not qo j M C5 03 877120713 3 13PM EDT FEY DESDE Rewer TeDTES 1 ram nl mo selected IRE Commies Funsal Jenifer 8712013 312 PM EDT 7 assigned to Blue bu Changes Jennifer 5 8 2013 3 45 PM EDT 3 0 Changes Logged Fas Accepted Parficipsson Joseph V 5 6 2013 342 PM EDT e Netied Co Imiestiaators te Agree to Participate Bain Jennifer 5i5r2013 2 013 PM EDT 7 Fieasa log into and accept parscipatianr for this study Thank you 24 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Modified Study Workspace The Modified Study workspace looks similar to the original study workspace however you ll notice the title says Modified Study Validity of Hew Ballard 5care for Gestational Aga Assessment in Harcotkc Exposed Neonates Windows Internet Explorer hip n tgers edu Fe H x oet PD select Favodes ds i gt The validity of New Ballard Score for Gestational Age ii RUTGERS ers IRB Cormmittea Homoj Logom T THE STATE UNIVERSITY Sandbox Of MEW
6. My Commitlees zi 3 My inbox pend Tut Filter Name Abvancad hs 1 t 11 27 Adminis rator System Scheduled T T2012 11 28 Agminissrasor System Scheduled TifTi201z 11 15 Administ wot Soe TiO 11 15 Green meeting 10 23 2013 Administrator System Scheduled 11712012 11 27 All Administrator System Scheduled Tarn 2 10 37 Administrator System Sheed Tate 1035 AM Lo mese ___ 34 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Green meeting 10 23 2013 Windows Internat Explorar 1 P R8 x 8 X T F select sit Fortes d moeting on 1023 2013 dw Pee Thr e UTGERS ms IRE Committee Member Home Logoff THE STATE UNIVERSITY Sandbox T OF NEW IEKSE EIRE HOME IRB STUDES USER PROHLES Me tings gt Gr en meeting an Tnm en x Current State Green meeting on 10 23 2043 SCHEDULED Start Time 300pm Dais 102312013 Localtiun 5 View Meeting agenda E Agenda Items G Heeling Agenda Stanley S Bergen Building Room 503 amp Confirmed Atlendeas t My Actn ties de CONT Afianidanco e Decline Attend ance Db Minutes Document EJ Send Email to IRBA i RIP emp Confirm Attendance Decline Attendance proie DEO MED CAD nN E WE CUFTIFTHA UE
7. the tools you need in order to complete your role in the Study My Roles application process Use the following guidelines to process your Studies When you are using you must tell the system which ROLE you s Complete reviews for all items in your inbox by clicking on the study name warn to work In a Meetings for your committee are listed on the Upcoming Meetings tab Conimillee Merdbor a af prior neis 16 located in the All submissions tab Committees dur Upcoming Filter by ID 6 Advanced LI ID Name ClDateMod ed Type Sue Campus Study 4 411 4 110 gf Mod2013000216 2 for IRB Stud 8 28 2013436 Modification Newark The Validity of New Ballard Score for Gestabional Age Assessment in Narcotic 2012001855 Review Exposed Neonates CAO0000515 2014 Redewtor Fro201300318 8714720713 1011 Contmuing In Newark Test Cv Review Continuing In Newark Test CY Review Review 84 2013 10 11 AM ce CROO000515 2014 Review for Pro2013003183 Done of Trusted sites me Kio The Continuing Review Workspace is similar to that of a New Submission Review except that the header information will include a continuing review ID and a description of the continuing review 17 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY You may open the Printer Version or view the continuing
8. AM EDT 7 Assigned to Claribel Vega al Submit Principal Investigator Training 842013 10 04 AM EDT raa r halg ajian igni IL Lu Te pran UL PEEL nh i cnT f Trusted sites X 18 RUTGERS THE STATE UNIVERSITY OF NEW IERSEY To begin the review Acknowledge or Defer the Continuing Review by clicking the appropriate buttons under My Activities Home IRE Studies RB Studies Acie Nurse Paticinatior 3033 Rem for Praz tOODOTFERT Current State Continuing Review 2011 Review for Pro2010000787 CR00000136 Pro2010000TBT Stratford Camder eee dem ops Initial study submission type Research Pratocoli Srtudy Review Type Full AB Revere view Contimuing Review Principal Investigator Stratford Plt Health Systems and Policy Stratfond Camden Study Coordinator Stratford Study HSAP School of Public Health SS rrinter rrenaty version Study Status CO pan to Enrollment No enrolment ta date Type of report Continuing Ampart Humber subjects enrolled to Are any changes to the research being no Activities cate proposed at this time Log Private Comment Related Modifications Related Reportable Events Nanve Link to Modri amp catian State Mame Link to Reportable Evert Zia There are na itema There are no arma display i Activity One Stradiasd IRB Fdiminrstralcs S201 541 AM PDT
9. Claribel 8 14 2013 10 11 EDT Assigned to Green Re assign Owner Vega Claribel 8 14 2013 10 10 AM EDT 3l Assigned to Claribel Vega PI Submit Principal Investigator Training 8 14 2013 10 04 EDT 793 Crested Conftiniina Review Princinal Invectinatar Training 914412142 41 11 4M ENT OD L 081 gt There are several items that appear in all workspace types e The left navigation bar is the white area that appears on the left side of each workspace page e Activities are available to reviewers in the navigation pane e Ahistory of all the submission s activities appears under the History tab Other tabs include documents submitted in the project and reviewer notes RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Reviewing a New Study To conduct a review in elRB you will e Preview the study e Acknowledge or Defer Review e View the study e Enter reviewer notes e Complete required checklist e Submit the review Preview the study Aconvenient way to preview a study is to click on the Printer Friendly Version button RUTGERS ms IRB Committee Member My THE STATE UNIVERSITY Sandbox OF NEW JERSEY IRB STUDIES ee IRB Studies gt Test CV gt 2014 Review for Pro2013003183 Current State Continuing Review 2014 Review for Pro2013003183 CR00000515 Pro2013003183 Newark Current study status Approved Stud
10. Reviewer Cliacklisl lot Expedited Review Corridas Hambar IRB 8 6 2013 2 44 PM EDT hana ranearded t Expedited Review Pumsal ennter M E 72033 948 AM EDT Open files uploaded to the project from links with the smart form view Attachments can also be found in the Attachments tab in the Study Workspace i RUTGERS THE STALE UNIVERSITY OF NEW JERSEY Study Smart form view Edit View Windows Internet Explorer Go kg https eirt box rutgers edu e esourceAdministration Project ProjectEd roje 1 webri entity Entity OID DFF 1C35CA45 A074 A9C6B37D amp M rtfo bea p Gs 5 File Edit View Favorites Tools Help x convert P Select ZI Favorites S Suggested Sites ATRE tec B geh Safety Tool 4 RUTGERS eIRB 3 View Study Pro20130031 THE STATE UNIVERSITY Sandbox am OF NEW JERSEY Show Errors Print Jump 1 Study identification Continue gt 9 Reviewer Notes 1 Study Identification 1 Study Identification reat ifie 1 2 IRB Researcher Training Records 4 There are no items to 1 3 Conflict of Interest 2 1 4 Required Departmental Division Reviews 1 5 Review Type Hei 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 5 3 R
11. Study After you have used the View Differences feature you may click Edit Study to enter reviewer notes Note Edit Study does not actually allow you to edit the study because the Modified Study workspace is a copy of the original study it appears identical p Validity of New Ballard Score for Gestational Assessment in Harcotic Exposed Neonates Windows Internet Explarer Ge ngers edu Fu T x Fy Convert Pi Seet E The validity of New Balard Score for Gestational Age u RUTGERS ers IRB Committee Horne THE STATE UNIVERSITY Sandbox OF MEW IEBAXATY IRE STUDIES BR Th Validiy of New Ballard Score tor Gestalianal in pesed Medication 2 Far IRE Study SEro2012001855 The Vadit panas of Mow Ballard Soong for Gestational Aga amp ssasament in Narcohe Exposed Modified Study The Validity of New Ballard Score for Gestational Age Assessment in Narcote Exposed Neonates M57 Pro2012001855 Newark Description The goal of nis study is bo determing fe validity of using the New Ballard Score for assessing gestational age in a specific group 64 meonabes who hae ben exposad to narcotics The M hypothesis is thal narcotic axposed infants any inappropriately assigned an alder gestational age using the New Ballard score compared to ot
12. certain aspects of the study Stipulations may only be removed by submitting required documents for review by the IRB Examples Approval Notices Certificate of Confidentiality Letters of Agreement Note Application is approved Approval Denied The IRB determines that based on all applicable federal regulations the research cannot be approved Research activities may not be conducted at Rutgers or by Rutgers employees or agents Ds UTGERS THE STATE UNLVERSITY OF NEW JERSEY Tabled L The IRB determines that there are major substantive issues that must be resolved or there is a lack of sufficient information about the research to proceed with its review The IRB review may not proceed and approval may not be granted until the convened IRB has approved a revised application incorporating all requested information or changes Applicability For this level of review the changes required are major and complex the protocol is judged to have serious problems or lack sufficient information for the committee to appropriately assess the risks to subjects Deferred L The IRB is not able to make all the determinations due to a lack of sufficient time for discussion b because it feels it lacks the required expertise or c an Expedited Reviewer does not feel it meets the criteria for Expedited Review At that time the study must be a reviewed at a later convened meeting providing sufficient discussion time
13. 1 0 Study Menbhicabon IMHE This i Pup Fi sep iri pour Parana Applicat You will be guided appropriate for rented exactas poor acera 18 the of qur projpessit HResearah Study Maisan Mack Page Says i study Praz TzguTbss 1 dy Baca Dana Cranes 444 The Modified Study is copy of the originally approved study The reviewer notes work same way in this view as the previous submission examples 2 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY After you enter your reviewer notes and continue through the entire smart form application you will end at the Final Page of the Modified Study To return to the Modified Study Workspace select Finish MITT dy gt 8 ES v fidem X hipe lbetopsdiner c RUTGERS Sandbox Y Reviewer owes Type Show Era damp 19 Page Fa cue operta Es nish Submis eon Type Feztancl Eran Sairis sian M87 P 7512001255 Vou Inm WIN TOL ee dupersmeg uri Ba Pree ae De woran aod digi on Sube Elady Yi
14. 35 PM Member dfasdf L Committee Member Change Request IRB 8 7 2013 8 7 2013 Jump To 1 Study Identification Committee 3 34 PM 3 34 PM Member add study personnel A summary of reviewer notes can be viewed from the Study Workspace under the Reviewer Notes tab Again these notes will only be visible for IRB staff and other reviewers LS RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Submitting Your Review Once you are Satisfied with your reviewer notes you will want to complete the reviewer worksheets In order to fill out the Reviewer s Checklist forms simply click on checklist on the left hand side Reviewer Checklist for Exempt Review Categories Reviewer Checklist for Expedited Review Categories 3j Reviewer Checklist for Research Involving Pregnant Women 3j Reviewer Checklist Research Invoking Neonates 3 16 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Reviewing a Continuing Review To view a study s continuing review workspace return to My Home select the name of the continuing review listed under My Inbox IRB Committee Member Home RUTGERS THE STATE UNIVERSITY Sandbox OF NEW IERSET HOME RA STUDIES USER PROFILES Page for IRB Commitee Member Current Role Page for IRB Committee Member Welcome to your Personal Folder the central resource for managing your Study applications Your Personal Folder provides
15. Committee Member My Home Logoff THE STATE UNIVERSITY Sandbox OF NEW JERSEY v Execute Submit Review on CR00000515 Windows Internet Explorer DBR A Current State inuing Re BENE NN Review Documents Add View Continuing Review n 4 Description Expedited E Printer Friendly Version inci There are no items to display Review Type Expedited Continuing Report My Activities jd Review Motion istime Log Private Comment Revisions to be reviewed by Approval with conditions ZO n v Reviewer Notes Approved Display Reviewer Notes Approved with Stipulations TT vy Reviewer Checklist for Risk Level Deferred Expedited Review Request Changes Categories Request Clarification WIRB Denied WIRB OK to Process U TES Should review occur more frequently than once a year Q NA Clear lecify how often eted all reviewer checklists O Yes Clear If no please add reviewer checklist comments PI s Trusted sites fy 100 20 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Reviewing a Study Modification Study modifications are different from other workspace views within elRB since there are several steps that study staff must take to initiate the activity Each step in the process has its own workspace the Modification Request comes first followed by the changes applied to a Modified Study To view the Modification workspace click the name of the modificat
16. E UNIVERSITY Sandbox OF NEW JER IRB STUDIES BRIS st gt 2014 Review for Pro2013003183 Current State CN n Review 2014 Review for 2013003183 0000515 Pro2013003183 Newark IN REVIEW Study Title Test CV _ IRB review View Continuing Review Initial study submission type Research Protocol Study Review Type Expedited i2 Printer Friendly Version Principal Investigator Training Principal Investigator Medicine Robert Wood Johnson Medical School Study Coordinator p rocess Study Status Active Open to Enrollment Enrollment has begun Type of report Continuing Report Number subjects enrolled to date 95 Are any changes to the research being proposed at this time Log Private Comment Notice 0 Display Reviewer Notes Related Modifications Related Reportable Events Name Linkto Modification State Name Link to Reportable Event State L eft N av i g at j on pp ckiist for There are no items to display There are no items to display xpedited Review Categories Ta bs Bar mAAR Reviewer Checklist Attachments Stamped Documents Modifications Reportable Events Reviewer Notes Change Log Continuing Review CM Submit Review Filter by Activity v Cal Advanced Activity Author Activity Date Fonward to Expedited Review Vega Claribel 8 14 2013 10 11 EDT m Selected IRB Committee Vega
17. S GUIDE creen tette tente tests te tn 38 APPROVED ccsssecssscsecsssccesscssscscscsesecscsecscscsucsescsusssacacsuenecucsssesucssacsussssesssssacsussesucssassesusaesesusaeacsesseaceeeaes 38 APPROVED WITH CONDITIONS sscccssssececssecesscscsecessecsesssecesscscssscsusssacsecsesecusavacsussesecssseacsesseaesuceeeess 38 APPROVED WITH STIPULATIONS ssssseeeoeeesseesseeoseeseseesstessteeseresteesttossrosttosteosteestrosstentresurensresseeeseees 39 APPROVAL DENIED ccccsssessecessecssccesecsesecsssesecscscsecssscsecscacscsecsesucssscsucssaesussesesucessesusssaesesssaesecusaeeueseaes 39 TABLED cscccsssscececsscesecsssecccssscsecsesesscsssecsesssescscsesecsssecsesssesscsssecsecssecscssscssesesucessssecsescsecscessesecensesensesees 40 DEFEBREDS 40 ADMINISTRATIVELY CLOSED sssecsssssesssececcscscsssscsecssscsecssscsecssscsucscacsecsesecssaesesussesecusavacsesscsesecasaeceees 41 SUSPENDED ccccscssecscecscsssececessssecessccscsssecsescsecsssesecsesescsucsssesscsssecsesssecssssucsesssecsesesecesscsucsesssecseasscsuessses 41 REQUEST CHANGES CLARIFICATIONS cccsscsessssecesecsecsescsccesscsecscscscsssesucsesececsesucssscsecucssacsucseaceueseaeesees 41 NO FURTHER ACTION REQUIRED c ccccssssssessssesssscsecscscsecsesesececsesecscscsucssscsucessecucassesucseaesucsessaecesaeeucneaes 42 42 ACKNOWLEDGED 42 CONTACT US
18. SPURS PEMS ATE NG a MEAT Procossed Reported itema smedited items whieh have been sppreved Project PI Title Type Submission Project Stale There are items to display Expired Studies There are ng ilem bo display You can Confirm or Decline your meeting attendance by selecting the appropriate button located on the left navigation pane Select View Meeting Agenda to open the smart form page of the agenda J3 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Glossary Attachments Lists documents attachment to a study Change Log Lists changes made to the initial application Conditions Status of contingencies for the approval of the study Current State Specifies where the study is in the IRB review process Three possible study states include In Review Meeting in Progress or In Revisions Review Department Approvals Lists the department s that approved the study elRB Home Brings you back to the elRB homepage History List of all actions performed on this study submission IRB Studies Lists all elRB studies Jump To Menu A tool located at the top of a smart form in a project which enables users to navigate through the submission pages without having to search through pages unnecessarily Logoff Ends your elRB session Modification The form which study staff completes indicating the proposed changes made to a Study Modified Study A co
19. THE STATE UNIVERSITY eIRB User Manual for Committee Members Ver 2 1 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Table of Contents AC rette ENT EUIS UU Ns 3 DESIGNATED REVIEWER WORKFLOW cccssccsssssececsesccesecsesecsesccecsssecsssssecsssesececsssesussesecscacaecusaesecseacesesees 4 PERSONAL WORKSPACE MY HOME cernerent tette nentes tette tete ense 6 STUDY WORKSPACE scsscecscscscsecscsecssscsccscscsucsesesssssscsecsescsessessscsusacsussescsucsesecssassesucssaesesusasscssacsucssacsecseas 7 REVIEWING A NEW STUDY ccccsscccsssscsesscsecesesssscscsececscseccsesesucscsececssacsessesussssesccssaesesseasacscessesnsassucacaes 8 ADDING REVIEWER NOTES c cccccsssecsssssccscsssecesscsecscscsecscscsececscsecssscsecsssesucscsecusacsesscsesesusacsesecseaesucseaeeeess 13 REVIEWING A CONTINUING REVIEW ccccccssscecssscsesesececseceesecsssesecsesecscsssecscssscsecessesessesececsesesucacsececaeass 17 REVIEWING A STUDY MODIFICATION s cccsssccesssscsesesecsecscsesecsesececsesesssscsecscssscsecsesesussesucscsesecusaesecseasaes 21 MODIFIED STUDY WORKSPACE 25 REVIEWING A REPORTABLE EVENT ccccssscecssscsecssscsecesscsccecscsecssscsecscscsussssecscsescsucsescsssesecucsesecucacacecseass 32 REVIEWING AN IRB MEETING AGENDA c ccsssscecessssessescsccecscsecessesececsesucecscsececsesucsssccusassesecseacsucsaes 34 GLOSSARY 36 IRB DETERMINATION
20. at no further changes revisions or corrections are required on the part of the investigator or the IRB committee Action required L The IRB Executive committee determines that further changes revisions or corrections are required on the part of the investigator or the IRB committee Acknowledged 1 Upon receipt of a reportable event the IRB reviews and issues confirmation of the submission 42 RUTGERS THE STATE UNIVERSITY NEW JERSEY HSSP amp Campus IRB Office Locations and Contact Information Website http Human Subjects Protection Program Office 973 972 1149 FAX 973 972 1598 65 Bergen Street SSB 507 Newark NJ 07107 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 rbhs rutgers edu hsp 43 Newark IRB Office 973 972 3608 FAX 973 972 0906 65 Bergen Street SSB 511 Newark NJ 07107 email IroNWK ca rutgers edu Stratford IRB Office 856 566 2712 FAX 856 566 7195 4O East Laurel Road UEC 1106 Stratford NJ 08084
21. by of Bealls amp Pro2012001855 Pid Review Exposed Neonates c CR ODU515 2014 Review Tor Pronti sks 84 2013 1011 Continuing In Newark Test Cy D REO0000071 abcdefg 9 9 2013 12 24 Reportable Event In Newark PM Review wf Trusted stes fg Aim e Note Reportable Events are easy to recognize because their icon is an exclamation point as compared to other study states 32 RUTGERS THE STATE UNLVERSITY OF NEW JERSEY abcdefg Windows Internal Explorer 6 e https nigar ad Ge Foote 2 RS e IRB IRB Committee Marmbor My Hore Logol THE STATE Sandbox OF MEW JERSI M7 E o omo Pages Safety EIRE HOME IRB STUDE 5 RB Siudies Reportable Eventabcdefg REOQU0OO71 Pro2012003152 Newark Principal Investigator Training Fri a View Reportable Event Department Ej printer verson i View Differences Expedited El Printer version J View Differences Dale 8 8 2013 12 24 PM EDT Acknowledge Review Finis Antia T PUTES rinripal Imastigatar Traini 992013 12 20 EDT Defer Review Event rincipal Investigator Training 3 9 2013 12 17 PM EDT The process for reviewing a Reportable Event is the same as the previous submission examples e Decide whether to Acknowledge or Defer the Reportable Event e View the Reportable Event by selecting View Reportable Ev
22. d click OK in the new window that opens Sse ote Pte Le Daan Where see mo itera Bos diapimey ri umb EL E 22 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Viewing the Modification Click View Modification to open the Modification smart form The Modification will contain information about the proposed changes to a study The actual changes to the study are accessed through View Modified Study Editie Windows intarnet Explorer go https rutgers edu x conet select dpFeedes E Bede odor Page RUTGERS Exit Hide Show Errors Print Jump To Modification Request E VP s xc Back CU Reviewer Hoe Modification Request Minor Non Substanttve Change Justification Creates ee There are no items to di Subject Notification Final Page Exit Errors Pini Jump Fiequest Continue gt gt Modification infomeion Modification Request 10 Degree of change Minor Hon Substanti Change liist Dl Cot ol CHR ON MGE CC Gl M a 2 0 Indicate the type of change and or addition Check all that apply Sekt Persian Change in Study Personnel Description of Changes briefly summarize the change We would like io add Joseph Schwab to our study team C
23. e reserved for when you submit your review RUTG E RS elRB Views Study Praz013003140 Sandbox lt lt Back Jump To 1 Study Bentfcalien Continup gt gt Reviewer Notes Ga Clear Reviewer Notes Reviewer Date Created Date Modified Commitee Member Change Reque Re Commies B 7 2013 3 34 BI7 2013 3 24 PM CM Committee Member Change Request Help 1 0 Study identification IRE Newark This is the first step in your Research Application You will be automatically guided to the appropriate forms needed to complete your submission 10 Select the of submission Tor your project Research Protecoli study Research Tissue or Data Bank Facilit dad HCICIRB Independent Emergency Permission Hurnanitanan Use Device HUD Quality ality Improvement Only Western 8 VIRB 20 Tite of Project If Research Tissue or Datal bank Describe where the research issue OR data bank is physically located Insttuton Department Buding Floor Room off Trusted stes Atom Your reviewer note will become visible on the page it is related to by selecting the small black arrow on the left side of the yellow panel You may delete the note or add an additional note To edit the existing note click on the link Committee Member Change Request Once you have completed all reviewer notes for each appropr
24. eli 8 Caecoy coe 9 Qus ce cee eee eee ee eee at ee mm 07 ec Be Ae EI LX P ee dg s RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Personal Workspace My Home When you log in to elRB all submissions assigned to you will be listed under My Inbox RUTGERS ers IRE Commer Member My Home THE STAT NEW IE 1 i h FaCITY Sand box HHH HOM SEINNES PROHLES Current Role Page for IRB Committee Member COMMITTEE MEMBER Welcome to your Personal Folder the central resource for managing your Study appkeations Your Personal Folder provides all tha tools you need in order to complete your rele in the Study My Roles application process Use the following guidelines to process your Studies When you are using elRB you must tell the system which ROLE you Complete reviews for all items in your inbox by clicking on the study name 1 i eie M Kee eed i cue ME Uh To review a submission click on the study Commitee Member A listing of pror reviews is located in the All submisssons tab Current Role Determines access Date Modi Ip Name Stale Study level pha 4 100 page GF Mod2013000216 Hodibcstion 2 fer RB 53 812013 465 Modficabon In The Validity of New Ballard Score for Gestational Age Assecement in Harcos Multiple roles will amp Pra204 2001855 Reinw Em
25. ent e Add Reviewer Notes in the same manner as before within the smart form application 23 RUTGERS THE STATE UNLVERSITY OF NEW JERSEY Reviewing an IRB Meeting Agenda Each month you will receive an email from elRB indicating that the meeting agenda is ready to view To view studies assigned to other reviewers select the Upcoming Meetings tab in the grey menu bar at the top of your My Home page view Select the name of the upcoming meeting you wish to view Page for IRA Member Windows Internet Explorer bau x Convert Bonet o m El i Page fcr Committee Member RUTGERS eIRB STATE UM Sandbox IRB Committee Member Hore Logon ERE HHM STUHE S USER PRHOHLES Page for RE Commitee barie Current Role Paga for IRB Committee Member Valcome to your Personal Folder ihe central resource for managing your Study applications Your F ersonal Folder peevdes all the tools you need in order t6 complete your role in the Study My Rolas appbcation process Use following gusdelimes lo process yout Studies When you are using HRA you mut tell the system which ROLE you Complete ribns for all tems an your inbox by clicking an The study name Wank bo Work in Meetings for your committee are listed on the Upcoming Meetings Tab Committee Memis listing of peior reviews is located in the All submissions tab
26. ent approved training records on your researcher profile Verify that the infomation below is correct Contact your local IH office Tor any discrepancies Principal Investigator Training Principal Investigator Date Completed Renewal Deadline Study Coordinador Date Completed Renewal Deadline Cuo Inestigerdor s Dale Completed Renewal Deadline There ara no items to display Other Study Staff Hamu OF ACCESS 0 Date Renewal of Trusted shes fas Ai RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Acknowledge Review After previewing the printer version of the study you will decide whether to Acknowledge Review or Defer Review located under My Activities Once you Acknowledge Review you can begin your review You will want to view the study so that you can enter comments and questions about the study If you Defer Review you may send a comment to the IRB Office noting the reasons for the deferral My Activities Ei Log Private Comment Fem Acknowledge Review CM Defer Review 10 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Viewing a New Study To access the study select the View Study button Once you have selected View Study a window will open containing the smart form pages completed by the study staff raining Windows Interne Explores E Gu Wow atts jets rer Ay m don rant P Edt Yew Favorkes Took
27. evens E Bn Dee eet en eee pm cenar se e nang o EODE coh PERTH PIRA FO TERM 3100 FE cro t o x A exe cale wo eh 2 02 Ema Ee fudevsh XR Dockmewkm checks Ya de rare RUTGERS m Sandbox J HEW Transisa Ej ere of There are moibemstiocdsplagy Study Identification IRB Stratford Camden Tras as thu first Step in your Research Apphcoban Tou wall be automahcally to thee approprabe forms needed to Completes your subine 1 0 Select the type of submission for your study Reseanch Protecol Study Facilitated Povia F eernissicn Westen IRB WIRE 2 0 Full Titles of Research Clutarmic Acid to decrease vincri sten im Children with KJ 3 0 Short Tithe Study Name Fucks wiih comcer kj To add Reviewer Notes select Add A new window will open where you will add your comments about the section in question Click OK after you write your note or Cancel to cancel the activity Add Rewiewer Mote Windows Internet Explorer Add Reviewer Note Commitee Member Change Request Note Required cancer Le RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Note Please restrict these notes to the item you would like changed or clarified on a given smart form page General comments about the study should b
28. eview Type Risk Determination 1 0 Select the type of submission for your study 3 0 Review Type Risk Determination Research Protocol Study 3 1 Risk Determination Expedited Qualification Research Tissue or Data Bank Facilitated Review or NCI CIRB Independent Review 4 Study Funding Emergency Permission 4 0 Funding Humanitarian Use Device HUD 4 1 Adding Sponsors Quality Assurance Quality Improvement Only 4 2 Other Funding Source Western IRB WIRB 4 3a Coverage of Study Related Costs 1 lt 2 0 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 Training 3 0 Short Title Study Name Training From this view you may 1 Navigate using the Back or Continue button 2 Add edit and delete reviewer notes 3 Use Jump To menu to select the specific page you wish to see the name of the page is the link to the text Jump To 4 Exit to return to the study workspace 12 RUTGERS THE STALE UNLVERSITY OF NEW JERSEY Adding Reviewer Notes Reviewer notes are added to each page where the designated reviewer wishes to make comments These notes will only be viewable by IRB Staff who will finalize them for study staff and other reviewers LEUN ioe Windkears e Bow nerd fames iem cin co D PP ete
29. ght hand corner To navigate to the other revised pages click Next You will only see the pages that have been revised 26 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY r Wo Tiie Windows Internet Explorer 6 tps edu x Convert d fS Select dy Faves da 2 iho Trie Be Rutgers Rutgers Biomedical omo Page Safety a 6 i A RUTG E RS eIRB IRB Committee borita Hore Logol sawnen Sandbox E MB HOME IRE STUDIES USER PROF WE amp Sacks hance toe Humber of on fis page 1 Number of madifrad page s 2 Currently Approved Pr Proposed Modifications Back to Change Log 1 3 Conflict of interest 1 3 Conflict of Interest 1 0 1 0 Upload study specific Rutgers Financial Disclosure Form for all project personnel 2 0 fein financial andlor irnbelbectusl Document i UMDNJ Financial Disclosure Jone_financial Disclosure Document UMDNJ Financial Disclosure This page highlights a change in which a revised document was uploaded Note The view differences feature may show differences in documents and in certain lists that may not always be accurate If you are unsure about a change please contact the IRB for clarification To exit the View Differences application click the Back to Changes Log button 21 RUTGERS TRE STATE UNIVERSITY OF NEW JERSEY Viewing the Modified
30. hat reviewers may access submissions to the IRB 1 Login to elRB and view the Inbox 2 Click on the link in email notifications 3 Go to the meeting agenda in eIRB This manual demonstrates the recommended process for designated reviewers e Login to elRB e Select the submission you wish to review Preview the study e Enter reviewer notes e Submit your review and upload the reviewer worksheet Email Notifications When a study has been assigned for you to review you will receive an email from eirb ca rutgers edu The ID will link you to the elRB Log In Page and after you log in the Study Workspace RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Subjed Rutgers University ef Send Email to IRBA Activity 5 NUTGERS THE STATE UNIVERSITY Or IRRSHY eee Fap oy ae eee ee F aaa dc ri ee i ee eee Ia eg eee sere nci eet P Fass ee panes ee pe Gee AE ge piar ee ee dera ee Application Requites Your Review 165 Praz09 9000325 Tithe Effects of TH Blockers on Preumoccora Infechon 01 20070344 NE Descnpbon An applcabon cententhy waling dor your nini To mamgate to the project workenace gick on the ID Reviewer Initial 3 3 09 doc COTS Ta o Ps ay oe ee eee ee ee oe Bis sa datis el pr Be ee pr aO Ju dai eet ieee aiie Po meal 4 pee ser Oe mee eect be ed pees cele 9 pode ef ph ae r
31. he Submit Review button then e Upload any documents e Record any comments e Select Review Motion e Check off Review Complete e Select OK to submit 2d UTGERS THE STATE UNIVERSITY OF NEW JERSEY Reviewing a Reportable Event To review a reportable event select the title of the study listed under My Inbox IRE Committee Member Home Logon RUTGERS eIRB Voesnionesn Sandbox HRE SAMURRA HORE IRE 5 S USER PROFILES Page for IRB Committee Member COMMITEE MEMBER Welcome t your Personal Folder the central resource for managing your Study applications Your Personal Folder provides all the tools you need in onder ta complete your rale in the Sudy My Roles application process Use the following guidelines to process your Studies When you are using you must tell the system which ROLE you Complete reviews for all tems in your inbox by clicking on the study name want 10 work in a Meetings for your committee are listed the Upcoming Meetings tab listing of prot rs located in the All submrsssons tat My Committees Upcoming Meetings Filter by 1D AE ted E ID nate Meditiod Type St Campus Study 100 nage 1 REMOMOT 1 12 24 Reparnable Event in Pewar Pll BTS OT at Trait WEI Vallai
32. her methods of dating as of narcolic MODIFICATION exposur in affecting neuromuscular development determine New Bala a To determine if the Mew Ballard Assessment ts comparatively higher than dating based on either last menstrual period or ultrasound dating in narcoltic exposed neonates bj To determina if neuromuscular score of Ballard Score comelates with time To withdrawal symptoms or length of treatment ime for withdrawal in marcotic amposed neonates E Forsch Che Pinar aaa thi Mad2013000216 Activibes TRO Previewer Holes Activity Author Date m Change Lag Page 1 3 Contact of interest Bain Jenner M 5 6 2013 153 EDT 7 On Page 1 3 Conflict af Interes Change Log Page 1 Study idantificaton 3 n Page 1 Study Identification Bain Jennifer Zi amp r2013 1735 EDT 20 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY MUTTER em oo Favortes 9 ooo BA ngs eda x Fet x Be hio ferns eIRB Sandbox j Deon Pert Jump t cw IRH Private change T Reviewer Notes Pewee Dr Sethe unde anm A 0H Change siki Dr oam eain aad He rmi ic rcd a Change complabed Ani Hiis BEd 138 ig Pee ces Dr Goran ID penannad
33. iate smart form page select Exit at the top of the page to return to the Study Workspace 14 UTGERS THE STATE UNIVERSITY OF NEW JERSEY Viewing Reviewer Notes RUTGERS IRB Committed My Hore Logol THE STATE UNIVERSITY Sandbox OF NEW FLARE STUDIES GE eno IRE Studies gt training Current State Siudyctra ning Pro2013003140 Hewark Pt Training Principal investigator IRB Admin Pungal C1 view Study Committee Blue Review Expedited dE Printer Version Type of Submission Research Protocoll Study Sponsor Department Funded If View Differences Co Inestigators Who Have Not Accepted Parbcipation Co Anvestigators Who Have Declined Participation There are aa items 19 display There are no items t display Activibirs A Display management assan checklist th Display PAR m Disptay Reviewer Noles ggf Lon Private Commen TN Atachments Stamped Documents Department Approval ReviewerNoles ChangeLog Commis MIT ss Activ N Advanced Reviewer Notes Reviews Change Log Futerby tye Type Date 7 Date Created Modified CL Committee Member Change Request IRB 8 7 2013 8 7 2013 Jump To 7 0 Study Summary Protocol Section 1 Committee 3 35 PM 3
34. ion listed under My Inbox gt RUTGERS m THE STATE UNIVERSITY Sandbox OF NEW JERSE IRB Committee Member My Home EIRB SANDBOX HOME IRB STUDIES USER PROFILES Page for IRB Committee Member Current Role Page for IRB Committee Member COMMITTEE MEMBER Welcome to your Personal Folder the central resource for managing your Study applications Your Personal Folder provides all the tools you need in order to complete your role in the Study My Roles application process Use the following guidelines to process your Studies When you are using elRB you must tell the system which ROLE you Complete reviews for all items in your inbox by clicking on the study name wantto work in Meetings for your committee are listed on the Upcoming Meetings tab Committee Member listing of prior reviews is located in the All submissions tab My Committees Upcoming Meetings Blue Green Filter by ID clear Advanced Red ID Name Date Modified State Campus Study K to3ot3P DI 100 page E Mod2013000216 Modification 2 for IRB Study 8 28 2013 4 36 2012001855 Modification In Newark The Validity of New Ballard Score for Gestational Age Assessment in Narcotic Review Exposed Neonates Kd Jt3o3 m 10 V Trusted sites f Qim E 21 RUTGERS THE STALE UNIVERSITY OF NEW JERSEY Viewing
35. nd answers presented to and answered by study staff Additionally any files uploaded into the form appear as clickable links within the printer friendly version You may print or close the printer friendly version by selecting the two buttons at the top of the page You may also save the page by selecting File then Save As in your internet browser E Print CROQ000515 2014 Pro2013003183 Windows Internet Explorer a3 nto Tensei vont AROMA BR IR osse abe T x me Totes 58 lage tor Arica Fry Gore 201 x Galery Desion D mb Pape War Toke Ge MES 7 E75 New Window TGERS m SAndDOox ti IFRSET Blog with Windows Live Date Thursday September 05 2013 12 07 43 PM Mew 1 0 Study Status ontinuing Review Final Report Siudy ILE Proz0 13003183 Study Name Test CV Print Close 10 of Report Continuing 2 0 Please mndicate which of the following applies to your shady Chack all that apply Hecords Text Size gt Specimens mn Encoding kieran intervenir Caret Browsing Properties IRB Researcher Training Recorda 5 View Source he tawang Infonmabon r5 3 read ont ew taken trem your cur
36. nt Fink of MEARE Independent Kivija Emergency Permission Emergency Permission Hurnanitaran Use Device HUD Humanitarian Use Device HUD Quality Assurance Quality Improvement Only Quality AssuranceQuality Improvement Only Westem IRB WIRB Western IRB WIRB Full af Project Research Tissue or Data bank Descnbe where the research issue OR dala bank is i Full Titia of Project Research Tissue or Data bank Describe where me research issue OR dataj bank Fs ptr sically located Institutian Deparment Building Floor Rom physically located institution Crepartrent Building Floor roam The Validity of Mew Ballard Score for Gestational Age Assessment in Harcolic Exposed Neonates The Validity of New Ballard Score for Gestalional Age Assessment in Harcotic Exposed Neonates Short Tithe Study Name Short Title Study The Validity of New Ballard Score for Gestasonal Age amp ssessmant in Marcotic Expased Neonates The Validity of New Ballard Score for Gestational Age Assessment in Harcotic Exposed Neonales Principal Invesbgator 7 Repository Administrator Principal investigator Repository Administrator Study Coordinator Contact Parson I Study Coordinator Contact Person The Study Identification page will always appear regardless of whether there are changes to that page You will be able to see at a glance the changes on each page in the upper ri
37. or b reviewed by the campus Executive IRB committee for sufficient expertise or c reviewed by a fully convened IRB committee 40 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Full Board Committee Actions or Requests Administratively Closed This is an administrative process by which a previously approved study has expired and the principal investigator has not submitted a Continuing Review application or a Final Closure indicating study completion Suspended The IRB determines that in the best interest of human subjects some or all aspects of the research must cease temporarily This may occur when a study is under investigation due to compliance issue s following a protocol deviation adverse event or unanticipated event involving risks to human subjects or others Request Changes Clarifications 1 Atthe time when the IRB reviews and approves a research study or proposed changes to a previously approved research study the IRB requests modification of the application at which time the investigator must either a provide clarifications to specific questions or 41 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY b submit requested changes to revised documents such that based on the assumption that these changes or clarifications are satisfactory the IRB is able to make all of the determinations required for approval No further action required The IRB Executive committee determines th
38. pens smart form applications and allows committee members to submit reviewer notes Your name Access Modify personal contact information This tab also allows you to change your password 23 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY IRB Determinations Guide Approved 1 The IRB determines that based upon all applicable federal regulations and a review of all submitted documents the research may proceed without any conditions An Approval notice will be issued at which time the research may be initiated or continued Approval with Conditions 1 At the time the IRB reviews and approves a research study the IRB requires that before research can be approved the investigator make changes specified in the action letter debriefing memo Examples Submission of the signed Financial Disclosure Form Completion of CITI Training Revised Research Protocol Clarification of information provided in the application Revised language to be incorporated into consent documents Conflict of Interest Determination Note Application is not approved at this stage Applicability For this level of re review the clarifications changes required are minor RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Approved with Stipulations L The IRB has approved the proposed research or changes as submitted with stipulations Stipulations mandated by the IRB may prohibit the investigator s from conducting or initiating
39. pocad Neonates E CROWDS 2014 Review for Pra2013003123 842013 Continuing In Newark Test be listed here if L Keven E O Review tnr Prot 20 144 HAT 4002 Continuing In Mewark Leapers Meemi amp sspssment applicable Pu Review 4 10 Select correct role Each role has own inbox You can always return to this view by selecting Home in the upper right hand corner Studies requiring your review will appear in Inbox There are four types of submissions e Submissions Pro e Continuing Reviews CR e Reportable Events RE e Modifications Mod Current State specifies where the study is in the RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Study Workspace Each type of submission new study continuing review study modification and reportable event will have its own Workspace 2014 Review for Pro2013003183 Windows Internet Explorer Oc 2 dbo rutgers edue IRB R ooms Displa PagesiLaycutin x Containerecom webridge entiby Entiby OID 945E46416D045D4A9A345EF amp FFAC2FD6 v E Live See hb pir Ple Edit Favorites Tals Help x E fib Select Favorkes Ssu T 3 2014 Review for Pro2013003183 Q Fc A CD ode Pages SHeys Tes Qe gt IRB Committee Member My Home Logoff TET RS ems STAT
40. py of an approved study where study staff has made actual changes to the IRB My Activities Displays the actions that you can perform at this point in a study Log Private Comment Allows you to add a comment or upload a document only viewable by IRB Staff and Committee Members My Committees Provides a quick link to the IRB committees you serve on My Home The default user page Always takes you back to your personal workspace page My Roles Shows your current role and lists multiples roles if applicable This section determines your access level and personal workspace Navigation Pane The location in every workspace which holds all available activities for the study 5G RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Printer Version Opens a page to view an entire document that displays all sections in its entirety and prints easily on most printers The printer version view contains clickable links to certain study documents which opens in a new window You cannot add reviewer notes to this version Reviewer Notes Lists notes left by the reviewer Reviews Lists assigned reviews for reviewer Stamped Documents This section lists all IRB stamped documents These PDF documents are watermarked with an IRB approval and expiration date User Profiles Lists personal profile and contact information for elRB members View Differences Opens a page to view and compare changes made to the original application View Study O
41. r M 5102013 1 53 PM EDT 1 3 Conflict af Interes Change Log Page Bain Jennies EAPO 1 35 EDT in Paga 1 Stud To see the changes to a study Click on the View Differences button located on the left navigation pane 25 RUTGERS THE STALE UNIVERSITY OF NEW JERSEY View Differences The View Differences page enables reviewers to easily compare changes made to a study Tithe Windows Internet Explorer oc hips nigar edu x Piset a 2 g BA No Tele X Rutgers 1 Pape Tes Committed Mamber Home Logol RUTGERS Currently Approved Pro2012001855 lumber of modifications on 1 Proposed Mod ifications umber of mo nis on this page Humber of madiftad page s 2 urrently Approved Pro2012001855 Proposed Modifications 1 0 Study Identification IKE Newark 1 0 Study kdentrfication IRB This is the first step in your Research You will be automatically guided io the appropriate forms needed to This ts the first step in your P oe H complete your submission complete your submission Hum ber of modificati onts an this 1 1 0 Select the type of submission for your project 10 Select the type Research Protocol Study Research Prf dre qo emer eim mere Number of modified page s 2 Faciitated Review of HCHCIRB Indepanda
42. review the same way you view the smart form pages with a new submission by selecting View Continuing Review RUTGERS THE STATE UNIVERSITY Sandbox OF NEW IRB My Home Logan RE STUDIES 1 amp Current State 1000515 Pro2013003183 Newark Ih REVIEW is enn Study Title Test CV view Continuing Review study submission type Research Protocol Stud Review Type Expedited printer triendly version Principal investigator framing Principal Imeesigator Medicine Robert Wood Johnson Medical School Study Coordinator Study Status Active Open to Enrollment Enrollment has begun Type of report Continuing Report Humber subjects enrolled do date 95 Are any changes to the research being proposed this time Notice view Continuing Review Related Reportable Events E Name Linkto Reportable state v n cw Printer Friendly version eae PR v Review Alacmens Stamped Documents Medications Reparable Events RedewerNales Changelog icy _ Com Aithor Dale Forward to Expedited Vega Clanbel 81472013 10 11 AM EDT Cominities Vega Clanbel 8142013 10 11 AM EDT 7 Assigned to Groen Re assign vega Claribel 8 14 2013 10 10
43. the Modification Workspace The Modification workspace is where study staff initiates the form that describes the proposed changes the Modification or Amendment Modification 2 for Study 01 2001 855 Windows Interna Explorer Go https qutger s edu x comert da g Modification 2 for TRE Study fProz012001855 RUTGERS eIRB Sandbox om o Pag Safety E IRB Committee bomber Home EIRE HOME IRB STUDE 5 RE Studies The Valid of Current State FA View Modification F Who Have Declined Pa BS wwemesewsue m There items to display UO idi T8 view Changes There are no items to display View Modification Print Friendly Modification E Activity Date 8 7 2013 3 13 EDT Selected IRE Committir d Etiudy 87 2043 3 12 PM EDT 3 Assigned to Glue E changes Submitted rinE Fri 552013 3 45 EDT 1 0 Changes Logged se Accepted Parlicipa amp an Ip 5 6 2013 3 42 EJ Hatifled Co Imestigalors 00 Agree 50612013 2 01 EDT a Please log into elRE and accept paricpation this study Thank yout Pi EM NM mcm SAR Aip eee v Trusted sites The Modification workspace contains the same Printer Version and header description as a new study You must Acknowledge or Defer the review to begin an
44. u oan PRR D lun of Teo tod s By Ipgging iraa Ihe study woAappor submi me Enpre MIE i RHEGED and KM iret Gilig Finish ip the ang easm ig tha workspace a Mae in Pw hah of pout ix Meg Aviles didi eben 12 bries in rh Katy MUH JES Cee rA EEG DH ro poe mune Tapy all pa meyin 12 bog hh erie cock on Agres qe 30 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY UTR T UD el ET RETI ee ty ee el o RPM TRISTIS L7 Los x 2 ae zz Siate View Stratlord Beard 1 E min Frendi Amendment 7 view study There are na fema to ER rerna 73 Changes Review Documents era Deseriebbon Than are no items to display submit Review Type Review Motion vi Review Complete Approved Appreved with Request Changes Request Clatications x WIRB Denied WIRE OK En Process a carato Pi 2 t82010 1147 AM PST BGO In the Modification Workspace submit your review by clicking on t
45. urrent Subjects are any subjects anroSed in the study Description of Changes m briefly Su mm arize the chan Yes We would like to add Joseph Schwab to our study team Exit Hidershow Errore Print Jump To Liediicatien Request Continue gt gt i hd fg gt hm 7 Click Exit to return to the Modification Workspace 23 RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Modified Study Workspace In the Modification workspace Click on View ee button to open the Modified Study workspace Medication 2 for Siudy Pred 2001855 Windows Internet Explorer go deme cce x ac en RB Modification 2 for IRE Study Pro2012001855 RUTGERS eIRB IAE STATE UNIVERSITY Sandbox JE Catei Member Home Loge a REL STUFE MEETS ML Validity of Mew Ballard Score for Gestational Age Acsusementin Harcebce Exposed Hepralgs Modificalien 2 IRB Siudy 0 1200 1255 iai 2 ine EUR Hf ro2012004855 Mod 201000218 Bievrark Thesaripiicin Wie would Bi add Or Joseph Solan lo our Study earn Study Tite The Validity of New Ballard Score tor Gestational age Assessment in Marcotic Exposed Neonates Principal Investigator Elmer D ayed Shady Coordinator eet nena Original Study ID Pro2012001855 Committee view Sandy Review Type Expedied Meaning
46. y Title Test CV Initial study submission type Research Protocol Study Review Type Expedited QS Prnterrrienaly version Principal Investigator Training Principal Investigator Medicine Robert Wood Johnson Medical School Study Coordinator Study Status Active Open to Enrollment Enrollment has begun Type of report Continuing Report My Activities Number subjects enrolled to date 95 Are any changes to the research being proposed at this time Notice Printer Friendly Version Related Reportable Events mill m Name Link to Reportable Event State gt GIS Hiv Ww no items to display Expedited Review Categories Reviewer Checklist Continuing Review Attachments Stamped Documents Modifications Reportable Events Reviewer Notes Change Log cm Submit Review Filter by Acivity v Clear Advanced Activity Author Activity Date firea Forward to Expedited Review Vega Claribel 8 14 2013 10 11 AM EDT firea Selected IRB Committee Vega Claribel 8 14 2013 10 11 AM EDT 7 Assigned to Green firea Re assign Owner Vega Claribel 8 14 2013 10 10 AM EDT 7 Assigned to Claribel Vega PI Submit Principal Investigator Training 8 14 2013 10 04 AM EDT Tov Craatad Continuing Raviow Princinal Invactinatar Trainina 2144 0042 41 11 ENT RUTGERS THE STATE UNIVERSITY OF NEW JERSEY Printer Version The printer friendly version allows reviewers to preview all questions a

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